Author Info for Knobbe Martens

Jessica Achtsam

Boston Scientific closes acquisition of TAVI device company, Symetis

On March 30, 2017, Boston Scientific announced an agreement to acquire Symetis SA, a privately-held Swiss company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices, for $435 million in cash… more

Acquisitions, Boston Scientific, Innovation, Medical Devices, Technology

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William Adams

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who… more

Amgen, Apotex, Appeals, Biologics, Biosimilars

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Janet Allendorph, Ph.D.

Federal Court Lacked Jurisdiction over Contract Dispute Implicating Patent Infringement

INSPIRED DEVELOPMENT GROUP v. INSPIRED PRODUCTS GROUP, LLC - Before Prost, Newman, and Stoll. Appeal from the United States District Court for the Southern District of Florida. Summary: Alleging that a contract issue… more

Appeals, Breach of Contract, Dismissals, Diversity Jurisdiction, Federal Question Jurisdiction

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Dan Altman

When and Where to File Patent Applications

Excerpt: "In general, a patent is only valid in the country (or, in some cases, countries) where the patent office that issued it has responsibility. With so many patent offices around the world, how does one decide in which… more

Canada, Canadian Intellectual Property Office (CIPO), Grace Period, Innovation, Intellectual Property Protection

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Jeremy Anapol

New Trial Granted Because “Nearly All” of the Defendant’s Noninfringement Evidence Was Untimely

The district court erred by admitting untimely expert testimony on noninfringement and by refusing to grant a new trial after the jury found noninfringement. Trudell Medical International (“Trudell”) sued D R Burton Healthcare… more

Appeals, Claim Construction, Daubert Standards, Discovery, Evidence

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Maria Anderson

Clarity and Progress at the USPTO: The USPTO Publishes Revised Guidance on Patent Eligible Subject Matter

On Monday, January 7, 2019, a revised guidance for subject matter eligibility (USPTO Section 101 Revised Guidance) will take effect at the USPTO. With the newly revised guidance, the USPTO aims to clarify and standardize the… more

Abstract Ideas, CLS Bank v Alice Corp, Judicial Exception, Mayo v. Prometheus, New Guidance

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Bailey Arenberg

Keeping PACE With CRISPR

AGILENT TECHNOLOGIES, INC. v. SYNTHEGO CORP. - Before Prost, Linn, and Reyna. Appeal from the Patent Trial and Appeal Board. Obviousness does not require all claimed limitations to be expressly disclosed in a primary prior art… more

Appeals, CAFC, Intellectual Property Litigation, Inter Partes Review (IPR) Proceeding, Life Sciences

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Kenneth Aruda, Ph.D.

Limits of Inherent Anticipation in Product-By-Process Claims

RESTEM, LLC v. JADI CELL, LLC - Before Moore, Schall, and Taranto. Appeal from the Patent Trial and Appeal Board. Inherency in product-by-process claims requires the prior art process to inevitably produce the claimed produce,… more

Appeals, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Trial and Appeal Board

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Charlene Azema

May I Still Call Her Daddy? IP Considerations for When Influencers Outgrow the Brands That Back Them

When they launched “Call Her Daddy” in 2018, Sofia Franklyn and Alexandra Cooper were relatively unknown. They were two New York City friends candidly dishing about dating and sex without any euphemisms on the internet. Barstool… more

Brand, Contract Negotiations, Contract Terms, Influencers, Instagram

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Jonathan Bachand

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on… more

Appeals, Enforcement Actions, Imports, Intellectual Property Litigation, Intellectual Property Protection

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Brian Barnes

Deleted Definition “Highly Significant” for Claim Construction

DDR HOLDINGS, LLC V. PRICELINE.COM LLC, BOOKING.COM B.V. - Before Chen, Mayer, and Cunningham. Appeal from the United States District Court for the Northern District of Delaware. Summary: Deleting a definition provided in… more

Appeals, Claim Construction, Patent Applications, Patent Infringement

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Derek Bayles

Protecting and Enforcing your High Technology Intellectual Property

In This Presentation: - Software Patents Issues in the USPTO - Functional Claiming in Software Patents - Covered Business Method (CBM) Review - Will the Supreme Court kill all software patents this term? -… more

Covered Business Method Patents, Patent Applications, Patent Reform, Patents, Technology

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Harper Beasley

Aerospace Update | July 2025

Space Technology Investments Clear the Launch Tower in 2025Tom Cowan Investments in space technology are off to a strong start in the first half of 2025. The rising trend over the last four years, as mentioned in a… more

Aerospace, Federal Funding, Government Agencies, Hydrogen Power, Innovation

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Vikas Bhargava

Settlement 5 Days Before Final Written Decision Deadline Results in Termination Of IPR

In an order issued in Petroleum Geo-Services Inc. v. Westerngeco LLC, IPR2016-00407, IPR2016-00499, Paper 29 (P.TA.B. Jul. 5, 2017), the PTAB terminated the proceedings after the parties indicated that they had settled their… more

Final Written Decisions, Inter Partes Review (IPR) Proceeding, Motion to Terminate, Patent Trial and Appeal Board, Patents

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Eric Blosser

Did They Want to Infringe? – Federal Circuit Denies Declaratory Judgment When Party at No Risk of Lawsuit

[MITEK SYSTEMS, INC., v. UNITED SERVICES AUTOMOBILE ASSOCIATION [OPINION]] - Before Taranto, Schall, and Chen. Appeal from the United States District Court for the Eastern District of Texas. The plaintiff could not seek… more

Appeals, CAFC, Declaratory Judgments, Indemnification, Intellectual Property Litigation

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Christian Boettcher

Women's Health Medical Device Company Caldera Medical Acquires UVision 360

Caldera Medical, Inc. on October 8th, 2024, announced the acquisition of UVision 360, Inc. Caldera Medical develops medical devices for women’s health, including surgical products for the treatment of stress urinary… more

Acquisitions, Health Technology, Medical Devices

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Yanna Bouris

Schrader Hit With $31 Million Patent Verdict Over Tire Pressure Sensors

A Delaware jury has awarded Wasica Finance over $31 million in patent damages against Schrader Int’l. In 2013, Wasica accused Schrader Int’l of infringing a patent entitled “Device for Monitoring and the Air-Pressure in… more

Damages, Inter Partes Review (IPR) Proceeding, Patent Infringement, Patent Litigation, Patent Trial and Appeal Board

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Jared Bunker

Insurance Coverage for Intellectual Property Lawsuits

In this episode of the Knobbe IP+ podcast, Knobbe Martens partner Jared Bunker speaks with guest David A. Gauntlett, principal of Gauntlett & Associates, on how businesses may use insurance policies to defend against… more

Commercial General Liability Policies, Commercial Insurance Policies, Defense Strategies, Insurance Industry, Intellectual Property Litigation

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Cheryl Burgess

Invalidating Patents Under §101 in the Early Stages of Litigation Still Possible Post-Berkheimer and Aatrix

Patent eligibility challenges under 35 U.S.C. §101 have been effective tools for defendants to obtain early dismissal of a case without extensive fact finding since the Supreme Court ruling in Alice. Whether a claim recites… more

Abstract Ideas, Appeals, CLS Bank v Alice Corp, Federal Rule 12(b)(6), Genuine Issue of Material Fact

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Ted Cannon

Federal Circuit Decision May Give Second Chance to Some PTAB Litigants

The Court of Appeals for the Federal Circuit (“Federal Circuit”) has issued an important decision affecting inter partes review (“IPR”) and possibly other cases decided by the Patent Trial and Appeal Board (“PTAB”). The… more

Administrative Patent Judges, Appeals, Appointments Clause, Constitutional Challenges, Ex Partes Reexamination

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Paige Cappelli

ARPA-H Announces New Funding related to AI-Enabled Medical Tools

The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability… more

Artificial Intelligence, Department of Health and Human Services (HHS), Machine Learning, Medical Devices

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Jeremy Carney

PTAB Finds Claims Directed to an MRI Machine Patent-Ineligible

The Patent Trial and Appeal Board (“PTAB”) recently held in Ex parte Itagaki and Nishiara (PTAB 2016) that claims reciting a magnetic resonance imaging apparatus are directed to ineligible subject matter under 35 U.S.C. § 101… more

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Spencer Carter

Objective Evidence in Determining Obviousness

MEDTRONIC, INC. v. TELEFLEX INNOVATIONS - Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective… more

Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Medical Devices, Medtronic, Obviousness

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Jason Champion

Copyright exhaustion in the US: what the Kirtsaeng and ReDigi decisions tell us about the future of the first sale doctrine and secondary markets for copyrighted goods

The concept of copyright ‘exhaustion’, or the ‘first sale’ doctrine, refers to the principle that once a copyright owner places a copyrighted item in the stream of commerce by selling it, they have exhausted their exclusive… more

Capitol Records, Copyright, Digital Goods, First Sale Doctrine, Grey Market

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Andrea Cheek

NCAA Rules Limiting Education-Related Benefits Violate Antitrust Laws

NATIONAL COLLEGIATE ATHLETIC ASSOCIATION v. ALSTON - Before the United States Supreme Court; Opinion by Justice Gorsuch; Concurring Opinion by Justice Kavanaugh; On writs of certiorari to the United States Court of Appeals for… more

Alston v NCAA, Antitrust Violations, College Athletes, NCAA, Restraint of Trade

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Bryant Chen

Federal Circuit Holds District Court Abused Its Discretion by Excluding an Authenticating Witness

JIAXING SUPER LIGHTING ELECTRIC APPLIANCE, CO. v. CH LIGHTING TECHNOLOGY CO., LTD. - Before Dyk, Chen, and Hughes. Appeal from the United States District Court for the Western District of Texas. The Federal Circuit reversed the… more

Abuse of Discretion, Appellate Courts, Damages, Evidence, Expert Testimony

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Rosaleen Chou

Ethical Brand Protection in the Age of Social Media: Fair Ball or Foul?

Presentation Goals - • WHAT - Build and maintain strong brand equity through proper trademark policing • HOW - Protect the brand via a custom enforcement strategy • CONSIDERATIONS - Promote ethical investigations in… more

Amazon, Attorney-Client Privilege, Cease and Desist, Corporate Branding, Corporate Counsel

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Michael Christensen

FTC’s Proposed Noncompete Ban in Doubt

On April 23, 2024, the United States Federal Trade Commission (“FTC”), via a 3-2 vote, issued a final rule, which, according to the FTC’s rule summary, provides a comprehensive ban on new noncompetes nationwide and bans existing… more

Federal Trade Commission (FTC), Final Rules, Healthcare, Non-Compete Agreements

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Brian Claassen

Federal Circuit Affirms Toshiba Win against NPE

On April 25, 2016, the Court of Appeals for the Federal Circuit affirmed the judgment of invalidity on two patents in favor of Knobbe Martens client Toshiba Corporation… more

Patent Infringement, Patent Invalidity, Patent Litigation, Patents, Toshiba

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Samuel Cockriel

IPR Proceedings Were Not Prohibited by a Forum Selection Clause in a Non-disclosure Agreement

KANNUU PTY LTD. v. SAMSUNG ELECTRONICS CO., LTD. Before Newman, Prost, and Chen. Appeal from the United States District Court for the Southern District of New York. Summary: The forum selection clause in the parties'… more

Breach of Contract, Forum Selection, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Non-Disclosure Agreement

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David Cohen

In Re Rembrandt Techs., LP Patent Litig.

Federal Circuit Summary - Before O’Malley, Mayer, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A case may be exceptional if: (1) fact witnesses are compensated based on the outcome… more

Abuse of Discretion, Appeals, Attorney's Fees, Exceptional Case, Frivolous Lawsuits

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Paul Conover

Patent Law Update for Medical Device Companies 2018 (Presentation)

Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session… more

Abstract Ideas, Administrative Procedure, America Invents Act, Biotechnology, Claim Amendments

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Adam Copeland

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions… more

Acquisitions, EU, FDA Approval, Health Technology, Healthcare

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Dalton Couch

No Takebacks: The High Bar for Departing From Patent Lexicography

ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. - Before Taranto, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Once the high threshold for lexicography is met, there must be a clear… more

Appeals, CAFC, Claim Construction, Intellectual Property Litigation, Life Sciences

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Tom Cowan

Aerospace Update | July 2025

Space Technology Investments Clear the Launch Tower in 2025Tom Cowan Investments in space technology are off to a strong start in the first half of 2025. The rising trend over the last four years, as mentioned in a… more

Aerospace, Federal Funding, Government Agencies, Hydrogen Power, Innovation

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Tyler Cox

IPR Standing Arguments Not Presented to the Board Are Forfeited

APPLE INC. v. GESTURE TECHNOLOGY PARTNERS, LLC - Before Moore, Prost, and Stoll. Appeal from the Patent Trial And Appeal Board. A patent owner forfeits its argument that an IPR petitioner lacks standing under 35 U.S.C… more

Administrative Procedure Act, Appeals, Appellate Courts, Intellectual Property Litigation, Inter Partes Review (IPR) Proceeding

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Douglas Crandell

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to… more

Clinical Trials, Federal Food Drug and Cosmetic Act (FFDCA), Food and Drug Administration (FDA), Life Sciences, Medical Research

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Scott Cromar

Why is Intellectual Property Important?

In This Presentation: - Intellectual Property (IP): •Refers to a category of exclusive rights created by statute, including: –Copyrights –Trademarks –Trade Secrets –Utility Patents –Design… more

Copyright, Design Patent, Patents, Trade Dress, Trade Secrets

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Carol Pitzel Cruz

The Supreme Court Holds that Non-Public Sales May Trigger the On Sale Bar Under the America Invents Act

On Tuesday, January 22, 2019, the U.S. Supreme Court held in a unanimous decision that, even where the details of the invention are kept confidential, a commercial sale may place the invention “on sale” under the Leahy-Smith… more

America Invents Act, Appeals, Assignment of Inventions, Confidentiality Agreements, Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc

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Justin Culbertson Ph.D.

End of an Era: The After Final Consideration Pilot Program 2.0 Concludes

The sun is officially setting on the United States Patent and Trademark Office’s (USPTO) After Final Consideration Pilot Program 2.0 (AFCP 2.0)[1]. This program, which has been instrumental in facilitating patent prosecution… more

Compliance, Fees, Patent Applications, Patent Prosecution, Patents

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Jane Dai, Ph.D.

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated value… more

Intellectual Property Protection, Life Sciences, Patents, Pharmaceutical Industry, Pharmaceutical Patents

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Aaron Davis

Clarity and Progress at the USPTO: The USPTO Publishes Revised Guidance on Patent Eligible Subject Matter

On Monday, January 7, 2019, a revised guidance for subject matter eligibility (USPTO Section 101 Revised Guidance) will take effect at the USPTO. With the newly revised guidance, the USPTO aims to clarify and standardize the… more

Abstract Ideas, CLS Bank v Alice Corp, Judicial Exception, Mayo v. Prometheus, New Guidance

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Alex Martin del Campo

Litigation Update | July 2025

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a… more

Appeals, Design Patent, Doctrine of Equivalents, Intellectual Property Litigation, Obviousness

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Jordan DeOrio

Specify the Steps of Information Manipulation or Lose under § 101

Before Lourie, Bryson, and Stark. Appeal from the United States District Court for the Central District of California. Summary: Patent claims that merely recite result-orientated, functional language without specifying the… more

Alice/Mayo, Appeals, Motion to Dismiss, Patent Infringement, Patent-Eligible Subject Matter

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Elizabeth "Lizzy" Do

A Launchpad for Startups in the Space Domain: Apollo Accelerator

In 2023, the U.S. Space Force launched the Space Domain Awareness (SDA) Tools, Application, & Processing (TAP) Lab. The SDA TAP Lab aims to accelerate the delivery of space battle management software to operational units… more

Department of Defense (DOD), Early Stage Companies, Innovation, Intellectual Property Protection, Mentors

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Geetha Durairaj, Ph.D.

CRISPR Dispute Heats Up With Recent Federal Court Decision

On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by the… more

Appeals, Biotechnology, CAFC, CRISPR, Life Sciences

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Lincoln Essig

[Webinar] Fair Use and Generative AI – What the Meta and Anthropic Cases Mean for Your Business - August 19th, 12:00 pm - 1:00 pm PT

Knobbe Martens attorneys Mark Lezama and Lincoln Essig, along with Sam Olive, Senior Director and Associate General Counsel, Intellectual Property at Cisco, will be hosting a webinar on Copyright and AI: Legal Risk After Meta… more

Artificial Intelligence, Audits, Continuing Legal Education, Copyright, Fair Use

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Cesar Estrada

Litigation Update | July 2025

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a… more

Appeals, Design Patent, Doctrine of Equivalents, Intellectual Property Litigation, Obviousness

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Jacob Etling

Inventive Concepts Must Be Included in the Claim Language

United Services Automobile Association v. PNC BANK N.A., - Before Dyk, Clevenger, and Hughes. Appeal from the United States District Court for the Eastern District of Texas. A claim that merely recites a system for conducting… more

Alice/Mayo, Banking Sector, Patent Infringement, Patent Litigation, Patents

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Ari Feinstein

Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor

On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely for… more

Amicus Briefs, Clinical Trials, En Banc Review, Food and Drug Administration (FDA), Hatch-Waxman

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Henry FitzGerald

Resolving Claim Construction Dispute at 12(b)(6) Stage May Be Error if Specification Indicates Claim Term Does Not Have its Plain Meaning

UTTO INC. v. METROTECH CORP. Before Prost, Taranto, and Hughes. Appeal from the United States District Court for the Northern District of California. Summary: The district court erred in construing the claims at the motion to… more

Appeals, Claim Construction, Motion to Dismiss, Patent Infringement, Patents

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Brian Flynn

Johnson & Johnson to Acquire Abbott Medical Optics

Johnson & Johnson recently announced an agreement to acquire Abbott Medical Optics for $4.325 billion. Abbot Medical Optics, a subsidiary of Abbot Laboratories, reported $1.1 billion in sales in 2015. According to the press… more

Acquisitions, Johnson & Johnson, Medical Devices, Popular

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Serah Friedman Ph.D.

Enforcing a Patent Known to be Invalid Can Trigger Attorneys’ Fees

ENERGY HEATING, LLC v. HEAT ON-THE-FLY, LLC - Before Moore, Prost, and Stoll. Appeal from the U.S. District Court for the District of North Dakota. Summary: Enforcing a patent with knowledge that it is invalid can… more

Appeals, Attorney's Fees, Bad Faith, Declaratory Judgments, Inequitable Conduct

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Michael Fuller

Renewed Efforts in Congress for Pharmaceutical Patent Reform

With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political… more

BPCIA, Hatch-Waxman, Healthcare Reform, Legislative Agendas, New Legislation

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Eric Furman, Ph.D.

Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans pay… more

Department of Health and Human Services (HHS), Drug Pricing, Executive Orders, Food and Drug Administration (FDA), Healthcare Reform

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Mariam Ghapantsyan

No Injury, No Appeal: Patent Owners Must Show Actual Injury for Article III Standing

DOLBY LABORATORIES LICENSING CORPORATION v. UNIFIED PATENTS, LLC - Before Moore, Clevenger and Chen. Appeal from the Patent Trial and Appeal Board. A patent owner lacks Article III standing to appeal an inter partes review… more

Appeals, Article III, Inter Partes Review (IPR) Proceeding, Judicial Authority, Patent Litigation

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Justin Gillett

Federal Circuit Holds District Court Abused Its Discretion by Excluding an Authenticating Witness

JIAXING SUPER LIGHTING ELECTRIC APPLIANCE, CO. v. CH LIGHTING TECHNOLOGY CO., LTD. - Before Dyk, Chen, and Hughes. Appeal from the United States District Court for the Western District of Texas. The Federal Circuit reversed the… more

Abuse of Discretion, Appellate Courts, Damages, Evidence, Expert Testimony

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Ian Gillies

One Name, Two Claims: Prince’s Estate and Apollonia Clash Over Trademark Rights

Bono, Madonna, Beyoncé, Rihanna, Eminem, Drake, Cher, Sting, Lorde, Flea, Adele, Bjork, Seal, Pink: these celebrities all share the same elite status of fame to be known by a single name. But the standalone celebrity name… more

Celebrities, Entertainment Industry, Lanham Act, Music Industry, Name and Likeness

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Brenden Gingrich, Ph.D.

The Intersection of FRAND Obligations and Anti-Suit Injunctions

TELEFONAKTIEBOLAGET LM ERICSSON v. LENOVO (UNITED STATES), INC. Before Lourie, Prost, and Reyna. Appeal from the Eastern District of North Carolina. Summary: The threshold requirement for anti-suit injunctions, that the… more

Anti-Suit Injunctions, ETSI, EU, FRAND, Good Faith

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T. Tyler Golian

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on… more

Appeals, Enforcement Actions, Imports, Intellectual Property Litigation, Intellectual Property Protection

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Jordan Gottdank

BrainsWay Deep TMS System Receives FDA Clearance for OCD Treatment

Israel-based BrainsWay recently announced the de novo FDA clearance of its Deep Transcranial Magnetic Stimulation (TMS) system for treatment of obsessive compulsive disorder (OCD)… more

FDA De Novo Clearance, Israel, Medical Devices

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Brian Graham

AIPLA Legislative Proposal to Overrule Recent §101 Caselaw

With the continuing uncertainties regarding application of the subject matter eligibility standard enumerated in 35 U.S.C. §101 by both courts and the U.S. Patent Office, organizations that have an interest in clarifying the law… more

AIPLA, CLS Bank v Alice Corp, Innovation, Intellectual Property Owner’s Association (IPO), Patent-Eligible Subject Matter

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Zachary Greenberg

Running in Place: When a Running Royalty Is Actually a Lump Sum License

ECOFACTOR, INC. V. GOOGLE LLC - Before the en banc court, Moore, Lourie, Dyk, Prost, Reyna, Taranto, Chen, Hughes, Stoll, and Stark. Appeal from the United States District Court for the Western District of Texas. A district… more

Appeals, Appellate Courts, Business Litigation, Contract Disputes, Damages

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Zachary Grinovich

An Alternative for Treating Mitral Regurgitation Receives Support for Ongoing Trial

Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t close… more

Clinical Trials, FDA Approval, Health Technology, Healthcare, Investment

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Mitch Hadley

Boston Scientific Announces Acquisition of Symetis for $435 Million

Boston Scientific Corporation recently announced an agreement to purchase Swiss medical device maker Symetis SA for $435 million in up-front cash. The acquisition is expected to close in the second quarter of 2017… more

Acquisitions, Boston Scientific, Medical Devices

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Anna Hankal

Relying on Irrelevant Factors to Award Attorneys’ Fees Is a Red Flag

Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Colorado. Summary: Awarding attorneys’ fees may be an abuse of discretion if the court relies on factors that should be given… more

Abuse of Discretion, Appeals, Attorney's Fees, Motion for Summary Judgment, Patent Infringement

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Julia Hanson

Sunkist Squeezes Out a Win and Kisses Kist Goodbye!

SUNKIST GROWERS, INC. v. INTRASTATE DISTRIBUTORS, INC. - Before Prost, Taranto, and Stark. Appeal from the Trademark Trial and Appeal Board. The TTAB incorrectly found that similar trademarks created distinct commercial… more

CAFC, DuPont Factors, Lanham Act, Likelihood of Confusion, Trademark Application

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Jeremiah Helm, Ph.D.

Deleted Specification Portions Undermine Claim Construction

FMC Corp. v. Sharda USA, LLC - Before Moore, Chen, and Barnett. Appeal from the Eastern District of Pennsylvania. The district court erred by construing a claim term based on disclosures made in a provisional application and an… more

Appeals, Appellate Courts, CAFC, Claim Construction, Patent Infringement

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Robert Hilton, Ph.D

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI® (ciltacabtagene… more

Clinical Trials, Drug Pricing, FDA Approval, Johnson & Johnson, Medical Research

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Luke Holbrook

Zoned Out: The Zone of Natural Expansion Doctrine Can Only Be Used Defensively

DOLLAR FINANCIAL GROUP, INC. v. BRITTEX FINANCIAL, INC. [OPINION] - Before Prost, Taranto, and Hughes. Appeal from the United States Patent and Trademark Office, Trademark Trial and Appeal Board. The zone of natural expansion… more

Appeals, Financial Services Industry, Intellectual Property Litigation, Lanham Act, Trademark Cancellation

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Catherine Holland

Suede Timbs on My Feet Make [Nas’s] Cipher Complete, but Timberland’s Section 2(f) Evidence Was Slacking and Acquired Distinctiveness Was Lacking

The TTAB has affirmed a refusal to register the trade dress configuration mark (see below) of the popular Timberland boot, a wardrobe staple in hip-hop culture (see The World is Yours by Nas), stating the configuration failed to… more

Acquired Distinctiveness, Fashion Industry, Trademark Act, Trademark Registration, Trademark Trial and Appeal Board

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Brian Horne

Schrader Hit With $31 Million Patent Verdict Over Tire Pressure Sensors

A Delaware jury has awarded Wasica Finance over $31 million in patent damages against Schrader Int’l. In 2013, Wasica accused Schrader Int’l of infringing a patent entitled “Device for Monitoring and the Air-Pressure in… more

Damages, Inter Partes Review (IPR) Proceeding, Patent Infringement, Patent Litigation, Patent Trial and Appeal Board

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Damien Howard

Visual Memory v. Nvidia – Configurability of memory system found to be a basis for patent-eligibility

The Federal Circuit recently decided a patent subject-matter eligibility case relating to computer memory in Visual Memory LLC v. Nvidia Corp. In a divided opinion, the Federal Circuit reversed the district court and held… more

Abstract Ideas, Appeals, Claim Construction, CLS Bank v Alice Corp, Computer-Related Inventions

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Curtis Huffmire

Patent Law Update for Medical Device Companies 2018 (Presentation)

Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session… more

Abstract Ideas, Administrative Procedure, America Invents Act, Biotechnology, Claim Amendments

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Daniel Hughes

A Published Patent Application Is IPR Prior Art as of Its Filing Date

Before Lourie, Prost, and Stark - Summary: In an IPR, a patent application is considered a “printed publication” as of the application’s filing date, not its publication date. Samsung filed a petition for IPR of a Lynk Labs… more

Filing Deadlines, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Obviousness, Patent Litigation

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Brandon Hupka

The Printed Matter Doctrine: Lost in Communication

Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: Claim limitations requiring communications to be “encrypted” or to deliver “program code” were not subject to the printed matter doctrine… more

Patent Litigation, Patent Trial and Appeal Board, Patents, Printed Matter Doctrine

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Jonathan Hyman

FDA and FTC Crack Down on Delta-8 THC Copycat Products

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing warnings… more

Advertising, Cannabidiol (CBD) oil, Cannabis Products, Cease and Desist Orders, Enforcement

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Bruce S. Itchkawitz, Ph.D.

Revenge of the Present Invention

Patentees suing alleged infringers have learned from a long history of federal district court and Federal Circuit rulings that (paraphrasing the Miranda warning given to criminal suspects) “anything you say [in the patent or… more

Inventions, Patent Applications, Patent Infringement, Patent Litigation, Patent-Eligible Subject Matter

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Kurt Jacobs

A Patent Does Not Guarantee the Patent Owner Will Be First to Market

INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary… more

Appeals, CAFC, FDA Approval, Generic Drugs, Injunctive Relief

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Susan Janicki, Ph.D.

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated value… more

Intellectual Property Protection, Life Sciences, Patents, Pharmaceutical Industry, Pharmaceutical Patents

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Jason Jardine

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market… more

Food and Drug Administration (FDA), Government Agencies, Healthcare, Life Sciences, Orphan Drugs

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Russell Jeide

2019 Eligibility Guidance Leads to Unpredictable Results at the PTAB

In January of 2019, the Patent Office, under Director Iancu, issued new guidance to all USPTO personnel evaluating patent subject matter eligibility under the requirements of 35 USC Section 101. The guidance sought to add… more

Abstract Ideas, New Guidance, Patent Applications, Patent Examinations, Patent Trial and Appeal Board

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Joe Jennings

Jury Verdict of Patent Infringement in Favor of iLife Against Nintendo Awarding $10 Million in Damages

Judgments and Awards - On August 31, 2017, a jury in the Northern District of Texas returned a verdict of patent infringement in favor iLife and against Nintendo. The case went to trial after the Federal Circuit on July 26,… more

Damages, Jury Verdicts, Nintendo, Patent Infringement, Patent Royalties

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Aaron Johnson

No Shortcuts to the “Reasonable Pertinence” Analysis in the Analogous Art Inquiry

DONNER TECHNOLOGY, LLC v. PRO STAGE GEAR, LLC - Before Prost, Dyk, and Hughes. Appeal from the Patent Trial and Appeal Board. Summary: A determination as to whether a reference is analogous art to a claimed invention… more

Analogous Art, Inter Partes Review (IPR) Proceeding, Inventors, Obviousness, Patent Litigation

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Agnes Juang, Ph.D.

FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries

On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive… more

China, Clinical Trials, Data Privacy, Executive Orders, Export Controls

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Mark Kachner

Not a Cowboy Claim Construction, University of Wyoming’s Patent Adequately Defined Claim Term

CHEVRON U.S.A. INC. v. UNIVERSITY OF WYOMING RESEARCH - Before Newman, Lourie, and Schall. Appeal from Patent Trial and Appeal Board. Summary: Intrinsic evidence is sufficient support for claim construction in an… more

Claim Construction, Claim Terms, Expert Testimony, Interference Proceeding, Intrinsic Evidence

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Daniel Kamkar

The Tangential Exception to Prosecution History Estoppel

ELI LILLY AND COMPANY v. HOSPIRA, INC. Before Lourie, Moore, and Taranto. Appeal from the District Court for the Southern District of Indiana. Summary: A narrowing claim amendment does not necessarily surrender all… more

Claim Amendments, Claim Limitations, Doctrine of Equivalents, Patent Applications, Patent Infringement

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Ben Katzenellenbogen

How to Pull Off the Great Balancing Act | Law Practice Today

Maintaining a healthy balance between work and personal life can be challenging in any career. With the demanding workflow that comes with being a lawyer finding a balance can often prove to be even more challenging. However,… more

Professional Development, Young Lawyers

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Lauren Keller Katzenellenbogen

Choosing the Right IP to Protect Fashion Goods

It’s hard to be a fashion innovator. It’s far easier to be an imitator. Success requires enormous investment in creating and marketing new designs, with no certainty that the designs will succeed. The imitator merely needs to… more

Copyright, Counterfeiting, Design Patent, Fashion Branding, Fashion Design

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Sameer Khan

Aerospace Update | July 2025

Space Technology Investments Clear the Launch Tower in 2025Tom Cowan Investments in space technology are off to a strong start in the first half of 2025. The rising trend over the last four years, as mentioned in a… more

Aerospace, Federal Funding, Government Agencies, Hydrogen Power, Innovation

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Daniel Kiang

An Examiner’s Allowance Does Not Create an “Especially Weighty” Presumption of Written-Description Support

MONDIS TECHNOLOGY LTD., HITACHI MAXELL, LTD., NKA MAXELL HOLDINGS, LTD., MAXELL, LTD. v. LG ELECTRONICS INC., LG ELECTRONICS USA, INC. - Before Taranto, Clevenger, and Hughes. Appeal from the United States District Court for… more

Appeals, CAFC, Patent Infringement, Patent Invalidity, Patent Litigation

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Nicole Kim

Skinny Labeling May Not Be Enough to Avoid Induced Infringement Allegations

Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Delaware. Summary: The totality of the complaint’s allegations must be considered when assessing whether induced patent… more

Food and Drug Administration (FDA), Infringement, Labeling, Patent Infringement, Pharmaceutical Patents

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Andrew Kimmel

FTC Settlement With Fertility-Tracking App May Have Costly Ramifications for Companies Who Use Third-Party Data Analytics Software

On January 13, 2021, the FTC announced that fertility app developer Flo Health, Inc. (“Flo”) agreed to a settlement over allegations that the company shared app users’ health information with third-party data analytics… more

Analytics, Consent Order, Data Privacy, Data Processors, Data-Sharing

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Brianne Kingery

A Published Patent Application Is IPR Prior Art as of Its Filing Date

Before Lourie, Prost, and Stark - Summary: In an IPR, a patent application is considered a “printed publication” as of the application’s filing date, not its publication date. Samsung filed a petition for IPR of a Lynk Labs… more

Filing Deadlines, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Obviousness, Patent Litigation

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Kregg Koch

NVIDIA Collaborates with Medtronic to Build AI Platform for Endoscopy Devices

NVIDIA announced in a press release a collaboration with Medtronic to integrate NVIDIA’s artificial intelligence (AI) technology into certain of Medtronic’s products. NVIDIA is a graphics processing unit (GPU) company, and… more

Artificial Intelligence, Medical Devices, NVIDIA, Popular, Software

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Dylan Kramer

Results of The Deferred Subject Matter Eligibility Response Pilot Program

On June 18, 2025, the United States Patent and Trademark Office (USPTO) hosted an informational call to share the results of a study on the Deferred Subject Matter Eligibility (DSMER) Pilot Program, three years after its launch… more

Government Agencies, Inventions, Patent Applications, Patent Examinations, Patent-Eligible Subject Matter

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Sashank Krothapally

The Votes Are In: Highly Descriptive Marks Are Difficult to Protect

HERITAGE ALLIANCE V. AMERICAN POLICY ROUNDTABLE - Before Prost, Taranto, and Stark. Appeal from the Trademark Trial and Appeal Board. Continuous-use evidence is not necessarily prima facie evidence of acquired distinctiveness… more

Appeals, Trademark Litigation, Trademark Registration, Trademark Trial and Appeal Board, Trademarks

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Lindsay Laddaran

Federal Circuit Has Jurisdiction to Review Joinder Decisions in IPRs

FACEBOOK, INC., V. WINDY CITY INNOVATIONS LLC Before Prost, Plager, and O’Malley. Appeal from the Patent Trial and Appeal Board. Summary: The Federal Circuit has jurisdiction to review challenges to the Board's joinder… more

Facebook, Inter Partes Review (IPR) Proceeding, Joinder, Jurisdiction, Patent Infringement

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Alan Laquer

The Supreme Court holds that a copyright claimant may not sue for infringement until the Copyright Office has granted or refused registration of the work at issue

On Monday, March 4, 2019, the U.S. Supreme Court held in a unanimous decision that, under § 411(a) of the Copyright Act, a claimant may not bring suit for copyright infringement until the Copyright Office has either granted or… more

Appeals, Copyright, Copyright Infringement, Copyright Litigation, Copyright Registration

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Stephen Larson

Gunn v. Minton: The Supreme Court's Correction of the Federal Circuit's Overly Broad Assertion of Jurisdiction Over State-Law Claims

For nearly two decades, the Federal Circuit has applied a lenient standard for federal jurisdiction that routinely sweeps state law claims into the exclusive jurisdiction of the federal courts merely because the claims require… more

Attorney Malpractice, Certiorari, Gunn v Minton, Jurisdiction, Patents

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Irfan Lateef

Federal Circuit Review | July 2025

In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of… more

CAFC, Doctrine of Equivalents, Inter Partes Review (IPR) Proceeding, Obviousness, On-Sale Bar

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Peter Law

Design Patent Protection for Fashion

On May 12, 2020, the United States Patent and Trademark Office issued over 700 new design patents. Fashion-related designs figured prominently among the new patent grants including accessories like eyeglasses (see U.S. Design… more

Design Patent, Fashion Branding, Fashion Design, Fashion Industry, Intellectual Property Protection

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Christy Lea

How New U.S. Tariffs Could Reshape Patent Litigation in the Medical Device Industry

As the U.S. imposes sweeping new tariffs on over 180 countries and territories—including a baseline 10% rate and steep increases for China (originally 145%, now reduced to 30% for 90 days) and Taiwan (32%, now reduced to 10% for… more

Contract Disputes, Intellectual Property Litigation, International Trade Commission (ITC), Medical Devices, Patent Infringement

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Jae Jin Lee

The Board Must Provide Reasoned Explanation When Discarding Material, Unrebutted Evidence

CQV CO., LTD. v. MERCK PATENT GMBH - Before Cunningham, Chen, and Mayer. Appeal from the Patent Trial and Appeal Board. The Board erred by failing to explain why it discarded material and unrebutted evidence that a reference… more

Appeals, Intellectual Property Litigation, Intellectual Property Protection, Obviousness, Patent Litigation

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Sabing Lee

Medical device innovations and IP: A strategy is everything.

Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens. The medical device industry is driven by innovation, where great ideas are developed into… more

Innovation, Intellectual Property Protection, Inventions, Medical Devices, Patents

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Christopher Lewis

Venture Capitalist Funding in Medtech Increasing

Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter of… more

Digital Health, Investment, Investment Opportunities, Life Sciences, Medical Devices

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Mark Lezama

[Webinar] Fair Use and Generative AI – What the Meta and Anthropic Cases Mean for Your Business - August 19th, 12:00 pm - 1:00 pm PT

Knobbe Martens attorneys Mark Lezama and Lincoln Essig, along with Sam Olive, Senior Director and Associate General Counsel, Intellectual Property at Cisco, will be hosting a webinar on Copyright and AI: Legal Risk After Meta… more

Artificial Intelligence, Audits, Continuing Legal Education, Copyright, Fair Use

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Chang Lim

Johnson & Johnson Acquires French Surgical Tech Firm Orthotaxy

On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery… more

Acquisitions, Johnson & Johnson, Medical Devices

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Kendall Loebbaka

Fireball Frenzy: When First Registering a Mark, Genericness of a Mark Is Determined at the Time of Registration

BULLSHINE DISTILLERY LLC v. SAZERAC BRANDS, LLC - Before Moore, Reyna and Taranto. Appeal from the Trademark Trial and Appeal Board. In assessing genericness, the TTAB considers how the mark was understood at the time of… more

Appeals, Generic Marks, Intellectual Property Litigation, Judicial Authority, Lanham Act

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Rory Lootsma

Zimmer Biomet to Acquire Paragon 28

Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28 at approximately $1.1… more

Acquisitions, Healthcare, Investors, Life Sciences, Manufacturers

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Raymond Lu

A Patent Must Describe What Is Claimed, Not What Infringes

Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment… more

Appellate Courts, Claim Construction, Intellectual Property Litigation, Intellectual Property Protection, Patent Infringement

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Nathanael Luman, Ph.D.

USPTO Proposes Phillips-Type Claim Construction For Post Grant Proceedings at the PTAB

The USPTO published a Notice of Proposed Rulemaking on May 9, 2018 seeking to change the claim construction standard for PTAB trials from the current broadest reasonable interpretation (BRI) to the claim construction standard… more

Broadest Reasonable Interpretation Standard, Claim Construction, Covered Business Method Proceedings, Inter Partes Review (IPR) Proceeding, International Trade Commission (ITC)

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Sarah Haj-Maharsi

Finding Common Ground? — Federal Circuit Clarifies IPR Estoppel

INGENICO INC. v. IOENGINE, LLC Before Dyk, Prost, and Hughes. Appeal from the United States District Court for the District of Delaware. IPR estoppel does not preclude reliance on public-use evidence that is substantively… more

Appeals, CAFC, Estoppel, Inter Partes Review (IPR) Proceeding, Obviousness

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Joseph Mallon

National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process

On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for Scientific… more

Bias, Grants, National Institute of Health (NIH), Peer Review, Research and Development

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Joshua Martineau

Where Method Claim Steps Are Connected by “And,” a Covered Method Must Perform Each Step

SIERRA WIRELESS, ULC V. SISVEL S.P.A. Before Moore, Schall, and Taranto. Appeal from the Patent Trial and Appeal Board. The Board erred by finding method-claim steps connected by “and” to be conditional and by never explaining… more

Appeals, Claim Construction, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Obviousness

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Christie Matthaei

Commissioner’s Exercise of Vacant Director’s Duties Does Not Violate Appointments Clause

ARTHREX, INC. v. SMITH & NEPHEW, INC. Before Moore, Reyna, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: During vacancies of Director and Deputy Director of the U.S. Patent and Trademark Office, the… more

Administrative Patent Judges, Appointments Clause, Arthrex Inc v Smith & Nephew Inc, Constitutional Challenges, Federal Vacancies Reform Act

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Hans Mayer

Potential Claim Construction Error Is Harmless When Not Relied Upon by the Board

BOT M8 LLC v. SONY INTERACTIVE ENTERTAINMENT LLC - Before Prost, Reyna, and Cunningham. Appeal from the Patent Trial and Appeal Board. Summary: A party challenging the Board’s decision by alleging claim construction… more

Claim Construction, Intellectual Property Protection, Patent Litigation, Patent Trial and Appeal Board, Patents

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Kathryn McCarthy

A Question for Everyone: Juries Must Determine Infringement on a Patent-By-Patent Basis

OPTIS CELLULAR TECHNOLOGY, LLC v. APPLE INC. - Before Prost, Reyna, and Stark. Appeal from the United States District Court for the Eastern District of Texas. Patent plaintiffs have a right to a unanimous verdict on each legal… more

Appeals, CAFC, Damages, Intellectual Property Litigation, Jury Trial

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Alistair McIntyre

No Shenanigans: IPRs and Interference Estoppel

IGT v. ZYNGA INC. - Before Prost, Reyna, and Taranto. Appeal from the Patent Trial and Appeal Board (PTAB). Interference estoppel does not apply when the interference was terminated due to a threshold issue… more

Inter Partes Review (IPR) Proceeding, Interference Proceeding, Obviousness, Patent Invalidity, Patent Litigation

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Katherine McMorrow

FTC Warns Trade Associations and Influencers of Not-So-Sweet Penalties for Failing to Sufficiently Disclose Sponsorship of Aspartame and Sugar Products

Social media and influencer marketing is now critical for business promotion. However, organizations and influencers that misrepresent, fail to disclose, or include inadequate disclosures regarding their sponsorship or… more

Advertising, Beverage Manufacturers, Disclosure Requirements, Endorsements, Federal Trade Commission (FTC)

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Bryan McWhorter

2019 Eligibility Guidance Leads to Unpredictable Results at the PTAB

In January of 2019, the Patent Office, under Director Iancu, issued new guidance to all USPTO personnel evaluating patent subject matter eligibility under the requirements of 35 USC Section 101. The guidance sought to add… more

Abstract Ideas, New Guidance, Patent Applications, Patent Examinations, Patent Trial and Appeal Board

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Jonathan Menkes

FDA and FTC Crack Down on Delta-8 THC Copycat Products

In a concerted effort to combat the illegal sale of delta-8 THC edibles packaged to look like popular snacks, the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have recently begun issuing warnings… more

Advertising, Cannabidiol (CBD) oil, Cannabis Products, Cease and Desist Orders, Enforcement

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Kimberly Miller, Ph.D.

The Supreme Court Holds that Non-Public Sales May Trigger the On Sale Bar Under the America Invents Act

On Tuesday, January 22, 2019, the U.S. Supreme Court held in a unanimous decision that, even where the details of the invention are kept confidential, a commercial sale may place the invention “on sale” under the Leahy-Smith… more

America Invents Act, Appeals, Assignment of Inventions, Confidentiality Agreements, Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc

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Phillip Minnick, Ph.D.

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market… more

Food and Drug Administration (FDA), Government Agencies, Healthcare, Life Sciences, Orphan Drugs

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Daniel Mittelstein

An Examiner’s Allowance Does Not Create an “Especially Weighty” Presumption of Written-Description Support

MONDIS TECHNOLOGY LTD., HITACHI MAXELL, LTD., NKA MAXELL HOLDINGS, LTD., MAXELL, LTD. v. LG ELECTRONICS INC., LG ELECTRONICS USA, INC. - Before Taranto, Clevenger, and Hughes. Appeal from the United States District Court for… more

Appeals, CAFC, Patent Infringement, Patent Invalidity, Patent Litigation

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Ashley Morales

A Request for Sanctions Before the ITC Is Not Appealable to the Federal Circuit

REALTEK SEMICONDUCTOR CORPORATION v. ITC - Before Reyna, Bryson, and Stoll. Appeal from the United States International Trade Commission. The Federal Circuit lacks jurisdiction to hear appeals of non-final determinations from… more

Administrative Procedure Act, Appeals, Enforcement Actions, International Trade Commission (ITC), Judicial Authority

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Sean Murray

Federal Circuit Year in Review 2024

Report summary -Knobbe Martens' inaugural Federal Circuit Year in Review report offers a comprehensive overview of the most significant Federal Circuit rulings of 2024 and how they could shape IP law in the years ahead. Covering… more

Copyright, Intellectual Property Litigation, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Obviousness

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Susan Natland

GDPR: Ready for the EU’s New Data Privacy Law? What You Need to Know

What is the GDPR? The European General Data Protection Regulation (GDPR) is a new law going into effect on May 25, 2018 that grants European residents broad, never-before-recognized data privacy rights, and imposes… more

Compliance, Corporate Fines, Data Breach, Data Collection, Data Privacy

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Philip Nelson

Recent Machine Learning Studies in Medical Imaging Applying FDA Principles

Medical imaging is one of the most promising fields for use of AI tools, as pattern recognition and large data sets can enhance human diagnosis (e.g., by radiologists) or even compete with them. A review of AI methodologies was… more

Algorithms, Artificial Intelligence, Food and Drug Administration (FDA), Machine Learning, Medical Devices

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Nefi Oliva

Litigation Update | July 2025

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a… more

Appeals, Design Patent, Doctrine of Equivalents, Intellectual Property Litigation, Obviousness

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Theodore Papagiannis

Newly Issued U.S. Patent for Knobbe Martens Client Pinnacle Spine Group, LLC

Knobbe Martens client Pinnacle Spine Group, LLC, a developer of innovative spinal fusion systems, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,216,096 titled Intervertebral Implants and… more

FDA Approval, Medical Devices, Patents, USPTO

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Hyunjin Park

Performing Claimed Features Faster Than Humans by Using Generic Computers Is Not Sufficient as an Improvement to Computer Technology

Trinity Info Media, L.L.C. v. Covalent INC. Before STOLL, BRYSON, and CUNNINGHAM. Appeal from the United States District Court for the Central District of California. Summary: Patents directed to connecting users based… more

Abstract Ideas, Intellectual Property Protection, Patent Infringement, Patent Litigation, Patents

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Raina Patel

Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval

The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver… more

Food and Drug Administration (FDA), Medical Devices, Mesothelioma

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Jamal Perry

Consider the Relevant Technology Carefully Before Claiming Ranges in Patent Applications

RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A - Before Chen, Stoll, and Cunningham. Appeal from the Patent Trial and Appeal Board… more

Intellectual Property Protection, Patent Applications, Patent Litigation, Patent Trial and Appeal Board, Patents

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Isabella Pestana

Jepson Claim Preamble Requires Written Description Support for Conventional Aspects of the Invention

IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation). Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim, the… more

Appeals, Biotechnology, Claim Construction, Life Sciences, Patent Litigation

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Matthew Petersen

Deleted Specification Portions Undermine Claim Construction

FMC Corp. v. Sharda USA, LLC - Before Moore, Chen, and Barnett. Appeal from the Eastern District of Pennsylvania. The district court erred by construing a claim term based on disclosures made in a provisional application and an… more

Appeals, Appellate Courts, CAFC, Claim Construction, Patent Infringement

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Wendy Peterson

Music Licensing Basics: How to Legally Use Someone’s Music in Your Business

Introduction - •Music copyrights: –Musical works – sheet music and lyrics •Author is generally composer/lyricist and controls •Can be administered through a music publisher -… more

ASCAP, BMI, Copyright, Fair Use, IP License

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Gregory Phillips

A Discussion With Amazon Counterfeit Crimes Unit’s Joe Wheatley: How Amazon Finds Bad Actors and Removes Counterfeit Products

In this inaugural episode of the Knobbe IP+ podcast, Knobbe Martens partner Greg Phillips speaks with Joe Wheatley, Senior Counsel, Amazon Counterfeit Crimes Unit, about how the Counterfeit Crimes Unit searches the Amazon… more

Amazon Marketplace, Corporate Branding, Counterfeit Goods Regulation, Counterfeiting, E-Commerce

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Arash Pia

The Patent Trial and Appeal Board Has Jurisdiction Over IPRs Challenging Expired Patents

Before Lourie, Dyk, and Hughes. Appeals from the United States Patent and Trademark Office. Summary: The Patent Trial and Appeal Board has jurisdiction over IPRs concerning expired patents because the review of such patents… more

Appeals, Apple, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Jurisdiction

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Adam Powell

To Limit or Not to Limit: What Is the Basis of Your Prior Art Distinction During Prosecution?

VECTURA LIMITED v. GLAXOSMITHKLINE LLC - Before Prost, Bryson, and Wallach. Appeal from the United States District Court for the District of Delaware Summary: Distinguishing prior art based on the structure of the… more

Appeals, Claim Construction, Patent Infringement, Patent Litigation, Patents

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Susan Pratt, Ph.D.

Domestic Marketing and Distribution of an Imported Product May Satisfy the Economic Prong of the Domestic-Industry Requirement

LASHIFY, INC. V. ITC - Before Prost, Taranto, and Chen. Appeal from the U.S. International Trade Commission. Warehousing, quality control, distribution, sales, and marketing expenses incurred in connection with an imported… more

Domestic Industry Requirement, Imports, Intellectual Property Protection, International Trade Commission (ITC), Patent Infringement

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James Raleigh

An Obvious Solution to an Unknown Problem?

IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in… more

Indefiniteness, Intellectual Property Litigation, Life Sciences, Obviousness, Patent Infringement

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Rhett Ramsey

No Tariffs on Aerospace Products Traded Between U.S. and European Union

On July 27, 2025, the US and EU reached a trade agreement. As part of the agreement, the US will impose a 15 percent tariff “on the vast majority of EU exports. ” President Trump signed an Executive Order on July 31 providing… more

Aerospace, Aircraft, Aircraft Equipment, Airlines, EU

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Joseph Re

This Year’s Top Ten IP Cases

#10 Design Patent Damages § 289 - Samsung Elecs. Co., v. Apple Inc., 580 U.S. _ (Dec. 6, 2016) - In the case of a multicomponent product, the relevant article of manufacture for arriving at a damages award under… more

Apple v Samsung, Article of Manufacture, Broadest Reasonable Interpretation Standard, Calculation of Damages, Commercial Offer for Sale

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Nathan Reeves

Litigation Update | July 2025

JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a… more

Appeals, Design Patent, Doctrine of Equivalents, Intellectual Property Litigation, Obviousness

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Joseph Reisman, Ph.D.

Teva v. Amneal Oral Arguments and Claim Construction Order: Recent Developments in the Ongoing Debate Over the Orange Book Listing of Device Patents

As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal… more

Abbreviated New Drug Application (ANDA), Claim Construction, Federal Trade Commission (FTC), Food and Drug Administration (FDA), Hatch-Waxman

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Morgan Robertson

Exhibit Combustion: Disavowing Contradictory Statements Contained in Complaint Exhibits

HEALTHIER CHOICES MANAGEMENT CORP. V. PHILIP MORRIS USA, INC. Before Taranto, Stoll, and Cunningham. Appeal from the United States District Court for the Northern District of Georgia. Summary: A plaintiff can… more

Intellectual Property Protection, Patent Infringement, Patent Litigation, Patents

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Jacob Rosenbaum

Can § 101 Carry the Weight?

POWERBLOCK HOLDING, INC. v. IFIT, INC. - Before Taranto, Stoll, and District Judge Scarsi. Appeal from the United States District Court for the District of Utah. Under step one of the Alice test, claims should be considered in… more

Abstract Ideas, Alice/Mayo, Appeals, CAFC, Patent Infringement

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Marissa Rosenbaum

What’s Enough to Show Information Is “Trade Secret” for Filing Under Seal?

DEPUY SYNTHES PRODUCTS, INC. v. VETERINARY ORTHOPEDIC IMPLANT, INC. Before Prost, Clevenger, and Dyk. Appeal from the Middle District of Florida. Summary: Internal efforts to maintain confidentiality are not enough to… more

Amended Complaints, Confidentiality Agreements, Patent Infringement, Patent Litigation, Patents

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Oren Rosenberg

China Responds to European Union’s Medical Device Restrictions With Restrictions of Its Own

China has imposed restrictions on procurement of European medical devices, following the European Union’s vote to limit Chinese companies from participating in public procurement tenders for medical device contracts last… more

China, EU, European Commission, Foreign Policy, International Trade

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Mark Rubinshtein

Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor

Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023. In this context many companies have pursued products to help diagnose or sense heart activity. In the last few… more

Artificial Intelligence, Digital Health, FDA Approval, Healthcare, Innovative Technology

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Zachery Rufa

Equitable Estoppel: Misleading Silence Not Enough Unless It Was Relied on and Caused Prejudice

FRAUNHOFER-GESELLSCHAFT v. SIRIUS XM RADIO INC. - Before Lourie, Dyk, and Reyna. Appeal from the United States District Court for the District of Delaware. The defense of equitable estoppel requires showing that the patentee… more

Appeals, CAFC, Equitable Estoppel, Patent Infringement, Patent Litigation

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Matthew Ruth

UK Proposes Approving Medical Devices Based on Approval in Other Countries

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published… more

Australia, Canada, EU, Food and Drug Administration (FDA), Labeling

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Michael Salamy

Reissue Applications Are Bound by the Scope of the Claims as Written, Not as Intended

IN RE KOSTIC - Before Stoll, Clevenger, and Cunningham. Appeal from the Patent Trial and Appeal Board. When considering whether a reissue claim broadens the scope of the original patent, the PTAB determines the actual scope of… more

Appeals, CAFC, Claim Construction, Intellectual Property Litigation, Inventors

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Ed Schlatter

Knobbe Martens Client STAR Envirotech Wins Affirmance of IPR Decision Finding Patent Valid

On December 31, 2015, the U.S. Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision that a STAR Envirotech patent relating to its evaporative emission testing tools is valid and not… more

Automotive Industry, Inter Partes Review (IPR) Proceeding, Obviousness, Patent Trial and Appeal Board, Patent Validity

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David Schmidt, Ph.D.

PTAB Applies Collateral Estoppel to Exclude Purported Patent Owner

The PTAB issued an order applying collateral estoppel to determine that one purported owner of U.S. Patent 7,215,752 and U.S. Patent 7,844,041 (the “challenged patents”) had no authority to act as the patent owner in Microsoft… more

Collateral Estoppel, Dismissal With Prejudice, Expungement, Inter Partes Review (IPR) Proceeding, IP Assignment Agreements

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Melanie Seelig

The Defend Trade Secrets Act: What You Should Do Now

On May 11, 2016, President Obama signed the Defend Trade Secrets Act (DTSA) into law. The DTSA is an expansion of the Economic Espionage Act of 1996 and generally authorizes a civil action in federal court for the… more

Anti-Retaliation Provisions, Defend Trade Secrets Act (DTSA), Employment Contract, Immunity, Misappropriation

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Jessica Sganga

“All of the Lights” on Yeezy as Walmart Opposes Yeezy’s Trademark Application

In April 2021, big-box retailer Walmart Apollo, LLC (“Walmart”) filed a trademark opposition against Yeezy LLC’s (“Yeezy”) U.S. Trademark Application Serial No. 88/746444 for its sun rays design mark, shown below (“Yeezy’s… more

Fashion Design, Fashion Industry, Intellectual Property Protection, Kanye West, Trademarks

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Ben Shiroma

Federal Circuit Instructs PTAB How to Apply Public Accessibility Standard

WEBER, INC. v. PROVISUR TECHNOLOGIES, INC. - Before Reyna, Hughes, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: Copyright notices in product manuals, which prohibited their reproduction and… more

Copyright, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding, Patent Infringement, Patent Litigation

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Harnik Shukla

Results of The Deferred Subject Matter Eligibility Response Pilot Program

On June 18, 2025, the United States Patent and Trademark Office (USPTO) hosted an informational call to share the results of a study on the Deferred Subject Matter Eligibility (DSMER) Pilot Program, three years after its launch… more

Government Agencies, Inventions, Patent Applications, Patent Examinations, Patent-Eligible Subject Matter

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Charles Sirek

Pulling the Cord on Unstated Claims Limitations

IQRIS TECHNOLOGIES LLC v. POINT BLANK ENTERPRISES, INC. Before Lourie, Linn, and Stoll. Appeal from the United States District Court for the Southern District of Florida - The district court erred in construing the term “pull… more

Appeals, Appellate Courts, Claim Terms, Intellectual Property Litigation, Patent Infringement

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Joshua Stowell

Federal Circuit Upholds $112 Million Win for Knobbe Martens Client CardiAQ

On September 1, the U.S. Court of Appeals for the Federal Circuit affirmed a $112 million win for Knobbe Martens client CardiAQ in its trade secret misappropriation case against former service provider Neovasc. A three-judge… more

Breach of Contract, Damages, Duty of Honest Performance, Enhanced Damages, Life Sciences

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Craig Summers

Nike's Shoe Patents Outrun Puma's Challenge

On May 3, 2018, Nike filed a lawsuit against Puma in the U.S. District Court for the District of Massachusetts accusing Puma of infringing seven of its utility patents related to footwear. In an earlier post on this blog, we… more

Abstract Ideas, Affirmative Defenses, CLS Bank v Alice Corp, Fashion Design, Federal Rule 12(b)(6)

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Ningxi Sun

Raft Acquires N3bula Systems

On June 17, 2025, Raft announced its acquisition of N3bula Systems. Raft is a defense technology company that specializes in delivering autonomous data fusion, AI/ML, and data solutions tailored for U.S. military and government… more

Acquisitions, Artificial Intelligence, Automation Systems, Defense Sector, Department of Defense (DOD)

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Sheila Swaroop

Federal Circuit’s Lashify Decision Expands “Domestic Industry” at the International Trade Commission

Lashify, Inc. v. International Trade Commission Before: Prost, Taranto, and Chen. Appeal from ITC Investigation. The Federal Circuit expands the economic prong of the domestic-industry analysis to include domestic spending on… more

Appeals, Enforcement Actions, Imports, Intellectual Property Litigation, Intellectual Property Protection

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Jason Swartz

U.S. Design “Rocket Docket” Grounded

The U.S. Patent Office’s program for expedited examination of design applications under 37 CFR 1.155 (often called the design “rocket docket”), which was suspended earlier this year, was formally canceled in an amended federal… more

Accelerated Examination Program, Design Patent, Filing Fees, Final Rules, MPEP

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Nickolas Taylor

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent… more

Abbreviated New Drug Application (ANDA), Appeals, CAFC, Claim Construction, Generic Drugs

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Vlad Teplitskiy

When and Where to File Patent Applications

Excerpt: "In general, a patent is only valid in the country (or, in some cases, countries) where the patent office that issued it has responsibility. With so many patent offices around the world, how does one decide in which… more

Canada, Canadian Intellectual Property Office (CIPO), Grace Period, Innovation, Intellectual Property Protection

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Justin Theam

Can § 101 Carry the Weight?

POWERBLOCK HOLDING, INC. v. IFIT, INC. - Before Taranto, Stoll, and District Judge Scarsi. Appeal from the United States District Court for the District of Utah. Under step one of the Alice test, claims should be considered in… more

Abstract Ideas, Alice/Mayo, Appeals, CAFC, Patent Infringement

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Melis Tirhi

Tying Claimed Technological Advancements to Specific Technological Methods Is a Winning POV on Patent Eligibility

Before Reyna, Prost, and Schall. Appeal from the United States District Court for the Northern District of California. Summary: Claims are patent-eligible under 35 U.S.C. § 101 where the written description discloses improving… more

Alice/Mayo, Patent-Eligible Subject Matter, Patents, Prior Art, Summary Judgment

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Savannah Torborg

Fireball Frenzy: When First Registering a Mark, Genericness of a Mark Is Determined at the Time of Registration

BULLSHINE DISTILLERY LLC v. SAZERAC BRANDS, LLC - Before Moore, Reyna and Taranto. Appeal from the Trademark Trial and Appeal Board. In assessing genericness, the TTAB considers how the mark was understood at the time of… more

Appeals, Generic Marks, Intellectual Property Litigation, Judicial Authority, Lanham Act

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Alexander Trimes

Commissioner’s Exercise of Vacant Director’s Duties Does Not Violate Appointments Clause

ARTHREX, INC. v. SMITH & NEPHEW, INC. Before Moore, Reyna, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: During vacancies of Director and Deputy Director of the U.S. Patent and Trademark Office, the… more

Administrative Patent Judges, Appointments Clause, Arthrex Inc v Smith & Nephew Inc, Constitutional Challenges, Federal Vacancies Reform Act

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Makoto Tsunozaki Ph.D.

FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries

On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation of Americans’ sensitive… more

China, Clinical Trials, Data Privacy, Executive Orders, Export Controls

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Terry Tullis

Design Patents Update

In This Presentation: - Part I: Design Patent Overview ...Apple v. Samsung ...What is a Design Patent? ...Differences Between Utility and Design Patents ...Ins and Outs of the Specification ...Benefits &… more

Apple v Samsung, Attorney's Fees, Design Patent, Patent Infringement, Patent Litigation

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Mauricio Uribe

Using Technology and Empowering Communities to Mitigate Wildfire Risk – The Story of FlameMapper

In the latest episode of the Knobbe IP+ podcast, Knobbe Martens partner Mauricio Uribe speaks with Shea Broussard, Oliver Curtis, and Jim Kniss, the team behind FlameMapper, an AI-based solution for mitigating wildfire risk… more

Artificial Intelligence, Climate Change, Environmental Policies, Innovative Technology, Intellectual Property Protection

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Jeff Van Hoosear

Of Broccolini and Branding: Don't Let Your Trademark Wilt

Congratulations on successfully trademarking your product or brand! Now it’s crucial to protect that investment through diligent trademark oversight and enforcement. This involves actively monitoring for, and taking appropriate… more

Brand, Cease and Desist, Dilution, Enforcement, Goods or Services

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Gerard Von Hoffmann

Newly Issued U.S. Patent for Knobbe Martens Client Pinnacle Spine Group, LLC

Knobbe Martens client Pinnacle Spine Group, LLC, a developer of innovative spinal fusion systems, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,216,096 titled Intervertebral Implants and… more

FDA Approval, Medical Devices, Patents, USPTO

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Sabrina Wang

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation… more

510(k) RTA, Biotechnology, FDA Approval, Medical Devices

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Kelsey Weinman

Inaction Can Lead To Argument Forfeiture on Appeal

ALIVECOR, INC. v. APPLE INC. Before Hughes, Linn, and Stark. Appeal from Patent Trial and Appeal Board - A party in a PTAB proceeding forfeits the ability to challenge an opposing party’s discovery obligation violation through… more

Administrative Law Judge (ALJ), Appeals, Disclosure Requirements, Discovery, Evidence

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Douglas Wentzel

Sunkist Squeezes Out a Win and Kisses Kist Goodbye!

SUNKIST GROWERS, INC. v. INTRASTATE DISTRIBUTORS, INC. - Before Prost, Taranto, and Stark. Appeal from the Trademark Trial and Appeal Board. The TTAB incorrectly found that similar trademarks created distinct commercial… more

CAFC, DuPont Factors, Lanham Act, Likelihood of Confusion, Trademark Application

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Matthew Whitehead

Application of Safe Harbor Exceptions to the Anti-kickback Statute

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical device… more

Anti-Kickback Statute, Government Agencies, Health Care Providers, Healthcare Fraud, Investors

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Wentao Wu

Proposed FAA Rule to Allow Drone Operations Beyond Visual Line of Sight

The Federal Aviation Administration (FAA) and Transportation Security Administration (TSA) on August 7, 2025, issued a notice of proposed rulemaking (NPRM) related to “drones.” The notice proposes regulations to enable… more

Aviation Industry, Beyond Visual Line Of Sight (BVLOS), Comment Period, Drones, Federal Aviation Administration (FAA)

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Daniel Yarbrough, Ph.D.

Microbiome Regulation Emerges From the Shadows: FDA to Co-Host Workshop on Live Cell Therapeutics

Research supporting the role of the microbiome in human, animal, and plant health continues to grow at a staggering rate. While the wave of new health technologies emerging from this research rises, companies working in the… more

Clinical Trials, Food and Drug Administration (FDA), Intellectual Property Protection, Life Sciences, Medical Research

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Lynda Zadra-Symes

Bulk-Filed Patent Applications Claiming Distant Priority Trigger Prosecution Laches

HYATT v. HIRSHFELD - Before Reyna, Wallach, and Hughes. Appeal from the United States District Court for the District of Columbia. Summary: The PTO met its burden to prove prosecution laches for bulk-filed patent… more

35 U.S.C. § 145, Board of Patent Appeals, Laches, Patent Applications, Patent Examinations

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Sophia Zahn

Medtech Leaders Speak Out On Impact of Global Tariffs

Some Medtech companies recently addressed the potential impact of global tariffs in their Q1 2025 earnings calls. Johnson & Johnson and Abbott were among the first to speak on the implications of these tariffs and how their… more

China, International Trade, Johnson & Johnson, Medical Devices, Pharmaceutical Industry

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Alexander Zeng

Recent Developments in Medical Casts

On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device seeks to… more

3D Printing, Healthcare, Intellectual Property Protection, Inventions, Life Sciences

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Baiyu Zhu

No Error: The Board Committed No Procedural Error by Relying on Evidence Outside of the Prior Art Reference

SAGE PRODUCTS, LLC v. STEWART [OPINION] - Before Reyna, Cunningham, and Stark. Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board. The Board did not abuse its discretion by relying on… more

Appeals, Claim Construction, Expert Testimony, Intellectual Property Litigation, Inter Partes Review (IPR) Proceeding

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William Zimmerman

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who… more

Amgen, Apotex, Appeals, Biologics, Biosimilars

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Marko Zoretic

Intellectual Property Protection Strategies for Successful Business in the US and Canada

Imagine that you are a founder of a revolutionary technology startup in Canada. Your company is about to release its blockbuster product that will disrupt the entire industry and catapult your company to fame and fortune. Your… more

Berne Convention, Canada, Copyright, Cross-Border Transactions, Intellectual Property Protection

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Nicholas Zovko

No Tariffs on Aerospace Products Traded Between U.S. and European Union

On July 27, 2025, the US and EU reached a trade agreement. As part of the agreement, the US will impose a 15 percent tariff “on the vast majority of EU exports. ” President Trump signed an Executive Order on July 31 providing… more

Aerospace, Aircraft, Aircraft Equipment, Airlines, EU

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