Sterne, Kessler, Goldstein & Fox P.L.L.C.

Section 337 Now Viable for “Mere Importers” After Federal Circuit’s Lashify Decision

For years, the U.S. International Trade Commission maintained that the potent remedies available under Section 337 were unavailable to intellectual property owners considered to be nothing more than “mere importers.” That…more

Appeals, Domestic Industry Requirement, Enforcement Actions, Foreign Manufacturers, Importers

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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The Interface Between District Court Litigation and Contested Office Proceedings under the AIA: Motions to Stay

What is the standard for deciding a motion to stay in view of a contested office proceeding? Courts typically consider: (1) whether a stay will unduly prejudice or present a clear tactical disadvantage to the nonmoving…more

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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Ingenico: Federal Circuit Narrows the Scope of IPR Estoppel Under § 315(e)(2)

On May 7, 2025, the Federal Circuit issued a precedential decision in Ingenico Inc. v. IOENGINE, LLC that narrows the scope of inter partes review (IPR) estoppel under 35 U.S.C. § 315(e)(2), resolving a longstanding district…more

§315(e), Appeals, CAFC, Estoppel, Inter Partes Review (IPR) Proceeding

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Ingenico: Federal Circuit Narrows the Scope of IPR Estoppel Under § 315(e)(2)

On May 7, 2025, the Federal Circuit issued a precedential decision in Ingenico Inc. v. IOENGINE, LLC that narrows the scope of inter partes review (IPR) estoppel under 35 U.S.C. § 315(e)(2), resolving a longstanding district…more

§315(e), Appeals, CAFC, Estoppel, Inter Partes Review (IPR) Proceeding

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MarkIt to Market® - June 2019: Blockchain-Based Names: New Frontier for Brands (and Squatters)

Blockchain technology has garnered attention from various sectors over the past ten years, much of it due to the rise of Bitcoin and other cryptocurrencies. Cryptocurrencies have gained popularity and notoriety for their…more

Authentication, Blockchain, Brand, Counterfeiting, Cryptocurrency

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2021 PTAB Year in Review: Analysis & Trends: The Resurgence and Perils of Ex Parte Reexaminations

Ex parte reexaminations have re-emerged as an increasingly important component of patent litigation and licensing negotiations. With the passage of the America Invents Act (“AIA”) and the advent of inter partes reviews (“IPRs”)…more

America Invents Act, Estoppel, Ex Partes Reexamination, Patent Infringement, Patent Invalidity

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PTAB Spotlight Series with Daniel Block

In our PTAB Spotlight Series, attorneys will share their valuable insights on PTAB practice today, the challenges and opportunities clients face, and the trends practitioners should follow…more

Ex Partes Reexamination, Final Written Decisions, Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Trial and Appeal Board

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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or…more

Artificial Intelligence, Biologics, Data Management, Draft Guidance, Filing Requirements

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PTAB Year in Review – Caveat Experimenter: Using Experimental Data in PTAB Proceedings Comes With Risks

Parties involved in Patent Trial and Appeal Board (PTAB) proceedings sometimes contemplate submitting experimental data to support their positions. Although such data can be useful, there also are risks. Several recent cases…more

America Invents Act, Claim Construction, Discovery, Duty of Candor, Evidence

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Patent Prosecution Tool Kit: Patent Term Extension

Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product…more

Administrative Procedure, Food Manufacturers, Hatch-Waxman, Medical Devices, Patent Prosecution

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PTAB Strategies and Insights - November 2018: The Growing Influence of Post-Grant Proceedings in Section 337 Investigations

Since the passage of the Leahy-Smith America Invents Act (AIA), post-grant proceedings at the U.S. Patent and Trademark Office (USPTO) are interacting more with Section 337 investigations at the International Trade Commission…more

Administrative Proceedings, America Invents Act, Concurrent Litigation, International Trade Commission (ITC), Motion To Stay

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Global Patent Prosecution - November 2020: After Final Consideration Pilot Program 2.0 – Still Going Strong

Once a final rejection has been entered in an application, there is no right to unrestricted further prosecution. However, to advance the goal of compact prosecution, the USPTO introduced a program in 2012 that outlined when…more

Patent Applications, Patent Examinations, Patent Litigation, Patent Prosecution, Patents

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IP Hot Topic: USPTO Issues Final Rule Increasing Front-End Filing Fees

In addition to Continuation and Information Disclosure Statement (IDS) fee changes, the United States Patent & Trademark Office’s (USPTO) published final rule also increases front-end filing fees…more

Fees, Final Rules, Intellectual Property Protection, Patent Applications, Patents

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PTAB Issues Additional Information on New Pre-Institution Discretionary Briefing

On April 25, 2025, the USPTO issued additional information in response to frequently asked questions (FAQs) about the “Interim Processes for PTAB Workload Management” memorandum issued on March 26, 2025. As discussed in our…more

Administrative Procedure Act, Expert Testimony, Filing Deadlines, Inter Partes Review (IPR) Proceeding, New Guidance

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AI IP Year in Review - AI Inventorship: Navigating Patent Rights Around the Globe

The USPTO released proposed guidelines addressing the complex issue of AI inventorship. The USPTO is not the only agency attempting to tackle this issue; jurisdictions across the globe have been grappling with whether…more

Appeals, Artificial Intelligence, Canada, China, EU

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Patent Prosecution Tool Kit: Summary of Subject Matter Eligibility: Biotech/Pharma Inventions

It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. §…more

Biotechnology, Judicial Exception, Mayo v. Prometheus, Patent Prosecution, Patent-Eligible Subject Matter

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Patent Prosecution Tool Kit: Invoking an AIA Exception to Prior Art, 1.130 Declarations

Arguably, no other provision of the America Invents Act (AIA) is more important than 35 U.S.C. § 102. It defines what activities preclude patentability and what documents are available as prior art. Applications having an…more

Administrative Procedure, America Invents Act, Declaration, Exceptions, Litigation Strategies

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IP Hot Topic: Amended Rules at the ITC

The U.S. International Trade Commission (“ITC”) recently amended its Rules and Regulations, making a number of changes to its discovery and complaint-filing procedures. The new rules went into effect on February 3, 2025. The new…more

Administrative Procedure Act, Discovery, Federal Rules of Civil Procedure, Intellectual Property Litigation, International Trade Commission (ITC)

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IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections

A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug…more

Abbreviated New Drug Application (ANDA), Biosimilars, Food and Drug Administration (FDA), Generic Drugs, Intellectual Property Litigation

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PTAB Strategies and Insights - July 2018: The Board Opines On Where The Line Is On Sanctionable Behavior During Deposition

Following up on our article on depositions the Board recently denied a motion for sanctions by the Patent Owner, which alleged that the Petitioner’s questioning during deposition exceeded the scope of the witness’s…more

Declaration, Depositions, Motion for Sanctions, Patent Ownership, Patent Trial and Appeal Board

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IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion. In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the…more

Domestic Industry Requirement, Intellectual Property Protection, International Trade Commission (ITC), Investment, IP Litigation

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IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft…more

Bayh-Dole Act, Biden Administration, Comment Period, Disclosure Requirements, Drug Pricing

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Ingenico: Federal Circuit Narrows the Scope of IPR Estoppel Under § 315(e)(2)

On May 7, 2025, the Federal Circuit issued a precedential decision in Ingenico Inc. v. IOENGINE, LLC that narrows the scope of inter partes review (IPR) estoppel under 35 U.S.C. § 315(e)(2), resolving a longstanding district…more

§315(e), Appeals, CAFC, Estoppel, Inter Partes Review (IPR) Proceeding

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When Surfboards and Superstars Collide: How to Avoid a Wipeout [or Mayhem]

Pop icon Lady Gaga is no stranger to making waves, but a new lawsuit initiated by California-based surfboard company Lost International (aka Lost Surfboards), shows that even superstars can find themselves navigating choppy…more

Brand, Celebrities, Damages, Entertainment Industry, Goods or Services

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Federal Circuit in EcoFactor, Inc. v. Google LLC Probes the Limits for Gatekeeping Damages Testimony

Last week, in EcoFactor, Inc. v. Google LLC, the Federal Circuit issued its first en banc decision in a utility patent case in several years. The case involves the gatekeeping function of district courts vis-à-vis expert…more

Appeals, Appellate Courts, Contract Interpretation, Damages, Daubert Standards

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Patent Prosecution Tool Kit: Obviousness-Type Double Patenting

35 U.S.C. § 101 precludes a patentee from obtaining more than one patent on the same invention. Courts have extended this prohibition “to preclude a second patent on an invention which ‘would have been obvious from the subject…more

Administrative Procedure, Affirmative Defenses, Double Patent, Litigation Strategies, Obviousness-Type Double Patenting (ODP)

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2024 Design Patents Year in Review: Analysis & Trends

As we predicted in our 2023 report, 2024 was a banner year for design rights in the U.S. and elsewhere. In last year’s report, we noted that the U.S. Court of Appeals for the Federal Circuit (CAFC) agreed to consider en banc…more

Appeals, CAFC, Canada, China, Corporate Counsel

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2021 PTAB Year in Review: Analysis & Trends: Developments in Antedating Asserted Art at the PTAB

USPTO Patent Trial and Appeal Board (PTAB) decisions in 2021 show that antedating a prior-art reference remains a viable option to knock out a ground in an inter partes review (IPR) petition—patent owners were successful in such…more

Evidence, Final Written Decisions, Inter Partes Review (IPR) Proceeding, Inventors, Patent Applications

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Broadening on Reissue is Based on the Scope of the Language of the Claims, Not the Original Intention of the Applicant

Takeaways: - Claim construction for determining whether reissue claims are improperly broadened is based on fundamental claim construction cannons and not applicant intentions. - Patent Owners should check patented claims…more

Appeals, CAFC, Claim Construction, Inventors, Patent Litigation

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Latest PTAB Memo Bifurcates Pre-Institution Briefing; Creates New Separate Briefing on Discretionary Considerations

On March 26, 2025, the USPTO issued the attached memo titled “Interim Processes for PTAB Workload Management,” which significantly alters the pre-institution briefing procedure for IPRs and PGRs. Under the Interim Process,…more

America Invents Act, Filing Deadlines, Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Trial and Appeal Board

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Fast-Tracking Patent Applications in Asia

The process of patenting an invention can be cumbersome, resulting in Applicants waiting several years before their patents are picked up for examination. Various jurisdictions have realized the pressing need to shorten the gap…more

ASEAN Patent Examination Cooperation (ASPEC) program, Asia, China, Expedited Approval Process, India

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Is (Copyright) Paradise Lost for A Recent Entrance to Paradise and Other AI-Generated Works?

Last week, the D.C. Circuit Court of Appeals issued its opinion in Thaler v. Perlmutter. The opinion notably solidifies the U.S. Copyright Office’s position that works generated autonomously (and thus solely) by artificial…more

Algorithms, Appeals, Artificial Intelligence, Authorship, Copyright

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IP Hot Topic: The Federal Circuit Confirms That Commission Cannot Be Compelled to Issue Sua Sponte Order

The Federal Circuit upheld the ITC Commission’s discretionary power not to issue sua sponte orders to show cause why a party has not committed sanctionable conduct under Commission Rules or to explain its reason for not issuing…more

Administrative Procedure Act, Appeals, Intellectual Property Litigation, International Trade Commission (ITC), Investigations

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Critical Dates for Europe’s New Unified Patent and Unitary Patent Court Now Certain

Now is the time to act if you have European patents or a pending application. Europe’s new Unified Patent and Unitary Patent Court (UP/UPC), which have been in development for the better part of a decade, are finally on the…more

EU, Opt-Outs, Patent Infringement, Patent Ownership, Patents

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PTAB Issues Additional Information on New Pre-Institution Discretionary Briefing

On April 25, 2025, the USPTO issued additional information in response to frequently asked questions (FAQs) about the “Interim Processes for PTAB Workload Management” memorandum issued on March 26, 2025. As discussed in our…more

Administrative Procedure Act, Expert Testimony, Filing Deadlines, Inter Partes Review (IPR) Proceeding, New Guidance

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Global Patent Prosecution Newsletter - April 2019

Patent eligibility continues to be a hot topic in intellectual property law, and in our April issue of the Global Patent Prosecution newsletter, we look at three of the major forums impacting this area of IP. In our first…more

Patent Prosecution, Patent-Eligible Subject Matter, Patents, Pending Legislation, USPTO

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2024 Design Patents Year in Review: Analysis & Trends - Global Shifts in Design Law and Policy

2024 was a year of both big leaps and incremental advances in design law and practice globally. Years-long efforts came to fruition in the European Union and internationally with the Design Law Treaty, adopting significant…more

Canada, China, Design Patent, EU, Intellectual Property Protection

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PTAB Year in Review – PTAB Trends in 2024: Challenges to Genus Claims

In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that…more

Enablement Inquiries, Final Written Decisions, Genus, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding

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United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice

On May 10, 2024, the United States Patent and Trademark Office (“USPTO”) published a notice of proposed rulemaking in the Federal Register that could dramatically impact prosecution practices, especially for those practitioners…more

Double Patent, Life Sciences, Obviousness, Patent Applicants, Patent Applications

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IP Hot Topic: USPTO Publishes FAQs on Inventorship Guidance for AI-Assisted Inventions

Following the Inventorship Guidance for AI-Assisted Inventions, the United States Patent & Trademark Office (USPTO) has published a set of frequently asked questions (FAQs) and answers regarding the guidance..…more

Artificial Intelligence, Intellectual Property Protection, Inventions, Inventors, Machine Learning

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Patent Prosecution Tool Kit: Capturing After-Discovered Embodiments in Biotech Patents by Careful Prosecution

A Maddening Habit  - Biotechnology is an unpredictable science. When its practitioners wish to enforce their patents, they often run into a serious problem. Unlike chemists or pharmacologists, who for a century or so have…more

After-Discovered Embodiments (ADEs), Biotechnology, Means-Plus-Function, Patent Infringement, Patent Invalidity

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AI IP Year in Review - AI Developments at the USPTO

Navigating Inventorship of AI-Assisted Inventions: USPTO’s Guidance and Implications - The USPTO issued guidance on AI-assisted inventions on February 13, 2024. This guidance is part of the USPTO’s ongoing efforts to address…more

Artificial Intelligence, Innovation Patent, Intellectual Property Protection, Inventions, Inventors

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U.S. IP Update – May 2025

Sterne Kessler’s U.S. IP Update is a newsletter delivering the latest developments in U.S. intellectual property law, tailored for companies and legal counsel in Korea. Stay informed on key court decisions, policy changes, and…more

Alice/Mayo, Artificial Intelligence, FRAND, Intellectual Property Litigation, Intellectual Property Protection

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PTAB Issues Additional Information on New Pre-Institution Discretionary Briefing

On April 25, 2025, the USPTO issued additional information in response to frequently asked questions (FAQs) about the “Interim Processes for PTAB Workload Management” memorandum issued on March 26, 2025. As discussed in our…more

Administrative Procedure Act, Expert Testimony, Filing Deadlines, Inter Partes Review (IPR) Proceeding, New Guidance

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PTAB Strategies and Insights Newsletter - May 2023: Kyocera and the Brewing Debate Over Expert Qualifications at the PTAB

Technical experts play a key role in patent litigation, including in PTAB litigation. Indeed, experts are often the only witnesses to provide testimony in PTAB proceedings, and final written decisions often hinge on which…more

Corporate Counsel, Evidence, Expert Testimony, International Trade Commission (ITC), Inventions

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Penn State Wins On and Off the Field

Pennsylvania State University has secured wins on the field and in court this football season with a 10-1 football record (and likely a College Football Playoff berth), and a jury verdict in its favor in a lawsuit against…more

Goods or Services, Intellectual Property Protection, Likelihood of Confusion, Logos, Ornamental Design

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Estoppel Certification in Reexamination

Estoppel certification in reexamination prevents relitigation of resolved issues…more

Administrative Procedure Act, Estoppel, Intellectual Property Litigation, Patent Litigation, Patent Trial and Appeal Board

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2021 PTAB Year in Review: Analysis & Trends: The Resurgence and Perils of Ex Parte Reexaminations

Ex parte reexaminations have re-emerged as an increasingly important component of patent litigation and licensing negotiations. With the passage of the America Invents Act (“AIA”) and the advent of inter partes reviews (“IPRs”)…more

America Invents Act, Estoppel, Ex Partes Reexamination, Patent Infringement, Patent Invalidity

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2023 PTAB Year in Review: Analysis & Trends: The Staying Power of Fintiv: The Effect of Parallel Litigation at the PTAB in 2023

In 2023, Fintiv—the precedential Order issued in 2020 that established a six-factor framework that the Patent Trial and Appeal Board (PTAB) applies when evaluating whether to exercise its discretion to institute an America…more

America Invents Act, Final Written Decisions, Intellectual Property Litigation, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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Patent Prosecution Tool Kit: Update on Patent Subject Matter Eligibility & Abstract Ideas

Since the U.S. Supreme Court’s decision in Alice v. CLS Bank, patent stakeholders have faced many difficulties navigating the world of patent-eligibility. Through many Federal Circuit decisions and Guidance given by the U.S…more

Abstract Ideas, CLS Bank v Alice Corp, Computer-Related Inventions, Mayo v. Prometheus, Patent Prosecution

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PTAB Strategies and Insights Newsletter - December 2022: "LEAP to Chambers" Program: Associate Perspectives

On November 9, 2022, the USPTO’s Legal Experience and Advancement Program (LEAP) hosted "LEAP to Chambers," a new LEAP initiative to provide LEAP-eligible practitioners with an inside perspective on practicing before PTAB. …more

Administrative Patent Judges, LEAP, Oral Hearings, Patent Trial and Appeal Board, USPTO

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U.S. IP Update – May 2025

Sterne Kessler’s U.S. IP Update is a newsletter delivering the latest developments in U.S. intellectual property law, tailored for companies and legal counsel in Korea. Stay informed on key court decisions, policy changes, and…more

Alice/Mayo, Artificial Intelligence, FRAND, Intellectual Property Litigation, Intellectual Property Protection

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Does the United States Patent Office Protect Unpublished Applications When Searching the Internet and Artificial Intelligence Databases for Prior Art?

Short answer: Yes, but… Short answer: Yes, but… Many practitioners in sensitive technology areas file patent applications with non-publication requests or may abandon their applications if examination is not going well to…more

Artificial Intelligence, Databases, Internet, Notice of Allowance, Office Actions

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Patent Prosecution Tool Kit: Fast Track Patent Examination

Building a patent portfolio is an important part of new product development. For many startups, patents help credential their technology and attract investment. However, backlogs at the U.S. Patent and Trademark Office (USPTO)…more

America Invents Act, Intellectual Property Protection, Patent Portfolios, Patent Prosecution, Patent Prosecution Highway

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2024 Federal Circuit IP Appeals – Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (Moore, Lourie, Albright)

Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater…more

Appeals, Food and Drug Administration (FDA), Intellectual Property Litigation, Life Sciences, Motion to Dismiss

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Filings Up, Pendency Down – USPTO 2024 Year in Review (& Early Thoughts for 2025)

With 2024 now in the rearview mirror, it’s a great time to take a look at the past year’s U.S. trademark prosecution and examination numbers – and consider where the U.S. Patent and Trademark Office (“USPTO”) may be heading for…more

Filing Requirements, Intellectual Property Protection, Intent-to-Use, Lanham Act, Madrid Protocol

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2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions

2024 brought exciting developments at the Federal Circuit. The court issued its first en banc decision in a patent case in five years in LKQ, which significantly altered the standard for proving obviousness of a design patent…more

Appeals, Appellate Courts, Claim Construction, Damages, Design Patent

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Does Your Office Post-Grant Strategy Account for the Rise of Serial Challenges Flowing From the PTAB to the CRU?

After eight weeks of shifts in governmental policies, the patent bar is feeling repercussions from all directions. One critical area in flux is the post-grant challenge arena. With a reduced PTAB head count and a steady flow…more

Central Reexamination Unit (CRU), Ex Partes Reexamination, Intellectual Property Litigation, Litigation Strategies, Patent Invalidity

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USPTO Confirms Different Frameworks for Pre-AIA and Post-AIA Prior-Art Determinations

On November 15, 2023, Director of the United States Patent and Trademark Office (USPTO) Kathi Vidal designated as precedential the Patent Trial and Appeal Board’s (PTAB) final written decision in Penumbra, Inc. v. RapidPulse,…more

America Invents Act, Anticipation, Appeals, Claim Construction, Final Written Decisions

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Critical Dates for Europe’s New Unified Patent and Unitary Patent Court Now Certain

Now is the time to act if you have European patents or a pending application. Europe’s new Unified Patent and Unitary Patent Court (UP/UPC), which have been in development for the better part of a decade, are finally on the…more

EU, Opt-Outs, Patent Infringement, Patent Ownership, Patents

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Amazon’s Patent Evaluation Express (APEX) Program Has Declaratory Judgment Action Risks for Patent Owners

Amazon’s Patent Evaluation Express (APEX) program provides an expedited and low-cost tool for patent owners to stop the sale of infringing products on Amazon’s platform. But low cost does not mean low risk. The U.S. Court of…more

Amazon, Apex Doctrine, Appeals, Declaratory Judgments, Intellectual Property Protection

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The Federal Circuit Expands IP Enforcement Opportunities at the ITC

Last month the Federal Circuit issued a decision in the Lashify case that significantly broadens the opportunity for companies to bring a lawsuit before the U.S. International Trade Commission (“ITC”). The ITC is known for its…more

Appeals, Domestic Industry Requirement, Enforcement Actions, Exclusion Orders, Imports

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The Supreme Court Redefines Patent Exhaustion

In Impression Products, Inc. v. Lexmark International, Inc., No. 15-1189 (U.S. May 30, 2017), the Supreme Court fundamentally changed patent licensing in the United States by eliminating a key limitation on patent exhaustion,…more

Exports, Foreign Sales, Imports, Impression Products v Lexmark International, IP License

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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Patent Prosecution Tool Kit: Obviousness-Type Double Patenting

35 U.S.C. § 101 precludes a patentee from obtaining more than one patent on the same invention. Courts have extended this prohibition “to preclude a second patent on an invention which ‘would have been obvious from the subject…more

Administrative Procedure, Affirmative Defenses, Double Patent, Litigation Strategies, Obviousness-Type Double Patenting (ODP)

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Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,…more

Appeals, FDA Approval, Hatch-Waxman, Patent Litigation, Patent Term Extensions

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IP Hot Topic: The Federal Circuit Confirms That Commission Cannot Be Compelled to Issue Sua Sponte Order

The Federal Circuit upheld the ITC Commission’s discretionary power not to issue sua sponte orders to show cause why a party has not committed sanctionable conduct under Commission Rules or to explain its reason for not issuing…more

Administrative Procedure Act, Appeals, Intellectual Property Litigation, International Trade Commission (ITC), Investigations

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The Space Industry’s Legal Landscape: Developing Robust Intellectual Property Portfolios

As private industry and government entities increasingly venture into space, securing IP rights for space-related innovations has become a critical consideration. The global space industry is projected to generate more than $1.8…more

Intellectual Property Protection, NASA, Patent Applications, Patent Infringement, Patents

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IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections

A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection afforded by section viii carve-outs, a mechanism that allows Abbreviated New Drug…more

Abbreviated New Drug Application (ANDA), Biosimilars, Food and Drug Administration (FDA), Generic Drugs, Intellectual Property Litigation

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Selection Invention Found Unpatentable For Obviousness-Type Double Patenting

On August 21, 2014, the Federal Circuit issued a decision in AbbVie Inc. v. The Mathilda and Terence Kennedy Institute of Rheumatology Trust., holding that the claims to a selection invention were invalid based on…more

AbbVie, Double Patent, Inventions, Obviousness, Patent Litigation

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PTAB Strategies and Insights Newsletter - March 2022: Federal Circuit Rules on Two Means-Plus-Function/Indefinite Cases

The Federal Circuit issued two cases this week providing more clarity to when a functional claim feature should be considered a de facto means-plus-function claim that requires structural detail to meet the indefiniteness…more

Indefiniteness, Means-Plus-Function, Patent Applications, Patent Litigation, Patents

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Patent Prosecution Tool Kit: Fast Track Patent Examination

Building a patent portfolio is an important part of new product development. For many startups, patents help credential their technology and attract investment. However, backlogs at the U.S. Patent and Trademark Office (USPTO)…more

America Invents Act, Intellectual Property Protection, Patent Portfolios, Patent Prosecution, Patent Prosecution Highway

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IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft…more

Bayh-Dole Act, Biden Administration, Comment Period, Disclosure Requirements, Drug Pricing

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Maximizing Value for Space-Tech Start Ups

Houston, we fixed it. When an oxygen tank exploded during the Apollo 13 mission, the crew resorted to plastic covers from manuals and duct tape to return home. Now, the International Space Station has 3D printers capable of…more

Aerospace, Artificial Intelligence, Intellectual Property Protection, Inventions, Patent Applications

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Patent Prosecution Tool Kit: Patent Term Extension

Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product…more

Administrative Procedure, Food Manufacturers, Hatch-Waxman, Medical Devices, Patent Prosecution

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U.S. IP Update – May 2025

Sterne Kessler’s U.S. IP Update is a newsletter delivering the latest developments in U.S. intellectual property law, tailored for companies and legal counsel in Korea. Stay informed on key court decisions, policy changes, and…more

Alice/Mayo, Artificial Intelligence, FRAND, Intellectual Property Litigation, Intellectual Property Protection

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MarkIt to Market® - February 2024

Thank you for reading the February 2024 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss the advertising rights of luxury resellers and important updates to the Warner Chappell Music v. Nealy…more

Brand, Copyright, Copyright Litigation, Copyright Ownership, Counterfeiting

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U.S. IP Update – May 2025

Sterne Kessler’s U.S. IP Update is a newsletter delivering the latest developments in U.S. intellectual property law, tailored for companies and legal counsel in Korea. Stay informed on key court decisions, policy changes, and…more

Alice/Mayo, Artificial Intelligence, FRAND, Intellectual Property Litigation, Intellectual Property Protection

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Patent Prosecution Tool Kit: Medical Device Considerations

Preparing and prosecuting medical device patents can be unique and challenging. Patent owners and practitioners often must consider a wide range of converging technologies from the mechanical, electrical, chemical, and…more

Best Practices, Connected Items, Design Patent, Divided Infringement, Global Patent Prosecution

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Supreme Court Overturns Nearly $43 Million Trademark Infringement Award Based on Section 35 of the Lanham Act

The U.S. Supreme Court’s opinion in the Dewberry Group, Inc. v. Dewberry Engineers Inc. case was released Wednesday. In a unanimous opinion, the Court found that Section 35 of the Lanham Act, which provides that a plaintiff can…more

Appeals, Damages, Disgorgement, Intellectual Property Litigation, Intellectual Property Protection

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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2021 PTAB Year in Review: Analysis & Trends: Fintiv Continues To Take Center Stage: The Effect of Parallel Litigation at the PTAB in 2021

In 2021, Fintiv continued to be one of the hottest and most controversial issues facing the patent bar. The USPTO Patent Trial and Appeal Board’s (PTAB) precedential Fintiv decision enumerated factors that the PTAB applies when…more

America Invents Act, Inter Partes Review (IPR) Proceeding, International Trade Commission (ITC), Parallel Proceedings, Patent Applications

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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The Space Industry’s Legal Landscape: Developing Robust Intellectual Property Portfolios

As private industry and government entities increasingly venture into space, securing IP rights for space-related innovations has become a critical consideration. The global space industry is projected to generate more than $1.8…more

Intellectual Property Protection, NASA, Patent Applications, Patent Infringement, Patents

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2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions

2024 brought exciting developments at the Federal Circuit. The court issued its first en banc decision in a patent case in five years in LKQ, which significantly altered the standard for proving obviousness of a design patent…more

Appeals, Appellate Courts, Claim Construction, Damages, Design Patent

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2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions

2024 brought exciting developments at the Federal Circuit. The court issued its first en banc decision in a patent case in five years in LKQ, which significantly altered the standard for proving obviousness of a design patent…more

Appeals, Appellate Courts, Claim Construction, Damages, Design Patent

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Latest PTAB Memo Bifurcates Pre-Institution Briefing; Creates New Separate Briefing on Discretionary Considerations

On March 26, 2025, the USPTO issued the attached memo titled “Interim Processes for PTAB Workload Management,” which significantly alters the pre-institution briefing procedure for IPRs and PGRs. Under the Interim Process,…more

America Invents Act, Filing Deadlines, Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Trial and Appeal Board

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Federal Circuit in EcoFactor, Inc. v. Google LLC Probes the Limits for Gatekeeping Damages Testimony

Last week, in EcoFactor, Inc. v. Google LLC, the Federal Circuit issued its first en banc decision in a utility patent case in several years. The case involves the gatekeeping function of district courts vis-à-vis expert…more

Appeals, Appellate Courts, Contract Interpretation, Damages, Daubert Standards

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MarkIt to Market® - September 2023: How Design Patents Can Complement Brands' Trademark Portfolios

Many brand owners are familiar with the value of registered trademarks, which safeguard the goodwill cultivated between mark holders and consumers by reducing confusion as to the source of the associated goods. However, owners…more

Design Patent, Graphic Designs, Graphical User Interface, Intellectual Property Protection, IP Portfolio

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U.S. IP Update – May 2025

Sterne Kessler’s U.S. IP Update is a newsletter delivering the latest developments in U.S. intellectual property law, tailored for companies and legal counsel in Korea. Stay informed on key court decisions, policy changes, and…more

Alice/Mayo, Artificial Intelligence, FRAND, Intellectual Property Litigation, Intellectual Property Protection

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Arthrex SCOTUS Oral Arguments on Monday! We’ll Be Live Tweeting Updates

When oral arguments commence in United States v. Arthrex, Inc., No. 19-1434 (U.S.) on Monday, March 1, William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice Group, will be live tweeting updates from the…more

5 U.S.C. § 7513(a), Administrative Patent Judges, Appointments Clause, Arthrex Inc v Smith & Nephew Inc, Constitutional Challenges

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Patent Prosecution Tool Kit: Medical Device Considerations

Preparing and prosecuting medical device patents can be unique and challenging. Patent owners and practitioners often must consider a wide range of converging technologies from the mechanical, electrical, chemical, and…more

Best Practices, Connected Items, Design Patent, Divided Infringement, Global Patent Prosecution

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Broadening on Reissue is Based on the Scope of the Language of the Claims, Not the Original Intention of the Applicant

Takeaways: - Claim construction for determining whether reissue claims are improperly broadened is based on fundamental claim construction cannons and not applicant intentions. - Patent Owners should check patented claims…more

Appeals, CAFC, Claim Construction, Inventors, Patent Litigation

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Patent Prosecution Tool Kit: Implications of the BPCIA on the IP Strategies of Brand Companies and Biosimilar Developers

The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed…more

Biosimilars, BPCIA, Corporate Branding, FDA Approval, Hatch-Waxman

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A Reminder on the Benefits of a Federal Trademark Registration

During uncertain economic times, it may be tempting to forego the expense of filing for (or maintaining) a federal registration to protect a trademark, relying instead on common law rights acquired through use in commerce. This…more

Brand, Customs and Border Protection, Enforcement, Intellectual Property Litigation, Intellectual Property Protection

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IP Hot Topic: USPTO Establishes New Fees for More Than Fifty Cumulative IDS References

Along with other new and increased fees, including the surcharge for late-stage continuation applications, the United States Patent & Trademark Office published a final rule on November 20, 2024, that establishes new fees for…more

Final Rules, Information Disclosure Statement, Patent Applications, Patent Fees, Patents

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Patent Grace Period Laws in the IP5 Patent Offices: Some Similarities But Largely Different

Life science and other high technology companies most frequently file patent applications in five IP offices (IP5), namely: the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), the Japanese…more

America Invents Act, China, EU, European Patent Office, Grace Period

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MarkIt to Market® - July 2021: Bombing Atomically – Futura and the Future of Fluid Trademarks

This month, Google has celebrated July 4th, the start of the 2020 summer Olympics, and Ángela Peralta's 175th birthday, to name a few, through its iconic Google Doodles found atop the Google search page. Google is one of many…more

Artists, Brand, Fluid Trademarks, Intellectual Property Litigation, Intellectual Property Protection

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[Webinar] The Interplay Between District Court and PTAB: Estoppels, Evidentiary, Recovery - April 5th, 1:00 pm - 2:00 pm EDT

In conjunction with the release of the firm's year-in-review report, our speakers will discuss the recent cases surrounding IPR estoppels, evidentiary issues, and recovery, which notably highlight the interplay between the…more

Continuing Legal Education, Estoppel, Evidence, Intellectual Property Protection, Inter Partes Review (IPR) Proceeding

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United States Patent and Trademark Office Proposes Changes to Terminal Disclaimer Practice

On May 10, 2024, the United States Patent and Trademark Office (“USPTO”) published a notice of proposed rulemaking in the Federal Register that could dramatically impact prosecution practices, especially for those practitioners…more

Double Patent, Life Sciences, Obviousness, Patent Applicants, Patent Applications

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MarkIt to Market® – September 2024: Expanding Horizons: Potential Expansion of IP Rights for High-THC Cannabis Varieties

In the United States, the intellectual property rights system for plants is multifaceted, encompassing utility patents, plant patents, trademarks, and Plant Variety Protection (PVP) Certificates. These mechanisms offer different…more

Farm Bill, Intellectual Property Protection, Life Sciences, Marijuana, Patent Ownership

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IP Hot Topic: Imperative Information on the New Unified Patent Court (UPC) Launching June 1

The new European Union Unified Patent Court (UPC) and Unitary Patent go live on June 1, 2023. Enterprises operating in Europe should understand the risks and rewards of this new system, one of the most significant developments…more

Enforcement, EU, European Patent Office, Intellectual Property Litigation, Intellectual Property Protection

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A Reminder on the Benefits of a Federal Trademark Registration

During uncertain economic times, it may be tempting to forego the expense of filing for (or maintaining) a federal registration to protect a trademark, relying instead on common law rights acquired through use in commerce. This…more

Brand, Customs and Border Protection, Enforcement, Intellectual Property Litigation, Intellectual Property Protection

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2021 PTAB Year in Review: Analysis & Trends: A Niche Within a Niche: The PTAB’s Evolving Motion to Amend Practice

On March 15, 2019, the United States Patent and Trademark Office (USPTO) introduced a new Motion to Amend (MTA) Pilot Program. The Pilot Program gave patent owners an option to (1) receive Preliminary Guidance on the merits of…more

America Invents Act, Motion to Amend, Patent Litigation, Patent Trial and Appeal Board, Patents

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AI IP Year in Review - AI Developments at the USPTO

Navigating Inventorship of AI-Assisted Inventions: USPTO’s Guidance and Implications - The USPTO issued guidance on AI-assisted inventions on February 13, 2024. This guidance is part of the USPTO’s ongoing efforts to address…more

Artificial Intelligence, Innovation Patent, Intellectual Property Protection, Inventions, Inventors

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AI IP Year in Review - AI Developments at the USPTO

Navigating Inventorship of AI-Assisted Inventions: USPTO’s Guidance and Implications - The USPTO issued guidance on AI-assisted inventions on February 13, 2024. This guidance is part of the USPTO’s ongoing efforts to address…more

Artificial Intelligence, Innovation Patent, Intellectual Property Protection, Inventions, Inventors

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Update: FTC’s Ban on Non-Compete Agreements Set Aside

On May 7, 2024, the Federal Trade Commission (FTC) issued a Final Rule that renders invalid non-compete clauses in standard employment agreements. 16 C.F.R. § 910. On August 20, 2024, the United States District Court for the…more

Administrative Procedure Act, Arbitrary and Capricious, Constitutional Challenges, Employees, Employer Liability Issues

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The Supreme Court Heightens Antitrust Scrutiny For ANDA Reverse Payment Agreements Between Pharmaceutical Companies

The U.S. Supreme Court yesterday ruled on the long-awaited FTC v. Actavis case concerning ANDA reverse payments, resolving a sharp circuit split. The Court held that settlement agreements that include reverse payments to end…more

Abbreviated New Drug Application (ANDA), Antitrust Litigation, Federal Trade Commission (FTC), FTC v Actavis, Patent Infringement

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MarkIt to Market® – September 2024: Expanding Horizons: Potential Expansion of IP Rights for High-THC Cannabis Varieties

In the United States, the intellectual property rights system for plants is multifaceted, encompassing utility patents, plant patents, trademarks, and Plant Variety Protection (PVP) Certificates. These mechanisms offer different…more

Farm Bill, Intellectual Property Protection, Life Sciences, Marijuana, Patent Ownership

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2024 PTAB Year in Review: Analysis & Trends – 2024 PTAB Case Highlights

Abuse of Process and/or Sanctions – 37 C.F.R. § 42.12 - Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics, LLC, IPR2021-00847, IPR2021-00850, IPR2021-00854, IPR2021-00857 & IPR2021-00860 - Decision…more

Abuse of Process, Appeals, Attorney's Fees, Claim Construction, Denial of Institution

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2021 PTAB Year in Review: Analysis & Trends: Standard Essential Patents at the PTAB: Are SEPs Faring any Differently than non-SEPs? – Impacts and Analysis

Standard Essential Patents are on the Rise, as is Litigation - Standard-essential patents (SEPs) are on the rise as connectivity, a present-day necessity, relies on standards subject to SEPs. It is estimated that by 2025,…more

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

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Maximizing Value for Space-Tech Start Ups

Houston, we fixed it. When an oxygen tank exploded during the Apollo 13 mission, the crew resorted to plastic covers from manuals and duct tape to return home. Now, the International Space Station has 3D printers capable of…more

Aerospace, Artificial Intelligence, Intellectual Property Protection, Inventions, Patent Applications

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2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions

2024 brought exciting developments at the Federal Circuit. The court issued its first en banc decision in a patent case in five years in LKQ, which significantly altered the standard for proving obviousness of a design patent…more

Appeals, Appellate Courts, Claim Construction, Damages, Design Patent

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PTAB Strategies and Insights - September 2020: Does the Federal Circuit Treat APA Challenges Differently if Brought by Petitioner vs. Patent Owner? Yes.

Last month’s newsletter discussed Alacritech, Inc. v. Intel Corp, where patent owner Alacritech appealed a final written decision (FWD) of the Patent Trial and Appeal Board (“Board”) for inter partes review (IPR) IPR2017-01410…more

Administrative Procedure Act, Appeals, Burden of Persuasion, Final Written Decisions, Inter Partes Review (IPR) Proceeding

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2024 PTAB Year in Review: Analysis & Trends

The Patent Trial and Appeal Board (PTAB) continues to play a pivotal role in shaping the intellectual property landscape. In 2024, several developments affecting PTAB practice emerged, from new rulemaking at the USPTO to key…more

§315(e), Administrative Procedure Act, America Invents Act, Appeals, Corporate Counsel

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2024 ITC Section 337 Year in Review: Analysis & Trends

Section 337 investigations at the U.S. International Trade Commission (ITC) remain an efficient and powerful method for American businesses seeking relief from foreign acts of unfair competition, including infringement of…more

Enforcement Actions, Final Determinations, Government Shutdown, Intellectual Property Protection, International Trade Commission (ITC)

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