Author Info for Rothwell, Figg, Ernst & Manbeck, P.C.

Jenny Colgate

FTC Says: If You Want to Use Data In a New Way, You Need to Provide Actual Notice to End-Users Before You Do It

It is fairly standard language in privacy policies: “This privacy policy may be amended or updated from time to time, so please check back regularly for updates.” It sends the message that the company can change its data… more

Artificial Intelligence, End-Users, Federal Trade Commission (FTC), Information Sharing, Policies and Procedures

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Nicole DeAbrantes

PTAB Finds Another Patent Fails to Pass Muster Under 101

At the end of October, the U.S. Patent Trial and Appeal Board (“PTAB”) issued a final written decision in PGR2023-00023, finding all claims of a patent owned by Halliburton Energy Services unpatentable under 35 U.S.C. § 101… more

Alice/Mayo, Final Written Decisions, Fracking, Patent Applications, Patent Ownership

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Gregory DeLassus

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 afﬁrmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025). This… more

Clinical Trials, Enablement Inquiries, Inventors, Patent Applications, Patent Trial and Appeal Board

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Michael Ellenberger

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This… more

Artificial Intelligence, Biosimilars, Biotechnology, Clinical Trials, Food and Drug Administration (FDA)

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Aydin Harston Ph.D.

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 afﬁrmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025). This… more

Clinical Trials, Enablement Inquiries, Inventors, Patent Applications, Patent Trial and Appeal Board

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James Hastings

[Webinar] Managing Risks Through IP Innovation Management Training - October 4th, 2:00 pm ET

Of Counsel James Hastings will present a webinar titled "Managing Risks through IP Innovation Management Training" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences… more

Health Care Providers, Health Technology, Innovation, Intellectual Property Protection, IP Portfolio

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Kristen Logan

USPTO Withdraws June 2022 Guidance on Fintiv Denials

On Friday, February 28, 2025, the United States Patent and Trademark Office (USPTO) announced the withdrawal of the June 2022 memorandum titled “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with… more

Administrative Procedure Act, America Invents Act, Compliance, Inter Partes Review (IPR) Proceeding, International Trade Commission (ITC)

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Leo Loughlin

Reviewing 2024's AI Patent And Copyright Developments

Artificial intelligence dominated this year's emerging technology updates from the U.S. Patent and Trademark Office and the U.S. Copyright Office. These agencies, among many others, were kept quite busy under the directives set… more

Appeals, Artificial Intelligence, Biden Administration, Copyright, Copyright Office

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Jennifer Maisel

Reviewing 2024's AI Patent And Copyright Developments

Artificial intelligence dominated this year's emerging technology updates from the U.S. Patent and Trademark Office and the U.S. Copyright Office. These agencies, among many others, were kept quite busy under the directives set… more

Appeals, Artificial Intelligence, Biden Administration, Copyright, Copyright Office

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Mary Mullins

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with… more

Abbreviated New Drug Application (ANDA), Appeals, Biosimilars, Food and Drug Administration (FDA), Foreign Corporations

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Adam Nicolais

Federal Circuit Reverses Decision Finding Lack of Written Description for Patent Claiming a Pharmaceutical Composition Comprising the Two Active Ingredients in Entresto®

The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a… more

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

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Jennifer Nock

District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication. The… more

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James Pawlowski

Understanding the PTAB’s Recent Informative Decision: Cambridge Mobile Telematics, Inc. v. Sfara, Inc.

The Patent Trial and Appeal Board (PTAB) recently designated its decision in Cambridge v. Sfara (IPR2024-00952) as an informative decision.[1] This designation addresses an important issue in inter partes review (IPR)… more

Claim Construction, Intellectual Property Litigation, Inter Partes Review (IPR) Proceeding, Judicial Authority, Litigation Strategies

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Gary Prato

How to Effectively Use Patent Counsel to Navigate the USPTO’s Duty of Candor Guidance Regarding FDA Submissions

The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug Administration… more

Duty of Candor, Duty to Disclose, Food and Drug Administration (FDA), Foreign Patent Applications, Patent Applications

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Mark Rawls

The USPTO’s Inventorship Guidance for AI-Assisted Inventions

Last year, the USPTO ruled that an artificial intelligence (AI) cannot be listed as an inventor on a patent application. See USPTO Says AI Machine Cannot Qualify as an Inventor (e.g., “Robert Bahr, Deputy Commissioner for Patent… more

Artificial Intelligence, Design Patent, Inventors, Machine Learning, New Guidance

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Brian Rosenbloom

Continued Investment in AI Drug Discovery Points to Potential Future Significance of Inventorship in Biosimilar Litigation

On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins. According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory automation… more

Artificial Intelligence, Biosimilars, BPCIA, Inventors, Investment

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Jake Rosvold*, Ph.D

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted… more

Biologics, Biosimilars, BPCIA, Clinical Trials, Competition

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Michael Saunders

July USPTO Guidance Sets Stricter Standards for Evidence in IPR Petitions

Acting Director of the USPTO, Coke Morgan Stewart, issued a memorandum last week that will change the way petitioners levy challenges to patents via inter partes review (IPR). The change will apply to any petition for IPR filed… more

Administrative Proceedings, Evidence, Inter Partes Review (IPR) Proceeding, New Guidance, Obviousness

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Davide Schiavetti

[Webinar] Overcoming Unique Issues Regarding Trademark Searching and Filing for the Pharmaceutical Industry - April 24th, 2:00 pm ET

Trademarks in the pharmaceutical industry are important not only as part of a company’s intellectual property portfolio, but also as a matter of public health, and obtaining a trademark registration in the pharmaceutical… more

Artificial Intelligence, Food and Drug Administration (FDA), Intellectual Property Protection, Orange Book, Pharmaceutical Industry

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Alexander Shaver Ph.D.

District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication. The… more

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Daniel Shores

[Webinar] mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025 - May 14th, 2:00 pm ET

Partner Dan Shores will present a webinar titled "mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025" for Medmarc, the leading expert in the products liability risks facing medical technology and life… more

Intellectual Property Litigation, Intellectual Property Protection, Life Sciences, Medical Technology Companies, Moderna Inc.

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Andrew Stewart

Continued Investment in AI Drug Discovery Points to Potential Future Significance of Inventorship in Biosimilar Litigation

On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins. According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory automation… more

Artificial Intelligence, Biosimilars, BPCIA, Inventors, Investment

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Andrew Storaska Ph.D.

PTAB to Review Two Eylea® (aflibercept) Patents After Granting Mylan’s Challenges

The U.S. Patent and Trademark Office (USPTO) recently instituted two of Mylan’s petitions seeking Inter Partes Review of Regeneron’s U.S. Patent No. 9,669,069 B2 (the “’069 Patent,” subject of IPR2021-00880) and U.S. 9,254,338… more

Inter Partes Review (IPR) Proceeding, Patent Litigation, Patent Owner Preliminary Response, Patent Trial and Appeal Board, Patents

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Bryan Thompson

Director Review Codified as Director Vidal Steps Down—What is this Power and How Did Vidal Wield It?

With U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal’s return to private practice in December 2024 and the future permanent Director yet to be tapped for nomination, it is a good time to reflect on one of the most… more

Administrative Procedure Act, Appeals, Final Rules, Inter Partes Review (IPR) Proceeding, Patent Trial and Appeal Board

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Vivian Tian

Federal Circuit: Reissue Patents Get PTE Based on the Original Patent’s Issue Date

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the… more

Abbreviated New Drug Application (ANDA), Appeals, Food and Drug Administration (FDA), Hatch-Waxman, Patent Litigation

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Stephanie Waltersdorff

The USPTO Provides Further Guidance on Discretionary Denials Policy

The USPTO’s recent guidance on discretionary denials has shifted patent practitioners back to the Fintiv and Sotera Wireless framework… more

Administrative Procedure Act, Inter Partes Review (IPR) Proceeding, New Guidance, Patent Litigation, Patent Trial and Appeal Board

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Sheena Wang

Federal Circuit Denies Teva’s Request for En Banc Rehearing in Orange Book Patent Dispute

In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA… more

Appellate Courts, En Banc Review, Food and Drug Administration (FDA), Intellectual Property Litigation, Orange Book

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Richard Wydeven

Patent Invalid Due to Trade Show Demonstration More Than One Year Before Filing Date

In a cautionary tale for inventors participating in trade shows and other non-confidential presentations, on February 15, 2023, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision invalidating a… more

Appeals, Patent Applications, Patent Infringement, Patent Validity, Patents

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Martin Zoltick

“AI-Related” Chip Patents - 1.6 Billion Reasons Why Google May Have Agreed to Settle

Recent headlines have focused on the $1.6 billion damages claim and Google’s possible exposure in Singular Computing’s patent infringement lawsuit involving Google’s “AI-related” chips. $1.6 billion is certainly not chump change… more

Alice/Mayo, Anticipation, Artificial Intelligence, Damages, Failure To State A Claim

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Rothwell, Figg, Ernst & Manbeck, P.C.

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