News & Analysis as of

Pharmaceutical Patents Appeals United States Patent and Trademark Office

McDonnell Boehnen Hulbert & Berghoff LLP

MSN Laboratories Private Ltd. v. Bausch Health Ireland Ltd. (Fed. Cir. 2025)

As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...more

Foley Hoag LLP

The Enlarged Board of Appeal of the EPO Further Aligns Claim Construction With U.S. and U.K.

Foley Hoag LLP on

Key Takeaways: - The Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) issued its opinion in G1/24 on June 18, 2025 resolving divergent case law on how patent claims should be interpreted at the EPO. - The...more

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

Jones Day on

The PTAB has published its monthly statistics wrap up for April 2025. As expected, those statistics show a significant decline in the institution rate compared to the first six months of the fiscal year. In those first six...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Revives CRISPR-Cas9 Patent Priority Dispute

The CRISPR-Cas9 patent landscape remains complex and unsettled. The Federal Circuit’s latest decision in University of California v. Broad Institute1 revived the high-stakes dispute between UC2 and Broad3 over foundational...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Patent Term Extension for Reissued Patents is Calculated Using the Original Patent’s Issue Date Where the...

The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Wilson Sonsini Goodrich & Rosati

Method of Treatment Claim’s Limiting Preamble Must Satisfy the Written Description Requirement

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit issued a decision in the case of In Re: Xencor, Inc. In this Appeal from the Appeals Review Panel of the Patent Trial and Appeal Board (ARP), with regard to...more

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

mRNA/LNP Patent Litigation Update (Q1 2025)

As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...more

Foley & Lardner LLP

Jepson Claim Format Does Not Avoid Written Description Scrutiny

Foley & Lardner LLP on

Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the...more

Cooley LLP

End of the Road for Jepson Format Claims in the Life Sciences?

Cooley LLP on

In In re: Xencor, Inc., the US Court of Appeals for the Federal Circuit confirmed that the limiting preamble of a Jepson claim must be supported by the specification with “sufficient written description.” In its decision, the...more

McDermott Will & Schulte

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

Foley & Lardner LLP

Federal Circuit Decision Could Encourage More Reissue Patents

Foley & Lardner LLP on

The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more

Goodwin

The Court of Appeals for the Federal Circuit’s In Re Xencor Decision: Jepson Claims Require Written Description for Their...

Goodwin on

On March 13, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Xencor, Inc. (the Xencor decision). The Xencor decision affirms the decision of the Appeals Review Panel...more

Knobbe Martens

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

Knobbe Martens on

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,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

Goodwin

The Appeals Review Panel’s In Re Xencor Decision: The USPTO Provides Its Position on Written Description and Means-Plus-Function...

Goodwin on

On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more

McDermott Will & Schulte

PTO Continues to Wave Wands in Assessing Enablement

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Haug Partners LLP

Baxalta’s Antibody Patent Held Invalid under Amgen’s Enablement Standard by the Federal Circuit

Haug Partners LLP on

In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more

Fitch, Even, Tabin & Flannery LLP

Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more

Bass, Berry & Sims PLC

Ninth Circuit Affirms Broad Scope of False Claims Act’s Public Disclosure Bar

Bass, Berry & Sims PLC on

On August 25, the U.S. Court of Appeals for the Ninth Circuit issued an opinion in which it held that ex parte patent prosecutions by the Patent and Trademark Office (PTO) qualify as “other Federal . . . hearing[s]” under...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

McDermott Will & Schulte

Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2021

Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Cir. Sept. 1, 2021) - In an appeal from the United States District Court for the District of Delaware, the Federal Circuit affirmed the district...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2021 #4

Teva Pharms. Int’l GmbH v. Eli Lilly and Co., Appeal Nos. 2020-1747, -1748, -1750 (Fed. Cir. Aug. 16, 2021) - Eli Lilly and Co. v. Teva Pharms. Int’l GmbH, Appeal Nos. 2020-1876, -1877, -1878 (Fed. Cir. Aug. 16, 2021) - ...more

Fish & Richardson

2020 Post-Grant Report

Fish & Richardson on

In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more

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