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United States Patent and Trademark Office › Patent Litigation › Pharmaceutical Patents

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
Womble Bond Dickinson

Reminder: “Consisting essentially of” Is U.S. Patent Claim Language Needing Interpretation

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On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...more

Sheppard Mullin Richter & Hampton LLP

Lexicography: Clear And Unequivocal

Sheppard Mullin Richter & Hampton LLP on

This Federal Circuit opinion analyzes lexicography in the context of claim construction. Alnylam Pharmaceuticals owns U.S. Patent Nos. 11,246,933 (parent) and 11,382,979 (child). These patents relate to biodegradable...more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

Jones Day on

In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Jones Day

Acting Director Denies IPR Institution Based on “Settled Expectations”

Jones Day on

Under a new U.S. Patent and Trademark Office (“USPTO”) policy issued in March 2025, pre-institution inter partes review (“IPR”) proceedings are now bifurcated, consisting of a first phase in which the director considers...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Jones Day

USPTO Acting Director Denies IPR Institution Based on "Settled Expectations"

Jones Day on

Under a new U.S. Patent and Trademark Office ("USPTO") policy issued in March 2025, pre-institution inter partes review ("IPR") proceedings are now bifurcated, consisting of a first phase in which the director considers...more

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

Fish & Richardson on

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

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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

Wolf, Greenfield & Sacks, P.C.

Practical Guide to Claiming Small Molecules with Functional Language

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Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more

MoFo Life Sciences

Subject Matter Eligibility of AI Medical Treatments

MoFo Life Sciences on

Artificial intelligence (AI) has quickly become a springboard for breakthroughs in personalized medicine, enhanced medical imaging, and predictive modeling for drug development. And given the role it played in two recent...more

Foley Hoag LLP

A Super CRISPR Week – the Week of May 12, 2025: Patent Battles, Clinical Milestones, and Next-Gen Tools

Foley Hoag LLP on

Key Takeaways: Federal Circuit Reopens CRISPR-Cas9 Priority Fight. The CAFC vacated the PTAB’s earlier ruling that UC lacked prior conception of CRISPR-Cas9 in eukaryotic cells, remanding the interference for reconsideration...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Revives CRISPR-Cas9 Patent Priority Dispute

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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...

Akin Gump Strauss Hauer & Feld LLP on

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

Schwabe, Williamson & Wyatt PC on

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

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

American Conference Institute (ACI) on

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

DLA Piper

CDR Scanning Offers Hope for Genus Claims for Antibodies

DLA Piper on

In the landmark Amgen v. Sanofi case (previously covered here), the Supreme Court affirmed that patent claims drawn to a genus of monoclonal antibodies, which were claimed in terms of their function and the epitope to which...more

Hogan Lovells

Reissued patents get Hatch-Waxman PTE based on original patent date, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more

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

mRNA/LNP Patent Litigation Update (Q1 2025)

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

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

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

Key Patent Considerations for Antibody Drug Conjugates (ADCs)

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

In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more

Foley & Lardner LLP

Jepson Claim Format Does Not Avoid Written Description Scrutiny

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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

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

Sterne Kessler’s Reissue, Reexamination, and Supplemental Examination Practice Tips – March 2025

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

In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, 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

McDermott Will & Schulte on

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

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