News & Analysis as of

Written Descriptions United States Patent and Trademark Office Pharmaceutical Patents

Wolf, Greenfield & Sacks, P.C.

Practical Guide to Claiming Small Molecules with Functional Language

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

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

DLA Piper

CDR Scanning Offers Hope for Genus Claims for Antibodies

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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

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

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

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

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

PTAB Strategies and Insights: January 2022

The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2021: #4 to #6

After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more

Buckingham, Doolittle & Burroughs, LLC

Dear Patenticity: Patent Prophet

Dear Patenticity, I have a chemical invention and I want to obtain the broadest coverage I can. The problem is I have not done much lab work, so I only have a couple real examples. I know that the written description...more

Proskauer - The Patent Playbook

Juno v. Kite: Written Description and Claiming Antibodies and Chimeric Antigen Receptors—Lessons for Patent Prosecutors

The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Proskauer - Minding Your Business

CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35...more

Fenwick & West LLP

Written Description of Therapeutic Efficacy

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Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today’s first inventor-to-file system. However,...more

Fenwick & West LLP

Intellectual Property Bulletin - Winter 2021

Fenwick & West LLP on

Written Description of Therapeutic Efficacy - In two 2019 rulings, the Federal Circuit invoked the “written description requirement” of 35 U.S.C. § 112 to require evidentiary support for therapeutic efficacy. Now that the...more

American Conference Institute (ACI)

[Virtual Event] 18th Advanced Summit on Life Sciences Patents - August 5th - 6th, 9:00 am EDT

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...more

Harris Beach Murtha PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

Since 1999, the United States Patent and Trademark Office (“Patent Office”) has permitted the claiming of antibodies by disclosing the targeted antigen. In 2002, the Federal Circuit adopted Patent Office guidelines and...more

Foley & Lardner LLP

USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

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The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more

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