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Written Descriptions Life Sciences

MoFo Life Sciences

The PTAB Axes Skin Treatment Patent Under Amgen

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The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

Venable LLP on

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Sunstein LLP

Enablement Enigma: The Supreme Court Weighs In

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In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....more

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

McDonnell Boehnen Hulbert & Berghoff LLP

Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Broad Contingent Motion No. 2

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

McDonnell Boehnen Hulbert & Berghoff LLP

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)

The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if...more

McDonnell Boehnen Hulbert & Berghoff LLP

Senior Party Sigma-Aldrich Files Opposition to Broad Contingent Motion No. 2

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...more

MoFo Life Sciences

Stepping Stones To Success: Supporting Claims In The Life Sciences

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The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims....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

Proskauer - Life Sciences

“Negative” Patent Claim Limitations—May They be Adequately Described by Omission?

Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification...more

Knobbe Martens

Written Description: What Is the Proper “Dosage” to Satisfy This Requirement?

Knobbe Martens on

BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC. Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia. Summary: A specification may not...more

Proskauer - Life Sciences

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

Kramer Levin Naftalis & Frankel LLP

Federal Circuit Invalidates Early CAR-T Patent

On Aug. 26, 2021, the Federal Circuit held the asserted claims of Sloan Kettering’s CAR-T patent invalid for lack of written description, reversing the final judgment of a California district court awarding Sloan Kettering...more

McDonnell Boehnen Hulbert & Berghoff LLP

Juno Therapeutics, Inc. v. Kite Pharma, Inc. (Fed. Cir. 2021)

Dominating the entering gallery of the Impressionists exhibit at the Art Institute of Chicago is Georges Seurat's A Sunday on La Grande Jatte (see below). Painted in the pointillist style, the work comprises millions of...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

McDonnell Boehnen Hulbert & Berghoff LLP

CVC Files Motion in Opposition to Broad's Substantive Motion No. 4

On January 9th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its motion in opposition to Senior Party the Broad Institute (joined by...more

Sullivan & Worcester

Idenix Pharma: The difficulty of supporting broad pharmaceutical claims

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The Federal Circuit’s recent decision in Idenix Pharmaceutical v. Gilead Sciences (October 2019) demonstrates the difficulty of adequately supporting broad pharmaceutical claims and provides a potential roadmap to invalidity...more

Harris Beach PLLC

Patent Office Issues New Guidance for Antibody Written Description Requirements

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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

Federal Circuit Questions Written Description For Antibody Claims

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The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from...more

Morgan Lewis

Federal Circuit OK's Use of Post-Priority-Date Evidence

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The ruling found that the use of such evidence was proper for written description and enablement....more

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