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Patent Applications Patent Trial and Appeal Board Pharmaceutical Industry

Jones Day

Acting Director Denies IPR Institution Based on “Settled Expectations”

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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

DLA Piper

What is a “Clear and Unmistakable” Prosecution History Disclaimer?

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The Federal Circuit’s March 21, 2025 decision in Maquet Cardiovascular LLC v. Abiomed Inc. et al. (No. 2023-2045) and the recent Patent Trial and Appeal Board (PTAB) Delegated Rehearing Panel decision in SynAffix B.V. v....more

Parker Poe Adams & Bernstein LLP

Life Sciences Companies Have New Avenue to Challenge Patent Applications After Federal Court Ruling

Drugmakers and other companies in the life sciences industry seeking to invalidate patents have another arrow in their quiver thanks to a recent federal court decision....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

American Conference Institute (ACI)

[Event] 20th Paragraph IV Disputes - April 25th - 26th, New York, NY

Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more

McDermott Will & Schulte

[Webinar] 2024 IP Outlook: Trends Affecting Patent, Trademark, Copyright and Trade Secret Holders - December 12th, 1:00 pm - 2:00...

As 2023 draws to a close, new developments continue to emerge across the patent, trademark, copyright and trade secret spaces. Join members of McDermott’s Intellectual Property Group for a year-end review that will explore...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more

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

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

MoFo Life Sciences

Obviousness In Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms Of Action

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Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more

Knobbe Martens

Description Prescription

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REGENTS OF THE UNIVERSITY OF MINNESOTA V. GILEAD SCIENCES, INC. Before Lourie, Dyk, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: For drug patents, adequate written description of a broad genus...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

McDonnell Boehnen Hulbert & Berghoff LLP

OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019)

Last week, the Federal Circuit overturned an obviousness determination in an inter partes review by the Patent Trial and Appeal Board in OSI Pharmaceuticals LLC v. Apotex Inc.  The Court also reaffirmed its holdings in...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019)

Last week, in Supernus Pharmaceuticals, Inc. v. Iancu, the Federal Circuit reversed the entry of summary judgment by the District Court for the Eastern District of Virginia, which concluded that the U.S. Patent and Trademark...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

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As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

Patterson Belknap Webb & Tyler LLP

Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar...

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

McDermott Will & Schulte

PTAB Denies Priority Claim, Has No Affinity for “Antibody Rule”

Addressing enablement and written description issues in the context of a priority challenge, the Patent Trial and Appeal Board (PTAB or Board) found that the challenged claims were not entitled to the benefit of the parent...more

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