News & Analysis as of

Post-Grant Review 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

Knobbe Martens

Speculative Plans Are Insufficient to Establish Standing in PTAB Appeals

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INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. - Before Moore, Hughes, and Cunningham. Appeal from the Patent Trial and Appeal Board. Speculative plans for potentially infringing activity are insufficient to...more

Fish & Richardson

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

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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

Venable LLP

Venable’s BiologicsHQ Monthly Injection - October 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more

Venable LLP

PTAB Issues Final Written Decision Finding Seagen’s Adcetris® Patent Claims Unpatentable

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On January 16, 2024, the PTAB issued a Final Written Decision in a post-grant review (“PGR”) of claims in U.S. Patent No. 10,808,039 (the “’039 patent”) owned by Seagen Inc. (“Seagen”). PGR2021-00030 was filed by Daiichi...more

Goodwin

PTAB Issues Final Written Decision Finding Seagen Antibody-Drug Conjugate Patent Claims to be Unpatentable

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​​​​​​​On January 16, 2024, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office issued a Final Written Decision in a post-grant review (PGR) (PGR2021-00030) of claims in US Patent No....more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Topics in 2024

What should in-house counsel be on the lookout for in 2024? As we begin a new year, our attorneys look ahead at intellectual property topics they expect will be trending in 2024. They cover areas including life sciences,...more

Knobbe Martens

PREVAIL Act Proposes Significant Changes PTAB Proceedings

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IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more

Fish & Richardson

Biosimilars 2022 Year in Review

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2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Goodwin

Regeneron’s Disclaimer of Aflibercept Formulation Patent Causes PTAB Denial of Institution of Celltrion PGR

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On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231...more

Fish & Richardson

Biosimilars 2021 Year in Review

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2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Morgan Lewis

Blockbuster Biologics Review Issue 14

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Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Fish & Richardson

2020 Post-Grant Report

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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

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

Goodwin

Federal Circuit Addresses Standing in Decision on Appeal from PTAB

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Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review...more

Hogan Lovells

PTAB: Tribal Sovereign Immunity Does Not Provide a Basis to Terminate IPRs

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On February 23, 2018, in a much-anticipated decision, the PTAB ruled that tribal sovereign immunity could not be used to shield certain Allergan Inc. (“Allergan”) patents from review in a number of IPRs. Allergan had assigned...more

Troutman Pepper Locke

Allergan’s Mohawk Gambit Fails At The PTAB

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The Patent Trial and Appeal Board (PTAB) has not taken kindly to a move by the Irish drug company Allergan to shield its key patents on its dry-eye drug Restasis from challenge at the U.S. Patent Office by assigning these...more

Troutman Pepper Locke

PTAB Can Rely on New Evidence Introduced by Petitioner in its Reply

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In a decision last month, the Court of Appeals for the Federal Circuit gave petitioners in AIA proceedings yet another weapon to invalidate patents – by affirming a Patent Trial and Appeal Board (PTAB) decision that relied,...more

Goodwin

Issue Three: Keeping Tabs on the PTAB

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The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Troutman Pepper Locke

Bass’s First IPR Decision Rendered – Victory for Patent Owner, Shire Lpc

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If Kyle Bass’s Coalition for Affordable Drugs Series II hedge fund was hoping to reap a windfall from short positions in Shire Plc’s stock this week, it was dealt a major setback by a Patent Trial and Appeal Board (PTAB)...more

Sheppard Mullin Richter & Hampton LLP

Post-Grant Review Roils Patent Litigation Waters

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

BakerHostetler

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

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Pharmaceutical companies have reason to be pleased with the Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

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The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Troutman Pepper

Hedge Fund Troll Undetered by Initial Setbacks

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Kyle Bass and his hedge funds, the Coalitions for Affordable Drugs LLC, have failed in several of their initial attempts to knock out drug patents. In two decisions handed down late last month, the Patent Trial and Appeal...more

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