News & Analysis as of

Pharmaceutical Patents Clinical Trials Inter Partes Review (IPR) Proceeding

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Goodwin

Update on John Hopkins and Merck Pembrolizumab Litigation

Goodwin on

In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins...more

MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

Goodwin

Alexion and Amgen Settle IPRs Over SOLIRIS (eculizumab)

Goodwin on

Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis...more

Knobbe Martens

Completion of Phase I Safety Trials for FDA Approval May Not Be Sufficient to Show Reasonable Expectation of Success

Knobbe Martens on

OSI PHARMACEUTICALS, LLC v. APOTEX INC - Before Stoll, Newman, and Taranto. Appeal from the Patent Trial and Appeal Board. Summary: A pharmaceutical company’s statement touting the completion of Phase I safety trials...more

Bradley Arant Boult Cummings LLP

Evidence of Industry Skepticism Supports Finding of Nonobviousness - Intellectual Property News

In a precedential decision delivered recently, the Federal Circuit shot down arguments from Neptune Generics, LLC, Mylan Laboratories Ltd., and Fresenius Kabi USA, LLC that the Patent Trial and Appeals Board (PTAB) erred in...more

Knobbe Martens

Secondary Consideration of Skepticism Supports Non-Obviousness at PTAB

Knobbe Martens on

Before Moore, Wallach, and Hughes. Appeal from the Patent Trial and Appeal Board - Summary: Industry skepticism is a question of fact that weighs in favor of non-obviousness and can range on a scale, with the most weight...more

Knobbe Martens

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

Knobbe Martens on

Federal Circuit Summaries - Before Newman, Dyk, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: An injury-in-fact is required to establish Article III standing for judicial review of agency action,...more

Foley & Lardner LLP

PTAB Institutes Kyle Bass IPR Against Pharmaceutical Patent Based On SEC Document

Foley & Lardner LLP on

Kyle Bass has filed numerous prior IPR petitions against pharmaceutical patents, some of which have been denied due to use of prior art references that were not sufficiently proven to be “publicly accessible” (see “Clinical...more

Foley & Lardner LLP

Clinical Trials as Prior Art: PTAB Denies Bass IPR Petition With Only a "Hope" of Efficacy

Foley & Lardner LLP on

In the most recent loss for Kyle Bass’ hedge fund in IPR proceedings, the Board denied institution of an IPR based on a petition filed by Coalition for Affordable Drugs V LLC (CFAD) against Biogen MA Inc. IPR2015-01136, Paper...more

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