News & Analysis as of

Clinical Trials Prior Art

McDermott Will & Emery

Preliminary Injunction Upheld in Cancer Relapse Detection Case

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The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including...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

Rothwell, Figg, Ernst & Manbeck, P.C.

The Evolving Gene Editing Landscape: From Research Tool to Market

Gene therapies have been the subject of tremendous scientific research and investment. With hundreds of clinical trials in progress and many target applications, the biotechnology, agricultural, and pharmaceutical fields are...more

Haug Partners LLP

No Clear Error to Find Lack of Written Description for a Method of Treatment Patent Despite Separate Disclosures of the Drug,...

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Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Anticipation

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Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more

Rivkin Radler LLP

Behold the Prior Art: A (Patentable) Solution to the COVID-19 Pandemic?

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In his (perhaps, what will one day be a) seminal report on the results of a clinical trial, Dr. Didier Raoult and colleagues reported that after six days of administering hydroxychloroquine combined with azithromycin, 100% of...more

Foley & Lardner LLP

Federal Circuit Reverses PTAB On Reasonable Expectation Of Success For TARCEVA Patent

Foley & Lardner LLP on

In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....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

McDermott Will & Emery

Merely Articulating a Goal Does Not Provide Reasonable Expectation of Success

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The US Court of Appeals for the Federal Circuit affirmed a district court non-obviousness decision, finding that a prior art reference that articulates a goal without explaining how that goal is achieved does not provide a...more

Knobbe Martens

Federal Circuit Review - May 2019

Knobbe Martens on

Reasonably Continuous Diligence Is Not Negated If an Inventor Works On Improvements or Evaluates Alternatives to the Claimed Invention - In ATI Technologies ULC v. IANCU, Appeal Nos. 2016-2222, -2406, -2608, the Federal...more

Knobbe Martens

Prior Art Regulatory Guidelines That Recite a Goal Without Teaching How That Goal Can Be Achieved Are of Limited Value as an...

Knobbe Martens on

ENDO PHARM, INC., v. ACTAVIS LLC - Before Wallach, Clevenger, and Stoll. Appeal from the United States District Court for the District of Delaware....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

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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

Foley & Lardner LLP

Federal Circuit Takes A Narrow View Of Reasonable Expectation Of Success

Foley & Lardner LLP on

The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more

Foley & Lardner LLP

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

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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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