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Patents Clinical Trials Patent Litigation

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

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Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Womble Bond Dickinson

Unexpected Results in Hatch Waxman Litigation: A Review of Legal Decisions from 2023

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Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This...more

Bradley Arant Boult Cummings LLP

Spring Has Sprung Obviousness Trends from the Federal Circuit

There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...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

Robins Kaplan LLP

Novartis Pharms. Corp. v. Accord Healthcare, Inc.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...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: How Clinical Stage Patent Strategies Can Bring New Pharmaceuticals to Market

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Pharmaceutical companies only need patents for compositions of matter and general methods of use, right? Wrong. Discoveries can happen well into Phase III and IV and pharmaceutical companies should seek patent protection for...more

Foley & Lardner LLP

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

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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

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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

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Knobbe Martens

Federal Circuit Review - May 2019

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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...

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

Knobbe Martens

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

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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

Robins Kaplan LLP

Teva Pharms. USA, Inc. v. Sandoz Inc.

Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more

Foley & Lardner LLP

Federal Circuit Takes A Narrow View Of Reasonable Expectation Of Success

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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

Goodwin

Samsung Bioepis Biosimilar Updates

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We previously reported that, according to a May 10, 2017 record on ClinicalTrials.gov, Samsung Bioepis planned to start a Phase 3 clinical trial in September 2017 on SB11, its biosimilar of Roche’s Lucentis® (ranibizumab...more

Foley & Lardner LLP

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

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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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