Pharmaceutical Patents

News & Analysis as of

CardioNet Sues InfoBionic

On May 8, 2015 CardioNet, LLC and Braemar Manufacturing, LLC sued InfoBionic in the United States District Court, District of Massachusetts. The lawsuit alleges that InfoBionic’s MoMe® Kardia System infringes four of...more

Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

IP Dispute Resolution Review Newsletter, Spring 2015

In This Issue: - The New “Clear Error” Standard of Review in Patent Infringement Mediation - Trademark Trial Appeal Board Decisions Now Have Preclusive Effect - Engaging Panelists for Neutral Analysis Provides...more

Status of Pay-for-Delay Cases Nearly Two Years After Actavis – “It ain’t over ’til it’s over.”

Nearly two years ago the Supreme Court issued its opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013), holding that a reverse payment made by a brand manufacturer to a generic manufacturer to resolve pending patent litigation...more

Biosimilar Makers Turn to IPRs before Litigation under the BPCIA

A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to litigate the validity of patents that cover their proposed products prior to submission of their biosimilar applications to FDA. ...more

IP Newsflash - May 2015 #3

FEDERAL CIRCUIT CASES - Federal Circuit Reverses Summary Judgment of Noninfringement Under § 271(e)(1) for Consideration of Certain Post-FDA-Submission Activities, But Expresses Skepticism About Infringement...more

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

Court Report - May 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Galderma Laboratories LP et al. v. Glenmark Generics Inc USA 3:15-cv-01416; filed May 6, 2015 in the Northern District...more

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more

Analysis of Inter Partes Review and Post-Grant Review in the Life Sciences Industry Through First Quarter 2015

The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more

California Supreme Court Delineates a Structured Rule of Reason Analysis for Evaluating Reverse Payment or Pay-for-Delay...

On May 7, 2015, the California Supreme Court issued its long-awaited decision in In re Cipro Cases I & II, Case No. S198616 (May 7, 2015) (Cipro). Cipro holds that reverse payment settlements can be challenged under...more

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Senators Send Letter on Biosimilars to FDA

A group of Senators led by Sen. Lamar Alexander (R-TN), the Chairman of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter last month to Dr. Stephen Ostroff, the Acting Commissioner of the U.S. Food...more

Amgen Prevails on Temporarily Excluding Zarxio® From Market

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal...more

Lessons in Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

An emerging issue in Hatch-Waxman litigation – and potentially under the Biologics Price Competition and Innovation Act (BPCIA) – is the impact of the Supreme Court’s decision in Daimler AG v. Bauman, 134 S. Ct.746 (2014), on...more

Republican HELP Committee Members Request FDA to Step Up Finalizing Biosimilars Guidances and Transparency

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar...more

Amgen Wins Injunction against Neupogen® Biosimilar Pending Appeal

The Federal Circuit has granted Amgen’s emergency motion for an injunction against Sandoz, preventing that company from marketing, selling, offering for sale, or importing into the United States its FDA-approved ZARXIO®...more

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

Acorda Therapeutics, Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.). Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more

Biosimilars Access and Education Taking Center Stage with First Biosimilars in the Wings

Two new voices have emerged with goals to help expand patient access and information about biosimilars in the United States—the Biosimilars Forum and the Biosimilars Council, discussed below....more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.). Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation...more

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...more

Keeping Up With Kyle Bass

In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug...more

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