Patents Pharmaceutical Industry

News & Analysis as of

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Phigenix, Inc. v. ImmunoGen, Inc. (Fed. Cir. 2016)

Can any petitioner appeal a Board's final written decision from an inter partes review or post grant review proceeding? Contrary to the language of 35 U.S.C. § 141(c) which permits any party "who is dissatisfied with" the...more

Nexium Case Extends Actavis Ruling

Addressing a pay-for-delay and pharmaceutical-settlement antitrust jury trial for the first time since the 2012 Supreme Court of the United States decision in FTC v. Actavis (IP Update, Vol. 16, No. 7), the US Court of...more

Confidentiality in BPCIA Cases

The Biologics Price Competition and Innovation Act (“BPCIA”) contemplates the exchange of highly sensitive information from the pre-suit “patent dance” (see, e.g., 42 U.S.C. 262 (l)(2)(A)) throughout litigation, bringing...more

Addressing Increased Drug Costs -- A Proposal

The New York Times in a recent video (see "'Could You Patent the Sun?'") has returned to its theme against patenting, particularly with regard to patents for life-saving drugs. This time the paper invokes the meme of Jonas...more

When Time is Money

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Closed Case Is Reopened To Amend Induced Infringement Claims In ANDA Litigation Relating To Mitigare

Robinson, J. Plaintiff’s motion to reopen judgment and amend the complaint is granted. Plaintiff’s request for a preliminary injunction was denied and the denial was affirmed on appeal. On September 10, 2015, Takeda...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month (or more frequently) we will report on developments at the PTAB involving life sciences patents....more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month (or more frequently) we will report on developments at the PTAB involving life sciences patents....more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

Heartburn for Defense After Jury Verdict in Pepcid® Dispute

The recent jury verdict in a dispute over a generic version of the heartburn medication Pepcid® Complete® would be enough for anyone to reach for a few tablets of the accused product. After an eight day trial presided over by...more

Biosimilars: Solicitor General Recommends Granting Certiorari in Amgen v. Sandoz

Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more

PTAB Life Sciences Report -- December 2016 #2

About the PTAB Life Sciences Report: Each month (or more frequently) we will report on developments at the PTAB involving life sciences patents....more

Six Ways U.S. Joint Strategic Plan on IP Enforcement Impacts Public Health and Safety

On December 12, 2016, the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) in the Executive Office of the President issued a much-awaited interagency plan on intellectual property (IP) enforcement. The...more

Judgment For Plaintiffs After Cyclobenzaprine ANDA Trial

Robinson, J. The court enters judgment against defendants following 2-day bench trial. Trial took place on November 16 and 17, 2015. The disputed product relates to cyclobenzaprine formulations with extend release...more

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more

PTAB Life Sciences Report -- Part I December 2016

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Attorney-Client Privilege Held Not to Apply to Nonreporting Employee/Expert

Many years ago, we represented a client in a quandary. (We know, we know: that’s pretty much always the case.) The product had been sold for many decades, the early history was important in marshalling a defense, and there...more

Rx IP Update - November 2016

Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

MoFo IP Newsletter - November 2016

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes” - October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare...more

The World in US Courts: Orrick's Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities

Alien Tort Statute (ATS)/Torture Victims Protection Act (TVPA)/Anti-Terrorism Act (ATA) - District Court Dismisses ATS Claim Where Alleged Conduct in US Was Not Directly Linked to Injuries Claimed in Other Countries...more

Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA

Case Name: Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA, Civ. No. 15-656 (CKK), 2016 U.S. Dist. LEXIS 86952 (D.D.C. July 6, 2016) (Kollar-Kotelly, J.) - Drug Product and Patent(s)-in-Suit: Pradaxa® (dabigatran...more

Forest Labs. Holdings Ltd. v. Mylan Inc.

Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more

Bayer Pharma AG v. Watson Labs., Inc.

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016) - Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate / dienogest); U.S. Patent No....more

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

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