Patents Pharmaceutical Industry

News & Analysis as of

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

Case shows ever-changing nature of patent law

The America Invents Act (AIA), passed almost five years ago, continues to substantially change patent law in the United States — and questions about the law’s effects are still being litigated. One important question...more

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more

FDA (Finally!) Issues New Regulations to Clarify Pharmaceutical Patent Litigation: How to Use Patent “Use Codes”

On October 6, 2016, the FDA issued a final rule implementing certain provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) governing the approval of generic drugs, including...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Bass’s First IPR Decision Rendered – Victory for Patent Owner, Shire Lpc

If Kyle Bass’s Coalition for Affordable Drugs Series II hedge fund was hoping to reap a windfall from short positions in Shire Plc’s stock this week, it was dealt a major setback by a Patent Trial and Appeal Board (PTAB)...more

Supreme Court Again Refuses to Clarify Scope of Hatch-Waxman Safe Harbor

The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...more

EU Court Confirms European Commission’s Decision on Pay-for-Delay Agreements

On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...more

Third Circuit Creates Framework for Analyzing Numerosity

The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more

PTAB Life Sciences Report - September 2016 #2

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Medtronic Xomed, Inc. v. Neurovision Medical Products, Inc. - PTAB Petition: ...more

Searching for Causation in ACTOS Complaint

How explicitly must a complaint sounding in antitrust allege causation? At oral argument last week, the Court of Appeals for the Second Circuit evaluated the sufficiency of the plaintiffs’ allegations that certain Takeda...more

General Court of the EU Confirms Fines Imposed on Lundbeck and Generic Drug Manufacturers for Entering into Patent Settlements

On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, an originator company, and Merck (the parent company of...more

Double Patenting Decision Delivers Bitter Pill To Antibody Patent

In a recent decision on obviousness-type double patenting, Judge Wolf shortened the shelf life of a dispute between Janssen Biotech, Inc. (“Janssen”) and Celltrion Healthcare Co. Inc. (“Celltrion”), relating to a...more

The new “Pet” on the block: radio imaging with Zirconium-89

This is the third in a series of articles looking at the hot topic of the patenting of radiopharmaceuticals. In this article we are focusing on zirconium-89 (89Zr) labelled molecules, such as antibodies, and their use in...more

Bad Science Makes Bad Patent Law—No Science Makes It Worse (Part II)

In Part I, I explained some general criteria for laws of nature, considering the prototypes of Newton's laws and Einstein's E=mc2. Now I'll turn to whether there are laws of nature in biology. Biological generalizations,...more

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

Third Circuit Decertifies Class on Numerosity Grounds, Listing Relevant Factors for the First Time

The Modafinil decision bodes well for defendants and represents another step toward increased scrutiny of the class action device in the Third Circuit. On September 13, a divided panel of the U.S. Court of Appeals for...more

CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s Cimzia® (certolizumab pegol), a biologic medicine...more

Amgen’s Federal Circuit Appeal to Address Important BPCIA Disclosure Issue

The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more

Hartig Drug Co. v. Senju Pharmaceutical Co. (3rd Cir. 2016)

Perhaps one of the most influential first year law school classes for the task of learning how to "think like a lawyer" is civil procedure. Particularly when the professor is bold enough to engage students on the intricacies...more

PTAB Life Sciences Report - September 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH - PTAB Petition: IPR2016-01665;...more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more

Oxford Immunotec Ltd. v. Qiagen, Inc. (D. Mass. 2016)

Magistrate Recommends That Defendants' Motion to Dismiss Be Allowed for Kit Claims and Denied for Method Claims - Last month, in Oxford Immunotec Ltd. v. Qiagen, Inc., Magistrate Judge Donald L. Cabell of the U.S....more

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