Pharmaceutical Patents

News & Analysis as of

IPR Tracker: IPR2016-00383 (U.S. Patent No. 6,331,415) (Genzyme) (Cabilly II patent) – Denying Institution of IPR

The PTAB has denied IPR on U.S. Patent No. 6,331,415. On June 8, the PTAB instituted a separate Genzyme petition against this patent (IPR20016-00460), which was joined to an earlier Sanofi-Aventis and Regeneron IPR...more

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

Supreme Court Defers Certiorari Decision In Amgen Sandoz Biosimilar Patent Dance Dispute

On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more

Supreme Court Asks Solicitor General to Weigh In on Amgen v. Sandoz

Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the...more

Amgen Appeals Ruling on Requirement to Produce Manufacturing Information for a Biosimilar Product under Amgen v. Sandoz

Amgen has appealed a partial denial of its motion to compel in Amgen v. Hospira, No. 15-cv-839, currently pending in the District of Delaware. The case, filed last September, concerns Hospira’s proposed biosimilar of Amgen’s...more

Janssen Sues HyClone Laboratories Over Cell Cultures Used to Grow Celltrion’s Remicade Biosimilar

In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone...more

Amicus Briefs in Support of Sequenom's Petition for Certiorari: Dr. Chakrabarty, A Scientist's View

In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v....more

Amicus Briefs in Support of Sequenom's Petition for Certiorari: Eli Lilly and Company et al.

In March, following the Federal Circuit's denial of Sequenom's petition for rehearing en banc, Sequenom filed a petition for certiorari for Supreme Court review of the Federal Circuit's decision in Ariosa Diagnostics, Inc. v....more

Janssen Uses Manufacturing Info Obtained in BPCIA Litigation to Target Supplier

New developments arose on Tuesday in the dispute between Janssen and Celltrion over Celltrion’s biosimilar of Janssen’s Remicade® (infliximab). On May 31, the district court overseeing the BPCIA litigation (D. Mass., C.A....more

Post-Trial Rulings Issue In Bandamustine Case

Sleet, J. Post-trial opinion issues with respect to four patents-in-suit in ANDA trial relating to Bendamustine. Trial took place December 1 through 8, 2015....more

Health Alert (Australia) June 13, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Judgments: Victoria 1 June 2016 - JPP v Department of Health and Human Services (Review and Regulation)...more

Trial Opinion Issues In Suboxone® ANDA Case

Andrews, J. Trial opinion finding the asserted claims in one patent invalid and certain products would infringe if valid; the asserted claims of a second patent are valid and infringed; the asserted claims of a third patent...more

Magistrate Recommends Claim Construction In Coreg Case

Burke, M. J. Report and Recommendation regarding claim construction issues regarding six terms from one patent. A Markman hearing took place on April 4, 2016....more

FDA Announces Advisory Committee Meeting on Sandoz’s Etanercept Biosimilar

We previously reported on Sandoz’s aBLA for a biosimilar of Amgen’s ENBREL (etanercept) and the related BPCIA litigation. The FDA’s Arthritis Advisory Committee announced this morning that it will hold a public advisory...more

Survey of Pharmaceutical IPRs Filed By Generic Drug Company Petitioners

We have reviewed a sub-group of 111 IPRs filed by generic drug companies against pharmaceutical patents to assess outcomes and trends. While our survey was not intended to capture every IPR filed by a generic drug company, it...more

Protecting Proprietary Compound Structures: Key Lessons From Merck's Unclean Hands

Companies disclosing proprietary compound information must take steps to protect their interest in such information. Equally important, but often overlooked, companies receiving another party's proprietary information also...more

Bloomberg/BNA Releases Report on Biopharma IPRs

As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been...more

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

IP Developments In Biotechnology And Trade Secrets

2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets. Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom? Ariosa v. Sequenom was...more

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

On March 18, 2016, the Federal Circuit held that filing an abbreviated new drug application (“ANDA”) with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including...more

Court Report - June 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Orexo AB et al. v. Actavis Elizabeth LLC et al. 1:16-cv-00397; filed May 27, 2016 in the District Court of Delaware...more

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more

BIO International Convention 2016 Preview

BIO and Biosimilars - The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

Court Decides that ANDA Approved Before Patent Issued Cannot Infringe 35 U.S.C. § 271(e)(2)(A)

Although the Hatch-Waxman Act was passed by Congress decades ago, it still produces new questions. Despite vigorous argument by the patent owner, a district court dismissed a count alleging that the ANDA-filer infringed under...more

Court Report - May 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Allergan, Inc. et al. v. Somerset Therapeutics, LLC 1:16-cv-00392; filed May 26, 2016 in the District Court of...more

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