News & Analysis as of

Life Sciences Patents

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

by Morgan Lewis on

There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc. (D. Del. 2017)

Last month, in Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., District Judge Richard G. Andrews of the U.S. District Court for the District of Delaware denied a motion to dismiss filed by...more

Unknown Problem Plus Nonobvious Solution Cannot Render Patent for Sublingual Formulation of Asenapine Obvious

by McDermott Will & Emery on

The District Court for the District of Delaware found Forest Labs’ patent for sublingual or buccal compositions of asenapine and methods of using such compositions to treat mental disorders, including schizophrenia and mania,...more

PTAB Life Sciences Report - November 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Sawai USA, Inc. v. Astellas Pharma Inc. PTAB Petition: IPR2018-00079; filed October 16,...more

Rare Grant of Request for Rehearing in Biologics-related IPR

by Morgan Lewis on

Reconsideration leads to a reversal of course regarding a key claim limitation. On October 26, 2017, in Hospira, Inc. v. Genentech, Inc., the Patent Trial and Appeal Board (PTAB) granted Hospira’s request for rehearing and...more

PTAB Life Sciences Report - November 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pfizer Inc. v. Biogen, Inc and Genentech, Inc. PTAB Petition: IPR2017-02126; filed October 6,...more

Bioquark Seeks to Reverse Brain Death

Last year, two biotech companies announced that they had received institutional review board (IRB) approval for a study focused on the clinical intervention of brain death in humans. The study, entitled "Non-randomized,...more

PTAB Life Sciences Report - October 2017 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complete Genomics, Inc. v. Illumina Cambridge Ltd. - PTAB Petition: IPR2017-02172; filed...more

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

PTAB Life Sciences Report - October 2017

About the PTAB Life Sciences Report:  Each month we will report on developments at the PTAB involving life sciences patents. Sun Pharmaceuticals Industries, Ltd. v. Novartis AG - PTAB Petition: IPR2017-01929; filed...more

Merck Sharp & Dohme B.V. v. Warner Chilcott Co. (Fed. Cir. 2017)

The Supreme Court most recently revisited the proper standards for making an obviousness determination ten years ago, in KSR Int'l. Co. v. Teleflex. Inc. While in some ways changing the obviousness standard, for example...more

Federal Circuit Questions Written Description For Antibody Claims

by Foley & Lardner LLP on

The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from...more

Guide to the U.S. Patent Office’s Materials on Subject Matter Eligibility

by Knobbe Martens on

Since 2014, the USPTO has periodically issued examination guidance, analysis examples, and other insights to guide evaluation of patent subject matter eligibility under 35 U.S.C. § 101. These documents are available on the...more

Lessons for Life Science and Medical Device Companies Post-Nautilus

by Robins Kaplan LLP on

Under the U.S. Patent laws, claims must particularly point out and distinctly claim what the inventor understands her invention to be. Up until three years ago, the inquiry for determining indefiniteness was to ask whether...more

Federal Circuit OK's Use of Post-Priority-Date Evidence

by Morgan Lewis on

The ruling found that the use of such evidence was proper for written description and enablement....more

USPTO Update on Patent-Eligibility for Life Science Inventions

by Foley & Lardner LLP on

On August 2nd 2017, the USPTO hosted a Bicoastal Biotechnology/Chemical/Pharmaceutical Customer Partnership that focused on the USPTO’s current thinking on patent-eligibility. The meeting followed the USPTO’s June 25th, 2017...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part XIII: The Microbiome and Antibiotic Resistance

Antibiotic resistance is a major problem in the United States and is considered by the World Health Organization (WHO) to be one of the largest threats to human health. The top 12 bacterial threats classified by WHO are...more

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Business Litigation Report - August 2017

Supreme Court Highlights Importance of Statute-Specific Venue Rules - The Supreme Court upended nearly thirty years of practice when it ruled, in the TC Heartland LLC v. Kraft Foods Group Brands LLC U.S. , 137 S.Ct. 1514...more

August 2017: Life Sciences Litigation Update

Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2017-1645, 2017 WL 2192945 (Fed. Cir. May 19, 2017). On May 19, 2017, the Federal Circuit issued a precedential opinion in Mylan Institutional LLC v. Aurobindo Pharma Ltd....more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Cleveland Clinic Foundation v. True Health Diagnostics, LLC (E.D. Va. 2017)

District Court Finds Method of Detecting Claim to Be Directed to Patent Ineligible Subject Matter - Earlier this month, in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, District Judge Leonie M. Brinkema of...more

MiMedx Group, Inc. v. Liventa Bioscience, Inc. (N.D. Ga. 2017)

In the general chaos that has resulted from the Supreme Court's recent forays into trying to delineate the proper standards for patent subject matter eligibility (AMP v. Myriad Genetics, Mayo Collaborative Labs v....more

Doctrine of Equivalents under Enzo Biochem Inc. v. Applera Corp.

by Knobbe Martens on

Before Prost, O’Malley, and Wallach. Appeal from the District of Connecticut (nonprecedential). On August 2, 2017, the Federal Circuit affirmed a decision by the U.S. District Court for the District of Connecticut granting...more

Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2017)

Last week, in Enzo Biochem Inc. v. Applera Corp., the Federal Circuit determined that the District Court for the District of Connecticut accurately interpreted the Federal Circuit's decision in Enzo Biochem, Inc. v. Applera...more

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