Life Sciences Patents

News & Analysis as of

News from Abroad: Not One But Two Decisions Fine Tune the Australian Patent Office's Approach to Life Science Technologies

Two recent Australian Patent Office decisions have provided clarity as to the patentability of isolated nucleic acid sequences following the High Court's decision in D'Arcy v Myriad Genetics ('Myriad'). The first decision is...more

UK announces intention to ratify the Unified Patent Court Agreement

The UK Government yesterday announced that its plans to ratify the Unified Patent Court Agreement (“UPCA”) will not be derailed by Brexit. The UK Minister of State for Intellectual Property, Baroness Neville Rolfe, made the...more

Post Grant Review: § 112 and Eligibility Issues in Chemical and Life Sciences

Post Grant Review (PGR) petitions are on the rise, and nearly half of all petitions to date have challenged patents in Biotechnology and Organic Chemistry, or Chemical and Materials Engineering technology centers. We have...more

Freedom to Operate and the Use of AIA Review

Freedom to Operate: •Identifying infringement risk •Third party patent (infringement) – claim searching –Timing •Discrete, continuous –Searching •In-house, search agency –Screening/analyzing •Ranking...more

PTO Schedules s. 101 Roundtables

At 81 Fed. Reg. 71485, The PTO has scheduled two roundtables at the PTO to receive feedback from the IP community, particularly on the Examples that were promulgated in May. The first roundtable will be on November 14th from...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VIII, The Microbiome and Immunotherapy I

Introduction - Cancer immunotherapy or immuno-oncology (I-O) has gone mainstream. You may have heard about these topics in the media. Along with having surgery and radiation therapy, Former President Jimmy Carter was...more

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...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

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VII, The Microbiology of the Built Environment

Many research efforts into the microbiome have focused primarily on the human microbiome, i.e., microorganisms within and on the body, and how changes in these microbial communities correlate with changes in health and...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

USPTO Announces 2016 Patents for Humanity Winners

On Thursday, the U.S. Patent and Trademark Office announced the latest winners of the Patents for Humanity program. The Patents for Humanity program, which was launched by the Office in February 2012 as part of an Obama...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

European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?

The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences...more

LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)

The complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed...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

D. Mass Court Extends Myriad to Peptide Panels

In a great leap backwards for patenting life sciences, Magistrate Judge Cabell invalidated claims in a number of patents licensed to Oxford Immunotec that are directed to e.g., “A kit for diagnosing infection in a human host...more

PTAB Life Sciences Report - August 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Illumina, Inc. v. Scripps Research Institute - PTAB Petition: IPR2016-01619; filed...more

Investment in Biotechnology Companies -- Nature Biotechnology Report

Despite an understandable amount of gloom and doom in patenting circles regarding the effects of the recent Supreme Court and Federal Circuit jurisprudence on life sciences patents (Mayo v. Prometheus; AMP v. Myriad Genetics;...more

Business Litigation Report - August 2016

Circuit Courts Align to Shield SEC Administrative Proceedings from Collateral Constitutional Attack - In response to the financial crisis of the late 2000s, Congress passed the Dodd-Frank Wall Street Reform and Consumer...more

PTAB Life Sciences Report

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

Federal Circuit Finds Life Sciences Subject Matter Patent Eligible

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

PTO Provides Additional Guidance on Patent Eligibility of Life-Sciences Method Claims

On July 14, 2016, the PTO sent a memorandum to the examining corps regarding the recent rulings in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), and Ariosa Diagnostics,...more

Method For Preserving Hepatocytes Patent-Eligible, Despite Use Of Newly-Discovered Natural Cell Characteristics

Rapid Litigation Management, Inc. v. CellzDirect, Inc., No. 2015-1570 (Fed. Cir. July 5, 2016) - The Federal Circuit recently held that a patent covering a process for producing a preparation of frozen liver cells...more

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

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