News & Analysis as of

Life Sciences

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

Italian Regions cannot recommend against use of costly medicines – says highest administrative court

by Allen & Overy LLP on

A recent decision by the Italian Council of State (CS) comes as welcome news for the innovative pharmaceutical industry as it sets important boundaries to the initiatives that regional authorities can take in the attempt to...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

Pharma Distributors Trade Association Sued for Conspiracy to Exclude Competition for its Track and Trace Software

On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software,...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

CFDA Issues New Classification Catalogue for Medical Devices In China

by Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

Agriculture Biologicals Company NewLeaf Symbiotics Announces Second Close to Complete its $30MM C Round Financing

by Bryan Cave on

NewLeaf Symbiotics announced that it has completed the second close of its $30MM series C financing, accelerating plans to convert proven applications of its unique biologicals platform into products for large-scale...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Life Sciences Quarterly: A View From Washington: What to Expect From the SEC

by Ropes & Gray LLP on

What should we expect from the U.S. Securities and Exchange Commission regarding the status of new and existing initiatives by Congress and SEC policy, and how will it affect disclosure, governance and capital formation? In...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

The EU regulatory challenges and liability risks associated with 3-D printed medical devices

by Hogan Lovells on

In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies....more

Five Takeaways From Fenwick’s Sixth Annual Digital Health Investor Summit

Fenwick’s Sixth Annual Digital Health Investor Summit started on an upbeat note with Rock Health’s Megan Zweig sharing the venture fund’s mid-year funding report. After the uncertainty brought by the 2016 presidential...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

A road map to life sciences M&A in the Netherlands

by Hogan Lovells on

U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...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

The commission assessment – a decision-making aid for EMA's relocation?

by Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

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