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Science, Computers & Technology Intellectual Property Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:

Testing of Jenex TherOZap™ Device Set to Begin

Luminar Media Group recently announced that, after completing development of a working prototype device, the Jenex Corporation has signed an agreement with the Techna Institute at the University Health Network to begin...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

PTAB Life Sciences Report -- Part II - April 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Teva Pharmaceuticals USA, Inc. v. Allergan, Inc. - PTAB Petition: IPR2017-00576; filed...more

Health Alert (Australia) March 27, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 21 March 2017 - Hicks v Mater Misericordiae Ltd [2017] QSC 38 - The applicant brought proceedings against the respondents...more

Novartis Secures FDA Approval for Breast Cancer Drug Kisqali

On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more

Ingestible e-Pill Approved For Use in Hospitals

BodyCap, a France-based company said to be dedicated to the development of miniature wireless electronic sensors, recently announced that its e-Celsius® device has earned CE mark approval and is now commercially available for...more

ANDA Update - March 2017 Volume 3, Number 1

by McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

The Cross-Industry Promise of Blockchain

The blockchain protocol (a form of a ‘distributed ledger system’) was originally designed as a platform to process Bitcoin transactions. The protocol enables peer-to-peer transactions and eliminates the need for a trusted...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

by Fish & Richardson on

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Limiting Extraterritorial Reach of U.S. Patents: "Substantial" Means More than One

by Foley Hoag LLP on

Last week, the Supreme Court provided much-needed clarity to U.S. companies concerned about their potential liability for supplying a single component of a multicomponent invention abroad. The Court’s decision in Life...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

by McDermott Will & Emery on

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

by Miles & Stockbridge P.C. on

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more

Rx IP Update - February 2017

by Smart & Biggar on

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

Could the 'Dance' Already Be Over? ACA Repeal and Biosimilars

Originally posted in BNA’s Life Sciences Law & Industry Report, 11 LSLR 04 - February 17, 2017. As President Donald Trump completes his first several weeks in office, he has made clear that one of his top priorities is...more

Briefing Complete in Appeal in Amgen v. Apotex

by Goodwin on

The parties in Amgen v. Apotex have completed briefing in Amgen’s appeal to the Federal Circuit from the district court’s judgment of noninfringment. As we have previously reported, in September 2016 the District Court for...more

FDA Request for Justification Found to Provide a Mere Research Suggestion—Not Conception of Claimed Formulation

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower court’s holding that a patent covering a chelating-agent-free drug...more

Hurdles for Neulasta Biosimilars

A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far...more

Update: Praluent® Injunction Stayed by Fed. Circuit

by Goodwin on

On February 8, the Federal Circuit issued a stay of the permanent injunction granted against the sale of Sanofi and Regeneron’s Praluent® (alirocumab). The injunction was to have become effective on February 21, 2017, but as...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

by McCarter & English, LLP on

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more

Implications of the FDA's Recent Guidance on the Biologics Price Competition and Innovation Act

In December 2016, the FDA published an industry guidance related to the Biologics Price Competition and Innovation Act. This guidance offers suggestions to sponsors on the design and use of clinical pharmacology studies to...more

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