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RxIP Update - February 2017

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 significant...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

Briefing Complete in Appeal in Amgen v. Apotex

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

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In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Issues Draft Guidance on Demonstrating Interchangeability Under the BPCIA

On January 17, 2017, the Food and Drug Administration (FDA) issued its long-awaited draft guidance on licensure as an interchangeable biological product approved under the Biologics Price Competition and Innovation Act of...more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

Health Law Insights: January Newsletter

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

FDA Response to Biosimilar Naming Petitionx Just Issued

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

Sandoz’s Enbrel Biosimilar on Hold Until Patent Case Resolved

As we reported last August, the FDA has already approved Erelzi®, Sandoz’s biosimilar version of Amgen’s psoriasis drug Enbrel.® However, the head of generics at Novartis (Sandoz’s parent) told Reuters this week that their...more

Direct Infringement Prong of 35 U.S.C. § 271(b) in a Hatch-Waxman Case May Be Satisfied When the Prescribing Physician Directs or...

On January 12, 2017, the Federal Circuit affirmed the district court’s holding that, under Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc), the acts of patients may be...more

FDA Releases Biosimilar Guidance for Industry

On December 29, 2016, the FDA issued guidance to assist applicants seeking FDA approval of a proposed biosimilar product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). To obtain such approval, an...more

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

Top 5 Patent Red Flags in Life Sciences Due Diligence

Since IP represents 75 to 90% of the value of life science transactions, due diligence is a critical component of the valuation process....more

The Life Sciences Report - Winter 2017

Consumer Digital Health: Market Shift Is Leading to New Opportunities - The newest wave of consumer digital health investment focuses on applications encouraging consumers to change health-related behaviors, shifting...more

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Nexium Case Extends Actavis Ruling

Addressing a pay-for-delay and pharmaceutical-settlement antitrust jury trial for the first time since the 2012 Supreme Court of the United States decision in FTC v. Actavis (IP Update, Vol. 16, No. 7), the US Court of...more

Claim Terms Are Construed In Medical Devices Case

Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on November 17, 2016. The disputed technology relates to biometric belt connectors....more

Court Grants Motion to Dismiss for Lack of Case or Controversy Even Though Patent Holder Did Not Provide Covenant Not to Sue

Tech Pharmacy filed a patent infringement action against Defendant Alixa Rx LLC and Defendant Golden Gate National Senior Care LLC d/b/a Golden LivingCenters (collectively, "Defendants"). Tech Pharmacy subsequently filed its...more

Scottish government to reform approval process for new end-of-life and orphan medicines

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

Rx IP Update - December 2016

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

News from Abroad: Antibodies in the European Patent Office

The European Patent Office (EPO) continues to grant many patents relating to antibodies, and in doing so applies the same patentability criteria as to other inventions. However, some commentators have suggested that...more

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