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U.S. Appeals Court Renders First Interpretations Of Biosimilars Law

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners of original biologic products) in another. The result for Amgen and Sandoz is that Sandoz can start selling Zarxio™, its biosimilar version of Amgen’s Neupogen® (filgrastim) product, on September 2, 2015. The result for other biosimilar applicants is less clear, since the court’s decision leaves open more questions than it answers.

The [...]

The best things in life are unexpected because there were no expectations (Eli Khamarov)

Apart from the enthralling Lyrica saga which began in earnest back in January, and the main trial of which recently began before Arnold J, 2015 has not witnessed many significant pharmaceutical patent decisions from the UK patents courts. Thus, three cases in this field which, rather like London buses, arrived almost simultaneously, have provided welcome food for thought to life sciences patent enthusiasts.

The three cases were Smith & Nephew v Convatec (24 June 2015) and Eli Lilly v Actavis (25 June 2015) from the Court of Appeal and a decision from Arnold J in Hospira v Genentech (24 June 2015), part of the on-going campaign to clear the way in respect of certain Genentech patents relatin [...]

SPC revoked, PI lifted, but no damages awarded

In the Sanofi v. Teva ruling of 10 July 2014, the Court of Milan clarified the test for abuse of process, and denied an award of damages allegedly caused by the issue of a preliminary injunction which was later lifted due to the revocation of the enforced SPC.

The case concerned the Italian part of the irbesartan saga, in which Sanofi was engaged in several countries in the enforcement of its CoAprovel SPCs, covering irbesartan + hydrochlorothiazide. In the aftermath of the Medeva/Georgetown decisions, Sanofi obtained preliminary injunctions against generic CoAprovel in several jurisdictions, on the assumption that the combination irbesartan + hydrochlorothiazide was “specified in the wo [...]

U.S. Appeals Court Strikes Blow To Diagnostic Method Patents

The Federal Circuit has issued its long-awaited decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., but the decision is not good news for those seeking to obtain or enforce U.S. patents on diagnostic methods. The appeals court affirmed the district court’s finding that Sequenom’s claims are invalid under 35 USC § 101, applying the analytical framework set forth in the U.S. Supreme Court’s Mayo decision in a way that could have a ripple effect across the diagnostic and personalized medicine industry.

The Claims At Issue 

The Sequenom patent at issue was U.S. Patent 6,258,540. The claimed technology relates to diagnostic methods for determining certain fetal characteristics such as [...]

Fordham Conference 2015 – Biosimilars

Penny Gilbert from Powell Gilbert LLP explains the position of biosimilars in the pharmaceutical industry. Biosimilars are essentially generic versions of biologics. Traditional generic compounds are  chemical reproductions of the patented compound which makes regulatory approval more straightforward. Biological compounds (proteins or antibodies which are produced from genes) are not identical with one another and have higher hurdles in terms of achieving regulatory approval. The cost of bringing it to market is significant. Doctors may be less willing to prescribe biosimilars as compared to generic chemical compounds when considering the alternatives to the originator’s product. Undertakin [...]

Monopoly on Test Results? Protection of Immaterial Products as “Fruits” of a Patented Method under Sec. 9 (3) German Patent Act

Based on method claims, German Patent Law does not only grant the patentee an exclusive right to exercise the method on the German territory, but also a monopoly to offer, bring into circulation or to use in Germany a “fruit” that is the immediate result of the patented method (Sec. 9 (3) German Patent Act). This is true even if the method has been carried out, and the “fruit” has therefore been “picked”, in another – not designated – country and has then been imported into Germany.

Following a 2012 decision of the Federal Supreme Court (“MPEG-2 Videosignalcodierung”), which specifies how this rule applies to immaterial products like data, the District Court Munich now ha [...]

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