Biologics

According to the Convention on Biological Diversity (CBD), ‘biologics’ means ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’. Related fields are bioengineering, biomedical engineering, biomanufacturing, molecular engineering. The application of patent law to biotechnological inventions has to deal with a number of particularities. Are biological materials mere ‘discoveries’, and therefore not patentable or man-made ‘inventions’? Limitations to patent rights, in particular a research and experimental use exception, have been considered important for innovation.

Biologics, Scope of protection, SPC, Validity

(Hoffmann Eitle)/

The German Federal Patent Court (FPC) has recently published its first decision (3 Ni 28/11 of 2 May 2012 “Ranibizumab”, GRUR 2013, 58) dealing with the interpretation of related CJEU Judgments “Medeva” (C-322/10) of 24 November 2011 and “University of Queensland” (C-630/10) of 25 November 2011. In the view of the FPC, the infringement test, which had been utilized by the German Federal Court of Justice in examining the condition of Art. 3(a) of the Regulation, can thus no longer be relied upon. Further, the FPC ruled that the requirement that an SPC can only be granted for active ingredients which are specified or identified in the wording of the claims of the basic patent, applies likewise to products of single active ingredients and combinations of active ingredients.

Biologics, European Union, Exceptions to patentability, Germany

(Rospatt Osten Pross)/

by Miriam Büttner On 27 November 2012 the German Federal Supreme Court (BGH) decided on the ethical problematical question, if neural precursor cells which origin from human stem cells are patentable or not (case no. X ZR 58/07). Background of the decision: Subject of this BGH decision is the validity of German patent no. 197…

Biologics, Exceptions to patentability, United States of America

(Foley&Lardner LLP)/

On November 30, 2012, the U.S. Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), taking on the debate over the patent-eligibility of human genes. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA…

Biologics, Italy

(Trevisan & Cuonzo)/

On 3 September 2012, the Adminstrative Court decision in the Italian antitrust case involving Pfizer was published. This decision completely reversed the ruling of the Italian Antitrust Authority which had initially found Pfizer guilty of abuse of dominant position and applied a 10.6 million euro fine (see my earlier post here). In substance, the Administrative…

Biologics, Inventive step, Italy, Validity

(Trevisan & Cuonzo)/

By ruling of 10 July 2012, the Court of Turin decided in the first instance an infringement action filed by Italian company Novamont against German and French companies Biotec and Biosphère, for the alleged infringement of three Novamont patents concerning starch based plastic materials used in the production of biodegradable shoppers. The Court denied the…

Biologics, Case Law, Equivalents, Extent of Protection, Netherlands

(Brinkhof)/

The Dutch Supreme Court held that Art. 69 EPC in conjunction with art. 1 Protocol for the application of Art. 69 EPC provides a guideline for the determination of the scope of protection. Other “viewpoints” are the essence of the invention and the inventive idea behind the wording of the claims as opposed to the…

Biologics, Exceptions to patentability, United States of America

(Foley&Lardner LLP)/

On Friday, July 20, 2012, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU “gene patenting”/BRCAI case), which is on remand in view of the U.S. Supreme Court decision in Mayo v. Prometheus. Reading the tea leaves from the judges’ questions and…

Antibodies, Biologics, Exceptions to patentability, United States of America

(Foley&Lardner LLP)/

Practitioners and applicants have been wondering how the USPTO would respond to the July 20, 2012, U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which held that Prometheus’ personalized medicine method claims could not be patented because they were directed to a law of nature, and so excluded from patent-eligibility under 35 USC…