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, Covid-19, Inventive step, Plausibility, Sufficiency of disclosure, United Kingdom, Validity

(Bristows)/

On 8 October 2024, Mr Justice Meade handed down judgment in BioNTech SE and Pfizer Inc., (together, BioNTech/Pfizer) v CureVac SE. Meade J found CureVac’s patents, relating to split poly(A) tails in mRNA, invalid for obviousness and insufficiency due to (i) lack of plausibility and (ii) because the purported technical effect does not in fact…

Biologics, Pharma, Pharmaceutical patent, UPC

(Dhenne Avocats)/

Reading the title of this paper, perhaps you will smile, thinking about all the discussions that this issue has already ignited, even before the UPC came into force. Since the beginning, most patentees in the pharmaceutical field were suspicious concerning the new jurisdiction, especially regarding the same old question: pro-patentee or not? Hostile/not hostile to…

Biologics, Case Law, Covid-19, Damages, Infringement, Inventive step, Patents, United Kingdom, Validity

(Bristows)/ /1 Comment

Moderna secured a double victory in the Patents Court last week (2 July 2024) in proceedings against Pfizer and BioNTech.  In the first decision, Meade J found its modified mRNA patent to be valid and infringed by Pfizer and BioNTech’s “Comirnaty” vaccine.  In the second decision, Richards J rejected Pfizer and BioNTech’s defence based on…

Biologics, Brazil, Generics, Guidelines, Infringement, Pharma

(RNA Law)/

Prepared by Rob Rodrigues, Brenno Telles and Dara Offrede On Friday June 21, 2024, the government formally introduced regulations addressing the new framework for Partnerships for Productive Development (PDP). The Ministry of Health published new guidelines (Ordinance #4,472/20241) as part of the government policy to foster the “National Strategy for the Development of the Economic-Industrial…

Antibodies, Biologics, France, Pharma, Pharmaceutical patent, SPC

(Dhenne Avocats)/ /1 Comment

25 May 2022, the Paris Court of Appeal overturned the refusal of the French National Institute of Industrial Property (INPI) to grant an SPC on avelumab. This is a reversal of the “nivolumab” case law on the interpretation of Article 3(a) of Regulation (EC) No 469/2009 (hereafter the SPC Regulation).   In this case, Dana-Farber…

Biologics, Case Law, Infringement, United States of America

(Gibson, Dunn & Crutcher LLP) and , (Ropes & Gray LLP)/

Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1]  In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…

Biologics, Case Law, Germany, Novelty

, (Hoffmann Eitle)/

If a patent only provides the skilled person with a general scientific explanation as to why the procedure disclosed therein is suitable for the purpose in question and does not disclose a new technical teaching in relation to this purpose, but merely a discovery of biological correlations, then this is insufficient to acknowledge novelty (continuation…

Biologics, Infringement, United States of America

, , (Ropes & Gray LLP) and (Gibson, Dunn & Crutcher LLP)/

For manufacturers of biologics and biosimilars facing potential patent litigation in the U.S., the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of disputes in federal district court. Biosimilar applicants who find themselves on the receiving end of a potential patent infringement complaint in district…

Biologics, European Union, Generics, Legislation, Pharma, SPC

, (Vossius & Partner)/

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…