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.
On December 23, the Brussels Enterprises Court issued a significant judgment confirming that Samsung Bioepis’ notification complies with the legal requirements for relying on the SPC Manufacturing Waiver for export purposes, dismissing claims brought by Amgen on multiple fronts (Dutch language judgment here and English machine translation here). It is the first judgment on the…
Although plastics are essential to the economy, plastic pollution is threatening ecosystems all over the planet. Plastic waste remains in the environment, taking from decades to centuries to naturally decompose. In addition, plastic materials also degrade, producing small particles, which are not visible to the human eye, leading to the terms “microplastic” and “nanoplastic”. Microplastics…
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…
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…
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…
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…
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…
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…
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…
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…
