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 3 March 2017, the English Patents Court (Henry Carr J) issued a decision (here) in the joined claims filed by Fujifilm Kyowa Biologics (FKB) and Samsung Bioepis/Biogen (S/B) against AbbVie Biotechnology Limited (AbbVie) for so-called Arrow declarations in relation to dosage regimes of adalimumab (sold by AbbVie under the brand name Humira) for the…
by Chloe Dickson On 30 November 2016 the Court of Appeal handed down judgment in the latest chapter of the Hospira v Genentech epic surrounding Genentech’s blockbuster drug trastuzumab (Herceptin®) (Hospira v Genentech [2016] EWCA Civ 1185). This instalment concerned a patent for use of the antibody trastuzumab in combination with a traditional chemotherapeutic agent,…
Panel session 2 of the second day of the Congress was a discussion session about biosimilars. Moderator Dominic Adair (Partner, Bristows (UK)) led his panellists Fritz Reiter (Regulatory CMC Team Leader, Sandoz GmbH (AT)), Prof. Mei-Hsin Wang (National Yunlin University of Science and Technology (TW)) and Bryan Zielinski (Vice-President, Assistant General Counsel, Pfizer (US)) through…
Okay, this result, which was recently reached by TBA 3.3.04 in decision T 394/11 (in German language), may perhaps not come as a big surprise to you, since we all learnt in school that acetic acid is a classic example of an organic acid as opposed to an inorganic acid. Yet it raises two interesting…
Case reported and summarized by Gregory Bacon, Bristows LLP Mr Justice Carr is only a few months into his judicial career, but having already provided welcome guidance on the role of plausibility in considering both the questions of inventive step and sufficiency (see earlier blog post on Actavis v Eli Lilly), he has now produced…
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…
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…
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…
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…
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…
