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.
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…
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)….
Inventions regarding a method of improving the yield of triploid seedless watermelons by pollination with a specific type of diploid water melon are not to be regarded as an essentially biological process for the production of plants and are therefore not excluded from patentability under Article 53(b) EPC. These biotechnological inventions according to Rule 26(2),…
