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.
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),…
Thanks to Miquel Montaña’s brilliant Christmas post, we have learnt a lot about the lucina sine (aut cum) concubitu and the legal impact her involvement may have had for the application of Directive 98/44/EC to the event leading to the holidays that we have just been celebrating. While I must admit that even after having…
Regular readers of the Kluwer patent blog may recall that in April 2014, the English Patents Court revoked two patents relating to trastuzumab, the active ingredient in Herceptin, which is marketed outside of the US by Roche. One patent was for a dosage regimen and the other related to a composition of trastuzumab containing certain…
Although Brian Cordery will try to have you believe that the title of this blog is borrowed from William Shakespeare’s Twelfth Night, it may well have been taken from the Report from the Commission to the Council and the European Parliament dated 14 July 2005 on Development and implications of patent law in the field…
Last week, in In Re Roslin Institute, the U.S. Court of Appeals for the Federal Circuit held that cloned cattle, sheep, pigs and goats are non-patent eligible subject matter under 35 USC § 101. While the result that these cloned animals cannot be patented may not be surprising, the basis for the court’s finding–that the claimed subject matter…
In my earlier posts (here and here) I reported and commented on the first two phases of the Italian Pfizer antitrust case, in which the Italian Antitrust Authority (IAA) accused Pfizer of having abused of a dominant position by judicially enforcing patent rights against generic latanoprost in the Italian Courts. A small but potentially meaningful…
It could be argued that 2013 is proving to be somewhat unkind to UK patentees when it comes to the issues of sufficiency and priority. On 25 June 2013, in a typically comprehensive judgment running to some 90 pages, Arnold J held that Janssen’s patent was invalid for insufficiency. The relevant facts were as follows:…
