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.

(Indirect) infringement, Antibodies, Biologics, Extension of subject matter, Inventive step, Pharma, Revocation, Scope of protection, Sufficiency of disclosure, United Kingdom, Validity

(Bristows)/

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…

Biologics, United States of America

(Foley&Lardner LLP)/ /1 Comment

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…

Biologics, Inventive step, Novelty, Revocation, United Kingdom

(Bristows)/

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…

Biologics, Exceptions to patentability, United States of America

(Foley&Lardner LLP)/

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…

Antibodies, Biologics, United Kingdom, United States of America

(Bristows)/

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…

(Indirect) infringement, Biologics, Extent of Protection, Germany, Injunction, Scope of protection

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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)….

Biologics, Case Law, EPC, EPO Decision, Kluwer Patent Cases

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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),…

Amendments, Biologics, Germany

(Hoffmann Eitle)/ /2 Comments

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…

Biologics, Inventive step, Second Medical Use, United Kingdom, Validity

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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…