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.

Antibodies, Biologics, Case Law, Damages, Infringement, Injunction, Litigation, United Kingdom, Validity

, (Bristows)/

Whilst being wary of placing too much emphasis on statistics (the phrase “lies, damn lies and statistics” comes to mind), the authors have seen figures which suggest that the last ten years have consistently seen English patent litigation outcomes which are overall less favourable to the patentee than their opponents. That is until 2017, when…

Biologics, China, Litigation, Pharmaceutical patent

(Baker & McKenzie), (Baker & McKenzie FenXun (FTZ)), and , (ZY Partners)/

On October 8, 2017, the Chinese Communist Party and the State Council jointly issued a special opinion on the reform of drug and medical device approval system (“Innovation Opinion”). The Innovation Opinion together with an earlier China Food and Drug Administration (“CFDA”) document (“Circular No. 55”) issued in May 2017 (collectively “Reform Opinion”), propose that…

Biologics, Conference, Pharma, Pharmaceutical patent, SPC

(Bristows)/

The afternoon of the first day of C5’s Pharma & Biotech conference in Amsterdam (27 February 2018) concluded with a lively panel session on biosimilars. Chaired by Bristows partner Dom Adair, the panel comprised Dr Corinna Sundermann (Senior Vice President, IP, Fresenius Kabi), Dr Lorenz Kallenbach (Corporate Patent Counsel, Merck) and Brian Coggio (Of Counsel, Fish…

Biologics, EPC, EPO, European Union

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The European Patent Office amends its Regulations in order to exclude from patentability plants and animals exclusively obtained by an essentially biological breeding process. The decision, during the 152st meeting of the Administrative Council of the EPO, came after years of discussion and decisions to the contrary by the Enlarged Board of Appeal in the so-called Broccoli-II…

Biologics, Pharma, Priority right, United Kingdom

(Bristows) and (Bristows )/

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…

Biologics, Inventive step, Revocation, United Kingdom, Validity

(Bristows)/

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,…

Biologics

(Bristows)/

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…

Amendments, Antibodies, Biologics, EPC, Validity

(Hoffmann Eitle)/

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…

(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…