Bio-Science Law Review - Volume 14 - Issue 6

The Importance of Certainty in the Regulation of Biosimilars
Kim O'Connell and Suzy Madar
King & Wood Mallesons, Sydney

Biologics are highly complex and inherently variable products derived from biological sources. Unlike traditional generic medicines which are less complex and usually derived from synthetic processes, it is not possible to establish that a biosimilar is 'essentially similar' to the reference product. Consequently, cheaper generic biosimilar products are not generally able to be substituted for the originator reference product at pharmacy level. For the cheaper alternative to be dispensed, the prescriber must have specifically prescribed the cheaper biosimilar. Earlier in the year, the Australian Pharmaceutical Benefits Advisory Committee indicated that biosimilar products would be able to be substituted for a reference biological product at pharmacy level where the biosimilar had been shown to be a 'safe and effective equivalent treatment'. However, it remains unclear what data manufacturers of biosimilar products must provide to establish that their product is sufficiently similar to the reference product to enable substitution at pharmacy, and importantly, it is not clear how such data will be evaluated.

Warner- Lambert v Actavis: The End of the Beginning?
Paul Inman and Ailsa Carter
Wragge Lawrence Graham & Co, London

In the English Patents Court, Mr Justice Arnold has ruled that Warner-Lambert's 'second medical use' patent to pregabalin for the treatment of pain (Swiss form claims) is invalid for insufficiency, and in any event, would not have been infringed by Actavis' activities involving its generic pregabalin medicine, 'Lecaent'. Further, Warner-Lambert and Pfizer are liable for threats and Actavis is entitled to declaratory relief. The authors explain why, with complex questions raised on construction, inventive step, insufficiency and infringement, the case looks set to visit the higher courts in the United Kingdom.

Nanomaterials in the EU Cosmetic Products 1223/2009 Regulation
Aratz Ramirez De La Piscina

Nanotechnologies, the group of technologies that through the manipulation of materials on nano-scale seek their different and beneficial properties, have experienced substantial growth over the past decade. In this sense the cosmetics industry has been one of the pioneers in the technical exploitation and commercialisation of products containing manufactured nanomaterials, although the scientific knowledge of their properties, behaviour and potential health and environmental hazards is still dominated by a large uncertainty. Within this context the article focuses on the legal treatment given to nanomaterials in the EU Cosmetic Products Regulation 1223/2009, a legal framework where the precautionary and transparency principles should play a meaningful role.

UPOV and the Plant Variety Protection System: A Case Study of Colombia
Sherine Jose

This article argues that developing nations need to pursue alternative or improved methods to protect new plant varieties to fully capture the benefits a Plant Variety Protection (PVP) system has to offer. The article explores the arguments about unfairness towards farmers of the UPOV system with the support of quantitative data depicting big differences between the acceptance of applications from residents and non-residents in developing countries and in developed countries.

Case Comments
Amgen v Sandoz: US Appellate Court Rules that the Information Exchange Contemplated by the Biologics Price Competition and Innovation Act of 2009 is Optional
Vinta Kailasanath and Dr David Marsh
Arnold & Porter LLP, Washington DC

On 21 July 2015, the US Court of Appeals for the Federal Circuit issued the first appellate decision interpreting the patent dispute resolution provisions set forth in the Biologics Price Competition and Innovation Act of 2009 and determined that the information exchange process contemplated by 262(l) is not mandatory. The court also determined that an applicant filing an abbreviated biologics licence application must wait for Food and Drug Administration approval of its biosimilar product prior to providing 180 days' advance notice to the reference product sponsor that it intends to begin commercial marketing.

Leo's Patent not 'Obvious to Try' Because There Was 'No Reasonably Optimistic Expectation' of Success Regarding the Claimed Invention
Paul Inman and Andrew Maggs
Wragge Lawrence Graham & Co, London

The Court of Appeal has overturned Birss J's decision in Teva v LEO and ruled that LEO's patents regarding its Dovobet ointment for psoriasis are valid, a judgment that provides, among others, useful guidance on the 'obvious to try'doctrine.

Patent Term Extensions: USA, Japan, Germany, EU