ARTICLES
VACCINES AND SPCS: THE CJEU REACHES A FORK IN THE ROAD
SIMON COHEN AND PAUL ENGLAND
Taylor Wessing LLP, London
The use of vaccines in the prevention of disease is nothing new and they are often protected by patents and supplementary protection certificates (‘SPCs’). However, in more recent times, two developments have taken place: i) guidance has come from regulators that treatment of populations with vaccine combinations is preferred to single vaccines, and ii) there has been an increased need to use adjuvants with vaccines to improve their efficacy. Both of these developments have placed strain on the legislative regime governing SPC protection (the ‘SPC Regulation’), which whilst intended to supplement patents for the protection of investment in medicinal products, was not drafted with such combinations in mind.

Deciding whether certain classes of medicinal products should be protected by SPCs and, at the same time, maintaining clear and consistent application of the SPC Regulation has been difficult for the courts. One UK Court of Appeal judge was forced to state that the SPC regime risks failing large areas of pharmaceutical research, making it ‘not fit for purpose’. In addition, a UK High Court judge has said that it is ‘dysfunctional’. However, until very recently, the interpretation of the SPC Regulation on the subject of SPC protection for combinations, including vaccines, had achieved a measure of clarity for makers of combination products. However, an apparent attempt by the Court of Justice of the European Union in Neurimto respond to the commercial argument for wider protection by SPCs expressed by the Court of Appeal judge, has now caused disarray. In that case the court used a so-called ‘teleological’ approach to the interpretation of the SPC Regulation that appears to contradict earlier cases that were thought to have settled on a ‘strict’ approach. It is this disarray that caused the frustration expressed by the latter High Court judge and a further reference to the CJEU.

The case referred, GlaxoSmithKline Biologicals v Comptroller-General of Patents, is where these issues have now come to a head. It concerns vaccines again – adjuvant and vaccine combinations – and takes the SPC regime to a fork in the road: the CJEU can choose to go the new teleological route, or stick to the strict approach. Whichever way the CJEU chooses to go it is likely to have far-reaching commercial consequences for certain medicinal products, such as vaccines, and the pharmaceutical industry in general.

EXCEPTIONS TO PATENTABILITY: AUSTRALIA V EUROPE
DR OLIVER MILLS
Lecturer, School of Law,
National University of Ireland, Galway

In Australia, judicial activism has, in the past, reshaped traditional patent law criteria in respect of emerging technology with the result that subject-matter once precluded from patentability there is now accommodated. What amounts to ‘patentable invention’ is examined in the context of methods for treatment of the human or animal body. By contrast, in Europe, the same subject-matter is precluded from patent protection. In addition, the cases in Europe demonstrate a conflict in regard to both the scope of protection and the extent of exclusion of certain other moral-related and biological subject-matter, which, by extension of legal argument and analogy with the Australian experience in dealing with exclusions, is not easily justified. By adopting a similar approach, in like manner with Australian courts, European patent granting authorities can adequately protect biotechnological inventions, and exceptions, no matter how described or defined, are no longer necessary.

CASE COMMENTS
CJEU REFERENCE ON MEANING OF ‘HUMAN EMBRYOS’: DOES IT INCLUDE PARTHENOTES?
INTERNATIONAL STEM CELL CORPORATION V COMPTROLLER GENERAL OF PATENTS
NINA O’SULLIVAN
S J Berwin LLP, London

Deputy Judge Henry Carr QC has referred a question to the Court of Justice of the European Union (‘CJEU’) which seeks to clarify the CJEU’s ruling in Brüstle in relation to the definition of a ‘human embryo’ pursuant to Article 6(2)(c) of the Biotech Directive (Directive 98/44/EC on the legal protection of biotechnological inventions). The Court’s question relates to the patentability of parthenotes, ie unfertilised human ova whose division and further development have been stimulated by parthenogenesis (ie the initiation of embryogenesis without fertilisation by activation of an oocyte in the absence of sperm). The Court notes that, in contrast to fertilised cells, parthenotes contain only pluripotent cells and therefore are incapable of developing into a human being. Whilst, in Brüstle, the CJEU did specifically refer to parthenotes, the Court decided that it was unclear whether its test turned on merely commencing the process of development of a human being (whether or not the potential exists for the completion of the process). Further, given the different factual matrix, the Court concluded that a reference to the CJEU was appropriate. However, the Court expressed its own preliminary view that, as the process of development of a parthenote was incapable of leading to a human being, it should not be excluded from patentability as a ‘human embryo’.

UK COURT OF APPEAL OPENS THE WAY FOR PAN-EUROPEAN JURISDICTION ON INFRINGEMENT
ACTAVIS GROUP HF AND MEDIS EHF VELI LILLY AND COMPANY
NICK KEMPTON AND PENNY GILBERT
Powell Gilbert LLP, London

US SUPREME COURT: UNANIMOUS NARROW RULING LEAVES OPEN QUESTIONS WITH RESPECT TO OTHER SELF REPLICATING TECHNOLOGY AND THE CONDITIONAL SALE DOCTRINE
BOWMAN V MONSANTO
VINITA KAILASANATH
Arnold & Porter LLP,
Washington

US SUPREME COURT RULE OF BRCA1 AND BRCA2 PATENTS
ASSOCIATION OF MOLECULAR PATHOLOGY V MYRIAD GENETICS
VINITA KAILASANATH
Arnold & Porter LLP,
Washington

BOOK REVIEWS
CROP GENETIC RESOURCES AS A GLOBAL COMMONS. CHALLENGES IN INTERNATIONAL LAW AND GOVERNANCE
MICHAEL HALEWOOD, ISABEL LOPEZ NORIEGA AND SELIM LOUAFI (EDS)

ALL THAT MATTERS – BIOETHICS
DONNA DICKENSON