Bio-Science Law Review - Volume 17 - Issue 3

Articles
MEDICINES FOR THE MANY
AISLING O’DWYER, SHAYNA-RADHIKA PATEL AND GARETH MORGAN CMS Cameron McKenna Nabarro Olswang LLP

Publication of the UK Labour Party’s 2019 policy document ‘Medicines for the Many: Public Health Before Private Profit’coincided with negotiations between the NHS and Vertex over the high cost of the latter’s cystic fibrosis treatment, and set out a plan for transforming the innovation system into one that benefits public health. This article explores whether the current system of incentives and rewards is still fit for purpose and suggests some small changes that might provide some ‘rebalancing’ without the need for wholesale change.

DRUG PRICING REGULATION IN INDIA – A LAYER CAKE
ADARSH RAMANUJAN Patent Agent and Founder, Law Chambers of Adarsh Ramanujan, India

Drug pricing in India (quite apart from the pharmaceutical industry in general or regulation thereof) is a complicated subject – the political, social (and perhaps, emotional) overtones alone are sufficient to make legal discussions on the subject hardly objective. To be fair, this is an India-centric or even a developing-country centric phenomenon and in recent times, the subject of excessive pricing of drugs has become a subject for discussion even in developed countries. In such recent debates  and events, the discussion often turns to competition/antitrust law for solutions. In some developing jurisdictions, the solution is sometimes seen through the prism of compulsory licensing systems for patented drugs. Indian law offers both these solutions, though it does not stop there, with at least three different systems, if not more, to address issues in this area. This only makes it more challenging to understand and navigate the regulatory environment. A clear understanding of the systems in India, however, would explain why competition law intervention in India for alleged excessive pricing in the pharmaceutical sector takes a back seat. As this article will demonstrate, direct government intervention (without an adjudicatory/investigative process) has proved to be a far more effective tool in the hands of the government.

PLANT VARIETY PROTECTION IN HUNGARY
LEVENTE TATTAY Professor in the Faculty of Law and Political Sciences, Catholic Unversity Pázmány Péter

Plant varieties in Hungary are protected under the International Convention for the Protection of New Varieties of Plants of 1961 (‘the UPOV Convention’). Hungary acceded to the revised text of this Convention in 2002. Hungary became a member of European Union and of the European Plant Variety System in 2004. Hungarian plant varieties may be protected to EU level and in accordance with national regulations. Protection is granted for a variety that can be distinguished from any other plant variety, is uniform, stable and new and has been given an appropriate variety denomination. Plant variety protection valid in Hungary can be obtained by filing a national application or, for the territory of the EU, by filing an application for a Community plant variety right if the plant variety meets the legal requirements. The owner of the plant variety protection has the exclusive right to utilise the plant variety or to give permission for its use to others. The territorial validity and the term of plant variety protection are limited, meaning that the protection is valid only in Hungary or international organisation where it was granted. The main category of delimitations relating to plant variety protection is the farmers’ privilege.

CASE COMMENTS

PROFESSOR SHANKS’ LONG BATTLE FOR COMPENSATION FINALLY REWARDED
PAUL ENGLAND Senior Professional Support Lawyer, Taylor Wessing

In circumstances where an invention made by an employee belongs to the employer, the employee may nonetheless be entitled to compensation. Under section 40 of the UK Patents Act 1977, this requires there to be an ‘outstanding benefit’ to the employer. Amongst other matters regard must be had to the size and nature of the employer’s undertaking when deciding whether there is an outstanding benefit. The meaning of these terms has now been examined by the Supreme Court in the long-running Unilever Plc and Others v Ian Alexander Shanks litigation. Here, in deciding to make a £2 million compensation award to Professor Shanks, the court assessed the important factors that apply and those that are not relevant.

ORPHAN MARKET EXCLUSIVITY: EMA VSHIRE PHARMACEUTICALS IRELAND LIMITED
ALASDHAIR McDONALD CMS-Cameron McKenna Nabarro Olswang LLP

In EMA v Shire Pharmaceuticals Ireland Limited the CJEU ruled that companies can seek orphan status for a new product containing the same active substance as an existing orphan product. The author comments that this decision will likely give rise to new orphan designations for reformulated products and suggests that the EU Commission should legislate if it does notagree orphan exclusivity should be available in analogous situations.

UNITED STATES: YET ANOTHER PHARMACEUTICAL PATENT FALLS UNDER THE SCRUTINY OF 35 U.S.C. §112: IDENIX PHARMACEUTICALS LLC VGILEAD SCIENCES INCSTEPHANIE SCRUGGS Partner, Bradley Arant Boult Cummings LLP

The United States Court of Appeals of the Federal Circuit upheld a lower court’s post-trial decision to overturn a jury verdict requiring Gilead to pay Idenix over $2.5 billion for infringement of a hepatitis C treatment patent, ruling the patent is invalid for lack of written description and enablement.