The Practical Difficulties In The Enforcement Of Second Medical Patents In The EU

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RESEARCH QUESTION:

How are the problematic issues of second medical use claims adjudicated by the courts of EU Member States?

Sezai Yılmaz

1 vlog

Second medical patents have been considered patent eligible since 1984 with the landmark case G5/83 of Board of Appeal EPO. The decision was a mere reflection of a need of promoting biomedical development. Second medical patents, being a purpose limited patents, protects only the new purpose of an existing drug. In principle, infringement arises when a generic drug is used for the new patented purpose. When a doctor prescribes a drug, the prescription does not mention the indication but only the active ingredient. Pharmacists are not informed about the intended purpose and they usually substitute affordable generic drugs for branded patented drugs. Due to contributory behaviours when prescribing and dispensing a drug, many generic products end up being used for the patented purpose hence second medical patent infringement arises. In several European court decisions, the predominant approach is one that holds Generic Companies liable for their act and omission. Generic products for instance are required to exclude the new patented purpose from its Summary of Product Characteristics (SmPC) and Product Information Leaflet (PIL). They are required to ensure that the package of their drug, together with its appearance, avoids making any confusion. Notifying Clinical Commissioning Groups (CCGs) and superintendent pharmacists is considered to be an important step in preventing patent infringement. Generic companies are under obligation to inform authorities in a drug purchasing tender, that their products cannot be used for the patented purpose. Examining all these European court decisions, it becomes apparent that there is no possibility to eradicate infringing use of generic drugs. The courts of Member States however burden generic companies with numerous duties. In the end, the objective is to minimise the risk of infringing use and to achieve a fair balance between ensuring biomedical development and promoting public health.

1. Article 63(1), Convention on the Grant of European Patents (European Patent Convention)
2. Article 11(2) and Article 3(3)(b) of Directive 2001/83/EC and Regulation (EC) 726/2004 respectively
3. Clara Ducimetiére, “Second Medical Use PatentLegal Treatment and public health issues” [2019] SOUTH CENTRE p.43
4. According to the figures, 95% of all prescriptions in the UK did not show the indication that the drug is prescribed for. Christopher Hayes, “What is the intention with skinny labels and second medical use patents [2015] Journal of Generic Medicines V11 n34 p.166
5. Article 54(5), Convention on the Grant of European Patents (European Patent Convention)
6. Guidelines for examination Part GVI, 7.1. First or further medical use of known products, The European Patent Convention
7. WarnerLambert Company, LLC v Actavis & Ors (2018) UKSC 56 para 84
8. Novartis AG v. Sun Pharmaceutical Industries (Europe) BV, 12 May 2014, preliminary injunction case before the District Court of The Hague, case number C/09/460540 / KG ZA 14185