Second Medical Use patented drugs will become increasingly prevalent in the near future. The Pregabalin case provides that those active substances hold the potential for extensive legal conflicts in the field of patent law as soon as generic companies enter the market.
Still, public healthcare providers in most European countries have a high degree of interest in concluding agreements with generic companies in order to take advantage of their favourable prices. Also, in Germany, public sickness funds attempted to conclude rebate contracts for generic Pregabalin. As a result, Pregabalin became subject to procurement law.
The attempt of sickness funds to conclude rebate contracts in Germany led to a flood of legal proceedings in addition to a large number of contract variations. This article will give a short overview of the resulting legal situation in Germany.
PREGABALIN AS PROCUREMENT LAW CASE IN GERMANY
As it is widely known, the active substance Pregabalin can be used to treat three different conditions: seizures in partial epilepsy, anxiety disorders and neuropathic pain. Out of these three indications, only the treatment of neuropathic pain is protected by a second medical use patent. In this situation, several public sickness funds in Germany published public tenders in order to conclude rebate contracts for Pregabalin. Some of those tenders distinguished between the patented and non-patented indications, while others did not. All of those concepts became subject to tender review proceedings.
In the first tender review proceedings, the patent holder initiated a procurement review against a public sickness fund, who had not distinguished between the patented and non-patented indications. In those proceedings, the Higher Regional Court Düsseldorf ruled in second instance that such tenders were invalid due to potential breaches of patent rights (OLG Düsseldorf, decision dated 1st December 2015 - VII Verg 20/15). As a result the Court indicated that a subdivision between patented and non-patented indication(s) might be in line with procurement law.
The same tender was subject to a patent infringement claim at the Social Court in Hannover (decision dated 14th September 2015 - S 2 KR 374/15 ER). In its final decision, the Social Court came to the same result as the Higher Regional Court Düsseldorf in that tenders without distinction between patented and non-patented indications are inadmissible.
As a result of these proceedings, another sickness fund decided to tender an alternative version of a rebate contract for Pregabalin. It distinguished between the patented and non-patented indications in different lots. As a peculiarity, the sickness fund admitted either companies with a marketing authorization exclusively for the patented indications or companies with a marketing authorization exclusively for the non-patented indication. As a result, the patent holder himself, (holding solely a marketing authorization for all indications and no restricted version) could not participate in this tender. This led to a tender review procedure against the new tender.
In addition, generic companies were concerned that due to peculiarities of the German regulatory system for medicinal products, a patent infringement could not be excluded by the tender design. As one generic company feared being subject to patent infringement claims as a result of participating in the tender, this company also filed a tender review procedure.
- As a result, the Higher Regional Court Düsseldorf decided that:
- a tender for Pregabalin must not exclude the patent holder from participation and
- the tender for the non-patented indications is admissible under the condition that sickness funds inform the relevant physicians on the requirement to prescribe the patented drug for neuropathic pain.
(decision dated 11th May 2016, VII Verg 2/16 and decision dated 17th August 2016, VII Verg 13/16).
SUMMARY AND OPEN QUESTIONS
In conclusion, German sickness funds may now tender rebate contracts for Pregabalin if the following conditions are met:
- the tender design differentiates between patent-free indications and patented indications;
- the tender for Pregabalin must not exclude the patent holder from participation;
- the tender includes an information letter directed at physicians and pointing to the patent situation as well as working towards dispensing the medicinal product in conformity with patent law.
However, with these guidelines from German procurement reviewing bodies, the legal situation in Germany is not entirely resolved as open questions remain. It is unclear whether the courts which are competent for patent law infringements will consider the solutions by the Higher Regional Court Düsseldorf in procurement law proceedings as compatible with patent law. In addition, side letters to physicians have no binding effect and therefore might not be considered effective by other courts. Given the great number of active ingredients with second medical use patents, it remains to be seen how the case law in Germany will develop.
This article is part of the International Life Sciences and Healthcare update for January 2017