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Reverse Payment Settlements in the Pharmaceutical Industry – The Patent Misuse Defense in Reverse Payment Settlement Cases and its Suitability for the Finnish Legal System

Opinnäytetyöt 9.7.2020, Gradut ja muut tutkielmat

This thesis focuses on reverse payment patent settlements in the pharmaceutical industry and the patent misuse defense as a legal tool against abusive practices concerning reverse payment settlement cases.

In the pharmaceutical industry, reverse payment settlement agreements (also known as ‘Pay for Delay’) have become more common phenomenon while drawing attention and raising debates among intellectual property and competition law professionals as well as pharmaceutical community in the United States and in the European Union. In a nutshell, reverse payment settlement agreement refers to a situation in which a patent holder (owner of the patented drug or the ‘originator drug’) pays a substantial amount of money or gives other forms of value to a potential patent infringer (generic drug manufacturer) in order to settle and to avoid a patent litigation proceeding. When the patent protection for the originator drug expires, originator companies usually obtain patents for second medical indications in order to prevent generic competition in the market. Taken into account that these ‘secondary’ patents of originator companies are not generally as strong as the ‘primary’ patents’, generic manufacturers may enter the market with their product with a risk of patent infringement litigation. In order to prevent the generic market entry, originator companies may conclude reverse payment settlement agreements with generic manufacturers typically containing a transfer of value from the originator to the generic while a generic manufacturer generally agrees to stay out of the market a certain period of time.

As these settlements between originator and generic manufacturers constitute a legally complex phenomenon within the field of intellectual property and competition law, this thesis aims to find a new legal tool from the field of patent law that could be applied in reverse payment settlement cases, especially in the Finnish legal system and from the generic manufacturers’ point of view. After discussing about reverse payment settlements in detail, I will present the patent misuse doctrine as an affirmative defense in patent litigation, originally created by the Supreme Court of the United States, and evaluate how the concept of patent misuse fits into reverse payment settlement cases. While discussing on the patent misuse defense, I will also research the abuse of rights doctrine known in many civil law countries since the idea of the prohibition of abusive practices by patent holders contains many similar features with the United States based patent misuse doctrine, but the prohibition of abuse of rights is based on civil law principles, and in this way, is closer to civil law traditions.

Lastly, I will research and discuss if the patent misuse defense originated from the United States could be present in the Finnish legal system or, at least, act as a source of inspiration, especially, for the Finnish Patents Act (550/1967). Since many civil law countries already recognize the abuse of rights doctrine that shares a lot of same features with the patent misuse doctrine, it is worthwhile to examine if there could be an additional legal tool available in reverse payment settlement cases against the abusive practices of right holders.

Asiasanat
• Kilpailu - Kilpailunrajoitus - Lääke - Oikeuden väärinkäyttö - Oikeusvertailu - Patentti

Linkit
• Patenttilaki
• Laki varallisuusoikeudellisista oikeustoimista, 36 §