A Skinny Label - The intersection of EU competition law and patent law, and the abuse of dominance by the enforcement of second medical use patents

Abstract: EU competition law is the safeguard of the functioning of the internal market, and not many fields of law other than patent law can delimit the scope of competition law. A patent’s value is based upon an exclusive right to the invention and product as protected by the patent. The value stems from the monopoly to the market, namely, an exclusiveness to produce, market, offer and sell the product for a limited time-period. Such an exemption from competition law is unique, and the intersection of the two fields of law creates a dynamic field that nurses a competitive market. A pharmaceutical patent is unique in its character and position in relation to other patents. It is only within the sphere of pharmaceutical patents where an already known and previously patented active substance can be protected multiple times. The possibility stems from the exemption to novelty in the EPC, known as second medical use. Second medical use patents have recently caused a stir around EU when utilised in infringement proceedings against generic companies, producing products to compete with the originally patented product, i.e. the reference medicinal product. Skinny labelling stimulates competition on the market of the reference medicinal product. Simplified, a skinny label is when the indication that is protected by a second medical use patent has been erased from, e.g., the label, leaflet or packaging. Such a removal facilitates the launch of generic products on the reference medicinal product’s market without infringing the valid second medical use patent. Skinny labelling is consequently a direct articulation of the balance struck between competition law and patent law. Since the patented and generic products are based on the same active substance, substitution is possible based on the active substance. Such substitution has occurred, and led lawsuits around Europe. Relevant questions arising from such substitution, and following lawsuits, are (i) can the patent holder of a second medical use patent righteously claim infringement of its patent by the generic product, and file a lawsuit against the generic pharmaceutical company, and (b) could such an infringement proceeding against the generic pharmaceutical company constitute an abusive expansion of the patent’s scope of protection, and consequently violate Article 102 TFEU? The dynamics of EU competition law and patent law is a rather well scrutinised area of law, but the problem of skinny labelling shines some light on new aspects of the intersection that needs to be clarified and settled. The thesis is studying the possible limitation imposed on a second medical use patent holder when scrutinising the problem from a competition law perspective. A balance must be struck between the two fields of law and there are different solutions to find such equilibrium, and this thesis provides one of them.