More generally, the case is expected to have a significant impact on other late payment cases: complaints against the European Commission`s decisions on the fine imposed on Lundbeck and Servier are currently pending before the ECJ and raise issues similar to those raised in the Court of Justice decision, with Lundbeck being considered by the same judges who ruled on the reference to the CTU. The Commission has also opened an investigation into cartels and abuse of dominance in patent comparisons between Cephalon and Teva for modafinil, a drug used to treat certain sleep disorders. Although it has announced its intention to close its investigation in 2019, the Commission has not yet rendered its decision and may have waited for the court`s decision before doing so. Lundbeck`s decision comes two years after the U.S. Supreme Court`s pioneering ruling on patent enforcement contracts for payments in Actavis2 and less than a year after the British CMA imposed significant fines on GSK and some generic drug manufacturers under similar agreements3. Since the announcement of the transaction communication in June 2008, several cartel cases have been resolved. The first transaction decision was made in 2010 (DRAMS). Since then, about half of the decisions taken have been made in accord with the settlement procedure. Information about these cases can be found in the respective press releases. Typically, the title of the press release refers to the billing process.
The leniency communication is an instrument for gathering evidence, while regulation is an instrument of effectiveness. “Pay for delay” agreements are a form of patent dispute settlement agreement in which a generic manufacturer recognizes the patent of the initiation pharmaceutical company and agrees not to market its generic drug for a specified period of time. In return, the generic drug company receives a consideration in the form of a payment from the initiator. For more information, visit eLeniency. This online tool can also be used in billing procedures. It is only after the expiry of the exclusivity period that tariff competition between manufacturers of non-marker (generic) drugs will take place. Generic drugs have the same active ingredients as initiating drugs and, according to the Commission, are on average 50% cheaper than initiating drugs. The CMA also stresses the importance of generic drug entry in terms of price competition and freedom of choice.
The judgment confirms that the fact that the transaction agreements concerned do not exceed the scope and the remaining validity of the patent to which they relate is essential for the “relevant” assessment.