Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary.
Nevertheless, we are still exposed to risks from litigation or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, data protection law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents, and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee.
For instance, we are currently involved in litigation with Merck & Co. Inc., Kenilworth, NJ, United States (outside the United States and Canada: Merck Sharp & Dohme Corp. (MSD)), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things.
Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a substantial to critical impact on our business and earnings.
Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded.
In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing.
Risks due to antitrust and other government proceedings
Raptiva®: In December 2011, the federal state of São Paulo, Brazil, sued us for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product Raptiva®. We have taken appropriate accounting measures for these issues, which relate to various legal cases. Risks in excess of this with a negative effect on the net assets, financial position, and results of operations cannot be ruled out, but are considered possible with minor impact.
Risks in connection with a settlement agreement concluded by the divested Generics group
Paroxetine: In the United Kingdom, Merck KGaA, Darmstadt, Germany, was subject to antitrust investigations by the British Competition and Market Authority (CMA) in connection with the generics business that was divested in 2007. In March 2013, the authorities informed us of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd., United Kingdom and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in connection with the antidepressant drug paroxetine, violated British and European competition law. They stated that our company was liable as the then-owner of Generics (UK) Ltd. And because it was involved in the negotiations for the settlement agreement. The investigations into Generics (UK) Ltd. started in 2011, without this being known to us. After the European Court of Justice confirmed in January 2020 that such settlement agreements can violate European competition law, the Competition Appeal Tribunal (CAT) set a low single-digit million euro figure fine in May 2021 that Merck KGaA, Darmstadt, Germany, paid in September of fiscal year 2021. The risk is considered to be more than likely with minor impact. A provision in a low double-digit million euro amount was recognized for the risk of additional potential claims as of December 31, 2021.
Citalopram: In connection with the generics business that was divested in 2007, Merck KGaA, Darmstadt, Germany, was accused of breaching EU antitrust law through agreements entered into by its former subsidiary Generics (UK) Ltd., relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. The European Commission imposed a fine in June 2013. Our company filed a lawsuit against the Commission’s decision with the European Court (EC) in August 2013. The lawsuit was rejected in 2016. Our company subsequently filed an appeal against this decision with the European Court of Justice (CJEU), which confirmed the first-instance ruling of the EC in March 2021. Although the fine of € 18 million was paid in 2013, additional potential claims were considered to be probable. A provision in a mid-double-digit million euro amount was recognized for these proceedings as of December 31, 2021. The risk is considered to be more than likely with minor impact.