Indian pharmaceutical company Panacea Biotec Ltd announced today that it has received notice of an arbitration proceeding initiated by Canadian firm Apotex Inc. The dispute relates to a 2014 collaboration agreement between the two companies for the development and supply of a pharmaceutical product aimed at the US market.
Apotex has claimed damages of $118.14 million from Panacea Biotec, alleging breach of obligations under the collaboration agreement. According to Panacea Biotec’s regulatory filing, Apotex believes the company caused delays in seeking US FDA approval for the product under development.
However, Panacea Biotec stated that it considers Apotex’s claims to be “frivolous, unsubstantiated” and contrary to facts.
The company said it does not expect the arbitration to have any material financial impact based on its assessment. Panacea Biotec added that it has appointed international legal counsel to contest Apotex’s claims and file a counter-claim to recover dues owed under the collaboration agreement.
The arbitration will be administered by the International Court of Arbitration in Paris. The collaboration agreement was originally signed between Apotex and Panacea Biotec in 2014, but was later assigned and novated to Panacea’s material subsidiary, Panacea Biotec Pharma Limited, in 2019.
With both companies making contradictory claims, the arbitration proceedings will likely be lengthy and hotly contested, with the outcome likely depending on the specific terms and obligations laid out in the 2014 agreement.
Panacea Biotec is one of the largest vaccine manufacturing companies in India. Apotex, which is one of Canada’s largest pharmaceutical companies.
There have been several cross-border disputes involving Indian pharmaceutical companies.
One of the most notable cases was German drug maker Bayer AG’s patent infringement suit against Indian company Natco Pharma in 2019. Bayer sued Natco for allegedly violating patent on its blockbuster cancer drug Nexavar. However, the Delhi High Court rejected Bayer’s appeal and upheld Natco’s right to launch a generic version of Nexavar under a compulsory licensing provision.
In another high profile case, Swiss firm Novartis had sued Indian companies including Cipla, Natco and Ranbaxy in 2007 over patent issues related to its anti-cancer drug Glivec. However, Novartis lost the case in the Supreme Court in 2013 which ruled that Glivec was not eligible for patent protection under Indian law. The ruling was seen as a major victory for Indian pharma firms to make affordable generic medicines.
More recently in 2019, Celgene filed a lawsuit against Natco Pharma to prevent it from selling generic versions of Celgene’s cancer drug Revlimid in the US. Celgene settled its litigation against Natco in 2022 after reaching an agreement to delay launch of Natco’s generic.
Bristol Myers Squibb also filed patent lawsuits against Indian companies including Natco and Alvogen in the US in 2020 over its blood thinner Eliquis.
