The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva Drug Delivery), for patent infringement after Mylan filed an ANDA for a generic version of Symbicort. The judge concluded that “Mylan has failed to demonstrate by clear and convincing evidence that the asserted claims of the patents-in-suit are invalid for obviousness.” Within a week, Viatris and Kindeva announced that the FDA has tentatively approved their ANDA.
AstraZeneca initially sued for infringement of US patents 7,759,328. 8,143,239, 8,575,137, and 7,967,011. The company later substituted US patent No. 10,166,247 instead of the ‘011 patent. In September 2020, Mylan and Kindeva stipulated to infringement of the ‘247 patent, and Mylan stipulated to infringement of the disputed claims but argued that the claims were invalid.
AstraZeneca Executive VP, BioPharmaceuticals Business Unit, Ruud Dobber commented, “AstraZeneca is pleased with the Court’s decision, and we maintain full confidence in the strength of our intellectual property rights protecting Symbicort.”
Viatris and Kindeva reacted to the ruling by asserting that they “disagree with the district court decision” and add, “While the trial court decision prevents commercial launch at this time, the companies intend to file an appeal to continue vigorously defending their position that the patents are invalid. Viatris and Kindeva are committed to bringing a generic Symbicort to market as soon as possible.” Viatris notes that it does not expect any revenue from the generic Symbicort MDI in 2021.
Kindeva CEO Aaron Mann commented, “This FDA tentative approval reflects the strength of the partnership between Viatris and Kindeva, and further demonstrates Kindeva’s industry-leading capabilities in formulation, development, and manufacturing of complex combination products. Once final FDA approval is achieved, Kindeva looks forward to providing Viatris with reliable, quality supply from our state-of-the-art commercial filling and packaging lines in our Northridge, California facility.”
Viatris CEO Michael Goettler said, “The FDA’s tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients. It also further demonstrates our deep commitment to continuing to leverage our scientific and regulatory expertise for a wide range of noncommunicable and infectious diseases. Our success with this partnership and approval underscores how Viatris intends to execute and optimize our Global Healthcare Gateway as a Partner of Choice for companies such as Kindeva to expand access to medicines for patients worldwide.”
Read the AstraZeneca press release.
Read the Kindeva/Viatris press release.
