Bausch Ireland fends off challenge to its cancer patent
Pharma firm fails to show evidence to prove obviousness in rival’s patent | Treatment can be used to treat cancer as well as ulcerative colitis and asthma.
Mylan Pharmaceuticals has lost its challenge to a patent for a cancer treatment owned by Bausch Health Ireland.
Mylan, now part of Viatris, filed a petition in March 2022 seeking inter partes review of six claims of US patent 7,041,786 B2, arguing that it should be cancelled on the ground that it was obvious.
The generic drug maker accused Bausch of creating a patent thicket, and has previously challenged at least four Orange Book-listed patents held by the pharma company.
“Not only is this a problem on an individual patent basis, but Bausch created a patent thicket, with multiple patents featuring patentably-indistinct claims issued on the same erroneous bases.
“Petitions are thus being contemporaneously filed for inter partes review of four nearly-identical patents that never should have issued. Review should be instituted in each case to cancel the challenged claims,” said Mylan in its petition.
But in a tribunal at the Patent Trial and Appeal Board (PTAB) on September 8, it was decided that Mylan had failed to supply enough evidence to prove obviousness.
The “comparatively strong” evidence supplied by Bausch, said the board, demonstrated that the treatment led to “unexpected” results showing “improved interconversion stability, potency, and binding affinity”.
In a final written decision, the PTAB ruled that the challenged claims of the ’786 patent are indeed non-obvious and therefore patentable.
The board also granted Bausch’s motion to exclude evidence in part and denied Mylan’s motion to exclude evidence.
Mutiple uses
The ’786 patent, issued in 2006, is titled “Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis”.
Agonists are substances that mimic the actions of a neurotransmitter or hormone to produce a response when it binds to a specific receptor in the brain.
The patent at issue relates to the “therapeutic use of guanylate cyclase receptor agonists as a means for enhancing the intracellular production of cGMP [cyclic guanosine monophosphate]”.
Bausch’s treatment, a peptide sequence, can be used to prevent or treat cancerous, pre-cancerous and metastatic growths, particularly in the gastrointestinal tract and lungs.
It may also be used in the treatment of inflammatory disorders such as ulcerative colitis and asthma, according to the decision.
MSN Laboratories Private and MSN Pharmaceuticals (MSN) filed a “substantially identical” petition, which was instituted and joined with Mylan’s proceeding.
ANDA filing
The dispute between Mylan and Bausch stems from Mylan’s filing of an abbreviated new drug application (ANDA) to market generic versions of Trulance, a plecanatide oral tablet product. The patent owner, Salix Pharmaceuticals, is named as a real party of interest alongside Bausch.
Trulance is directed to treating chronic idiopathic constipation and irritable bowel syndrome with constipation.
In April 2021, Bausch and Salix filed a complaint against Mylan and other defendants, alleging infringement of seven patents, including the ’786 patent.
Named counsel for Mylan in the PTAB case includes Jad Mills of Wilson Sonsini and Andrew Larsen of Merchant & Gould.
Named counsel for Bausch includes Justin Hasford of Finnegan.
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