Indivior launches lawsuits to defend Suboxone IP
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Indivior has filed patent lawsuits in the US against rivals for infringement relating to proposed generic versions of its Suboxone opioid addiction product, having recently lost a patent battle over an older patent.
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The lawsuits were filed against Dr Reddy's, Actavis, Par, Alvogen, Teva, and Mylan, and follows other patent infringement litigation over earlier issued Suboxone patents with these same companies.
Earlier this month Indivior said it intended to launch an appeal after a court ruled against an older patent, meaning generic versions of Suboxone could be sold in the US once they are approved by the US drug regulator.
The FTSE 250 company said it believed the approval and subsequent marketing of generic rivals of Suboxone "could potentially result in a rapid and material loss of market share" within months.
In late June Indivior was awarded US patent 9,687,454 that is now also contained in the FDA Orange book that protects Suboxone film from generic competition
On Friday, chief executive officer Shaun Thaxter said that the appeal over the older patent decision was still being prepared but that the new patent lawsuits were launched "to vigorously assert and defend our intellectual property".
"We strongly believe that these companies with their proposed generic products infringe on our intellectual property and we are taking the appropriate actions to enforce our position.
"Toward that end, we are also preparing our appeal against the recent decision in the lawsuit against Dr Reddy's (pending in the US District Court for the District of Delaware), and expect to file our appeal with the US Court of Appeals for the Federal Circuit shortly after the District Court judgement is entered."
Dr Reddy's, noted broker Numis, has not yet gained FDA approval and still needs to prove that it can manufacture at scale and decide whether to launch "at risk", which it rarely does.
"The announcement today further increases the probability of a settlement ahead of the expiry of the '514 patent in 2024, and makes it increasingly less likely that Dr Reddy's will launch in 2018, further bolstering Indivior's cash position, and putting the company in a very strong financial position to launch the monthly depot in Q1 2018, without generic competition on the film."