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Court rejects Restasis patent strategy

The US Patent Trial and Appeal Board (PTAB) has ruled it has the authority to decide on the validity of patents covering Allergan’s dry eye drug Restasis, despite the multinational transferring ownership of them to a Native American tribe in an attempt to protect them from challenge.

As a result, the PTAB also declined Allergan’s request to dismiss litigation brought by generic drug company Mylan, which is challenging the legitimacy of the patents.

According to Reuters, Allergan had attempted to use the New York-based tribe’s status as a sovereign entity to stop the PTAB from reviewing the patents, by claiming a legal doctrine called sovereign immunity that would have required the tribe’s permission before any litigation could proceed.

"We will continue to be steadfast in our efforts on both the legal and regulatory fronts to bring a generic version of Restasis to patients as quickly as possible."
Heather Bresch, Chief Executive Officer of Mylan

However, the PTAB ruled that tribal immunity does not apply to patent review proceedings. It also said Allergan had retained an ownership interest in the patents by licensing them back off the tribe, which meant review proceedings could continue without the tribe’s consent.

“The PTAB’s ruling reinforces our belief that Allergan’s manoeuvres to engage the St Regis Mohawk Tribe for patent protection were a sham,” Mylan CEO Ms Heather Bresch said in a statement following the decision.

“We will continue to be steadfast in our efforts on both the legal and regulatory fronts to bring a generic version of Restasis to patients as quickly as possible.”

Allergan declined to comment on its latest setback, but has previously said it believes the PTAB is flawed, and that it’s unfair patents can be challenged in two separate venues, something its CEO Mr Brent Saunders has called “double jeopardy”.

Despite this position, rival drug companies and US lawmakers from both parties criticised Allergan at the time, and one US senator went as far as to introduce a bill to prevent further attempts of companies taking advantage of tribal sovereignty.

Allergan holds patents for various elements of Restasis that are due to expire in 2024. However, the furor it created by trying to protect them appears to have been in vain, after a federal judge in Texas invalidated the Restasis patents last October on the grounds that they described obvious ideas – a ruling Allergan has appealed.

Should the appeal not prove successful, generic drug companies will be free to produce their own versions of the dry eye drug, once gaining FDA approval.

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