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11 January 2018Americas

Allergan tells Federal Circuit Restasis patents are valid

Allergan and the Native American tribe that acquired Allergan’s patents for Restasis (cyclosporine ophthalmic emulsion) have told the US Court of Appeals for the Federal Circuit that patents covering the dry eye treatment are valid.

In an opening brief, filed on Tuesday, January 9, the parties urged the Federal Circuit to overturn a lower court’s ruling that invalidated four patents at the centre of the clash.

Circuit Judge William Bryson, at the US District Court for the Eastern District of Texas, invalidated the claims as obvious in October last year.

At the same time, in a separate decision, the judge said that Allergan’s controversial patent licensing deal with the Saint Regis Mohawk Tribe could spell the end for the inter partes review (IPR).

After gaining the patents, the tribe sought to dismiss the IPRs filed by Mylan, based on the tribe’s sovereign immunity.

Yesterday, LSIPR reported that Allergan is attempting to remove itself from the IPRs, claiming that it lost its authority to handle the case after the patent transfer.

In the opening brief, Allergan and the tribe argued that the district court’s analysis was not supported by law and “substitutes statistical analysis for common sense”.

The appellants noted that the US Food and Drug Administration had approved Restasis because clinical trials showed that it “meaningfully” increases the amount of tears that patients produce, as opposed to providing palliative relief.

The brief added that the superior performance of the dry eye treatment over a higher concentration formulation was a “surprise to each witness who testified at trial who was also involved with the clinical trials”.

According to Allergan, the patents are based on this clinical finding, but the district court gave “scant consideration” to the tear production claim limitations in its obviousness analysis.

The opening brief went on to say that the Eastern District of Texas court had ignored the limitations in its “unexpected results” analysis, and instead produced a legally erroneous standard for unexpected results.

“The district court’s analysis raises a nearly impossible barrier for pharmaceutical companies to demonstrate unexpected results,” cautioned the drug maker and Native American tribe.

They also claimed that the lower court had made an error in ignoring other objective indicia of non-obviousness.

While the court acknowledged that Restasis had filled a “long-felt need for a therapeutic dry eye treatment”, it didn’t give the evidence weight, said the appellants.

The reason the court didn’t give weight to this evidence was because, according to the brief, it found that two “blocking” patents prevented others from competing in the market.

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