Science

Federal court quashes Allergan eye drop patents

Federal court quashes Allergan eye drop patents

A US judge has invalidated patents on Allergan PLC's dry-eye medicine Restasis (cyclosporine ophthalmic emulsion) on grounds that the patents cover ideas that are obvious, sending shares of the pharmaceutical company down 3.5%.

Allergan had previously made an unorthodox agreement with a NY state-based American Indian tribe in order to protect Restasis patents from challenges made through the U.S. Patent and Trade Office's inter partes review process, which is separate from any court decisions.

Allergan said in a statement Monday it's reviewing its options in the wake of the decision and it plans to appeal.

Allergan transferred its Orange Book-listed patents for Restasis to the tribe, describing it as a "sophisticated opportunity to strengthen the defense of our Restasis intellectual property in the upcoming IPR proceedings before the PTAB".

She noted the ruling comes after weeks of criticism on Capitol Hill, where politicians have slammed Allergan's move as a sham, with one US senator introducing a bill to ban attempts to take advantage of tribal sovereignty.

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According to the Mohawk tribe, sovereign immunity allows shielding of the patents. The measure was aimed to ward off a patent challenge different from the federal court case - that is underway in an administrative proceeding before a unit of the United States Patent and Trademark Office.

The drug giant, Allergan, wanted to protect its Restasis patents for as long as it could. The 135-page decision found that Allergan's patent protection for the drug ended in 2014, and that "Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection". Allergan also paid the tribe nearly $14 million.

Bryson said "sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities". "For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients", she said.

But Monday's decision wasn't made by that patent review board.

In a research note on Monday, analysts at Credit Suisse said Allergan suffered a "public relations backlash" from the deal without helping its bottom line.


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