Allergan sees off glaucoma patent challenges

Drugs companies Sandoz and Lupin have failed to reverse a US court’s ruling that they infringed patents owned by Allergan.

Yesterday, August 4, the US Court of Appeals for the Federal Circuit affirmed a 2014 ruling that both Sandoz and Lupin infringed five patents covering bimatoprost, the active ingredient used in Allergan’s Lumigan 0.01% product.

Lumigan 0.01% is used to treat patients suffering from glaucoma.

Both Sandoz and Lupin, as well pharma company Hi-Tech Pharmacal, submitted Abbreviated New Drug Applications to the US Food and Drug Administration to market a generic version of the Lumigan 0.01% product.

In response, Allergan sued all three companies in 2013. It claimed Sandoz’s and Lupin’s applications infringed five of its patents and that Hi-Tech’s infringed three patents.

At the centre of the dispute are US patent numbers 7,851,504; 8,278,353; 8,299,118; 8,309,605; and 8,338,479, which all three parties claimed were invalid on the grounds that they were obvious.

They also claimed that the ‘118 and ‘353 patents lacked “an adequate written description”.

The US District Court for the Eastern District of Texas consolidated the cases. Last year, the court ruled that the five patents were valid, dismissing the claims that they were obvious and lacked an adequate written description, and that the companies infringed the relevant patents.

On appeal, the defendants raised questions again about the validity of the patents in question. But the federal circuit rejected the challenges in its ruling yesterday.

“We conclude that the district court did not clearly err in finding that Allergan had produced ample evidence of teaching away and unexpected results, and that such evidence fully supports a conclusion of non-obviousness,” Judge Alan Lourie, presiding over the case, wrote.

Lourie added that the argument about a lack of adequate written description was “unpersuasive”.

Hi-Tech separately challenged the district court’s ruling that it infringed the three patents on literal grounds and doctrine of equivalents.

But Lourie said that because the federal circuit affirmed the Texas court’s ruling on literal infringement in its latest decision, it did not need to assess the challenge to the doctrine of equivalents finding.

Neither Allergan, Sandoz, Lupin, nor Hi-Tech had responded to a request for comment at the time of publication, but we will update the story should either company get in touch.