Lumigan is Allergan’s second-biggest drug. Not only Lupin Ltd making attempts to infringe but Novartis AG’s Sandoz unit, Actavis PlcHi-Tech Pharmacal Co. and would also infringe Allergan’s patents on the medicine.

Allergan owns five patents that are ′504, ′353, ′118, ′605, and ′479 patents, which are all listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations as claiming Lumigan 0.01% and its approved uses. After Allergan received FDA-approval of Lumigan 0.01%, Sandoz, Lupin, Hi–Tech, and Watson each submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to engage in the commercial manufacture, use, importation, sale, or offer for sale of generic versions of Lumigan 0.01% prior to the expiration of the ′504, ′353, ′118, ′605, and ′ 479 patents.

In response, Allergan sued each of the ANDA applicants in the United States District Court for the Eastern District of Texas, asserting that their ANDA filings infringed those patents. The district court consolidated those actions into one case.

Allergan alleged that Lupin Pharmaceuticals Inc. infringed U.S. Patent Number 7,851,504, “Enhanced bimatoprost ophthalmic solution,” when the drugmaker filed an abbreviated new drug application with the U.S. Food and Drug Administration seeking approval to produce and sell a generic version of Lumigan.

And Allergan won a patent infringement law suit which will prevent copies of its Lumigan 0.01% glaucoma treatment from entering the US market until 2027.

Lumigan is the pharmaceutical product which comes in different formulas according to California based company’s revenue it has generated $452.7 million in sales for the nine months and accounts for about 10% of the Irvine. Lumigan 0.01% solution on application found to slow down the progression of glaucoma which cause blindness.

The dispute is that the generic drug companies argued that the patents were of little different than ones covering Lumigan 0.03%.

Concluding Accordingly, The district court affirmed the determination that the asserted claims are not invalid for obviousness or for lack of an adequate written description and enablement, and that companies infringed the claims of the ′ 504, ′605, and ′479 patents.

Keywords: Lumigan, Allergan, Lupin, bimatoprost, Glaucoma.