Naproxen & Esomeprazole - USA

On Jul 10, 2017 a New Jersey district court ruled that Dr. Reddy’s Laboratories Ltd. and Mylan Pharmaceuticals Inc. are infringing on a patent held by Horizon Pharma for Vimovo (Naproxen & Esomeprazole) tablet.

This case arises out of Defendants’ submission of Abbreviated New Drug Applications (“ANDAs”) to the FDA pursuant to the Hatch-Waxman Act, 21 U.S.C. § 355(j), for the purpose of obtaining FDA approval for the commercial manufacture, use, import, offer for sale, and sale of a generic version of Vimovo. Specifically, DRL filed ANDA No. 202461 (“DRL ANDA I”) and ANDA No. 204206 (DRL ANDA II”). Mylan filed ANDA No. 204920 (“Mylan ANDA”). All three ANDAs included so-called “Paragraph IV” certifications to U.S. Patent No. 6,926,907 (“the ’907 patent”) and No. 8,557,285 (“the ’285 patent”). In response to those Paragraph IV certifications, Horizon asserted infringement of claims 5, 15, 52, and 53 of the ’907 patent. Horizon has also asserted claims 1 through 4 of the ’285 patent.

Mylan has stipulated that its ANDA product would infringe the Asserted Patents. Court previously granted summary judgment in DRL’s favor that its ANDA II product does not infringe the ’907 patent. Accordingly, the only infringement dispute at trial was whether DRL’s ANDA II Product infringes the ’285 patent.

Claim 1 of the ’285 patent

(i) “a pharmaceutical composition in unit dosage form”

Horizon provided unrebutted testimony that the DRL ANDA II Product is “a pharmaceutical composition in unit dosage form.” (Tr. 833:18-834:1.)

(ii) “therapeutically effective amounts of: (a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating”

Horizon provided unrebutted testimony that the DRL ANDA II Product includes a “therapeutically effective amount of esomeprazole.” Further, the esomeprazole in the DRL ANDA II Products is not surrounded by an enteric coating.

(iii) “therapeutically effective amounts of: (b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher”

Horizon provided unrebutted testimony that the DRL ANDA II Product contain therapeutically effective amount naproxen surrounded by a coating that inhibits its release

(iv) “wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole is released regardless of the pH of the medium”

Horizon provided unrebutted testimony that DRL’s ANDA II Product will provide some release of esomeprazole in medium.

Because DRL’s ANDA II Product satisfies each limitation of claim 1 of the ’285 patent, we find that Horizon has proven by a preponderance of the evidence that DRL’s ANDA II Product infringes that claim. Similarly claims 2 to 4 which depend on claim 1 and contain further limitations regarding particular amount of naproxen and esomeprazole would also encompass product at issue. Thus DRL’s ANDA II Product infringes claims 1 to 4 of US’285 patent.

Defendant also raised invalidity challenges under 35 U.S.C. § 103 or § 112 but court concluded that Defendants have not shown by clear and convincing evidence that the Asserted Patents should be invalidated.

Conclusion:

For the reasons discussed court find that the DRL ANDA II product infringes claims 1, 2, 3, and 4 of the ’285 patent and that those claims are not invalid under 35 U.S.C. § 112. For the reasons discussed here court find that the claims of the ’907 and ’285 patents are not invalid under 35 U.S.C. § 103 or § 112.