IP Law Daily, PATENT—N.D. W.Va.: Teva failed to show that Dey’s patents for Perforomist drug were invalid, (Mar 25, 2014)

By Peter Reap, J.D., LL.M.

Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd.(collectively “Teva”) failed to show that four patents held by Dey, L.P. and Dey Inc. (collectively “Dey”) associated with Dey’s respiratory drug Perforomist were invalid, the federal district court in Clarksburg, West Virginia, has decided (Dey, LP v. Teva Parenteral Medicines, Inc., March 21, 2014, Keeley, I.). Teva failed to meet its burden of proving by clear and convincing evidence the invalidity of the patents based on anticipation, obviousness, or lack of enablement.

Therefore, in light of its prior findings of Teva’s infringement, the court declared that making, using, selling, offering to sell, or importing the inhalation product described in Teva’s Abbreviated New Drug Application (“ANDA”) No. 91-141 constitutes infringement of the four patents-in-suit, and enjoined Teva from that conduct. The court also ordered that the effective date of the products described in ANDA No. 91-141 shall not precede the expiration of the patents-in-suit.

Background

In a letter dated May 12, 2009, Teva notified Dey that it had filed an ANDA seeking United States Food and Drug Administration approval to market a generic version of Perforomist. Teva also filed a Paragraph IV certification with the FDA, alleging that the four patents issued to Dey for Perforomist are invalid, unenforceable, and not infringed by Teva’s manufacture or sale of the proposed generic drug product.

Dey responded to Teva’s ANDA by filing this action pursuant to the Hatch-Waxman Act, the court noted. When a branded manufacturer files suit pursuant to that right within 45 days of notice of the Paragraph IV certification, as was the case here, the litigation automatically stays the generic’s entry to the market.

On September 21, 2012, Dey moved for partial summary judgment on the issue of infringement. Following a hearing, the court granted the motion, which Teva did not appeal. Thus, the only issue remaining was whether Teva established, by clear and convincing evidence, that the patents-in-suit are invalid.

Analysis

Teva argued that the patents-in-suit are invalid under the doctrines of anticipation, obviousness, and enablement. First, it contended that the Asserted Claims were anticipated by the Murakami and Gao Patents, as well as Sepracor’s transactions with ALP. Next, it argued that the Asserted Claims were obvious in light of the prior art. Finally, it contended that the Asserted Claims fail to enable a person of ordinary skill in the art to practice the invention without undue experimentation.

Anticipation. The Murakami Patent did not disclose each and every limitation of the Asserted Claims, and therefore did not anticipate and invalidate these claims, the court ruled. Teva next argued that, because the Gao Patent disclosed all of the elements of claims 3 and 34 of the '344 Patent, and claims 75 and 106 of the '953 Patent, these claims were invalid for anticipation. Instead, the court found that the Gao Patent did not disclose every limitation of claims 3 and 34 of the '344 Patent, or claims 76 and 106 of the '953 Patent, it did not anticipate and therefore invalidate these claims.

Teva contended that the Asserted Claims were invalidated by the on-sale bar of 35 U.S.C. § 102 (b), due to Sepracor’s transactions with “contract packager” ALP. The Sepracor Lots were not subject to a commercial sale in the one year prior to the time Dey applied for its patents, the court determined. Further, the Lots differ in composition from the Asserted Claims. Consequently, the Asserted Claims were not invalidated by the on-sale bar of 35 U.S.C. § 102(b).

Obviousness. Teva contended that, while no single prior art reference rendered Dey’s invention obvious, a combination of those various references did. The fact that certain features were disclosed in the prior art, however, was insufficient to establish that a claimed invention is obvious, according to the court. Here, there was no evidence that any combination of the prior art would indicate that an aqueous formulation of formoterol with long-term stability was possible. Furthermore, even if the elements of each Asserted Claim could be found somewhere in the prior art, any attack on the obviousness of Teva’s invention would be entirely hindsight driven and therefore legally incorrect.

Teva also contended that the Asserted Claims are obvious because Dey’s scientists used standard techniques in formulating their invention. Patent law, however, rejects the idea that novel inventions only arise from novel techniques, the court observed. The process by which an invention was created is irrelevant to the analysis of its patentability.

Dey argued that secondary considerations of commercial success, satisfying a long felt need, and copying further illustrated the nonobviousness of the patents-in-suit. Teva countered that Dey failed to provide sufficient evidence to establish that objective indicia supported a finding of nonobviousness. Dey’s arguments were more persuasive, the court reasoned.

There was no clear and convincing evidence that the scope and the content of the prior art included the motivation and capability to invent the patents-in-suit. Thus, the Asserted Claims were not invalid due to obviousness.

Enablement. Teva failed to demonstrate by clear and convincing evidence that the patents-in-suit failed the disclosure requirements set forth in 35 U.S.C. § 112. The required level of skill in the art is high—a person of ordinary skill in the art is an individual with an advanced degree in Pharmacy with experience in creating pharmaceutical formulations. The patents-in-suit provided sufficient guidance that such a skilled artisan could practice the claimed invention, according to the court.

The case is No. 1:09CV87.

Attorneys: David N. Greenwald (Cravath, Swaine & Moore), Edgar H. Haug (Frommer Lawrence & Haug, LLP) and Gordon H. Copland (Steptoe & Johnson, PLLC) for Dey, L.P. and Dey, Inc. Ashlee B. Szelag (Leydig, Voit & Mayer, Ltd) and Geraldine S. Roberts (McNeer, Highland, McMunn & Varner, LC) for Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.

Companies: Dey, L.P.; Dey, Inc.; Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Cases: Patent WestVirginiaNews