Lilly Can’t Get Stay of Generic Approval Extended in Rx Case

By Dana A. Elfin

Dec. 17 — Drugmaker Eli Lilly wasn't able to convince a federal court to extend the automatic 30-month stay of FDA approval of generic versions of its anti-clotting drug Effient (prasugrel) even though the court granted a stay in the patent litigation pending Patent Office review of two of the patents in the case.

U.S. Magistrate Judge Tim A. Baker of the U.S. District Court for the Southern District of Indiana Dec. 11 granted the defendant generic drug companies' motion to stay the Hatch-Waxman Act patent litigation over Effient until the U.S. Patent and Trademark Office issues a written decision regarding its inter partes review (IPR) of two of the patents in the case. Baker said a stay was justified because it could streamline the issues in the district court litigation and ease the burden on the parties and the court.

First Ruling on the Issue?

Patent law experts told Bloomberg BNA Dec. 16 that this ruling may mark the first time a court has considered the issue of whether staying patent litigation at the district court level pending IPR should also extend or toll the running of the automatic 30-month stay on generic drug regulatory approval provided for under the Hatch-Waxman Act.

“This decision illustrates that courts consider granted IPRs [to be] a basis for a stay of the district court action but that an extension of the 30-month stay of FDA approval is a discretionary question that depends on the particular facts of a case,” Robert E. Colletti of Frommer Lawrence & Haug LLP in New York told Bloomberg BNA.

IPRs, a type of post-grant review proceeding, were established under the America Invents Act of 2011 to allow third-party challenges of patents at the PTO. Parties are increasingly using them to challenge patents on pharmaceutical products.

30-Month Stay Expires June 2017

Under the Hatch-Waxman Act, the filing of a patent infringement lawsuit triggers an automatic 30-month stay of final FDA approval of the defendant's abbreviated new drug applications (ANDAs) to make generic versions of the branded drug at issue, unless the district court finds the patents invalid or not infringed before then.

In this case, the automatic 30-month statutory stay on FDA final approval of the defendants' ANDAs expires in June 2017.

“The decision creates the possibility that generic defendants could be in a position to launch at risk at the expiration of the 30-month stay without the district court considering the merits in any meaningful way,” Steven H. Sklar of Leydig, Voit & Mayer, Ltd. in Chicago told Bloomberg BNA. “In the event of a request for preliminary injunction by Lilly, the district court will have to evaluate any decision by the Patent Office in the IPR,” Sklar said.

The launch of a generic drug is considered to be “at-risk” if it is launched before patent litigation over the branded drug has been resolved.

‘No Basis' to Extend 30-Month Stay

Although Baker found that a stay would simplify the issues and streamline the case for trial as well as reduce the litigation burden on the parties and on the court, he said that there wasn't any basis to grant Lilly's request to issue a corresponding extension of the Hatch-Waxman Act's 30-month stay.

“The fact that Plaintiffs cannot get final resolution of their case before the expiration of the 30-month stay is not a recognized prejudice that can overcome the strong showing for a stay in this case,” Baker said. “There is no law that justifies this request.”

Congress did not tie resolution of the patent litigation to approval of the product, he said.

In fact, he said, the only basis that courts have relied on to extend the regulatory stay is when a party has failed to reasonably cooperate in expediting the litigation.

But no such circumstances exist in this case, Baker said, and denied Lilly's request to extend or toll the regulatory law stay.

No Prejudice to Lilly

Baker also rejected the argument that Lilly would be prejudiced by issuing a stay in the Hatch-Waxman litigation because the litigation might not be completed before the 30-month stay expires.

Instead Lilly “will have ample opportunity to seek an injunction once the IPRs are finally concluded, which eliminates any alleged prejudice,” he said.

Only two of the patents at issue in the litigation, U.S. Patent Nos. 8,404,703 and 8,569,325 (the '703 and '325 patents), are included in the PTO's review, which it instituted in mid-September. Those patents protect methods of using Effient and aspirin as directed on the label. A third patent, U.S. Patent No. 5,288,726 (the '726 patent), a compound patent, isn't included, and is set to expire in April 2017.

Effient is an anti-thrombotic drug approved to prevent or reduce the risk of blood clots and stent thrombosis in patients suffering from acute coronary syndrome and who receive stents.

Representing Indianapolis-based Lilly and its co-plaintiffs, Daiichi Sankyo Inc. and Ube Industries Ltd., which own the patents at issue and are based in Japan, were the firms of Williams & Connolly LLP, Washington, and Barnes & Thornburg LLP in Indianapolis.

Representing Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas Pharmaceuticals Ltd. were the firms of Sughrue Mion, PLLC in Washington and Riley Bennett & Egloff LLP in Indianapolis.

Representing Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India Pvt. Ltd., Apotex Corp., Apotex Inc., Panacea Biotec Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, Inc., and Watson Laboratories, Inc. were the firms of Winston & Strawn LLP in Washington and Chicago and Hoover Hull Turner LLP in Indianapolis.

Representing Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc. were the firms of Rakoczy Molino Mazzochi Siwik LLP in Chicago and Katz & Korin P.C. in Indianapolis.

Representing Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. were the firms of Lerner David Littenberg Krumholz & Mentlik LLP in Westfield, N.J. and Harrison Moberly LLP in Indianapolis.

Representing First Time US Generics LLC were the firms of Cittone & Chinta LLP in New York and Brannon Sowers & Cracraft PC in Indianapolis.

Representing Glenmark Pharmaceuticals Ltd. and Glenmark Pharmaceuticals Inc. USA were the firms of Duane Morris LLP in Chicago and Krieg DeVault LLP in Indianapolis.

Representing Hetero USA, Inc., Hetero Labs, Ltd., Hetero Labs, Ltd. Unit V, and Hetero Drugs, Ltd. were the firms of Cantor Colburn LLP in Hartford, Conn. and Atlanta, and Bingham Greenebaum Doll LLP in Indianapolis.

Representing Lupin Ltd. and Lupin Pharmaceuticals, Inc. were the firms of Kelley Drye & Warren LLP in New York, Chicago, and Parsippany, N.J., and Frost Brown Todd LLC in Indianapolis.

Representing Mylan were the firms of Alston & Bird LLP, New York and Atlanta, and Barrett & McNagny LLP in Fort Wayne, Indiana.

Representing Zydus Pharmaceuticals USA, Inc. and Cadila Healthcare Ltd. were the firms of Withers LLP in Greenwich, Conn., and Taft Stettinius & Hollister LLP in Indianapolis.