In this post, we take a look at how Eli Lilly and Company wins in multiple cases involving challenges of the validity of their U.S. patent no. 7,772,209 filed by a group of pharmaceutical giants.
Eli Lilly and Company Wins in Multiple Cases Involving Challenges of the Validity of their U.S. Patent No. 7,772,209 Filed by a Group of Pharmaceutical Giants
For decades we don't have proper medication to treat different types of cancer, one of which was Pleural mesothelioma. This is a rare and malignant cancer caused by inhaling asbestos fibers and which affects the lungs. This cancer develops in the thin inner and outer lining of the lungs. Once affected, the average lifespan is less than 18 months. As there is no permanent cure for this cancer, many people extend their lifetime by taking several medications, such as surgery, chemotherapy, and radiation.
Eli Lilly and Company (hereafter "Lilly") is a pharmaceutical company founded in 1876, and headquartered in Indiana. They sell products all over the world. On August 10, 2010, the United States patent 7,772,209 entitled "Antifolate Combination Therapies" was legally issued to Eli Lilly and Company. In 2004, Lilly introduced a chemotherapy drug called “Pemetrexed” that was sold under the brand name ALIMTA® and was approved by the FDA for the treatment of pleural mesothelioma cancer.
In 2015, several pharmaceutical companies, including Apotex Corp., EMCURE, Glenmark Pharmaceuticals, Heritage Pharmaceuticals, Neptune Generics, Fresenius Kabi USA, Mylan Laboratories, and Teva Pharmaceuticals (hereafter "Petitioners") filed Petitions, IPR2016-00237, IPR2016-00240, and IPR2016-00318, for inter partes review at the Patent Trial and Appeals Board ("PTAB") against Lilley’s ‘209 patent. In 2017, PTAB ruled against the Petitioners and held that Lilly’s ‘209 patent was valid. Unhappy with the decisions, Neptune Generics, Fresenius Kabi USA and Mylan Laboratories Ltd. appealed (18-1257, 18-1258, 18-1288, and 18-1290) to the Court of Appeals for the Federal Circuit (CAFC).
Jiangsu Hansoh Pharmaceutical Group Co., Ltd (hereafter "Hansoh") is one of the top 30 pharmaceutical corporations in China. On July 28, 2017, pursuant to FDCA procedures and the Hatch-Waxman Act, Hansoh sent a Notice Letter to Lilly stating that they had submitted an Abbreviated New Drug Application to the FDA seeking approval to market Pemetrexed Disodium injectable 100 mg/vial and 500 mg/vial drug product in the United States before the expiration of the '209 patent (Abbreviated New Drug Application No. 2008696). Hansoh was well aware that sending the Notice Letter would trigger a forty-five-day period for Lilley to bring an action for patent infringement under the FDCA.
On August 21, 2017, Lilly filed a patent infringement suit (1:17-cv-02864) against Hansoh in the United States District Court for the Southern District of Indiana for infringing claims 1 to 22 of the '209 patent. On December 18, 2017, both the parties filed a joint motion to stay the case pending the outcome of the appeal cases involving IPR2016-00237, IPR2016-00240, and IPR2016-00318. On April 26, 2019, Court of Appeals Federal Circuit Judges Moore, Wallach, and Hughes AFFIRMED the decision of PTAB's IPR.
On August 9, 2019, Lilly and Hansoh filed a Joint Motion to enter Final Judgment in case number 1:17-cv-02864. On August 13, 2019, the Stay was lifted and the Final Judgment order was entered by Judge Tanya Walton Pratt in favor of Lilly based on the decisions made by PTAB and CAFC. Judge Tanya Walton Pratt also indicated that Hansoh had infringed Claims 9, 10, 12, 13, 14, 15, 18, 19, 21, and 22 of Lilly’s ‘209 patent and ordered that the effective date of approval of ANDA No. 208696 shall be not earlier than the expiration of U.S. Patent No. 7,772,209.