Earlier today the United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement litigation relating to U.S. Patent No. 7,772,209. This matter arose as the result of the defendants’ filing of Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration (FDA). The ‘209 patent, covering a method of use, protects the co-administration of pemetrexed disodium with two nutrients – folic acid and vitamin B12, which protects against the side effects of the drug Alimta®.
The FDA approved Alimta® in 2004 for the treatment of malignant pleural mesothelioma, a rare type of cancer, which is usually associated with asbestos exposure, that affects the inside lining of the chest cavity.
In the United States, in order for a new drug to receive market approval, a New Drug Application, known as an NDA, must be submitted to the FDA. To lessen the burden on generics, Hatch-Waxman allows generic manufacturers to submit Abbreviated New Drug Applications, known as ANDAs, which allows the generic manufacturer to piggyback on the research data in the NDA, which alleviates the need for the generic manufacturer to undertake the very costly expense associated with an NDA. Under Hatch-Waxman an ANDA applicant must make one of four certifications regarding each patent that applies to the drug for which approval is being sought: (I) no such patent information has been submitted to the FDA; (II) the patent has expired; (III) the patent is set to expire on a certain date; or (IV) the patent is in valid or will not be infringed by the drug covered in the ANDA. Although making a paragraph IV certification is not an active act of infringement, when a paragraph IV certification has been made the patent owner of the drug covered by the NDA may immediately institute patent infringement proceedings. It is the paragraph IV certifications of the defendants that ultimately lead to Eli Lilly choosing to sue the defendants for infringement.
The defendants in this case sought FDA approval to market generic forms of pemetrexed, and further sought to sell their pemetrexed products with prescribing information (TX 3018) and patient information (TX 3017) that provides instructions to both doctors and patients that is identical to the methods described in the ‘209 patent.
Eli Lilly asserted claims 9, 10, 12, 15, 18, 19, and 21 of the ‘209 patent with respect to the ANDA Products. Each claim requires pretreatment with a specified amount of folic acid, up to 1000 µg, and with vitamin B12 in the amount of 55-1,500 µg in claims 12, 14 and 21, and 1000 µg in claims 15, 18, and 19, prior to administering pemetrexed. Claims 19, 21, and 22 further require a specific schedule for those pretreatments, and claims 15, 18 and 19 require administration of vitamin B12 by intramuscular injection. The Defendants’ product labeling for their proposed generic versions of Alimta® would instruct doctors to exactly follow the claimed regimen.
The primary focus of the infringement trial was on whether the steps of the claimed methods may be attributed to a single actor, thus supporting a finding that Defendants would induce infringement of the Asserted Claims. An earlier infringement determination by the district court was appealed to the Federal Circuit, but the parties mutually agreed to have the case remanded for trial in light of the Supreme Court’s decision in Limelight Networks v. Akamai Technologies (2014)(commentary here and here). Meanwhile, just two weeks ago the Federal Circuit sitting en banc clarified the law with respect to divided infringement in Akamai Technologies v. Limelight Networks (Fed. Cir. Aug. 13, 2015).
Eli Lilly and the defendants disputed whether physicians would directly infringe the patent by directing or controlling the administration of folic acid to patients. The district court explained that because the defendants do not treat patients they would not themselves directly infringe. Therefore, the defendants would only be able to be held liable for infringement under 35 U.S.C. § 271(b) if they actively induce infringement of the ‘209 patent. In order to establish liability for inducement there must be a finding of direct infringement by a third party.
Although the claim of infringement in this case is of a different sort than at issue in the Akamai saga, the district court explained that the factual circumstances are sufficiently analogous to those in Akamai to support a finding of direct infringement by physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b), under the new legal standard recently set forth by the Federal Circuit in Akamai Technologies v. Limelight Networks (Fed. Cir. Aug. 13, 2015).
More specifically, the district court determined that Eli Lilly demonstrated that the physician directs or controls the patient’s administration of folic acid such that the performance of all the claimed steps, including the administration of folic acid, can be attributed to a single person. As a result, the district court found the performance of all of the claimed steps of the ‘209 patent to be attributable to the administering physician and that administration by the physician would constitute direct infringement under 35 U.S.C. § 271(a). With a finding of direct infringement on the part of the administering physician the district court easily concluded that the defendants’ ANDA products would constitute inducement of the ‘209 patent by Defendants under 35 U.S.C. § 271(b).
The ‘209 patent provides Eli Lilly with exclusive rights for Alimta® until May 2022. In March 2014, the court previously upheld the validity of the vitamin regimen patent. The Alimta® compound patent remains in force through early 2017.
The case was Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., et al. (Case No. 1:10-cv-01376-TWP-DKL). For more information see the Findings of Fact and Conclusions of Law (dated August 25, 2015).