Last month I discussed the issuance of The Medicines Company’s US 7,582,727, which caught my attention because (a) uncommonly for a pharmaceutical patent, it had been filed not only with request a for accelerated examination, but also with a non-publication request, and (b) it issued less than seven months before TMC’s earlier US 5,196,404, the patent that covers its product bivalirudin (sold in the USA under the name Angiomax®), was due to expire on March 23, 2010. Within days of the issuance of the patent, Teva and one of its daughter companies had filed a paragraph IV certification.
Now, in the words of the late, great Paul Harvey, we get the rest of the story: Sherri Oslick at PatentDocs reports today that (not unexpectedly) last week TMC filed suit against Teva, Barr (a Teva subsidiary), and Pliva (which is owned by Barr). Hello 30-month stay to Teva/Barr/Pliva’s ANDA for Angiomax. Ok, not quite: Teva et al.’s ANDAs were filed before the ‘727 patent was listed in the Orange Book, so no 30-month stay is available. But TMC will no doubt seek a preliminary injunction, which can still be quite valuable, even if it doesn’t extend for a full 30 months.
Given the relative ease with which infringement of the claims of the ‘727 patent can be avoided, and Teva’s position as the first paragraph IV challenger of this patent, it will be interesting to see if this case settles with some sort of reverse payment scheme.
No less interesting is the filing last week by Teva of its own suit as a patentee against another ANDA filer, Lupin Pharmaceuitcals of India. Lupin filed a paragraph IV certification for US Reissue Patent No. 39,861, which claims a method for the co-administration of estrogen and progestin for female contraception. Teva is no stranger to litigation, but Teva is usually positioned as a defendant in patent infringement actions, or as a plaintiff in actions for declaratory judgment of non-infringement and/or patent invalidity. While the suit against Lupin is not the first time Teva has sued someone for infringement of one of its patents – Teva sued Amgen last spring for infringement of its US 7,449,603 – infringement suits in which Teva is the plaintiff remain the exception.