FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®

February 12, 2015

By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst

We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc. (“Mylan”), and which yesterday resulted in Final Approvals for Mylan and one other generic drug company to manufacture celecoxib, the active ingredient in Celebrex®.  That drug, which is indicated for the treatment of rheumatoid arthritis, osteoarthritis, short-term acute pain, and other conditions, is one of the highest-grossing drugs in the United States, with sales of about $2 billion in 2013.

We have reported on the case before (see here). But, to recap, the dispute centered on a reissue patent’s impact on 180-day exclusivity under the pre-MMA (the Medicare Modernization Act) statutory framework and FDA’s patent-by-patent approach to exclusivity.  Teva Pharmaceuticals USA, Inc. (“Teva”) was the only company to qualify as a first-filer of what is referred to as a Paragraph IV certification to an original patent for Celebrex®, U.S. Patent No. 5,760,068 (“the ‘068 patent”) when it submitted its celecoxib ANDA in early 2003.  In May 2008, a court decision invalidated the ‘068 patent, which Mylan, Watson Pharmaceuticals, Inc. (“Watson”) and Lupin Pharmaceuticals, Inc. (“Lupin”), argued triggered the running of Teva’s exclusivity tied to the ‘068 patent pursuant to the statutory “court decision trigger.”  Thus, as Mylan, Watson, and Lupin contended in court, Teva’s exclusivity period tied to the ‘068 patent expired in November 2008.  However, Pfizer, the company that sells the brand version of Celebrex®, later secured a reissue of the ‘068 patent from the United States Patent Office, U.S. Patent No. RE44,048 (the “‘048 patent” or the “reissue patent”).  Teva, Mylan, and Watson were all first-filers to the reissue patent.

On April 24, 2014, FDA, while agreeing that Teva, Mylan, and Watson were all first filers to the reissue patent, issued a letter decision stating that only Teva would be granted an exclusivity period – even though Mylan and Watson both had Tentative Approvals to market the drug – because FDA believed that Teva’s first-filing to the original ‘068 patent and its subsequent timely filing to the reissue ‘048 patent created a  “bundle of rights” that essentially preserved Teva’s exclusivity tied to the ‘068 patent.  Mylan sued FDA, arguing both that (1) Teva’s exclusivity period tied to the ‘068 patent had expired; and (2) the ‘048 patent was tied to a separate period of exclusivity that should be shared by all first-filers to that patent.  Watson intervened, along with Teva and Lupin.  The U.S. District Court sided with FDA and issued a final decision finding that, although Mylan’s, Watson’s, and Lupin’s position that the original exclusivity period had expired was plausible, FDA’s position must be afforded deference.  Teva received its Final Approval to market celecoxib on May 30, 2014, and began marketing the drug (pursuant to a settlement agreement with Pfizer) on December 10, 2014.

On December 16, 2014, the Fourth Circuit Court of Appeals reversed the District Court, agreed with Mylan’s, Watson’s and Lupin’s argument, and found that the statutory language was clear that the exclusivity period tied to the ‘068 patent had expired and could not be revived by a reissue patent.  Although the Court did not explicitly say it, they apparently agreed with our argument that there is no such thing as a “zombie” exclusivity period: one that can never die because it could be revived if an original patent was replaced by a reissue patent.  The Fourth Circuit also stated in its opinion that “[t]he plain language of the statute indicates that each patent that is the subject of a certification may trigger exclusivity,” indicating that first-filers to the ‘048 patent were entitled to a separate, shared period of exclusivity.

The Mandate on the Fourth Circuit decision issued Monday, and the District Court, at the request of the parties in the litigation, immediately remanded the case to FDA.  FDA yesterday granted Final Approvals to Mylan and Watson, permitting them to join in the exclusivity period that Teva began using about three months ago.  Although numerous companies have been selling what are referred to as “Authorized Generics” (licensed versions of Pfizer’s product, under Pfizer’s NDA) since mid-December, Mylan and Watson will now be able to distribute their own versions of the product, manufactured pursuant to their own ANDAs.