Pfizer Inc. announced on March 5, 2013 that the United States Patent & Trademark Office has granted Pfizer a reissue patent (U.S. Patent No. RE44048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. More specifically, the reissue patent explains that it covers a method of treating inflammation or an inflammation-associated disorder in a subject by administering a therapeutically-effective dose of 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide. The reissue patent will expire on December 2, 2015, which includes six months of pediatric exclusivity. The basic patent for celecoxib expires on May 30, 2014, which also includes six months of pediatric exclusivity.
“Continued development of new medicines that enhance patient lives is supported by protecting intellectual property and innovation,” said Amy Schulman, executive vice president and general counsel for Pfizer. “We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our intellectual property rights through December 2, 2015.”
Upon receiving this reissue patent, Pfizer immediately filed a lawsuit against Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc.; Watson Laboratories, Inc.; Lupin Pharmaceuticals, USA, Inc.; Apotex Corp.; and Apotex, Inc. in the United States District Court for the Eastern District of Virginia for infringement of the reissue patent.
The complaint filed by Pfizer and its wholly owned subsidiary G.D. Searle LLC, which is a Delaware limited liability company, asserts:
On information and belief, Defendants intend to market generic versions of Pfizer’s Celebrex® drug product beginning on or about May 30, 2013, which is prior to the expiration of the ‘048 patent. This will cause Pfizer to suffer irreparable harm— inflicting incalculable damage by causing Pfizer to lose substantial market share, to experience massive price erosion, and to lose goodwill and customers. This irreparable harm to Pfizer will occur even if generic versions of Celebrex® are subsequently removed from the market due to a later judicial determination that the ‘048 patent is valid, enforceable, and infringed. Accordingly, in the event that Pfizer is unable to obtain a full adjudication on the merits prior to May 30, 2014, it will need to seek a preliminary injunction to prevent such irreparable and irreversible harm.
Each of these generic companies previously filed an abbreviated new drug application (ANDA) with the United States Food and Drug Administration (FDA) seeking approval to market a generic form of celecoxib in the United States beginning in May 2014, prior to the December 2, 2015 expiration of the reissue patent.
I understand Pfizer’s assertions, save one thing: I just don’t understand the part about losing goodwill. Goodwill is defined as “an intangible business asset which includes a cultivated reputation and consequential attraction and confidence of repeat customers and connections.” Can one lose goodwill through another offering the same product for less?
It seems virtually impossible that any recognizable damage to goodwill would be able to be successfully asserted by Pfizer because it is reputational in nature and typically tied to the business name or trademarks. Certainly if Pfizer faces a market entrant selling the same drug for less money, they will experience price erosion and lose customers who choose to purchase the generic, but does that amount to damage to goodwill? No, not based on any legal theory I’m familiar with.
The assertion that a preliminary injunction may be necessary if the matter does not achieve a final resolution prior to May 30, 2014, is also worthy of comment. Should a case like this need judicial resolution via trial, it would be extremely unlikely to culminate before May 30, 2014, at least in any court other than the Eastern District of Virginia. The Eastern District of Virginia is known as the “Rocket Docket,” where things proceed with extraordinary speed. So don’t blink and stay tuned. This could get resolved far sooner than you might have otherwise anticipated.