The U.S. Patent and Trademark Office has ordered a re-examination of a key patent for Merck & Co.'s blockbuster Singulair allergy and asthma drug, saying new questions have been raised about its "patentability."
The Patent Office decision comes as a U.S. judge is preparing a ruling in a February trial in which Teva Pharmaceutical Industries Ltd. challenged the Singulair patent in an effort to sell copycat versions before patent protection expires in 2012. Merck has defended the patent's validity in an effort to maintain market exclusivity through the patent's expiration.
The Patent Office re-examination represents a separate avenue that could clear the way for early generic competition for Singulair, which had $4.3 billion in world-wide sales last year, or 18% of Merck sales.
A spokesman for Merck, which is based in Whitehouse Station, N.J., said Thursday the Patent Office hasn't yet drawn any conclusions, and the drug maker believes its patent is valid. He added that the company doesn't expect the patent re-exam to have any bearing on the current litigation with Teva, and that Merck isn't sure how long the re-exam will take.
The Patent Office ordered the re-examination on May 20, saying "a substantial new question of patentability" has been raised by a New York firm, according to documents on the Patent Office's Web site.
In April, a firm called Article One Partners LLC filed a request with the Patent Office to re-examine the patent, citing information that wasn't brought to the attention of the patent examiner who reviewed Merck's initial application in the 1990s, including a paper by a Merck scientist.
Article One describes itself as an online community that encourages members to dig up previously undisclosed evidence related to the validity of patents. Article One pays members who find valuable evidence, and it sells evidence collections and analysis to clients.
Under patent law, a patent can be declared invalid if previous research -- known as "prior art" -- renders the claimed invention obvious to someone skilled in the art of drug development. Or, a patent can be declared unenforceable if the applicant engaged in inequitable conduct, such as by withholding information from the patent application reviewer.
Teva wasn't involved in the request for the Patent Office re-examination. In a letter to a U.S. judge in the court case Thursday, a Teva lawyer said the Patent Office's re-exam decision supports Teva's position in the trial.
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