US Patent Office To Re-Examine Merck Singulair Patent
By Peter Loftus, Of DOW JONES NEWSWIRES
The U.S. Patent and Trademark Office has ordered a re-examination of a key
patent for Merck & Co.'s (MRK) 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. (TEVA) 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
worldwide 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.
Israel-based Teva made similar claims at a trial in federal court in February
in Trenton, N.J.Merck argued that Singulair was an original, non-obvious
invention, and that the claimed prior art wouldn't have taught someone skilled
in drug development how to make it.
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, and offered to
appear before the judge to discuss the action.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires
05-28-091618ET
Copyright (c) 2009 Dow Jones & Company, Inc.
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