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Article One Partners Uncovers New Prior Art Impacting the Validity of Merck's SINGULAIR Patent
Date:3/9/2009

Article One Asks U.S. Patent Office to Take a Second Look at Patent in a Reexamination Procedure, Based on New Art Uncovered by Article One Community

NEW YORK, March 9 /PRNewswire/ -- Article One Partners LLC has discovered new prior art impacting the validity of Merck & Co.'s SINGULAIR U.S. drug patent. A request is being filed today with the U.S. Patent Office to review the patent in a reexamination proceeding. An independent law firm and an independent expert join Article One's opinion that a substantial new question of patent validity is raised by the success of Article One's research and should be reviewed by the Patent Office. Validity opinions also were announced in the close of research for patents related to the drugs Boniva and Protonix.

The Article One community uncovered two prior art references submitted in the Study of SINGULAIR - MERCK posted on Article One's website, www.ArticleOnePartners.com. A key paper authored by Dr. Robert Young (one of Merck's own scientists) provides a roadmap of how to construct montelukast sodium and was not before the Patent Office when it granted the patent. This was identified by a U.S. graduate student, one of Article One's winners. The second reference came from a winning Advisor in Columbia, South America. It is a patent presenting compounds that are similar in structure to montelukast. The graduate student also uncovered critical new prior art demonstrating what scientists already knew at the time of the alleged invention.

The Study relates to a patent litigation brought by Merck to prevent Teva Pharmaceutical Industries, Limited, from making a generic version of SINGULAIR, for which Merck's patent (U.S. Patent No. 5,565,473) does not expire until 2012. Merck holds the patent for the drug montelukast sodium, which is sold under the brand name SINGULAIR to treat asthma and allergies. Worldwide sales for 2008 of SINGULAIR were $4.3 billion, per the full-year 2008 financial results released by Merck on February 3, 2009. In accordance with FDA procedure, Teva is stayed from generic drug production until Aug. 2009, unless the court extends the stay. Developments from the U.S. Patent Office can provide fundamental information to the parties to drive resolution of the litigation.

"The public deserves a second review by the U.S. Patent Office based on new prior art that was not before them when the original case was allowed. Our community uncovered critical references about the alleged invention and what was known to the scientists at the time," said Cheryl Milone, founder of Article One Partners. "Reexamination presents a balanced approach, putting key information that Merck has presented was not known at the time it applied for the patent, before the Patent Office."

Studies Close for Boniva and Protonix, Strengthening Both Patents with Validity Opinions

In the opinion of Article One, the validity of the patents for these drugs is strengthened. Article One has closed its patent study related to the drug Boniva, a Hoffmann-La Roche Inc. drug prescribed for the treatment of osteoporosis, with an opinion of validity. Article One also closed its patent study related to Protonix, the brand name for the Patent Holder Wyeth's pantoperazole sodium drug, administered to inhibit gastric acid secretion in and to protect the stomach and intestines of warm-blooded animals.

Importantly, only a U.S. federal court or the U.S. Patent Office can invalidate a U.S. patent. Article One is announcing only its own opinion based on its analysis of the prior art for purposes of determining winners to its Patent Studies. A court or the Patent Office may disagree with Article One's opinion. The prior art is listed in the announcement of the winning Patent Study and may be viewed on Article One's website.

The Article One community provides a powerful means for parties on both sides of an intellectual property dispute to better delineate the scope of an invention early in the development process and before litigation. Harnessing a global community of prior art researchers can pinpoint the patentable features and create the strongest patent rights.

"As demonstrated by the second announcement in one month of Prior Art found in an Article One Patent Study, our community is having a profound impact, with citizen review truly having an effect upon patent validation in both technology and healthcare/pharmaceutical markets," continued Cheryl Milone. "Teva and Merck can consider the prior art uncovered by Article One's Advisors as critical information. We encourage any companies involved in litigation to consider the Article One community as a resource that can help zero in on the core issues of patent validity to drive resolution of litigations."

About Article One PartnersArticle One Partners is a global online community working to legitimize the validity of patents. Community members - who Article One calls Advisors - have an opportunity to send in previously undisclosed evidence of patent validity. By tapping the unique knowledge and referral networks of our Advisors, this evidence known as prior art can be discovered. Prior art may come from published content anywhere in the world and in any language, including: previous patents; news or academic publications; non-digitized documents such as textbooks; or any public document provided to others, including conference or academic papers and business materials. Article One analyzes the prior art to determine whether it can show patents to be legitimized or invalid.

If Article One forms an opinion that patents are invalid, Advisors earn up to $50,000. Advisors who actively build the community also earn premium compensation in a Profit Sharing Plan, distributing approximately five percent (5%) of Article One's net annual profit. The result is a highly-rewarded community providing a second, citizen's review of U.S. patents to justify monopoly pricing for true innovation and energize U.S. patent reform. To learn more about Article One Partners, or to become a member of our community, please visit www.ArticleOnePartners.com .

Article One Partners and AOP are service marks of Article One Partners, LLC. All other product and company names are the trademarks and property of their respective owners.


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SOURCE Article One Partners, LLC
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