Patent Law

ArticleOne and Merck's Singulair: the need to cite employee science articles in the IDS

By Lawrence B. Ebert, Esq.

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."

and includes the text:

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.

The grant of the re-exam request illustrates why it is important for companies to cite all relevant scientific publications by employees when they file for patent applications. Here, two papers by one Merck Canada employee (named Young), which were not cited in the patent application of another Merck Canada employee (named Belley), gave traction to the re-exam request of Belley's patent. A patent application (and subsequent patent) of the one employee (Young, on which Belley was co-inventor) WAS CITED in the patent application of Belley; the problem was that the science papers were not.

IPBiz had previously observed:

Globes said that Barclays Capital noted, "Based on testimony offered and the tone of the proceedings, in our view the most likely outcome is that Merck's patent no. 5,565,473 will be upheld should there be no out-of-court settlement (which remains a possibility).

On 27 April 09, re-exam 90/009,432 was filed. The 501 form filed (information disclosure citiation [!] in a patent] included US Patent No. 5,104,882 (to Young) and two science papers by Young (one in "Drugs of the Future" (1988) and one in Advances in (...) Leukotriene Research (1989).

Young is not a named inventor on US 5,565,473, whose inventors are Canadian, with the research arising out of Merck Frosst Canada, Inc. (Kirkland, CANADA). The first named inventor on the '473 patent is Belley.

Young is the first named inventor of US 5,104,882, which ALSO arose out of Merck Frosst Canada, Inc. and includes the inventors Zamboni, Gauthier, and Belley.

One notes that inventor Michel L. Belley is common to both patents.

The '473 patent, at issue in the re-exam, mentioned three different related patent applications: 774414, 741888, and 596887. The application leading to the '473 patent is 08/392,592, filed February 23, 1995, with a priority chain:

This is a continuation of application Ser. No. 07/774,414, now abandoned, filed Oct. 10, 1991, which is a CIP of U.S. Ser. No. 741,888, Aug. 8, 1991, abandoned, which is a CIP of U.S. Ser. No. 596,887, Oct. 12, 1990, now abandoned. [IPBiz notes these ARE the applications cited in related US applications.]

The '882 patent, cited against the '473 patent derives from application 07/527,236, filed May 22, 1990, with a priority chain: This is a CIP of U.S. Ser. No. 356,478, filed 5/24/89, now abandoned, which is a CIP of U.S. Ser. No. 275,160, filed 11/22/88, now abandoned, which is a CIP of U.S. Ser. No. 125,050, filed 11/25/87, now abandoned.

In terms of Article One's handling of the matter, on 27 March 09, a letter went out FROM the USPTO noting that Article One had failed to include a statement pointing out each new question of patentability and thus had not complied with 37 CFR 1.510(b)(1). The USPTO lectured Article One: "It is not sufficient to merely state that the references were not of record in the prior prosecution of the '473 patent." The USPTO illustrated inappropriate language in the Article One request.

The USPTO grant of re-exam on 27 April 09 pertains to claims 1, 7 and 18-22 of the '473 patent. On page 8 of the 27 April 09 mailing, the USPTO notes that the Young '882 patent WAS CITED in the exam of '473 patent but was NOT applied. On page 9, the USPTO notes the 1988 publication of Young was NOT of record in the prosecution of the '473 patent.

Full post as published by IPBiz on May 31, 2009 (boomark / email).