Monday, October 24, 2005

Tamiflu patent to Gilead; licensed to Roche


While there may be some controversy and some dispute about who, under which laws, is entitled to manufacture the anti-viral medication oseltamivir (now being produced and marketed by Roche Pharmaceuticals as "TamifluĀ®") for the purpose of rapidly accumulating national or local stockpiles as a possible means of mitigating the effect of a potential global avian influenza ("bird flu") pandemic, or for other, more mundane individual treatment of the flu, there can be no doubt about who owns the patent on oseltamivir.

A quick visit to the page on the United States Patent and Trademark Office (USPTO) web site that contains the "Patent Assignment Abstract of Title" for Patent #5763483 (for oseltamivir) clearly shows that Gilead Sciences, Inc., located at 353 Lakeside Drive, Foster City, California 94404, is the patent holder, having been assigned it by the five named researchers who invented this particular "carbocyclic compound."

This patent having been filed, as shown on this page, on December 27, 1996, and with U.S. patents running for 20 years from the date of filing, Gilead Sciences' patent on oseltamivir will not expire until December 26, 2016.

The patent claims priority only to a provisional:
This application claims priority from U.S. Provisional Application Ser. No. 60/009,306, filed Dec. 29, 1995, was filed December 27, 1996, and issued June 9, 1998. The patent has been cited by 16 US patents.

A later patent (6,605,302) states:

A new class of specific anti-influenza agents, the neuraminidase inhibitors, has demonstrated potent inhibition of both influenza A and B viruses. Oseltamivir (OS, GS4104, EN 241104, RO 64-0796, oseltamivir phosphate, an antiviral neuraminidase inhibitor) is used for the treatment of viral infections; however, it does not treat nasal congestion. Oseltamivir is the ethyl ester prodrug of the carbocyclic transition state sialic acid analog RO 64-0802 (GS4071), a potent and selective inhibitor of influenza A and B virus neuraminidases. Oral oseltamivir was approved for treatment of acute influenza in the United States in 1999. It has demonstrated efficacy both in treating and preventing influenza illness.

Oseltamivir phosphate (Ro64-0796, GS4104) is a prodrug of oseltamivir carboxylate (Ro64-0802, GS4071), a potent and selective inhibitor of the neuraminidase glycoprotein essential for replication of influenza A and B viruses. Oseltamivir (Tamiflu.RTM.) is available from Roche Pharma.TM. AG (Switzerland). Alternatively, oseltamivir can be prepared according to the methods described in U.S. Pat. No. 5,763,483 to Bischofberger et al and U.S. Pat. No. 5,866,601 to Lew et al., the disclosures of which are hereby incorporated by reference.


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