Tuesday, October 18, 2005

Gilead's US 5,952,375 covering Tamiflu (oseltamivir)

Tamiflu (oseltamivir)is covered by US 5,952,375, filed February 26, 1996 and issued September 14, 1999. The application does claim priority. The '624 application is a continuation-in-part application of U.S. patent application Ser. No. 08/580,567, filed Dec. 29, 1995, abandoned which was a continuation-in-part application of U.S. patent application Ser. No. 08/476,946, filed Jun. 6, 1995, now U.S. Pat. No. 5,866,601 which was a continuation-in-part application of U.S. patent application Ser. No. 08/395,245, filed Feb. 27, 1995, abandoned all of which are now pending and are incorporated herein by reference in their entirety.

The '375 patent states:

A principal object of the invention is inhibition of viruses, in particular influenza viruses. In particular, an object is inhibition of glycolytic enzymes such as neuraminidase, in particular the selective inhibition of viral or bacterial neuraminidases. inhibitors that have a retarded rate of urinary excretion, that enter into nasal or pulmonary secretions from the systemic circulation, that have sufficient oral bioavailability to be therapeutically effective, that possess elevated potency, that exhibit clinically acceptable toxicity profiles and have other desirable pharmacologic properties.

The patent does not mention the word "anise" or "star anise."

The patent is assigned to Gilead but exclusively licensed to Roche. On October 18, Roche Holding AG said that it is building a new plant in the United States to boost production of its Tamiflu drug amid fears about bird flu, and is ready to seek help from other companies to meet surging demand. Tamiflu is made from an acid produced from the Chinese star anise plant, which is in limited supply because it is grown in only four provinces in China and is harvested between March and May. In the past year, however, Roche has developed a method for making the acid without the plant.

The Indian drug company Cipla Ltd. said Oct. 18 that it would ask for permission to produce the drug. "We will approach Roche for a license," Amar Lulla, joint managing director of Cipla, told Dow Jones Newswires. Cipla said last week that it planned to bring a generic version of Tamiflu to market early next year based on its own research into the antiviral oseltamivir.

Daniel Piller, a Roche spokesman, said the company had yet to receive any notification from Cipla. "If we receive a request, we will be open to discussions," Piller told The Associated Press. While no company has approached Roche directly, Reddy said, Roche "would welcome any company that made such a request to produce Tamiflu under license." He warned against companies seeking to break Gilead's patent, however, saying that it could take over two years to develop Tamiflu from scratch. Roche says there are 10 complex steps involved in making the drug.

Internet auction site eBay pulled the sale of Roche Holding AG's Tamiflu from its Web site on Oct. 18, after prices topped 100 pounds ($174) on growing fears about the spread of bird flu.

from the AP on Tamiflu:

Gilead made $44.6 million on royalty revenues from Tamiflu in 2004 but is on pace to more than double that in 2005, having made $48.1 million in the first six months of the year.

In June, 2005, Gilead charged Roche with failing to adequately promote and produce Tamiflu and invoked a contract clause to demand the return of all commercial and manufacturing rights.

Roche denied the charges and the issue appears headed to an arbitrator.

“We are confident we fulfilled our obligations under the licensing agreement,” Roche spokesman Terry Hurley said.

If Gilead were to win, Roche would still manufacture Tamiflu for two years while Gilead ramped up its factory.

“We believe this is an opportunistic move on Gilead’s part given that Tamiflu is entering a period of heightened demand,” analysts at Credit Suisse First Boston wrote in a note to investors last week.

Gilead spokeswoman Amy Flood declined to comment, but executives of both companies have repeatedly said, including in testimony to Congress, that Tamiflu production won’t be affected by the spat.

Separately, think back to the patent discussions surrounding CIPRO. See Lawrence B. Ebert, Where Have You Gone, Richard K. Lyon? Intellectual Property Today, December 2001.


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