USPTO Rejects Gilead’s Patents Covering Key HIV Drugs

In March 2007, PUBPAT (Public Patent Foundation) filed formal requests with the United States Patent and Trademark Office challenging four key HIV/AIDS drug patents held by Gilead Sciences, Inc. These patents relate to tenofovir disoproxil fumarate (TDF). Gilead markets TDF in the United States under the brand name VIREAD (and also as a part of its ATRIPLA combination product).

As part of its requests, PUBPAT submitted prior art that the Patent Office did not review before granting the patents to Gilead. PUBPAT also explained how the submitted prior art invalidates the patents and asked that the Patent Office undertake a review and revoke them. In July 2007, the Patent Office granted each of PUBPAT’s requests and ordered reexamination of all four patents. In December 2007 and January 2008, the Patent Office rejected all of the claims of each of the patents.

See the PUBPAT website here. See also IMAK and Sandeep’s blog for more details.

Gilead now has an opportunity to respond to the USPTO’s Orders. But while we wait to hear of the outcome, this “non final” rejection will certainly have ramifications for Gilead’s patent applications in India (2076/DEL/1997 and 896/DEL/2002), that have been opposed by IMAK.

Interestingly, CIPLA which is in the thick of the Tarceva litigation has opposed the Gilead patents in India. The Financial Express reports that if the Gilead patents are denied in India, CIPLA would be a major gainer. See here for article, which we’ve reproduced below:

“The US Patent and Trademark Office’s (USPTO) rejection of Gilead Sciences’ patent application for the AIDS drug, Viread, is expected to have a strong impact in the Indian as well as global HIV/AIDS drug market. The rejection may affect the decision of the Indian Patent Office on Gilead’s patent application for Viread here. Last year, Cipla had filed a pre-grant opposition with the Indian patent office against Viread, the much sought after second line AIDS drug, arguing that the grant of the patent in India will make the HIV drug unaffordable to patients worldwide.

On Wednesday, USPTO rejected four patents on Viread, claiming the molecules are known. But the ruling is not final and Gilead claims that the patents will be upheld. “Now, since the patent application is rejected in the US, chances for the application getting rejected in India become high and Gilead will be forced to withdraw the application,” a patent attorney told FE.

According to analysts, Cipla will be benefited from the verdict. Cipla is marketing a generic version of tenofovir at a cost of $700 per person per year in India, while Gilead’s tenofovir costs $5,718 per patient per year in developing countries. However, Cipla officials refused to comment citing that the matter was sub judice.

Last year, Gilead signed license agreements with 11 Indian Companies for manufacturing and selling Viread in 95 countries, including India. Cipla, which refused Gilead’s licensing offer, challenged Viread’s validity by filing a pre grant opposition, apart from Delhi Network of Positive People, an NGO. However, Indian firms who entered into agreements with Gilead remain unfazed by the verdict. MM Srinivas Reddy, director, marketing, Hetero Drugs, told FE, “We are not worried at all over the verdict. Gilead has the chance to go for further appeal. Let the final verdict come.”

Gilead sells tenofovir alone and in combination with other drugs like Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company reports.”

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