Make no mistake about it. This is a story that has an abundance of human drama, which manifests itself in great suffering around the world. Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans.

These numbers have meaning that numbers cannot convey. The meaning emerges in the stories of individuals, families and whole societies devastated by HIV/AIDS throughout the world. This is also a story that scares the bejeebers out of the patent community and all patent holders when filing provisional patent applications.

In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four key HIV/AIDS drug patents held by Gilead Sciences Inc. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor and WARF’s stem cells.

PUBPAT requested ex parte reexamination under 35 U.S.C. §§ 302-307 and 37 C.F.R. § 1.510 claiming they are all invalid under 35 U.S.C. §§102 and 103 and their existence is causing significant public harm and impeding scientific progress.

The patents challenged by PUBPAT, U.S. Patents Nos. 5,922,695, 5,935,946, 5,977,089 and 6,043,230, relate to the drug known generically as tenofovir disoproxil fumarate (TDF). Tenofovir disoproxil fumarate (also referred to as TDF or bis(POC)PMPA fumarate) is a nucleotide analog reverse transcriptase inhibitor (NtRTI) that is a significant treatment for HIV/AIDS patients. Gilead markets TDF in the United States under the brand name Viread and as a part of its Atripla combination product.

The Patent Office has now ordered reexamination of all four patents.

The ‘695 patent claims compounds comprising esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates, which are useful as intermediates for the preparation of PMPA. The ‘695 patent also claims methods of orally administering such phosphonomethoxy nucleotide analogs to patients infected with HIV.

The ‘089 patent claims (R)bis(POC)PMPA, compositions comprising (R)bis(POC)PMPA and a pharmaceutically acceptable carrier, and a method comprising orally administering to a patient infected with virus or at risk to viral infection a therapeutically effective amount of (R)bis(POC)PMPA.

The ‘230 patent claims a method of contacting a cell with an antiviral phosphonomethoxy nucleotide analog prodrug.

The ‘946 patent claims TDF, methods of making TDF and tablets containing TDF.

In order to have a reexamination declared, there must be a “substantial new question of patentability” present, which means that it is only necessary that:

(a) The prior art patents and/or printed publications raise a substantial question of patentability regarding at least one claim, i.e., the teaching of the (prior art) patents and printed publications is such that a reasonable examiner would consider the teaching to be important in deciding whether or not the claim is patentable; and

(b) The same question of patentability as to the claim has not been decided by the Office in a previous examination or pending reexamination of the patent or in a final holding of in validity by the Federal Courts in a decision on the merits involving the claim, see MPEP 2242, (I).

It is not necessary that a “prima facie” case of unpatentability exist as to the claim in order for “a substantial new question of patentability” to be present as to the claim.

Mainly, PUBPAT claims that these patents are anticipated or rendered obvious by Gilead’s own patent (U.S. Patent No. 5,922,695 issued to Arimilli et al. on July 13, 1999) and/or the prior art reference by Bischofberger et al., “Bis(POC)PMPA, an Orally Bioavailable Prodrug of the Antiretroviral Agent PMPA,” Conference on Retroviruses and Opportunistic Infections, 4th:104 (abstract no. 214) (January 2226, 1997), among others.

In addition, PUBPAT claims that these patents were also obvious in light of other prior art teachings that PMPA and bis(POC)PMPA were strong treatments for HIV and that bis(POC)PMPA fumerate would have been expected to have superior properties over free base bis(POC)PMPA. PMPA and bis(POC)PMPA were well known treatments for HIV

In a matter that really highlights the dangers of filing a provisional patent application without drafting a full application without all the details, PUBPAT points out that references can now be used against the patents where the documents published after the provisional — later than first thought.

The ‘230 and ‘695 patent claim priority to a provisional application, U.S. Appl. No. 60/022,708, filed July 26, 1996. However, PUBPAT argued, and the USPTO agreed, that the claims of these two patents are not entitled to claim priority to the ‘708 application’s July 26, 1996, filing date, because the ‘708 application’s specification was not sufficient to satisfy the written description requirement of 35 U.S.C. § 112. In the case of the ‘089 and ‘946 patents, the USPTO found that sufficient written description existed to support priority back to the ‘708 provisional.

A filing date will be accorded to a provisional application only when it contains:

a written description of the invention, complying with all requirements of 35 U.S.C. §112 1st paragraph

any drawings necessary to understand the invention, complying with 35 U.S.C. §113.

Therefore, it is essential that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.

Related Documents

    Patent Office Orders Granting Reexamination

(For Pwned, See Owned)

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    […] Speaking Truth to Power 8 11 2007 Patent Baristas » Gilead Sciences Pwned by Nonprofit Activists Patent Baristas wrote a very interesting article about public interest groups using the reexamination processes to fight underhanded corporate tactics and patent misuse. For more information on what you can do as a concerned citizen or small business owner check out Public Patent Foundation […]