navigating the patent maze

Two patent disputes between these two giants has been settled: a patent interference in the U.S. Patent and Trademark Office over who deserves a patent on transgenic broad leaf crops, and a patent infringement suit brought by Syngenta. The press releases from both companies provides little other information about what patents are at issue, making it difficult for this author to discuss the claims and their possible impacts.

The press release states that each company gets

“royalty-free, non-exclusive licenses related to the development, use and sale of transgenic crops containing agricultural technologies such as insect-protection and herbicide-tolerance produced through the use of the cross-licensed Agrobacterium-mendiated transformation technology.”

This settlement will likely be good for the customers of Monsanto and Syngenta, but if, as is surmised from the press release, that these patents encompass basic tools for plant transformation, we urge wide-spread licensing to all ag-biotech companies.

Cancer Research UK has announced the grant of European Patent No: EP 868 467 B1 and moreover, that public laboratories will be able to use the claimed invention without charge. Interestingly, the press release from Cancer Research neglects to state that Duke University is a co-owner of the patent. A related patent was granted in the year 2000 in the United States (US 6045997), although the claims of the two patents differ.

The BRCA1 and BRCA2 genes have been implicated in breast cancer development. Patents on the genes BRCA1 and BRCA2 and diagnosis based on mutations of these genes have prompted substantial public criticism of the granting of patents for human genes. Myriad Genetics, Inc. in Salt Lake City, UT holds many patents in the U.S. and Europe and markets a test for diagnosis of and predisposition to breast cancer. At least one of the European patents is still being opposed (a procedure whereby one challenges the patentability of the claims).

The latest Cancer Research patent claims specific nucleic acid sequences of the exons of a splice variant of BRCA2 and alleles. The full-length cDNA molecule is only claimed as the result of a detailed procedure for cloning. Full-length protein sequences and fragments are also covered. The key claim however, appears to be Claim 16, which claims a method of diagnosing a susceptibility or predisposition to breast, ovarian and prostate cancers by direct sequence analysis of nucleic acid or polypeptide or by PCR to screen for normal or mutant BRCA2 genes in patient samples.

In the U.S. patent, the claims are directed to the exon sequences or portions of those sequences that are at least 20 bases long and peptide sequences or fragments. There are no diagnosis claims, however. Presumably, there are still pending patent applications in the U.S. with claims to diagnosis.

It remains to be seen whether the European patent will be opposed. Oppositions can be filed up to 9 months after the grant date. It also remains to be determined what is the relationship of the patents of Myriad Genetics and Cancer Research and whether this new patent will affect the ability of Myriad to market their test.

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According to an IPS News article (dated 10 Feb 2004) Monsanto has decided to suspend sales of genetically modified (GM) soybean in Argentina. Argentina is the 3rd largest producer of soybean, behind Brazil and the US. The article says competition from black market sales of GM soy in Argentina is the reason Monsanto has ceased both sales of GM soy and all further R&D on GM soybean within Argentina.

Although farmers are entitled to cull seeds for the use of replanting new crops (Argentina’s 1973 seed law), the problem is the illegal sales of culled GM soybean seeds on the black market. Farmers argue the problem is not from small- or medium-sized farms selling culled GM seeds. Instead, the farmers say that they do not have the large scale seed infrastructure that would be required to produce the current large volumes of black market GM seeds. Furthermore, the farmers contend that the huge growth in black market sales indicates that the current controls and enforcement procedures are not adequate, and moreover it should be dealt with by the Argentine government.

The Free Trade Agreement is BIG news in Australia, where I am currently visiting. When I lived here, it amazed me how little attention in the U.S. is paid to such important world events. In this case, the FTA with Australia is only the second FTA that the U.S. has negotiated with a developed country (the first being with Canada as part of NAFTA).

Finally, a summary of the intellectual property provisions has been released by the US Trade Representative. The U.S.-centric version can be found here. As stated in the release, the patent part of the agreement:

- provides for the extension of patent terms to compensate for delays in granting the original patent, consistent with U.S. practice;
- limits the grounds for revoking a patent, thus protecting against arbitrary revocation; [comment: I wonder what this refers to]
- clarifies that test data and trade secrets submitted to a government for purpose of product approval will be protected against unfair commercial use for 5 years for pharmaceuticals and 10 years for agricultural chemicals;
- requires measures to prevent the marketing of pharmaceutical products that infringe patents, and to provide notice when the validity of a pharmaceutical patent is to be challenged;
- assures protection for newly developed plant varieties and animals [comment: this is already how both the U.S. and Australia operate].

The Australian-centric view of the FTA says very little about the patent provisions other than the outcome is increased harmonisation. A summary of the agreement can be found here.

From the United States Patent and Trademark Office:

The report presents a preliminary list of the U.S. universities receiving the most patents for invention (i.e., utility patents) during the 2003 calendar year. All campuses are included.

1-University of California- 439 patents
2-California Institute of Technology-139 patents
3-Massachusetts Institute of Technology-127 patents
4-University of Texas-96 patents
5-Stanford University-85 patents
6-University of Wisconsin-84 patents
7-Johns Hopkins University-70 patents
8-University of Michigan-63 patents
9-Columbia University-61 patents
10-Cornell University and University of Florida-59 patents each

University names can be some of the most problemmatic for searching. Let’s say that you want to find all 439 patents issued in 2003 that were assigned to the University of California. First off, you can’t limit searches for a particular year on the patent search form or on the assignment search form. Even if you could limit for the year 2003, a search for “university AND california” in the Assignee field will not return all 439 hits. Why is that?

The reason is three-fold. (1) There may be typographical errors of the assignee names, (2) there are different equivalent names, and (3) the assignee has changed since the patent issued. Number 3 won’t be discussed further (but see the post on the Assignment database at the USPTO). Some examples of reasons 1 and 2 will illuminate the problems.

Using the Corporate Tree database at Delphion, a fee-based patent database site, a search for the assignee “university of california” resulted in a list of the different names found in the USPTO assignment data. The proper and correct name is “The Regents of the University of California”. Some of the typos (typos are underlined) include:

“The Reents of the University of California”
“The Regents fo the Univerisity of California”
“The Regents of the University of Calfornia“

Some of the equivalent names include:

“UC Regents”
“The Regents of the Univ. of California”
“The Regents of the University of Calif.”
“Univ. of CA”

What should be obvious is that finding all patents, or patent applications, assigned to a particular entity can be challenging. Sometimes even extremely challenging. Furthermore, words in other searchable fields, such as the inventor name, title of the invention, etc., may also have typographical errors or alternative spellings (e.g., color vs colour; economize vs economize). Unfortunately, there is no easy solution to these issues.

The data for United States published patent applications pose challenges for searchers who want to find applications filed by a particular assignee — e.g. company, university. Unlike the rest of the world, an applicant for a U.S. patent must be the inventor(s). Most of the time however, the inventor assigns rights in the invention to an organization, typically his employer. The assignment, which is a contract between the inventor and organization, is recorded at the Patent Office and appears on the cover page of any ensuing patent. The paperwork that is filed with a patent application asks for the name(s) of the applicant(s) — the inventors. Assignments are separately filed at the Patent Office.

A patent application is published 18 months after it is filed. The assignee data may not be available at the time of publication. If it is not available, only the inventors will be listed. Therefore, a search for applications filed by a company or other organization will not necessarily yield a complete set of results. Conversely, an application that is uncovered by a search based on other criteria will not necessarily inform the user who really owns the invention.

What can be done to overcome this problem? One trick I use is to do a subsequent search of U.S. patents and WO applications using the inventors’ names as search terms and see who they have assigned to recently. If the patent dataset doesn’t give any useful results, then try searching a scientific database like PubMed. The affiliation of the authors is almost always listed.

[See also post on "more about searching for assignees"]

Yesterday, the Cambia IP Resource implemented Dekko version 3 for searching patent documents. The user will see a few cosmetic changes on the search interface page, but will find that the major change is a faster response time in returning search results. The new Dekko software is the first of the improvements on the route to expansion of the patent datasets, which is planned for completion the end of March 2004.