navigating the patent maze

Since 1991, when the NIH (National Institutes of Health) in the U.S. filed a patent application claiming thousands of EST sequences, controversy and disagreement about the legalities and wisdom of patenting such sequences has permeated law reviews and scientific journals. Now, despite other U.S. patents issuing with claims to EST (expressed sequence tags, i.e., partial sequences of cDNA molecules) sequences, the Board of Appeals of the USPTO recently affirmed a rejection of claims to EST sequences. (Ex parte Fisher, Appeal No. 2002-2046). The bases for the rejection upheld by the Board were (i) lack of utility and (ii) lack of enablement. The opinion of the Board is being appealed to the Federal Circuit, who will hear and decide on the case early next year.

Is there a difference between the EST sequences in Fisher and those in already issued patents? The EST sequences in Fisher are “naked sequences”, that is, sequences with no known function, sequence motifs, or other features that would demonstrate a specific use of the EST. Fisher argued that several uses were taught in the application, including: identification and detection of polymorphisms, use as probes in hybridization, and as primers for amplification. But without more information, such as the genes these ESTs are derived from, the Board concluded that the stated uses are general uses for nucleic acids and thus do not satisfy the particularity requirement for utility.

The opinion of the Board contains some useful guidance of the degree of disclosure that might be required to have patentable EST sequences in the future, assuming that the Federal Circuit ultimately agrees.

In the United States, a very long running interference battle over who first invented using Agrobacterium to transform plants has recently been decided. News of this critically important outcome comes only from the declared winner “Monsanto” and so the details of the claims in question are sketchy. What is clear though is that the patent that will soon issue is going to have a patent term of 17 years counted from the date of issuance.

For more information on the patents and science surrounding this technology, an overview may be downloaded. (Download as PDF)

Benefit sharing of rewards from inventions based on genetic materials (e.g., plants, insects) collected in developing countries is not only much-talked about but is also mandated by the Convention of Biological Diversity (CBD). The CBD is an international Agreement (although not signed by the United States) that has three main goals: the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits from the use of genetic resources (See Article 15).

On an individual bases, in 1996, the University of California at Davis, initiated a benefit sharing program with Mali stemming from a patented invention for a disease-resistance gene isolated from African rice. The idea was to license the technology to agricultural biotechnology companies, such as Monsanto and use the income to improve the lives of the world’s poor people.

Over the last 8 years, I have heard many references to this program as a model and ideal moral stance. Yet, as revealed in a lengthy article in the Sacramento Bee , nothing has been resulted in the way of benefit sharing. Sadly, it is a philanthropic failure. In well-researched detail, the article shows just how difficult it is to craft licenses and illustrates many licensing pitfalls. Hopefully, institutions and scientists who want to give back help to the developing world can learn from this well-meant attempt and fashion a workable and successful form of benefit sharing.

CREATE - the Cooperative Research and Technology Enhancement Act - was a bill in Congress that would amend the patent law on the non-obviousness requirement to create a safe harbor for inventions resulting from collaborations or research team efforts where team members are in different institutions.

The bill was passed by both the Senate and the House of Representatives, but must be cross-approved before being sent to the President for signing into law. Now that the Congress has adjourned for the political season, the bill will languish and is unlikely to get passed by this Congress.

The CREATE Act is a response to a Federal Circuit decision (Oddzon Products v Just Toys) in which the Court held that sharing of confidential information could be a reason to find an invention obvious when the inventors weren’t under an obligation to assign their rights to the same entity. Even Congress recognized the unfairness of this situation and its possible chilling of collaborative work.

For detailed information on this important bill, go to the horse’s mouth and read the Congressional Report on CREATE.

This announcement is from the GTG web site:

Genzyme will pay GTG a signing fee of $7.5M – of which $5M will be in cash and $2.5M will be in the form of “in-kind” Genzyme intellectual property now offered to GTG. Genzyme will also pay GTG a fee of $1M per year for the life of the non-coding patents (currently till 2015).

IP Strategy Today is an on-line journal published by bioDevelopments-International Institute, in collaboration with individuals at SWIFTT with financial support by the Rockefeller Foundation. The latest issue contains three articles dealing with intellectual property rights and human health issues:

(1) Keusch GT. 2004. Intellectual Property and Licensing and their Impact on Global Public Goods for Health Options for Public Sector and Academic Leadership. IP Strategy Today No. 10-2004. pp. 1-22.

(2) Saha R, K Satyanarayana and CA Gardner. 2004. Building a “Cottage Industry” for Health (and Wealth) The New Framework for IP Management in India. IP Strategy Today No. 10-2004. Pp. 23-58.

(3) Oehler J. 2004. The Role of Milestones in Licensing Deals to Assure Access to Health Products in Developing Countries. IP Strategy Today No. 10-2004. Pp. 59-70.

You can obtain a copy of the article here or visit the IP Strategy Today web site where you can download the current and all previous volumes.

In what has to be one of the pithiest, funniest comments written in a dissent of a Federal Circuit case, which decided that a patent disclosing an hourglass-shaped toothbrush was in an analogous field to a patent application for a hair brush, and thus could properly be considered as prior art… Justice Pauline Newman wrote,

A brush for hair has no more relation to a brush for teeth than does hair resemble teeth.

I couldn’t agree more !