navigating the patent maze

This year’s prestigious food prize has been jointly awarded to Professor Yuan Longping of China, Director-General of the China National Hybrid Rice Research and Development Center in Changsha, Hunan, China and to Dr. Monty Jones of Sierra Leone, former senior rice breeder at the West Africa Rice Development Center (WARDA), presently Executive Secretary, Forum for Agricultural Research in Africa (FARA), in Accra, Ghana.

From the press release at the World Food Prize:

In announcing these recipients, World Food Prize President, Ambassador Kenneth Quinn, lauded both scientists for their “breakthrough scientific achievements which have significantly increased food security for millions of people from Asia to Africa.” The Ambassador added that it was particularly fitting that these two pioneering rice breeders be honored during the United Nations International Year of Rice, the crop identified as the staple diet of more than three billion people around the world.

The World Food Prize, created in 1986 by Nobel Peace Prize Laureate Dr Norman E. Borlaug, is the world’s foremost award inspiring and recognizing breakthrough contributions to improving human development by increasing the quality, quantity, and availability of food in the world.

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In late October, a Los Angeles appeal court upheld more than $500 million in damages against Genentech Inc.  Although the award is large, it is still less than 1 percent of Genentech’s $51 billion market capitalization.

The case stems from 1976, when Genentech reached an agreement with City of Hope in Duarte, CA, to license technology for production of the proteins in bacteria that was invented by Riggs and Itakura at City of Hope.

Download City of Hope v Genentech (Word doc)

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Yours truly, along with two agricultural economists (Phil Pardey of University of Minnesota and Bonwoo Koo of IFPRI), have published an article in this week’s Science journal.  If you have an account, you can view the article on-line.  Because journals hold the copyrights, I will ask for permission to post a copy here.

Summary:  Much of the debate on the implications of intellectual property (IP) for protecting plant varieties occurs in the absence of an understanding of the specifics of the rights in particular jurisdictions, a practical sense of the rights claimed or granted, and their evolution over time. Moreover, existing information highlights rich-country developments, with little attention to developing countries. This Policy Forum reviews the approaches to plant-related IP protection worldwide, with data on the applications of plant breeders’ rights, and discusses possible implications of IP protection for food production and human health.

There is another place to go if you want PDFs of patents without paying.

• Download US, EP, PCT, Canadian, DE, UK and FR patents in PDF format at Intelprop.  The main functionality lies in its ability to download from a highlighted portion of text in a browser (IE, Opera and Firefox instructions are available.)

Who owns key aspects of RNAi technology in Australia and the United States is being contested. In Australia, Nucleonics, Inc. has filed a request for reexamination of Benitec and CSIRO owned Australian Patent No. 743316, citing 24 prior art documents to support their claim that the patent is invalid for lack of novelty and lack of an inventive step among other reasons. In March 2004 in the United States, Benitec sued Nucleonics and others for infringement of their U.S. Patent No. 6,573, 099. Benitec has also filed an opposition in Australia to a seminal patent in the field, the Fire/Mello patent, which is licensed to Nucleonics. Another opposition in Australia, to a Syngenta RNAi patent, has been filed by both Benitec and CSIRO. Because RNAi is such an important new technology, it is likely that more challenges will emerge.

RNAi is post-transcriptional gene silencing, an event in which genes are stopped from expressing in a sequence-specific manner. The silencing is mediated through targeted mRNA degradation. RNAi is believed to offer potential solutions to turning off genes involved in a variety of unwanted conditions, including viral diseases and cancer.

A recently issued patent US Patent No. 6,781,030, that has claims for methods of cloning mammals, including humans, has been criticized by some (see, 68 PTCJ 485, 27.08.2004), as violating a Congressional amendment barring funding for patents “on claims directed to or encompassing a human.” The US Patent and Trademark Office (USPTO) has responded to these charges, insisting that the ‘030 patent does not violate the Congressional Amendment to the Consolidated Appropriations Act, 2004.

The USPTO looked to the Congressional Record that contained discussions of the amendment. In the Record, the sponsor of the Amendment clarified that it would not “affect claims directed to or encompassing … methods for creating, modifying, or treating human organisms.”

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.