navigating the patent maze

Several pharmaceutical companies (Abbott, Merck, and Gilead Science) have apparently received a letter from the Health Minister of Brazil, Humberto Costa, giving them 21 days to grant a voluntary license for the productions of some anti-retroviral drugs.  If the companies aren’t forthcoming, the Brazilian Government is set to grant licenses under a compulsary licensing mechanism. 

(From a newsletter sent by Daniel Advogados as reported in the newpaper O GLOBO). 

In November 2004, I reported the conclusion of a long running dispute in the U.S. Patent Office on who first invented Agrobacterium-mediated transformation technology (previous post).  A few weeks ago, a joint press release from Bayer CropScience, Max Planck Society, and Monsanto announced that the interference ended by settlement among these parties.  Under the agreement, the organizations will cross-license their respective Agrobacterium-mediated transformation technologies; Bayer (the exclusive licensee of Max Planck’s technology) and Monsanto will provide each other non-exclusive licenses related to R&D and sale of transgenic crops; Monsanto will give Max Planck a license in the U.S. for research purposes.  No other details of the agreement are disclosed.

The chutzpah of the parties is revealed. 

From Bayer CropScience:  "This agreement secures freedom for the involved parties in the field of Agrobacterium-mediated transformation technology, thereby ensuring present and future market access for their respective technologies in the United States and Canada,"

From Monsanto:  "This is a positive development for agricultural biotechnology as a whole. This agreement enables their [MaxPlanck and Monsanto] respective agricultural innovations to reach consumers and farmers without hindrance."

If the technology is not licensed to anyone else - neither of these companies is known to widely license technology - then they are able to effectively stifle other companies from entering the transgenic plant field.  Agrobacterium is the most widely used method for transforming plants; there are very few other means of transformation, only bombardment (owned by Cornell and licensed to duPont) is frequently used.  With luck new transformation technology developed at CAMBIA using non-Agrobacterium strains will break the stranglehold. 

The blog "Law under the Microscope’" has two excellent discussions about this case.  The story of the collaboration and fall-out between City of Hope and Genentech demonstrates why wording in contracts is so important.  The jury awarded City of Hope USD 500 million.  (In my opinion, contracts are important to do right although they are rarely appreciated and only consulted when something goes wrong - and that is exactly when the wording becomes important.)

See original post on this site.
See Post 1 at Law under the Microscope about contractual interpretations.
See Post 2 at Law under the Microscope about fiduciary duty of licensors.

In a previous post, "The Public Patent Foundation Requests a Re-exam of the Latest Axel Patent", I reported that Columbia University had acquired and was enforcing a new patent (US Patent 6,455,275) claiming co-transformation of CHO (Chinese Hamster Ovary) cells.  CHO cells are frequently used in the production of human proteins. 

The litigation involving a handful of companies that balked at paying more royalties has taken an interesting turn; Columbia U has agreed to not enforce the patent against the companies (covenant not to sue).  The patent has not been invalidated however, and the re-examination of the patent continues at the US Patent and Trademark Office. 

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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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.”