Patent Baristas

The new biotechnology open-source group, called the Biological Innovation for Open Society ("BIOS"), announced that researchers from Australia published a paper in Nature describing a method of creating genetically modified crops that does not infringe on patents held by big biotechnology companies.

Like open-source software, they said the technique, and a related one already used in crop biotechnology, would be made available free to others to use and improve, as long as any improvements are also available free.

The researchers claim to have modified three types of bacteria so they could be used for transferring desirable genes into plants and these were tested on rice, tobacco and Arabidopsis.

BIOS is a spin-off of Cambia, a not-for-profit, Australian-based organization that licenses a variety of technologies under an open source principle. They believe that patents covering tools for genetically engineering plants have impeded the use of biotechnology in developing countries.

Current technologies, patented by Monsanto, Syngenta, Bayer CropScience and others, rely on Agrobacterium tumefaciens. Biotechnologist remove some of the disease-causing genes from the bacterium and insert the genes they want added to the plant, such as those providing resistance to insects or herbicides. With the new technique, called TransBacter, researchers at Cambia have modified other types of bacteria by transferring DNA from the Agrobacterium into the other bacteria.

Whether this technique will really be a true design around and circumvent current patent claim coverage is not clear.  It will be interesting to see if taking the necessary genes out of the Agrobacterium bacteria and placing them in non-Agrobacterium bacteria is enough.  Given the CAFC’s continued limitation of the doctrine of equivalents, the patent holders will need to rely on close coverage.

I’m not sure the whole idea of an open-source biotechnology initiative will gain traction given the tremendous cost of biotech research and the fact that patent protection tends to be critical to biotech commercialization – unlike open-source software.

I also would take issue with the statement on the BIOS web site that "Patents were intended to inspire, advance and promote the social benefits deriving from ‘science and the useful arts’. However, the complexity and volume of patents has obscured this focus."   This all sounds well and good until you realize that you can’t afford to develop technologies only to have all your competitors gain a free-ride on your research expenditures. 

As Lincoln said, in a speech in 1859 "The Patent system added the fuel of interest to the fire of genius" – financial rewards act as an incentive to genius like no other.

You can read the Nature paper at:  http://www.bios.net/daisy/bios/393/version/live/part/4/data

More info at the NY Times here.

A BIOS paper describing the Agrobacterium-mediated transformation of plants is here:  http://www.bios.net/daisy/bios/50/78

As noted on Law.com, people came out in droves to the U.S. Court of Appeals for the Federal Circuit on Tuesday to listen to arguments for a case on claim interpretation.  In Phillips v. AWH Corp., 363 F.3d 1207 (Fed. Cir. 2004), the claimed term “baffle” was limited to baffles that were at an angle greater than 90 degrees.  Although the dictionary definition for “baffle” was broad, the Federal Circuit concluded that the specification only disclosed an embodiment having baffles with an angle other than 90 degrees. Judge Dyk dissented, based on the concepts that the narrow interpretation was contrary to the plain meaning in the dictionary.

The en banc rehearing order asked for briefing on the following questions:

1.  Is the public notice function of patent claims better served by referencing primarily to technical and general purpose dictionaries and similar sources to interpret a claim term or by looking primarily to the patentee?s use of the term in the specification?   If both sources are to be consulted, in what order?

2.  If dictionaries should serve as the primary source for claim interpretation, should the specification limit the full scope of claim language (as defined by the dictionaries) only when the patentee has acted as his own lexicographer or when the specification reflects a clear disclaimer of claim scope?  If so, what language in the specification will satisfy those conditions?  What use should be made of general as opposed to technical dictionaries?  How does the concept of ordinary meaning apply if there are multiple dictionary definitions of the same term?  If the dictionary provides multiple potentially applicable definitions for a term, is it appropriate to look to the specification to determine what definition or definitions should apply?

3.  If the primary source for claim construction should be the specification, what use should be made of dictionaries? Should the range of the ordinary meaning of claim language be limited to the scope of the invention disclosed in the specification, for example, when only a single embodiment is disclosed and no other indications of breadth are disclosed?

4.  Instead of viewing the claim construction methodologies in the majority and dissent of the now-vacated panel decision as alternative, conflicting approaches, should the two approaches be treated as complementary methodologies such that there is a dual restriction on claim scope, and a patentee must satisfy both limiting methodologies in order to establish the claim coverage it seeks?

5.  When, if ever, should claim language be narrowly construed for the sole    purpose of avoiding invalidity under, e.g., 35 U.S.C. 102, 103 and 112.

6.  What role should prosecution history and expert testimony by one of ordinary skill in the art play in determining the meaning of the disputed claim terms?

7.  Consistent with the Supreme Court’s decision in Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), and our en banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998), is it appropriate for this court to accord any deference to any aspect of trial court claim construction rulings?  If so, on what aspects, in what circumstances, and to what extent?

8.  [In a separate concurring opinion by Judge Rader]: Is claim construction amenable to resolution by resort to strictly algorithmic rules, e.g., specification first, dictionaries first, etc? Or is claim construction better achieved by using the order or tools relevant in each case to discern the meaning of terms according to the understanding of one of ordinary skill in the art at the time of the invention, thus entrusting trial courts to interpret claims as a contract or statute?

9.  Chief Judge Mayer dissented, arguing that “any attempt to refine the process is future” as long as the court refuses to reconsider the fiction that claim construction is a matter of law.

See the rehearing order here.

Dennis Crouch’s Patently Obvious blog lists over 25 amicus briefs and other documents related to Phillips. 

Some have expressed concern that the United States Patent and Trademark Office (USPTO) hosted a two-day meeting last week to discuss substantive patent law harmonization. The participants, from 22 countries along with the EPO and EC, issued a Statement of Intent noting that they will convene future meetings to consider "issues with regard to intellectual property and development, including proposals for a WIPO Development Agenda and proposals relating to genetic resources.  Also, they indicated that for future meetings, they will invite "all Members of WIPO Group B, member States of the European Union, the European Commission, Member States of the European Patent Organization, and the European Patent Office."

Some developing countries and consumer groups expressed concern that the meeting was being held in part to circumvent the World Intellectual Property Organization (WIPO) and certain large developing countries that have pushed for a development agenda within WIPO.

While there is a proposal with WIPO for a substantive patent law treaty (SPLT) aimed at harmonizing substantive aspects of national patent laws, many feel that developing nations are using intellectual property issues as a way to push broader development goals.  Harmonization talks have been going on for years with no resolution.  Even with an agreement, I’m not sure how far that will take the developing nations if it doesn’t include China, India, and Brazil.

More here.

As part of a proposed $2.57 trillion fiscal year 2006 budget request for the USPTO is $1.7 billion, equaling anticipated FY 2006 fee collections from patent and trademark filings. The request represents a $149 million increase over FY 2005, and reflects an anticipated rise in patent and trademark fee collections. As part of the 21st Century Strategic Plan, the USPTO plans to hire 900 patent examiners and 75 trademark examining attorneys in FY 2006.   

This sounds good but I’m waiting to see if this holds up in light of the record deficits – a projected a $390 billion deficit for next year, down from $427 billion this year.

Monsanto Co. has resolved a patent dispute with Bayer CropScience and a German non-profit research organization in a worldwide cross-license deal. This ends a long-standing rift over Agrobacterium technology, a transformation technology used to transfer a gene into a host plant’s DNA with more precision and efficiency than other available methods. Scientists at Monsanto and at the Max Planck Society claim to have invented it.

You can read details about Agrobacterium-mediated transformation in plants here.

Bayer CropScience is the exclusive licensee for the Max Planck Society for the Advancement of Science. Both are based in Germany. Under the agreement, Bayer CropScience and Monsanto will cross-license the agrobacterium-mediated transformation in selected areas of the globe.

In October 2003, Monsanto and Bayer CropScience reached a truce on a 20-year patent dispute (the longest-running patent battle in the history of plant biotechnology), with both sides dismissing at least five lawsuits against each other. In that deal, the two agreed to license each other for various patented technologies, including products that are insect-resistant and herbicide-tolerant. The companies are still in a patent dispute over insect-resistant corn.

Press release here.

The United States Patent and Trademark Office revised the policy on when a second or subsequent request for reexamination is filed while an ?earlier filed reexamination? is pending, and the second or subsequent request cites only prior art, which raised a substantial new question of patentability (SNQ) in the pending reexamination proceeding.  See MPEP ? 2240 (8th ed. 2001)(Rev. 2, May 2004).  Under the new policy, the second or subsequent request for reexamination will be ordered only if that old prior art raises a substantial new question of patentability which is different than that raised in the pending reexamination proceeding.  If the old prior art cited (in the second or subsequent request) raises only the same issues that were raised to initiate the pending reexamination proceeding, the second or subsequent request will be denied.

See Notice here.

Barr Pharmaceuticals Inc. sued the U.S. Food and Drug Administration in the U.S. District Court for the District of Columbia, seeking exclusive rights to sell a generic version of Sanofi-Aventis’ Allegra-D allergy drug. In the suit, Barr is challenging the FDA’s policy of awarding generic exclusivity on a patent-by-patent basis rather than solely to the first company to file an application to sell a generic version of a branded drug. Allegra-D had U.S. sales of about $444 million last year.

Barr in July won tentative approval to sell generic Allegra-D, known by the chemical names fexofenadine hydrochloride and pseudoephedrine hydrochloride, pending resolution of its challenge to Aventis’s patent but fears the FDA will try to force it to share the 180-day marketing exclusivity period.

Sanofi-Aventis holds patents that do not expire until between 2012 and 2019 and in 2002, Aventis obtained and listed an additional Allegra-D patent, extending its patent protection, which Barr believes that another generic company filed the first application based on the subsequently listed patent.

More here.

Under a new National Institutes of Health (NIH) public access policy, which is designed to provide easier access to tax supported research, researchers who receive grant money from the National Institutes of Health will be "asked" to submit their results to a public Web site within a year after they are published in a scientific journal.

In this split-the-baby compromise, the NIH backed off its original proposal to require such disclosure. Publishers of scientific journals, fearing that free access would undermine their subscription base, lobbied hard to against it. Advocates argued that taxpayers should not have to pay subscription or per-article fees to see the results of federally supported medical research and that it applies only to about 10% of published articles. Both sides were left dissapointed.

Proponents of free access felt that the policy should have required disclosure instead of leaving it up to scientists to decide. Now, researchers will risk the wrath of publishers if they allow free access. While no one wants to see their market share threatened, I don’t think publishers should be put ahead of taxpayers.

Upon acceptance for publication, authors will be asked to submit their articles to PubMed Central (PMC), an NIH digital repository of full-text, peer-reviewed biomedical, behavioral, and clinical research journals. It is a publicly-accessible, permanent, and searchable electronic archive available on the Internet at http://www.pubmedcentral.nih.gov/.

Details of the new policy can be seen here.