Patent Docs

Biotech/Pharma Lobbying Scoreboard

June 6, 2008

By Donald Zuhn —

Last month, we reported on the lobbying expenditures for a number of biotech and pharmaceutical companies in the first quarter of 2008. Included on our list were Cephalon, Inc., which spent $512,000, Abbott Laboratories, which spent $880,000, and Amgen Inc., which spent $2.5 million. That list continues to grow with additional reports regarding first quarter spending by three other companies.

Yesterday, Forbes.com reported that Novartis AG spent almost $1.3 million in the first quarter of 2008 on lobbying. According to the Swiss pharmaceutical company’s disclosure form filed with the House clerk’s office, Novartis lobbied on follow-on biologics bills, as well as on bills related to the government’s influenza vaccine stockpiles and free-trade agreements with Peru, Colombia, and Korea.

In late May, Forbes.com reported that Monsanto Co. also spent nearly $1.3 million on first quarter lobbying. While a portion of that amount was spent to lobby on patent reform, the agricultural biotech company also lobbied on the theft of agricultural seeds, organic standards, endangered species, timber and greenhouse gas emissions legislation, international trade, and ethanol production.

Finally, BusinessWeek reported that Genentech, Inc. spent $591,000 on lobbying in the first quarter. According to Genentech’s lobbying disclosure, the money was spent to lobby on the patent reform and follow-on biologics bills. In addition, Genentech lobbied against a bill that would have allowed the government to directly negotiate pharmaceuticals prices for drugs distributed through Medicare.

For additional information regarding this topic, please see:

• "Lobbying Spending Spree Continues," May 20, 2008
• "Abbott’s First Quarter Lobbying Tab Hits $880,000," May 2, 2008
Patent Office Catch-22

June 5, 2008

By Kevin E. Noonan —

There was a time not so long ago where the U.S. Patent and Trademark Office seemed to be sincere in trying to accommodate the needs of inventors and the public in providing fair examination of cutting-edge technologies. This is particularly true in the biotechnology arts, with such innovations as the sequence listing database and (after some resistance) recognizing that nucleic acid claims were not prima facie obvious. That has changed, with the Office seeming to be happy in many instances to play an advanced game of "gotcha" with its biotechnology customers.

This new attitude was illustrated once again in a presentation by Julie Burke, a "Quality Assurance Specialist" in Group 1600 at the Biotechnology/Chemistry/Pharmaceutical Customer Partnership meeting held at the Patent Office this Wednesday. In her presentation she addressed "incorporation by reference," the sufficiency of disclosure requirements, and the standard for determining whether clarification of the identity of certain nucleic acids would be new matter. The particular issue involved whether and under what circumstances it was sufficient to identify a nucleic acid by its GenBank Accession Number. Ms. Burke sets out the "problem" in the very first substantive slide:

In patent specifications, every element or ingredient of the product should be set forth in positive, exact, intelligible language, so that there will be no uncertainty as to what is meant.

The relationship between sequence information submitted to a public database and the amino acid or nucleic acid product it identifies is sometimes indefinite, uncertain, and arbitrary.

She goes on to identify the bases for the "uncertainty": sequence information in public databases can "change from time to time," and these changes can be made by third parties. These changes can constitute new matter, according to Ms. Burke, and implicate the Office’s "New Matter Guidance" to Examiners to sensitize them to the issue. These considerations implicate the requirements for incorporating material by reference, which also is subject to new matter prohibitions, i.e., sequences that have been changed after an application incorporating them by reference has been filed. The rationale is that only a sequence having one version has been "uniquely identified"; even prior to the filing date, when multiple sequences for the same gene are identified, the existence of these sequences means the gene "may not be uniquely identified."

Many of the examples in Ms. Burke’s presentation involve claims to isolated nucleic acids, and insofar as the application of the "guidelines" are limited to such claims they may have some justification. But the reality is that the 25,000-30,000 human genes found by the Human Genome Project have been disclosed in public databases for almost 10 years, and patent applications on these genes were filed at the turn of the century. Ms. Burke’s presentation also mentions that the Office has changed its former policy of examining up to 10 sequences in a single application, and will now only examine one sequence per application (OG Notice dated March 27, 2007; see Patent Docs report). As a consequence, only a small percentage of human genes have been patented to date, and the likelihood is that the 20-year patent term limits will preclude most of the genes disclosed in most of the applications from ever being the subject of granted claims. Moreover, the business and intellectual property of the next 50 years in biology will not be the identification of genes but rather how different genes are differentially expressed in disease (inter alia, for diagnostics) or in response to different physiological stimuli such as therapeutic drug administration. These experiments take advantage of the information about these genes, using array technologies and other methods. The issue thus is not the same as with claims to the genes themselves; all that is required is that the skilled worker understand which genes are differentially expressed. Sequence variations, whether the results of allelic variation or sequencing disparities from different research groups thus would not create any ambiguity for the skilled worker as to the identity of the genes. However, the current Patent Office focus on whether there are sequence variations that preclude these genes from being "uniquely identified" elevates the formalism of sequence identity (important for sequence claims) to another "bright line" rule having the potential for being indiscriminately applied. And the proposed solution, including the sequence of genes in a sequence listing, merely increases the applicant’s burden without improving the quality of the disclosure for known genes.

Which, unfortunately, is not a unique position for the Office to take in recent years. Perhaps a change of administration will return the Office’s attitude from confrontation back to cooperation.
USPTO News: USPTO e-Commerce Update

June 5, 2008

By Christopher P. Singer —

The U.S. Patent and Trademark Office sent out an e-Commerce update today, June 5, 2008, that provided information regarding its new First Action Interview Pilot program (previously covered by Patent Docs here) and digital certificate maintenance tips (for EFS-Web and Private PAIR users). Regarding digital certificates, the notice confirmed that it is common for digital certificates to expire if users fail to take steps to maintain them. The USPTO suggests four tips (below) that should help to minimize the time required to fix any of the common expiration problems associated with digital certificates.

1. Use the authorization code and reference number received from the Electronic Business Center (EBC) to create and download your digital certificate within 120 days of receipt. After 120 days, the authorization code and reference number will expire and will need to be replaced.

2. Immediately after downloading your digital certificate, you should create a set of digital certificate self-recovery codes, which can be done here. Save these codes in a secure location. These codes allow you to immediately recover your certificate should any problem occur. If you do not create these self-recovery codes, the only recovery option you have is to contact the EBC and ask them to recover your certificate. EBC-assisted recovery will likely take several business days.

3. Active digital certificates are automatically renewed for indefinite access. This renewal occurs automatically while you are using your certificate. Therefore, it is important to use your certificate regularly, at least every 90 days.

4. If you have copied your digital certificate on multiple computers, be sure to document the locations of each copy. After automatic renewal, only the copy in use at that time of renewal will be valid; all other copies must be updated separately. If you experience problems with one of the copies of your certificate, the EBC suggests that you try the following steps before contacting them: (a) review the modification dates of all the copies of your digital certificate; (b) determine which copy is the most current; and (c) replace all outdated copies with a new copy of the most recent certificate.

The EBC Customer Service Center is also available to answer your specific questions about EFS-Web, PAIR, PKI, or any other aspect of the e-Commerce initiative. You can contact the EBC by phone at 866-217-9197 (toll-free) or 571-272-4100 or by an e-mail: ebc@uspto.gov.
Monsanto Moves to Address World Food Shortages

June 4, 2008

By Kevin E. Noonan —

American opinion has finally turned in support of the idea that global warming, and ecological concerns in general, are relevant and important to themselves and their children (despite years of opposition, both formal and informal, from the current Administration and its fellow-travelers from energy corporations and the right wing). In what could turn out to be a fortuitous combination of good public relations and good corporate citizenship, Monsanto today announced its intentions to be part of the solution to ecological problems rather than part of the problem. As reported by Andrew Pollack in The New York Times ("Monsanto Seeks Big Increase in Crop Yields"), Monsanto chief executive Hugh Grant "pledged" to work to develop seeds that would increase corn, soybean, and cotton yields by 100% by 2030 and would reduce the amount of water, land, and energy needed to grow them by 30%. Monsanto made the announcement at a meeting in Rome where world leaders were discussing the current crises of rising food costs and increases in food shortages. While the Times (predictably) noted that Monsanto would stand to benefit from the effort in increased acceptance of its genetically-modified food, not even the Times could gainsay the benefits to the world population by the efforts.

Monsanto evinced its eagerness for collaboration in noting that the company had consulted with "farmers, political leaders, academics and advocacy groups" in identifying the necessary technological steps required to increase food production in the face of rising world population and harsher growing environments, as well as competing needs for vegetation such as biofuels. Monsanto’s position that biotechnology provides both an approach and an opportunity to address these issues was supported by U.S. Undersecretary of Agriculture Edward T. Schafer; the United Nations and World Bank have less sanguine views, reflected in a recent review of agricultural technology. And some experts, such as Dr. James E. Specht, a "soybean genetic expert" at the University of Nebraska believes that the "hype-to-reality ratio [of Monsanto’s plans] is essentially infinity." Monsanto countered by citing new technology, specifically marker-assisted selection which it contended could "double" the rate of improvements produced by breeding. The approach also has the advantage on the world stage of not involving foreign gene introduction into crops, thereby avoiding the "Frankenfood" label that has inhibited acceptance of Monsanto’s existing genetically-engineered crops in Europe and elsewhere. And Monsanto admits that, to achieve its lofty goals it envisions producing genetically-engineered cotton and corn varieties that could grow with reduced water and fertilizer requirements, a key need for a drier future.

Another aspect of Monsanto’s new "warm and fuzzy" approach is a commitment by the company to share its technology with farmers in distressed areas, presumably at greatly reduced or no cost. The Times article specifically mentions initiatives in Africa where Monsanto will forego royalties from farmers using to-be-developed drought-resistant corn. Moreover, Monsanto is donating $10 million over the next five years to public programs directed to improvements in wheat and rice yields, two crops that have recently experienced sharp increases in price and decreases in supply. It is expected that this work would be performed by universities and government agencies, since these crops are not within Monsanto’s current corporate focus.

These actions are in sharp contrast with Monsanto’s track record for its principle generically-engineered Roundup Ready® crops, which are resistant to Monsanto’s Roundup® herbicide. Monsanto has made headlines over the past year or so in winning several patent infringement and breach of contract lawsuits against individual farmers in the U.S., based on replanting of seed produced from genetically-engineered plants (see links below). And Monsanto’s foray into genetic engineering approaches to drought-resistant and other crop varieties capable of thriving under harsher environmental conditions expected in the near future has been criticized by non-governmental organizations like the Erosion, Technology and Concentration (ETC) Group, who are generally opposed to patenting technology (see "ETC Group Opposes ‘Climate Ready’ Gene Patent ‘Grab’").

Even if Monsanto’s plans are in no way related to such criticisms, its actions are consistent with the company’s appreciation of a continuing trend: it can be just as important to win the political and public relations battle as the legal ones in technology areas that impact human health and well-being. Western pharmaceutical companies have learned that the establishment of the WTO has not led to the hoped-for respect for their patent rights around the world; indeed, through the Doha declaration and actions of individual countries in the developing world in implementing the WTO treaty, pharmaceutical companies are in no better shape (and in some ways it is much worse) with respect to protecting their patented technologies that they were beforehand (see "Indian Generic Drug Maker Seeks to Invalidate Cancer Drug Patent"). Even in the U.S., drug companies risk adverse governmental action when their concern with return-on-investment for their investors is perceived as being contrary to the common good. Monsanto has proactively thrown down the gauntlet to governments and NGOs more comfortable with criticizing than working with them, by boldly proposing to work with such groups to attempt to solve, or stave off, the coming food crisis. Let’s see which groups will be more interested in their own political agendas than finding a solution to the problem.

For additional information regarding this and other related topics, please see:

• "Monsanto and Syngenta Settle All Litigation Between the Companies," May 30, 2008
• "ETC Group Opposes ‘Climate Ready’ Gene Patent ‘Grab,’" May 19, 2008
• "Monsanto Co. v. David (Fed. Cir. 2008)," February 6, 2008
• "Monsanto Co. v. Bayer Bioscience N.V. (Fed. Cir. 2008)," January 28, 2008
• "Supreme Court Fails to Grant Certiorari in Monsanto Co. v. McFarling," January 7, 2008
• "Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir 2007)," October 7, 2007
• "Monsanto Co. v. McFarling (Fed. Cir. 2007)," June 4, 2007
• "Syngenta Seeds, Inc. v. Monsanto Co. (Fed. Cir. 2007)," May 7, 2007
Second Viread® Patent Survives Reexamination

June 3, 2008

By Donald Zuhn —

Yesterday, Gilead Sciences, Inc. announced that the U.S. Patent and Trademark Office had issued a Notice of Intent to Issue an Ex Parte Reexamination Certificate for U.S. Patent No. 5,922,695. The ‘695 patent became the second of Gilead’s four Viread® (tenofovir disoproxil fumarate) patents to survive reexamination. Last month, Gilead announced that U.S. Patent No. 6,043,230 had also survived reexamination. Still in reexamination proceedings are Gilead’s U.S. Patent Nos. 5,977,089 and 5,935,946.

The four reexamination proceedings were initiated in response to an ex parte reexamination request filed by the Public Patent Foundation (PUBPAT) on March 23, 2007. While PUBPAT has devoted a page on its website to the Viread®
patents, it has not yet posted a comment concerning either of the
Patent Office’s determinations regarding the ‘695 and ‘230 patents.

In the Notice of Intent issued with respect to the ‘695 patent, the Patent Office indicated that the patentee had overcome a 102(a) rejection of claim 1 over one reference by submitting a Rule 131 declaration showing that the inventors had prepared bis (isopropyloxy carbonyloxymethyl) PMPA in the United States prior to January 1997. The Office also explained that a 103(a) rejection in view of three references and the patentee’s own admission had been overcome by the patentee’s arguments made during reexamination proceedings. The Office further indicated that the patentee had established that bis carbonate prodrugs of PMPA are unexpectedly stable and useful, these prodrugs have satisfied a long felt need in the anti-HIV drug art, and that the invention is commercially successful.

The ‘695 patent is directed to a compound comprising an antiviral phosphonomethoxy nucleotide analog and the ‘230 patent is directed to a method comprising contacting a cell with such a compound. In the company’s press relaease, Gilead Senior Vice President and General Counsel Gregg Alton noted that the ‘695 patent was "the most integral to Viread’s novel exclusivity," and stated that the company was "pleased with the PTO’s swift analyses and actions, which have confirmed the strength of [Gilead’s] patent position."

On Gilead’s Viread® homepage, the drug is described as being a member of the nucleoside reverse transcriptase inhibitor (NRTI or "nuke") family of molecules. Viread®, which helps to block reverse transcriptase by interfering with the replication process (as shown in an animation on the Viread® homepage), can be used in combination with other HIV medications for the treatment of HIV-1 infection.
USPTO News: Patent Office Proposes Adjustments to Patent Fees

June 3, 2008

By Donald Zuhn —

The U.S. Patent and Trademark Office published a notice in the Federal Register today proposing adjustments to certain patent fees for fiscal year 2009. The adjustments are intended to reflect fluctuations in the Consumer Price Index (CPI).

Written comments regarding the proposed adjustments can be submitted at the Federal eRulemaking Portal, or by e-mail (Walter.Schlueter@uspto.gov), fax (571-273–6299), or regular mail (Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, Attn: Walter Schlueter), and must be received on or before July 3, 2008. Those submitting comments should consult today’s notice for additional instructions.

A listing of current fee amounts can be obtained here.
USPTO to Reexamine ExonHit Therapeutics Patent

June 2, 2008

By Donald Zuhn —

Last month, Larkspur, California-based biotech Jivan Biologics, Inc. announced that the U.S. Patent and Trademark Office had granted its request for an ex parte reexamination of U.S. Patent No. 6,881,571, which is owned by ExonHit Therapeutics S.A. The ‘571 patent is directed to devices for identifying differentially spliced gene products. ExonHit, which is based in Paris, France, had originally asserted the ‘571 patent against Jivan in an infringement suit filed in the U.S. District Court for the Northern District of California on March 12, 2007 (see complaint here).

In its Order
granting the reexamination, the Patent Office stated that Jivan, in a request filed in mid-March, had identified nine references each of which raised a substantial new question of patentability. Independent claims 1 and 12 of the ‘571 patent recite:

1. A device for identifying at least one differentially spliced gene product, wherein said device comprises a solid support material and single-stranded oligonucleotides of between 5 and 100 nucleotides in length attached to said support material, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule arranged serially on the support material, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of said differentially spliced gene product.

12. A method of producing a device comprising a support material and single-stranded oligonucleotide of between 5 and 100 nucleotides in length attached to said solid support material, wherein said method comprises: (a) providing said oligonucleotides, wherein said oligonucleotides comprise at least a first and a second oligonucleotide molecule, wherein said first oligonucleotide molecule comprises a first sequence that is complementary to and specific for an exon or an intron of a first gene, and wherein said first sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing, and wherein said second oligonucleotide molecule comprises a second sequence that is complementary to and specific for an exon-exon or exon-intron junction region of said first gene, and wherein said second sequence corresponds to a region of variability in at least one product of said first gene due to differential splicing; and (b) arranging and immobilizing said oligonucleotides serially on said support material, said device allowing, when contacted with a sample containing at least one nucleic acid molecule under conditions allowing hybridisation to occur, the determination of the presence or absence of at least one differentially spliced gene product.

In its press release, Jivan CEO Dr. Subha Srinivasan stated that the company was "pleased to hear that the USPTO has decided to reexamine the validity of this patent," and expected that the Office would either require ExonHit to amend the claims or invalidate the claims in their entirety.
Court Report

June 1, 2008

By Sherri Oslick —

About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.

Wyeth v. Sandoz Inc.
1:08-cv-00317; filed May 28, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 6,500,814 ("Hormonal Contraceptive," issued December 31, 2002) following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Wyeth’s Lybrel® (levonorgestrel/ethinyl estradiol, used as oral contraception). View the complaint here.

Oxford Gene Technology IP Ltd. v. BioArray Solutions Ltd.
1:08-cv-00320; filed May 28, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,307,039 ("Method for Analyzing a Polynucleotide Containing a Variable Sequence and a Set or Array of Oligonucleotides Therefor," issued October 23, 2001), 6,770,751 (same title, issued August 3, 2004), and 7,192,707 ("Method for Analyzing Polynucleotide Targets Using Tethered Oligonucleotide Probes," issued March 20, 2007) based on BioArray’s manufacture, use, and sale of its BeadChip products. View the compliant here.

Sepracor Inc. et al. v. Sun Pharmaceutical Industries, Ltd.
5:08-cv-00247; filed May 28, 2008 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a paragraph IV certification as part of Sun’s filing of an ANDA to manufacture a generic version of UCB’s XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis). View the complaint here.

Novartis Corp. et al. v. Dr. Reddy’s Laboratories, Inc. et al.
2:08-cv-02566; filed May 23, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 6,162,802 ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the Treatment of Cardiovascular Disorders and Compositions Therefor," issued December 19, 2000) following a paragraph IV certification as part of Dr. Reddys’ filing of an ANDA to manufacture a generic version of Novartis’ Lotrel® (amlodipine besylate/benazepril hydrochloride, used to treat hypertension). View the complaint here. As reported here, plaintiffs have previously asserted this patent against Dr. Reddy’s; the present complaint includes an additional generic Lotrel® dosage form.

AstraZeneca LP et al. v. Barr Laboratories Inc. et al.
1:08-cv-00305; filed May 22, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,423,340 ("Method for the Treatment of Inflammatory Bowel Diseases," issued July 23, 2002) and 5,643,602 ("Oral Composition for the Treatment of Inflammatory Bowel Diseases," issued July 1, 1997) following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of AstraZeneca’s Entocort® EC (budesonide, used to treat mild to moderate Crohn’s disease). View the complaint here.
Conference & CLE Calendar

June 1, 2008

June 4, 2008 – Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting (U.S. Patent and Trademark Office)

June 11, 2008 – Advanced Patent Licensing 2008: What You Need to Know Before Licensing Your Patent (Practising Law Institute) – San Francisco, CA

June 16, 2008 – Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) – San Francisco, CA

June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

June 18-20, 2008 – Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

June 23, 2008 – Multilateral Patents (Law Seminars International) – San Francisco, CA

July 1, 2008 – Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) – New York, NY

July 9-11, 2008 – Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

July 16, 2008 – Patent Claim Construction Workshop (Law Seminars International) – Seattle, WA

July 24-25, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

August 11-12, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

August 10-15, 2008 – Advanced Courses (Patent Resources Group) – Washington, DC

September 11, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

September 11-12, 2008 – Current Issues in Complex IP Licensing (Law Seminars International) – Philadelphia, PA

September 15-16, 2008 – Biotech Patents*** (American Conference Institute)

September 22-23, 2008 – USPTO Boot Camp: Patent Edition*** (American Conference Institute) – Alexandria, VA

September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

***Patent Docs is a media sponsor of this conference or CLE
Monsanto and Syngenta Settle All Litigation Between the Companies

May 30, 2008

By Donald Zuhn —

Monsanto and Syngenta announced last week that the two companies had reached a settlement with respect to all patent, antitrust, and commercial litigation between the companies and their subsidiaries, including Monsanto’s patent infringement suit on herbicide-tolerant corn technologies, Syngenta’s antitrust suit, and a dispute between the parties on herbicide-tolerant soybean technology.

Last fall, we reported on the Federal Circuit’s decision in Monsanto Co. v. Syngenta Seeds, Inc. (see Patent Docs report), where the CAFC affirmed a District Court finding of invalidity with respect to Monsanto’s U.S. Patent No. 4,940,835 and of non-infringement with respect to Monsanto’s U.S. Patent Nos. 5,538,880 and 6,013,863. A year ago, we reported on the Federal Circuit’s decision in Syngenta Seeds, Inc. v. Monsanto Co. (see Patent Docs report), where the CAFC affirmed a District Court determination of non-infringement with respect to Syngenta’s U.S. Patent Nos. 6,075,185 and 6,320,100 and a jury’s finding of infringement and invalidity with respect to Syngenta’s U.S. Patent No. 6,403,865.

Under the settlement agreement, Monsanto will grant Syngenta a global royalty-bearing license to its Roundup Ready 2 Yield soybean technology. In its press release, Monsanto noted that Syngenta accounted for approximately 12% of total U.S. soybean sales in 2007, and that Monsanto’s Asgrow and American Seeds brands represented approximately 27% of such sales in 2007.

In addition, the agreement calls for Syngenta to grant Monsanto a royalty-bearing license for its dicamba herbicide tolerance technology and for Monsanto to grant Syngenta a royalty-free license to its herbicide-tolerant corn technology (GA21 event) and its insect-protected corn borer technology (Bt11). The companies have also agreed to cross-enable the development of new herbicide-tolerant and Bt insect-protection products in corn, cotton, and soybeans.

Other details of the agreement were not disclosed.

For additional information regarding this topic, please see:

• Monsanto’s press release
• Syngenta’s press release

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