PATENT BATTLES ON AND OFF THE COURT
Phill Jones
December, 2007

Pioneer agbiotech companies have sprouted, bloomed, and merged with larger firms. During the industry's growth, patent rights sometimes get tangled. In October, the Court of Appeals for the Federal Circuit pruned one patent dispute that has roots dating back over a dozen years.

The court case began on May 12, 2004, when Syngenta announced that it had acquired a type of corn glyphosate tolerance technology from Bayer CropScience. The technology, GA21, enables farmers to control weeds in corn with post emergence applications of glyphosate herbicide. Syngenta said that it will offer the technology through the Garst brand and licenses with other seed companies.

On the same day, Monsanto made its own announcement: the company filed a lawsuit in the Delaware district court, alleging that Syngenta infringed a Monsanto patent by attempting to make and use glyphosate resistant genes and crops. Two months later, Monsanto sued Syngenta in an Illinois federal district court. This time, the company alleged that Syngenta infringed patents held by Monsanto's DeKalb Genetics Corporation. Eventually, both lawsuits merged into one Delaware court suit.

The combined lawsuit has three patents allegedly infringed by Syngenta: U.S. Patents Nos. 5,538,880, 6,013,863 and 4,940,835. The '880 and '863 patents, owned by Monsanto subsidiary Dekalb, claim methods of producing herbicide resistant transgenic corn plants and seeds. Monsanto contended that Syngenta had performed steps with the GA21 corn product, such as growing glyphosate tolerant corn plants from GA21 seed, which infringe claims 5 and 6 of the '863 patent and claims 4 to 9 of the '880 patent.

Syngenta argued that they could not have infringed the claims. Using particle bombardment, DeKalb had transformed corn cells with a gene construct provided by its collaborator, Rhone-Poulenc Argo, S.A. The result was GA21. DeKalb claimed the basic technique in the first claim of the '880 and '863 patents. Syngenta had neither performed the technique nor infringed claim 1 of either patent. The company could not have infringed the asserted claims, Syngenta argued, because these claims are dependent claims. They are dependent upon the two first claims of the '880 and '863 patents.

Delaware district court's Judge Sue L. Robinson agreed with Syngenta. A dependent claim incorporates all the limitations of the claim to which it refers. Syngenta must have carried out all steps described in the first claims of the two patents, steps that DeKalb had performed.

The third patent, Monsanto's '835 patent, contains claims to chimeric plant genes that confer glyphosate tolerance and function in "plant cells." Judge Robinson interpreted the term "plant cells" as embracing both monocot and dicot cells. The patent application of the '835 patent had been filed in 1986. At that time, according to several court cases, no method existed to transform monocot plant cells. The judge concluded that the asserted claims of the '835 patent are invalid due to a lack of enablement.

On May 10, 2006, Judge Robinson granted Syngenta's motion for summary judgment. Monsanto appealed to the Court of Appeals for the Federal Circuit. The appellate court affirmed Judge Robinson's decision on October 4, 2007. Monsanto has the option of appealing to the US Supreme Court.

Inventors Tackle a Brave New World of Obviousness
On April 30, the US Supreme Court reversed the Federal Circuit's decision in KSR International Co. v. Teleflex Inc. In doing so, the Court made it easier for a defendant to defeat patent infringement liability, while making it tougher for an inventor to get a patent.

In its KSR opinion, the Federal Circuit had applied the "teaching, suggestion, or motivation" test. Courts have used the TSM test to determine whether a patented invention would have been obvious, and therefore, not worthy of patent protection. The TSM test goes like this. Suppose that the prior art taught elements of a claimed invention. A patent claim is only proved obvious if the prior art, the nature of the problem solved by the invention, or the knowledge of a person having ordinary skill in the art revealed some motivation or suggestion to combine prior art teachings.

The Supreme Court decided, however, that prior art need not contain an explicit motivation or suggestion to combine elements of an invention. The motivation or suggestion, the Court says, may be found in the demands of the relevant technical field or in the marketplace.

On October 10, the US Patent and Trademark Office (USPTO) published its examination guidelines for determining obviousness in light of the Supreme Court KSR decision, including a list of rationales that patent examiners can use to support a finding of obviousness. According to one of these rationales, the formerly discredited "obvious to try" argument, the inventor had merely selected from a finite number of identified, predictable solutions with a reasonable expectation of success. The PTO's Board of Patent Appeals and Interferences has already applied the obvious-to-try rationale in at least one biotech case.

Inventors should peruse the Patent Office's guidelines before filing a patent application. The document helps to map out potential pitfalls.

PTO Rules! – Or, Does It?
In August, the USPTO published its new rules for filing patent applications, which would become effective on November 1. "These rules better focus examination and will bring closure to the examination process more quickly," said USPTO Director Jon Dudas, "while ensuring quality and maintaining the right balance between flexibility for applicants and the rights of the public." In other words, the new rules would help the Patent Office to clear its backlog of 750,000 patent applications. Who could argue with that? Many have.

The rules limit the ability to file continuing patent applications and the number of claims per application. According to the new rules, patent applicants may file only two new continuing applications and one request for continued examination. Each application may contain up to 25 claims, with no more than 5 of these independent claims. A patent applicant must convince a patent examiner of the necessity for filing additional continuing patent applications or claims.

The published rules with comments run about 130 pages. Here's a very small taste.
If a patent application exceeds the 5 independent/25 total claim threshold, then the patent applicant must file an examination support document (ESD). In counting the claims, an examiner will add claims found in any of the patent applicant's co-pending patent applications that the examiner decides have "patentably indistinct claims" (i.e., claim pretty much the same thing). If the newly filed patent application exceeds the threshold, because it contains claims to more than one invention, then the applicant can submit a suggested restriction requirement (SRR) and choose an invention to which there are no more than 5 independent claims or 25 total claims. If an application exceeds the 5/25 claim threshold and does not contain a SRR or ESD, a patent examiner will require the applicant to file an ESD or amend the application to meet the 5/25 claim requirement.

Does the ESD sound like a simple formality? It isn't. In its 16-page guidelines for drafting an ESD, the USPTO describes an ESD's basic components: a statement that the applicant performed a pre-examination prior art search with data on search logic used, files or database service used, and date of search; a listing of references deemed most closely related to the subject matter of each of the claims; for each cited reference, an identification of all the limitations of each of the claims disclosed by the reference; a detailed explanation pointing out how each of the independent claims is patentable over the cited references; and a showing of where each limitation of each of the claims finds support in the patent application.

Critics charged that the rules will drive up the costs of patent prosecution, while severely limiting the ability of inventors, particularly those in the life sciences, to obtain patent protection. GlaxoSmithKline PLC did more than level criticisms against the USPTO; the company filed for a preliminary injunction to stop implementation of rules that it characterized as vague, arbitrary and capricious. Even if the rules did not have these defects, GSK argued, Congress, not the USPTO, holds the authority to promulgate such restrictive rules. The company had to overcome a difficult hurdle: convince a judge that the new rules will cause the company to suffer irreparable injury.

On October 31, Judge James C. Cacheris heard arguments from GSK and the USPTO in the US District Court for the Eastern District of Virginia. A few hours later, patent bloggers announced GSK's victory. For now, the USPTO has been prohibited from activating the new rules.

GSK reportedly plans to file a request for a permanent injunction. Early indications are that the USPTO will fight.

Phill Jones
BiotechWriter.com
PhillJones@nasw.org