For 17 years, Harvard's oncomouse has run the maze of Canada's patenting process. On May 21, the transgenic mouse neared the end of its trip when the Supreme Court of Canada heard oral arguments on whether the critter is patentable under Canadian law.
The oncomouse journey began in 1985 when the President and Fellows of Harvard College filed a patent application with the Canadian Intellectual Property Office (CIPO), which included claims to nonhuman transgenic mammals with cells that contain an activated oncogene. By 1993, the CIPO examiner had decided to allow claims to the process for producing the transgenic mammals, but had rejected claims to the mammals themselves. The CIPO did not consider animals to fit into the patentable categories of "manufacture" or "composition of matter," as Harvard had been arguing.
In August, 1995, after review by the CIPO Commissioner of Patents and an oral hearing before the Patent Appeal Board, the CIPO confirmed the rejection of transgenic mammal claims. Harvard appealed the decision in the Federal Court of Canada, Trial Division.
The Federal Court of Canada dismissed the appeal on April 21, 1998. The judge decided that a transgenic mammal is not truly reproducible because too much is left to chance, including the chromosomal location of the transgene, and the degree of transgene expression. Consequently, the judge concluded that the transgenic mammal was not sufficiently reproducible to be a "composition of matter" or an "article of manufacture" under the Canadian Patent Act. Harvard then appealed its case to the Canadian Federal Court of Appeal.
On August 3, 2000, the appellate court determined that the oncomouse is a composition of matter and sent the case back to the CIPO with the direction to grant a patent on the transgenic animal claims. Now it was the government's turn to appeal. In the name of the Commissioner of Patents, the Attorney General of Canada filed an application to seek appeal to the Supreme Court of Canada. On June 14, 2001, the Supreme Court of Canada granted the application for appeal (Case No. 28155).
During May's oral hearing before the Supreme Court, the federal government warned that a decision to allow the issuance of claims to the oncomouse would open the door to the patenting of genetically-modified humans. On a less bizarre note, another government lawyer argued that the Court must consider the Patent Act in the context in which it was drafted in 1869, a time long before the advent of genetic engineering. Chief Justice Beverley McLachlin dismissed this argument, pointing out that the Patent Act was designed to deal with the development of future, unanticipated inventions. At least one member of the Court seemed skeptical about patenting the oncomouse. Mr. Justice Ian Binnie wondered why Harvard should be entitled to a patent on the transgenic animal when the Harvard researchers had only modified one out of 40,000 genes. Harvard's lawyer argued that the transgenic modification was not just a minor add-on. The nine justices are expected to issue a ruling by the end of this year, a decision that will affect about 600 patent applications on genetically-modified animals and plants.
Other Law News Bits - Monsanto v. Schmeiser: A Battle of Biblical Proportion?
Last year, the Federal Court of Canada (Saskatoon, Saskatchewan) ordered a farmer to pay Monsanto Company thousands of dollars because the company's genetically-engineered canola plants were found growing on the farmer's field. The case reaped worldwide attention in part because the farmer apparently was not taking advantage of the genetically-modified feature of the canola plants, and because the farmer's liability was based on a determination of patent infringement in a country that does not grant patents on plants.
In Monsanto v. Schmeiser, Monsanto sued Percy Schmeiser for infringing Canadian Letters Patent No. 1,313,830, which includes claims to a chimeric plant gene encoding 5-enolpyruvylshikimate-3-phosphate synthetase, an enzyme that confers resistance to glyphosate herbicide (sold as "Roundup"). The patent also includes claims to plant cells that contain the chimeric plant gene. Monsanto Canada licenses Canadian commercial seed growers to grow Roundup Ready canola, which expresses the patented gene.
The seed of a lawsuit was planted in the summer of 1997 when Monsanto received an anonymous tip that Roundup Ready canola was growing in Schmeiser's fields, even though the farmer did not have a license from Monsanto. The company sent Robinson Investigations, a private agency in Saskatoon, to perform random audits of canola crops growing in Saskatchewan. This led to the identification of Roundup Ready canola and the filing of the lawsuit.
During the trial, Schmeiser argued that the canola plants appeared on his farm as the result of cross-field breeding by wind or insects, among other potential scenarios. Judge W. Andrew MacKay, however, was persuaded by Monsanto's evidence that none of these potential sources of "contamination" could account for the concentration or extent of Roundup Ready canola present in the defendant's field. Besides, the judge emphasized that the source of Roundup resistant canola was "really not significant" for the resolution of the issue of infringement. Rather, the question was whether the defendant had made, used, or sold the patented invention.
The judge concluded that, in 1998, the defendant infringed Monsanto's patent by planting canola fields with seed saved from the previous year's crop, which was known or ought to have been known by the defendant to be Roundup tolerant and which contained the genes and cells claimed under Monsanto's patent. The defendant further infringed by selling seed harvested in 1998. After the court ordered Schmeiser to pay Monsanto, the defendant filed an appeal with the Federal Court of Appeal.
In May, the appellate court held two days of hearings to consider Schmeiser's appeal. Two of the three justices on the panel asked how a person could infringe Monsanto's patent if he did not know that Roundup Ready canola was growing in his field. As the lower court noted, however, intent does not enter into the basic question of patent infringement: a person either does or does not infringe a patent claim.
At least one of the appellate justices voiced concern that Monsanto could sue a farmer for patent infringement if the farmer had only two percent Roundup Ready resistant canola in 1,000 acres of conventional canola. Monsanto's lawyer responded that the company would not pursue such farmers through the court system, but would seek another solution. Justice Marc Noel, however, did not seem to find any comfort in "the good grace of Monsanto." It is nevertheless true that companies often refrain from suing for patent infringement if the costs outweigh the benefits.
Mr. Schmeiser has modestly depicted the dispute as "the classic David vs. Goliath struggle," and he has pelted Monsanto with 17 issues for appeal. When it comes to fighting a Goliath, however, a true aim counts for more than the number of stones slung.
Finally: The Festo Manifesto
On May 28, a unanimous US Supreme Court handed down one of the most anticipated decisions in the area of patent law, a ruling that affects the ability of a patent owner to successfully sue for infringement and that vacates the Federal Circuit's Festo decision. Before mulling over the Supreme's take on Festo, a short review is in order.
Courts analyze patent infringement in two stages. The first stage requires an interpretation of the meaning of the claim language and the scope of the claims. The second stage requires a determination of whether the defendant's product or process falls within the scope of the interpreted claims. If every limitation recited in a claim is found in an accused product or process, then the defendant has literally infringed the patent claims. On the other hand, if there is no literal infringement a court may still find that the defendant infringed under the doctrine of equivalents (DOE), a principle devised to prevent a person from getting around a patent by making merely insubstantial changes to the patented invention. The DOE allows a court to expand the literal interpretation of a patent claim and to recognize near-literal copying of a patented invention. However, there are limitations on the doctrine's use.
One limitation of the DOE is provided by prosecution history estoppel: a patent applicant cannot recover subject matter that the applicant surrendered during patent prosecution to obtain the patent. For example, suppose that a patent applicant tried to claim all polypeptides having the function of a native Bacillus thuringiensis toxin and that have an amino acid sequence at least 80% identical to the amino acid sequence of "SEQ ID NO:1." The examiner rejects the claim on the basis that the patent specification does not teach how to make toxins that are only 80% identical to the particular sequence. Eventually, the applicant narrows the claim to Bt-like polypeptides having amino acid sequences that are at least 90% identical to SEQ ID NO:1, and the patent issues. Prosecution history estoppel will prevent the patentee from successfully arguing that the DOE will expand the scope of the claim to cover Bt-like polypeptides with 80% amino acid sequence identity. But can the patentee use the DOE to expand the claim to cover polypeptides with identities between 80 to 90%? The Federal Circuit's Festo decision says "no."
In Festo, the Federal Circuit abolished the "flexible bar" theory of prosecution history estoppel in favor of an "absolute bar" rule. Under the flexible bar theory, a patentee can establish infringement outside the literal scope of an amended claim by showing that the patentee had not surrendered this subject matter to obtain the patent. Under the absolute bar approach, the patentee is deemed to have surrendered all subject matter outside the literal scope of the amended claim element. This means that the patentee no longer has the opportunity to show that certain equivalents would not have been barred from the scope of the claim by prior art or other patentability requirements. The operation of the absolute bar is illustrated by Mycogen v. Monsanto (59 USPQ2d 1852 (CA FC 2001)), in which Mycogen had apparently given up a broad claim to synthetic Bt toxin genes for a claim to a gene having a particular nucleotide sequence. Applying the absolute bar, the court would not allow operation of the DOE to expand Mycogen's claim to include Monsanto's gene with a nucleotide sequence that differed from Mycogen's sequence by 19%. This case also shows why the Federal Circuit's Festo decision was not popular with many patent owners.
The Supreme Court also did not care for the Festo decision. Chastising the lower court for ignoring Supreme Court precedent, Justice Kennedy wrote that instituting an absolute bar would be unfair to patent owners who had made decisions during patent prosecution in reliance of the flexible bar. Nevertheless, the Court seems to have met the Federal Circuit part way. Under the Supreme Court's ruling, there is a flexible bar, but the patentee must now overcome a presumption that prosecution history estoppel created an absolute bar. Going back to the hypothetical case, narrowing the claims from "at least 80%" identity to "at least 90%" identity, creates a presumption that the patentee's claim cannot cover polypeptides falling within the 80% to 90% range. The patentee can overcome this presumption by showing that, "at the time of the amendment, one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent." Just how a patentee can effectively make this showing will be determined as the Court's Festo rule is played out in the courts.
Phillip B. C. Jones, PhD., J.D.
Seattle, Washington
phillipjones5939@msn.com