In May, the ACLU filed a lawsuit seeking to invalidate patents relating to genes linked to breast and ovarian cancers. Last week, the plaintiffs filed a motion for summary judgment in the district court.
The plaintiffs argue that the claims are invalid for at least three reasons: (1) the patented genes and genetic mutations are naturally occurring and thus are not patentable subject matter under § 101 of the Patent Act; (2) the patents cover thought, knowledge, and ideas in violation of the First Amendment; and (3) the patents cover basic scientific principles thereby impeding, rather than advancing science, in violation of the Intellectual Property Clause of the Constitution (Art. 1, Sec. 8, Cl. 8).
Patentable Subject Matter
First, the plaintiffs argue that the patenting of human genes and the concept of looking at or comparing genes and genetic mutations violates Supreme Court precedent that prohibits patenting laws of nature, physical phenomena, and abstract ideas. The composition claims at issue in the case refer to purified, extracted, or isolated genes. “Isolating” a gene refers to the removal of the gene from the body and separating it from surrounding cellular material. The plaintiffs argue that PTO policy to grant such patents on isolated and purified genes violates Supreme Court precedent against patenting naturally occurring products.
The plaintiffs rashly disregard a number of cases where courts have upheld patents to isolated genes and DNA sequences. They argue that the courts erroneously focused on other issues, like novelty and utility, instead of the patentable subject matter question.
The plaintiffs also argue that the claims to methods of detecting genetic alterations specify the only step as analyzing various genetic sequences without specifying how this analysis would be conducted. The argument is that the claims cover the mere thought process of looking at the genes, thus the claims are not directed to patentable subject matter. Likewise, claims to methods of comparing two genes cover laws of nature and abstract ideas.
First Amendment
Next, the plaintiffs argue that the patenting of abstract ideas or thought or an entire body of knowledge violates the First Amendment. Several of the claims-at-issue relate to looking at genes and reaching a conclusion and others involve abstract mental processes. If a person looked at the genes and mentally reached a conclusion, he would infringe these claims. It is impossible for a competitor to design around or build upon a patent on a law of nature, such as a gene. These points seem to be a repitition of the subject matter arguments.
Intellectual Property Clause of the Constitution
The plaintiffs argue that the patents impede, rather than promote, the progress of science as required by the Intellectual Property Clause of the Constitution. To support this argument, the plaintiffs cite to the nature and range of the plaintiffs in the case, including pathologists, clinical laboratory scientists, researchers, geneticists, genetic counselors, women’s health advocacy organizations, and individual women. The plaintiffs also argue that the patents were not necessary to have the genes identified and sequenced.
Analysis
The majority of the ACLU’s brief is focused on its strongest argument (which is NOT that the patents violate the Constitution). The arguments that the isolated genes are naturally occurring and that the methods do not involve a machine or transformation of matter are going to have to be addressed by the patent owners.
As is usually the case in patentable subject matter cases, the arguments could be better formulated around novelty, non-obviousness, or enablement. The argument that simple isolation and purification of a naturally occurring gene should not qualify for patentability sounds like a lack of novelty or obviousness argument. The point that the method claims do not include sufficient detail on how to accomplish the patented methods sounds like an enablement argument.
The First Amendment argument is ridiculous. To a certain extent, all intellectual property protection laws restrain speech: they permit the owner to exclude another from certain action or speech. This does not mean they violate the First Amendment. This argument again is really directed to other sections of the Patent Act, rather than free speech. If the claims are not enabled, they are invalid under § 112, not the First Amendment of the Constitution.
The Intellectual Property Protection Clause argument is equally specious. First of all, it’s simply a matter of opinion. Just because they got together a large number of parties to serve as plaintiffs does not mean that the patents are invalid simply because the plaintiffs wish it so. IBM’s competitors probably wish IBM’s patents would all be invalidated. Simply because they all band together doesn’t mean the patents should be tossed out.
Other Issues
The patent owners have filed a motion for the court to dismiss the case based on lack of case or controversy and lack of personal jurisdiction by the court.
In addition to suing the patent owners, the plaintiffs have also sued the PTO. The plaintiffs argument against the PTO is that its policy of issuing patents such as those in this case violates the Consitution. The PTO has filed a motion to dismiss based on lack of subject matter jurisdiction and sovereign immunity. The PTO argues that the plaintiffs lack standing to bring the suit and that there is no redress available to them under the law.
