PTO Responds in Gene Patent Saga

In the ongoing saga by the ACLU seeking to invalidate certain gene patents and hold that such patents are unconstitutional, the PTO has filed its brief in opposition to the plaintiffs’ motion for summary judgment.  Instead, the PTO asks the court to enter judgment in its favor.

The PTO’s argument is summarized as follows.

First, the only claims alleged against the PTO are constitutional claims, that the patents were issued in violation of the IP Clause and the First Amendment of the Constitution.  The PTO argues that in order to adjudicate these claims, the court must first determine whether the patents were issued in violation of the patent statute.  If the patents are invalid as not being directed to patentable subject matter, not being novel, being obvious, or violating the enablement or written description requirement of 35 U.S.C. §§ 101, 102, 103, or 112, the court should not adjudicate the constitutional claims unnecessarily.  Only if the court determines that the patents were issued in compliance with the statute should the court determine whether the statutory provisions violate the IP Clause or the First Amendment of the Constitution.

IP Clause

The PTO argues that the statute clearly does not violate the IP Clause of the Constitution.  Initially, the PTO argues that it is unlikely that the IP Clause imposes any limitation on Congress’ power to enact the patent laws. 

Even if there is a limit on Congress’ power, the court would review the patent system to determine whether Congress had a rational basis to enact the patent laws under this provision.  Such a review would be limited to whether Congress used a rational exercise of legislative authority granted by the IP Clause.  Clearly, it did.  The power to issue patents for broad categories of inventions “adds to the general store of knowledge.”  Thus, Congress had a rational basis for enacting the patent laws.

Contrary to plaintiffs’ assertions that patents in the biotechnology field are unnecessary, the PTO argues that the high costs of bringing biotechnology products to market is another reason to permit strong patent protection in this area.  The disclosure requirement of the patent system adds to the knowledge of other researchers in the field.  Thus, Congress had multiple rational bases for permitting gene-based patents.

First Amendment

The PTO also makes a number of arguments against the the plaintiffs’ First Amendment claims.  First, the PTO argues that the First Amendment does not provide a substantive limitation on Congress’ authority to enact the patent laws.  If there is such a limitation, the courts have already interpreted the patent laws to accomodate First Amendment concerns.  Finally, the plaintiffs’ arguments are premised on the incorrect notion that patents on isolated and purified genes are patents on “information.”

The Patent Act promotes rather than inhibits free speech.  The patent laws require disclosure of an invention in order to be granted a limited monopoly.  Without the patent laws, the invention might otherwise be kept secret.  Contrary to the plaintiffs’ assertions regarding the high cost of obtaining rights in patents, the First Amendment does not require that its exercise be cost-free.

Patents might be deemed to be limitations on conduct–the ability to practice someone else’s patent without permission–but they are not limitations on speech.  Thus, the First Amendment should not be implicated.  Patent owners are not able to control knowledge with respect to their discoveries, they may only keep others from infringing their patents.  The plaintiffs’ arguments that patenting “abstract ideas” and “mental processes” are already dealt with by § 101 of the Patent Act.  Congress clearly did not violate the First Amendment by enacting the Patent Act.

The plaintiffs also argue that the patents were issued in violation of the First Amendment because they cannot be designed around.  The PTO argues that no court has ever recognized an absolute right to design around a patent.  Furthermore, the patents in this case would “normally be expected to spur competitors to seek and invent additional ways of determining predispositions to cancer, including by conducting research on other genes.”  The scope of patent protection for inventions that are difficult to design around should be left to Congress.

The isolated, purified genes claimed in the patents are chemicals that can convey information, they are not themselves information.  Because they are chemicals, they would be eligible to be patented, provided they meet the other requirements for patentability.


The PTO’s brief is well-reasoned and provides a solid legal argument.  It should be persuasive if this were a rational argument.  Unfortunately, given that the ACLU is using the media to inflame the debate, it has been emotional, rather than rational.  And given Judge Sweet’s earlier opinion in the case, it is difficult to predict how he will rule.

Patent Docs provides frequent updates on this case and the gene patenting debate in general.

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One Response to “PTO Responds in Gene Patent Saga”

  1. Magdalene Mcmindes Says:

    Many thanks for the article. I appreciate it. You have a very nice site.

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