Thursday, August 27, 2009

ACLU Moves for Summary Judgment in Case Challenging Patentability of Gene-Based Inventions

The ACLU has filed a motion for summary judgment asking a district court to invalidate many of Myriad Genetics’ patent claims directed towards the BRCA1 and BRCA2 breast cancer genes. The challenged claims are directed to isolated DNA molecules having the sequence of naturally occurring wild type and mutant forms of the genes, and towards methods of identifying mutations in the genes and/or correlating the existence of mutations with a predisposition for cancer. This lawsuit was discussed in an earlier post. Documents that have been filed in connection with the case can be found here, and in particular the motion for summary judgment can be found here.

In its brief, the ACLU argues that isolated naturally occurring DNA molecules, and cDNA molecules corresponding in structure to naturally occurring genes and messenger RNA, are unpatentable natural phenomena. This goes against the patent office’ longtime policy of allowing patents claiming isolated forms of genes and other naturally occurring molecules, based on the rationale that isolation from the cellular milieu constitutes sufficient human intervention to render the molecules patentable. The ACLU cites a number of cases predating Diamond v. Chakrabary which arguably support the proposition that the mere isolation of a natural occurring product is insufficient to render it patentable, and argues that Myriad’s gene patents preempt a natural phenomenon by effectively covering any use of the claimed naturally occurring genes.

ACLU make similar arguments with respect to method claims, arguing that owing to the breadth of the claims they effectively monopolize laws of nature and abstract ideas.

ACLU also makes constitutional arguments. For example, it alleges that genes embody information, and thus broad restrictions on the use of genes is tantamount to a restriction on thought and speech in violation of the First Amendment. They also point to Article 1, Section 8, Clause 8, the so-called "intellectual property clause," which provides Congress with the authority to grant inventors exclusive rights in their discoveries for the purpose of promoting the progress of science and useful arts, and argue that gene patents in fact impede rather than promote the advancement of science and medicine.

Many of the ACLU’s arguments are based on assertions that Myriad has employed its patents in a manner that harms the public interest, by blocking research, limiting patient options, preventing patients from getting second opinions, etc.