By CRG Staff

In front of a packed courtroom on April 4th, the Court of Appeals for the Federal Circuit heard arguments in Association for Molecular Pathology v. USPTO. This potential landmark case in patent law challenges the patents held by Myriad Genetics, a biotechnology company, on two human genes related to breast and ovarian cancer. The American Civil Liberties Union and the Public Patent Foundation filed suit in 2009 on behalf of researchers and women claiming that such patents wrongly restrict science and make it difficult for women to gain vital medical care (CRG has filed an amicus brief in the case). During the past 30 years, the U.S. Patent and Trademark Office has issued more than 50,000 patents related to genes in humans, animals, plants, bacteria and others. A final opinion in the Myriad case could likely determine whether patents connected to naturally occurring genes can be granted by the federal government.

Before reaching the merits of the arguments, the three-judge panel spent a significant amount of time exploring the procedural question of whether they had jurisdiction over the case-specifically, whether the plaintiffs had demonstrated that they had standing to sue. U.S. law requires that the parties to an action have a sufficient connection to and harm from the action challenged to support that party's participation in the case. Plaintiffs urged that several individuals and groups had demonstrated sufficient likelihood of injury to confer standing. The panel expressed some concern that such a finding might allow any customer wanting access to a cheaper product to be able to challenge a patent.

Turning to the merits, the panel entertained arguments from both the U.S. government as represented by the Solicitor General (the US Government had earlier filed a friend-of-the-court brief asserting that patents issued by the PTO covering isolated DNA are invalid), as well as from representatives of the litigants. The Solicitor General asked the judges to imagine a magic microscope that would allow them to gaze into and through everything in nature, arguing that no company can legally claim ownership over anything seen though such a lens. The ACLU attorney noted that isolation cannot be the test for patentability declaring:

If a surgeon cuts me open, and slices out my kidney, and takes it out and holds it in his hand, it's an 'isolated' kidney, but it's still a kidney. It's not an invention.

Myriad's attorney argued that isolated DNA has never existed in nature, that it is a product of human ingenuity, and therefore it satisfied the patentability test. Judge Bryson asked him:

To me, at least, it is an important question as to how preclusive your patent-and any other patent on any particular gene-would be if, in effect, you have to get 100, 200 or 1,000 licenses before you can sequence the genome of an

The judges generally struggled to identify any kind of patent eligibility test. Patentable compositions of matter must be different in kind from those that are naturally occurring. Judge Lourie, who appeared the least impressed by the ACLU's claims, came the closest by exploring a test centering on whether covalent bonds are broken. He noted that breaking those bonds changed the composition of an isolated strand of DNA from its counterpart in the human body. The ACLU argued that isolated DNA is identical to DNA, and stated that all Myriad did was "snip the gene." Judge Lourie reined in that argument, arguing that isolating DNA was "not research by tweezers." 

How the court will actually rule is impossible to predict, but an opinion is expected by late summer. Whichever way the court does rule, it is a certainty that the losing party will appeal to the Supreme Court for a final determination.

Search: GeneWatch
For centuries, human societies have divided population groups into separate races. While there is no scientific basis for this, people unquestioningly accept these classifications as fact.
View Project
Biowarfare and BioLab Safety
View Project