By James DeGiulio —

In another amicus brief filed in late October in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case, Prof. J. Jeffrey Hawley and Prof. Ann McCrackin, writing on behalf of amicus University of New Hampshire School of Law, criticize Judge Sweet's District Court decision substantively and procedurally.  Among several concise points, the professors criticize the District Court for overstepping its bounds by implementing a new restriction on patentable subject matter, applying the incorrect standard in the summary judgment ruling, and ignoring its charged duty to uphold controlling federal patent law.

The brief opens with the argument that the District Court has erroneously established a new limitation on patent-eligible subject matter.  DNA is acknowledged as a result of a "chemical union," which fits squarely within the Chakrabarty definition of a composition of matter.  The brief proceeds to address the "isolated" status of the sequences as distinct from naturally-occurring DNA.  Amicus notes that the criteria for patent-eligibility for compositions of matter, even those derived from naturally-occurring compositions, are that they be new and useful.  Put another way, the claimed subject matter is "markedly different" from the naturally-occurring composition.  Turning to the District Court decision, the brief criticizes the additional imposed exclusion on patent eligibility if the composition of matter "serves as the physical embodiment of the laws of nature."  The brief notes that no Supreme Court decision or Federal Circuit panel has established this limitation, citing the decision in Funk Bros. as the closest decision that can be read in such a way.  Of course, Funk Bros. can be distinguished, for the "new" bacteria at issue did not have a different use than the naturally-occurring bacteria.  Nothing in that decision suggests that if a composition of matter has a "unique characteristic" that "serves as the physical embodiment of the laws of nature" that it is disqualified from patent-eligibility under § 101.

Indeed, isolated DNA can acquire many different uses and can serve ends that DNA as it exists in nature cannot provide.  Relying again on Chakrabarty, the brief notes that a similar special exception to patent-eligibility sought in that case was denied.  Specifically, the Supreme Court rejected a proposed special exception to patent-eligibility for living matter.

The UNH brief presents supporting case law where no "special exception" for living matter was articulated when it was sought, including the In re Bergstrom decision in the C.C.P.A. and the Schering Corp. v. Geneva Pharmaceuticals decision of the Federal Circuit.  The pure prostaglandins in Bergstrom were found to "necessarily differ" from the less-pure natural compounds, thus the "pure" materials were found to be patent eligible.  In Schering, the Federal Circuit noted that a "purified" metabolite would be patent-eligible subject matter.  Metabolites function within the body and could be construed as a "physical embodiment of a law of nature," yet there was no suggestion that this might disqualify the patenting of purified metabolites.

The second major argument in the UNH brief deals with the summary judgment standard.  UNH argues that there are genuine issues of material fact remaining in the case and thus a summary judgment ruling was improper.  Patent eligibility under § 101 is amenable to summary judgment only in the absence of disputed issues of facts material to the issue.  Thus, the determination of the patent-eligibility of isolated DNA sequences hinges upon facts pertaining to the structure and functions of isolated DNA as compared to the natural DNA in the genome.

The dispute over the term "isolated" raises issues of material fact.  According to the appellees, isolated DNA is defined as a "fragment of DNA found on chromosome," whereas the appellants have defined isolated DNA as "removed from its naturally occurring environment," requiring "excision from the chromosome."  Clearly, the appellees' definition implies that DNA fragments can be removed without any change in structure or function.  This is not the case, as DNA removed from the genome has several different functions.  Two examples of additional functions for isolated DNA provided by the appellants are its use as probes or primers, rendering isolated DNA suitable for mutation detection, which DNA in its natural environment cannot perform.  The existence of these disputed facts, which must be viewed as evidence in favor of the appellants as the parties opposing the motion, renders the summary judgment finding by the District Court improper.

The brief's third argument addresses the policy considerations presented in the District Court's summary judgment ruling.  Amicus dismisses all of these policy concerns as irrelevant:  the funding for the tests; enforcement of the patents; impact of the patents on BRCA testing; and impact of gene patents on the advancement of science and medical treatment.  According to UNH, even if these policy concerns were relevant to a summary judgment motion, they should be resolved in a manner favorable to the appellants.  UNH points to Chakrabarty once again, where the Supreme Court determined a similar type of policy inquiry (the inflammatory "parade of horribles" argument) was inappropriate.  Indeed, such policy considerations are better suited for the legislative branch, not the courts.  This same finding was more recently echoed in In re Fisher.

Next, UNH finds the District Court at fault in failing to uphold the presumption of validity that Myriad's patents should enjoy.  If the District Court is merely going to ignore a binding federal statute, UNH charges the District Court to declare § 282 unconstitutional.  Indeed, the District Court did not cite to legal authority for reasons why the presumption of validity did not apply to this case, but rather cited the statistic that "40% of patents challenged in the courts have been found invalid."  The brief, however, explains away this statistic, stating only the truly close cases make it as far as a judgment on the merits.  A more accurate statistic, according to the brief, should be that the invalidation rates are as high as 40% for cases reaching final judgment, not merely being challenged in court.  Even if the District Court was free to weigh the value of federal statutes, it should not have done so with incomplete data.

By invalidating Myriad's patents, the District Court committed clear error, since the appropriate clear and convincing standard following the presumption of § 282 was not met.  In applying the "markedly different" test for distinguishing patent-eligible subject matter from products of nature, appellees must prove with a high probability that isolated DNA molecules encoding the BRCA genes are not "product[s] of human ingenuity having a distinctive name, character, and use."  The evidence presented by the appellees was insufficient, merely showing that isolated DNA exists "free-floating" within living cells during transient replication processes.  This evidence does not satisfy the appropriate test, as the appellees failed to produce clear and convincing evidence that isolated DNA does not have distinctive uses, instead contending without evidence that native DNA is certain to enable the same uses as isolated DNA at some undetermined time in the future.

In its last argument, amicus attacks the District Court's determination that Myriad's method claims fail the machine-or-transformation test.  Preliminarily, the brief notes that this is not the only test for subject matter eligibility.  UNH then follows by charging the Supreme Court with defining "abstract idea."  UNH recognizes that Bilski provides some clues about patent-eligibility, but finds these guidelines to be insufficient.

In an intriguing section of the brief, UNH proposes the following definition for an abstract idea:

A claim recites only an abstract idea when the claim describes the idea only in terms of results without specifying how to achieve the results.  Even if the claim specifies how to achieve the results, the claim is still abstract if the claim is wholly directed to an algorithm.  The result itself may be specified explicitly or implicitly; however, the manner by which the result is achieved must be explicitly recited in one or more steps.

After introducing a proposed definition of abstract ideas, the brief analyzes a representative process claim in one of Myriad's patents and declares the claim to recite patent-eligible subject matter.  The claim examined in the brief is claim 1 of U.S. Patent No. 5,710,001, which recites:

1.  A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected faun the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.

No abstract idea is claimed here, according to the brief.  The claim describes a process to screen a tumor sample, which produces a result by comparing a sequence of the BRCA1 gene from the tumor with a sequence from the non-tumor sample in order to detect a somatic alteration in the BRCA1 gene from the tumor sample.  Thus, the claimed process specifies how to screen the tumor, by using a very specific DNA sequence, and is therefore not directed to an abstract idea.

For additional information regarding this and other related topics, please see:

• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," October 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010