Amicus Briefs in AMP v. USPTO: Genetic Alliance

By Donald Zuhn --

In an amicus brief filed in Association of Molecular Pathology v. U.S. Patent and Trademark Office, Genetic Alliance adds its name to the list of groups supporting reversal of the District Court's decision that the claims of several patents on BRCA1 were invalid as encompassing non-statutory subject matter.  The not-for-profit, tax-exempt health advocacy organization also indicates its opposition to the "wholesale abolition of patents on isolated DNA molecules and their use in diagnostic methods."  The group opens the brief by noting that:

[It] not only wants diagnostic tests to be developed and made widely available, but also wants effective treatments to be developed.  It recognizes the importance of patents in providing incentives for investment in the discovery and commercialization of diagnostics, drugs, and other treatment modalities.  The wholesale invalidation of all patents on isolated DNA molecules (and potentially all compounds isolated and purified from natural sources), which is the logical consequence of the decision on appeal, would impede the investment, development, and commercialization of effective products and treatments for genetic diseases.

In the first part of the brief, Genetic Alliance argues that the District Court's opinion "suffers from several legal errors."  In particular, the brief states that the opinion "errs in stating that any compound from a natural source that is isolated and purified without chemical change cannot be patented."  The brief notes, however, that this is dictum because the claimed isolated DNA molecules are man-made compositions that differ chemically from native DNA in genes in the human body.  The brief then contends that the opinion "applies the wrong test for determining whether a man-made composition having a chemical structure related to, but different from, a natural substance falls within an exception to § 101," announcing "a 'requirement' that such claimed subject matter is unpatentable unless it is 'markedly different' from the composition in nature," which the brief argues is not the standard articulated in Diamond v. Chakrabarty.  The brief accuses the District Court of "[d]eparting from established law," by declaring by "judicial fiat" that nucleotide sequences constitute "a new exception to § 101."  The brief also contends that the opinion errs in holding that claims directed to diagnostic methods are unpatentable.

With respect to the brief's assertion that the District Court applied the wrong test for assessing the patent-eligibility of the claimed BRCA DNA molecules, Genetic Alliance first notes that "[l]ike any other chemical entity, isolated DNA molecules are patent-eligible compositions of matter unless they fall into a recognized exception to § 101."  Pointing to the District Court's derivation of a "requirement" from Chakrabarty that the claimed subject matter must be "markedly different" from what occurs in nature, the brief counters that "none of the other cases that the Opinion cites [including Chakrabarty] refer to a claimed composition as 'markedly different,' let alone describe that as a 'requirement' for patentability."  The brief contends instead that "to meet the Chakrabarty test a composition or manufacture related to a natural product must be (1) non-naturally occurring, (2) a product of human activity, and (3) ha[ve] a distinctive name, character, and use."

As for the District Court's "markedly different" requirement, the brief quotes a portion of the Chakrabarty opinion in which the Supreme Court compared Chakrabarty's patentable bacterium to the unpatentable bacteria in Funk Bros. Seed Co. v. Kalo Inoculant Co.:

Here, by contrast [to Funk Bros.], the patentee [Chakrabarty] has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility.  His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101."

While noting that the words "markedly different" appear in the above passage, the brief contends that the words are "found within an analysis showing that Chakrabarty's bacterium is patent-eligible because it is non-naturally occurring, a product of human intervention, and has a distinctive character and use" (emphasis in original).  The brief calls the District Court's use of the "markedly different" requirement "unprecedented," and argues that the determination of whether a claimed composition is "markedly different" from a related, naturally occurring composition is "highly subjective."

Applying the three-prong test that Genetic Alliance derives from Chakrabarty, amicus concludes that the claimed DNA molecules:  (1) are not found in nature (which, according to the brief, the District Court recognized), (2) "are all made by scientists and require substantial human intervention to prepare them," and (3) have properties and uses that differ in kind from genes in the body.  On this last point, the brief describes those properties and uses as follows:

Isolated DNA molecules can be used in research as targets for discovering new drugs and as tools for manufacturing protein drugs.  Isolated human DNA molecules can be used to produce human proteins in entirely different species, such as yeast or bacteria.  Isolated copies of DNA molecules can be sequenced for diagnosis.  The small, claimed DNA molecules (primers and probes), which do not exist in nature and do not code for any protein (only a small string of amino acids), are useful as chemical reagents, research tools, and as diagnostic and biological probes.  Isolated DNA molecules can be used in gene therapy. DNA in genes inside the body cannot directly be used in any of these ways.

The brief next takes issue with the District Court's conclusion that isolated DNA molecules are "products of nature," arguing that the District Court's opinion "inappropriately discounts" that "the isolated DNA molecules claimed in the BRCA patents are different chemicals from native DNA in genes, are made by human intervention, and have different uses than DNA in genes."  The brief states that:

There is no precedent for dismissing the significance of evidence that the claimed molecules are man-made, have different chemical structures from DNA in genes, and have different utilities.  In essence, the Opinion decides that for patent eligibility under § 101, the presence of information-carrying nucleotide sequences overrides all other considerations.

With respect to the District Court's discussion of the information-carrying aspect of nucleotide sequences, the brief contends that:

Apparently agreeing that all chemical compounds carry "information," the Opinion distinguishes patentable compounds as those in which the information is about their "own molecular structure," whereas information in DNA is directed to other molecules (proteins).  But other kinds of patentable macromolecules contain "information" directed to other molecules.  For example, antibodies, which are patentable subject matter, inherently contain "information" about the structure of other molecules (antigens), which reflects antibodies' primary function (binding to antigens) and makes them able to interact with antigens.

Returning to the Chakrabarty case, the brief asserts that if modified bacteria of Chakrabarty was found to be patent-eligible, then the isolated DNA molecules of the instant case are most certainly patent-eligible.  Summarizing the claimed invention in Chakrabarty, the brief states that:

The plasmids used by Chakrabarty occur naturally in certain strains of bacteria -- they were not produced by the inventor (except in one case in which two naturally occurring plasmids were fused by exposure to UV light).  The plasmids were transferred from one bacterium to another by the naturally occurring process of conjugation.  The resulting patentable bacterium (containing a number of plasmids) did not exist in nature.  However, the plasmids contained in the patent-eligible bacterium all exist in nature and function identically whether in their original bacterium host or in Chakrabarty's engineered bacteria.

(emphasis in original).  Thus, the brief concludes that "the genetic manipulation, purification, and change in structure required to engineer isolated cDNA molecules (as in the BRCA patents) result in molecules that differ far more in structure and function from native DNA than did Chakrabarty's patentable bacterium compared to bacteria found in nature."

Like other amici, Genetic Alliance argues that if isolated DNA molecules are to be deemed patent-ineligible, such determination is for Congress and not the courts.  Noting that "[t]he PTO has granted thousands of patents claiming isolated DNA sequences and their use, and the courts have adjudicated disputes regarding DNA patents, without questioning their patent eligibility," the brief advises the Federal Circuit "not [to] change this almost universally accepted interpretation of the patent statute without a clear and certain signal from Congress."  The brief then discusses how a holding of patent-ineligibility for isolated DNA molecules "would render portions of 35 U.S.C. § 103(b), § 271(e)(1), and § 271(g) meaningless, violating the statutory canon against interpreting a statutory provision in a manner that would render another provision superfluous."

As for the District Court's finding that "'purification of a product of nature, without more, cannot transform it into patentable subject matter' under § 101," the brief requests that the Federal Circuit "expressly repudiate this standard," stating that "[n]atural compounds that are purified and isolated, but are not altered chemically, have repeatedly been found to be patentable because '[the claimed] compounds . . . do not exist in nature in pure form.'"  The brief then concludes with a discussion of why the diagnostic method claims at issue are patent-eligible under § 101, arguing that the method claims require a transformation of matter into a different state or thing and that the method claims do not preempt the idea that mutations in the BRCA genes may increase cancer risk.

Nine amicus briefs have been filed in the AMP v. USPTO appeal (of which Patent Docs is aware):

• Alnylam Pharmaceuticals, Inc., in support of Defendants-Appellants, supporting reversal (brief)
• Biotechnology Industry Organization (BIO) and the Association of University Technology Managers, supporting reversal (brief)
• Genetic Alliance, supporting reversal, but not in support of either party (brief)
• The Intellectual Property Owners Association (IPO), in support of neither party (brief)
• United States, in support of neither party (brief)
• American Intellectual Property Law Association (AIPLA), in support of reversal, but in support of neither party (brief)
• Christopher M. Holman and Robert Cook-Deegan, in support of neither party (brief)
• Rosetta Genomics, Ltd., Rosetta Genetics, Inc., and George Mason University, in support of Defendants-Appellants, supporting reversal (brief)
• Gilead Sciences, Inc. and BioGenerator, in support of Defendants-Appellants and urging reversal (brief)

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

• "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

Comments

[EG]

Don,

The Genetic Alliance amicus brief throughly exposes the inanity of the Sweet's opinion on the patent-ineligibility of both the "isolated" DNA claims, as well as the diagnostic method claims. Without the intervention of man, the claimed "isolated" BRCA 1 and 2 sequences simply don't exist. And the diagnostic method claims require some pretty sophisticated and transformative procedures which can in no way be considered "abstract." What is unfortunate is that Sweet's opinion has caused so much ink to be written to confirm what should be established law, and at huge expense. What a waste of judicial resources.

[6]

In other news, people loled at The Genetic Alliance and their brief, and chuckled at EG.

Man, crazy weekend, sorry I haven't been around.

Btw Kev your site is broken on my browser now. The left hand column displays up at the top of the page with a big white spot where the other part of the page is supposed to be. The other part (the main part) of the page then displays all the way to the left after the left sidebar has displayed. And the rightmost column with all your links to other sites etc. displays after the main portion displayed, and the right hand part is also left aligned.

That is, the whole site appears left aligned with your left portion at the top, the main portion displaying after that, and the right hand column displaying after that.

[Donald Zuhn]

6:

The site displays fine on Firefox and IE on my Dell and on Firefox and Safari on my Mac.

Don

[General Admission]

I had the same view issue that 6 notes, but it somehow corrected itself (after several months of 'brokenview').

[6]

Yeah it's working today.