CPLRG™ 0085 - Association for Molecular Pathology v. Myriad Genetics, Inc. - Jun. 13, 2013

Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (Thomas).  For the Court’s slip opinion, click here.AMPMyriad06132013

AMP is a first-order, high-profile decision by the Supreme Court.  It was front-page news in the general media.

Like last year’s decision in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012), in which the Court held certain diagnostic methods to be unpatentable “principles of nature,” and unlike the Federal Circuit’s May 10, 2013, decision on Section 101’s application to computer-implemented methods and and systems, CLS Bank International v. Alice Corp. Pty., the Supreme Court was unanimous in an opinion by Justice Thomas.

Only Justice Scalia wrote separately, concurring because of his personal doubts about the full accuracy of the Court’s description of the molecular biology involved.

In AMP, the Court held that  “genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”  A patent owner had “found an important and useful gene,” to wit, one the mutations of which are indicative of an increased risk of breast cancer, but “separating that gene from its surrounding genetic material is not an act of invention.”  On the other hand, complementary DNA (cDNA) is “patent eligible because it is not naturally occurring.”  Unlike isolated DNA (deoxyribonucleic acid), cDNA omits the non-coding regions (introns) and retains the coding regions (exons) of the natural DNA nucleotide sequence.  It is not an unpatentable product of nature even though nature dictates the nucleotide sequence, to wit, one that contains the same protein-coding information, because “a lab technician unquestionably creates something new when cDNA is made.”General Importance of AMP.

Every patent professional with responsibilities relating to biochemical technology, in particular, DNA-related inventions and patents, will pay close attention to AMP.  But, every patent professional should be up to speed on the Court’s holding in AMP for at least two reasons.

A. Issue Catching Public Attention.   First, AMP was widely covered in the popular media, and the general issue–can you patent a human gene?–stimulates thought and discussion outside of legal and patent circles.  If you are patent professional and a friend, colleague, or family member asks for your opinion or assessment, you will not shine by dismissing the questioner with “Oh, I only focus on electrical patents.”

B. Influence on Other Section 101 Issues; Computer-Related and Digital Technology.  Second, the Supreme Court’s mode of analysis in AMP will influence how the courts and the Patent and Trademark Office apply the implied exception to Section 101 to all types of subject matter, including computer related and digital technology.

1. Three Part Exception; Distinguishing Principle from Application.   The exception comprises three parts: “laws of nature,” “natural phenomena,” and “abstract ideas.”  AMP focuses on the “natural phenomena” (or “product of nature”) part.  Mayo focused on “laws of nature”, and Bilski on “abstract ideas.”  See Bilski v. Kappos, 130 S. Ct. 3218 (2010).  In all three cases, the Court recognized a distinction between an abstract idea (or natural phenomena or law), which is not patent eligible, and an practical application of it, which is patent eligible.  Whether the Court provided clear and helpful guidance on how to draw that critical line can and is being debated.  The Court indicated that a patent claim must contain more than “conventional” or “field of use” limitations and must inject something “inventive” so that the claim does not “preempt” all applications of the abstract idea (or law of nature or natural phenomena).

2. AMP: Distinction Between Isolated DNA and cDNA; No Preemption Inquiry as to cDNA.  The general importance of AMP lies in the distinction the Supreme Court drew between the claims to isolated DNA and complementary DNA.  The Court determined that the former claims were to a natural phenomena.  That is, the chemical structure of genes, as they exist in the human body, were claimed.  In so concluding, the Court focused on the broad, functional scope of the claims.  It reasoned that the mere act of isolating the genes did not alter their natural character.  In that reasoning, it followed the old Funk Brothers decision.  (For a critique of Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (1948), see Chisum on Patents § 1.02[7][b].)

The latter claims, that is, to cDNA, the Court determined to be not for products of nature because the structure did not exist in the human body in that form.  Importantly, there is no indication in the Court’s opinion that it mattered (1) whether the information content drove the process of isolation and dictated the creation of cDNA from the natural DNA, (2) whether it was well-known or conventional to create such cDNA from a gene once it was known, (3) whether creating cDNA was “inventive”, or (4) whether the claims to cDNA might “preempt” practical applications of the gene (i.e., the natural phenomenon).  These are the genre of questions that Mayo and Bilski held to be determinative.  These are the questions that so divided the Federal Circuit judges in CLS Bank, discussed at Tab 7.  But in AMP, the Court does not discuss them.  Indeed, in response to the challenger’s argument that “cDNA is not patent eligible because `[t]he nucleotide sequence of cDNA is dictated by nature, not by the lab technician,’ ” the Court responded:  “That may be so, but the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a `product of nature’ and is patent eligible under §101 ….”

3. Absence of Threshold for Inquiry into Three Part “Exception” (Laws of Nature, Natural Phenomenon, Abstract Ideas).  Thus, the reason no preemption analysis was called for in AMP seems to be this:  the inquiry into preemption and conventionality are necessary only when a threshold for a Section 101 “exception” is met.  That is, a claim must embody, in some sense, an “abstract idea” (or natural phenomenon or principle of nature) before any further (and potentially problematic) inquiry into preemption is necessary.  In AMP, the threshold was not met for the cDNA claims because they were clearly drawn human-made “compositions of matter,” not products of nature.

To repeat, there is a substantial threshold before a Section 101 eligibility question will arise for a patent claim, whether in method or system form.  A claim must set forth an abstract idea, which, at the outset of any Section 101 analysis, must be identified and defined.  Many claims will not go over this threshold.  Cases such as CLS Bank and the Supreme Court’s Bilski recited methods that rather clearly were based on fundamental and known techniques for manipulating information: an escrow and a hedging strategy.  Well-drafted patent claims should not even “smell” like such an abstraction.

4. Importance of Specification; Characterization of Invention.  Another lesson from AMP is that a patent’s  specification as well as its claims should be carefully drafted to avoid potential Section 101 issues.  The Court relied, in part, on the patent specification description of the invention as a “discovery” of something already existing.  Hence, language in the style of “applicants have solved a problem with X by creating a Y structure” would be better than language as such as “it has bee discovered that Y is an effective solution to X problems.”  To a patent professional, there is little or no difference; to a generalist judge, at least the connotation is different.

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