Fractured CAFC panel again affirms patent eligibility of isolated DNA, and applies Mayo

Ryan Chirnomas | August 21, 2012

Association for Molecular Pathology et al. v. U.S.P.T.O. et al.

August 16, 2012

Panel:  Lourie, Bryson and Moore.  Majority opinion by Lourie, concurrence by Moore, dissent by Bryson.

Less than a month after hearing oral arguments, the CAFC panel of Judges Lourie, Bryson and Moore last week issued an updated decision in the controversial AMP v. USPTO (Myriad genetics) case. The CAFC reached the same conclusion as they did last year: (1) the Plaintiffs do have standing, (2) the isolated DNA and cDNA claims are patent eligible, (3) the “analyzing” and “comparing” method claims are not patent eligible and (4) the screening method claim is patent eligible.

As with the decision last year, the panel reached a unanimous conclusion with respect to the issues of standing, subject matter eligibility of the cDNA claims, and subject matter eligibility of the method claims.  However, the panel reached different conclusions with respect to the composition claims which recite isolated DNA.  Since the opinions of the Court are very similar to the opinions issued in 2011, this article will focus on the Judges’ views with respect to the impact of Mayo v. Prometheus (English summary; Japanese summary) on the claims in question, and particularly with respect to the isolated DNA claims.

Majority Opinion

Briefly, with respect to the standing issue, the Court again held that among the Plaintiff group of doctors, patients, scientific organizations and advocacy groups, only Dr. Osterer (formerly of NYU) has standing.  There was a relatively recent complication in that Dr. Osterer moved to Albert Einstein Medical Center, which perhaps does not offer, and is not qualified to offer, clinical genetic testing.  However, the panel maintained that Dr. Osterer has standing, stating that they will review the case on the facts presented and briefed to the Court.

Next, the Court attempted to distance themselves from the controversy surrounding this case by stating:

…it is important to state what this appeal is not about.  It is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion.  Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents.  The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent — that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter.  It is also not whether the claims at issue are novel or nonobvious or too broad.  Those questions are not before us.  It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo.  The issue is patent eligibility, not patentability.

As to the method claims, the Court unanimously agreed that the “analyzing” and “comparing” methods are not patent eligible, since they only recite mental steps, and do not recite the structure of physical DNA molecules.  As such, the Court stated that the holding of Mayo governs.

As to the claims reciting a method of screening for potential cancer therapeutics, the Court again held that these claims are patent eligible.  However, the Court shifted its focus from the machine-or-transformation test discussed in last year’s decision, and focused instead on the artificially created starting materials of the claimed method.  The method of claim 20 requires a host cell transformed with a gene which it does not normally possess.  Based on this, the Court held that unlike the claims in Mayo, claim 20 recites more than the simple application of a law of nature.  Notably, the Court stated:

By definition, however, performing operations, even known types of steps, on, or to create, novel, i.e., transformed subject matter is the stuff of which most process or method invention consists. All chemical processes, for example, consist of hydrolyzing, hydrogenating, reacting, etc. In situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible. It is rare that a new reaction or method is invented; much process activity is to make new compounds or products using established processes. Thus, once one has determined that a claimed composition of matter is patent-eligible subject matter, applying various known types of procedures to it is not merely applying conventional steps to a law of nature.

This language should be comforting, and may be helpful in responding to §101 rejections presented by the USPTO.  This passage demonstrates that the CAFC is aware that the Supreme Court’s Mayo decision could be taken to an extreme, since every method relies on the laws of nature on some level.  Thus, it appears that the CAFC interprets Mayo such that a method is patent eligible if either (1) a non-conventional step is applied to a natural object, (2) a conventional step is applied to a non-natural object, or (3) a conventional step is applied to a natural object to produce a non-natural object.

Moving back to the composition claims, here we once again see the three positions of the panel.  Judge Lourie took a rather straightforward view on the application of Mayo to the composition claims, arguing that Mayo is limited to method claims, and that Chakrabarty and Funk Brothers provide the “primary framework for deciding the patent eligibility of compositions of matter.”  Lourie then concluded that the isolated DNA molecules are markedly different from native DNA, and thus are patent eligible under §101.

Judge Lourie then moved to a policy discussion, explaining that §101 applies equally to all inventions, and that the Court is not authorized to conclude that isolated DNA is a special case–absent guidance from Congress.   Lourie also dismissed the preemption argument.  Referring to Mayo, Lourie concludes that “permitting patents on isolated genes does not preempt a law of nature.  A composition of matter is not a law of nature.”  According to Judge Lourie, isolated DNA molecules are not “mere reflections of a law of nature”…at least not “any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws. But the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”

Judge Moore’s concurrence

As in last year’s decision, Judge Moore agreed with Judge Lourie’s conclusion, but disagreed as to the reasoning to arrive at that conclusion.    In particular, Judge Moore did not agree that the structural differences (such as breaking of covalent bonds) between the isolated and native DNA are alone the proper basis of a patent eligibility analysis.  Instead, Judge Moore focused on novel functional features of the isolated DNA as the basis of patent eligibility, such as the use of isolated DNA as primers and probes.

Again, Moore views the patent eligibly of small fragments somewhat differently from that of the full isolated gene.  According to Moore, “[i]t is not the chemical change alone, but that change combined with the different and beneficial utility that leads me to conclude that small isolated DNA fragments are patentable subject matter.”

As to larger DNA sequences, Judge Moore again stated that if deciding the case “on a blank canvas,” she may decide that most or all of an isolated gene is not patent eligible.  However, Moore deferred to the long-standing policy of the USPTO, as well as the inaction of Congress and the well-settled expectations of the biotechnology industry.  Moore states:

It is not clear to me that Chakrabarty, Funk Brothers, or Prometheus leads inexorably to the conclusion that isolated DNA molecules are not patentable subject matter. I decline the invitation to broaden the law of nature exception.  Given the complicated technology and conflicting incentives at issue here, any change must come from Congress.….I will not strip an entire industry of the property rights it has invested in, earned, and owned for decades unchallenged under the facts of this case.

Additionally, it is worthy of note that Judge Moore also differs from Judge Lourie with respect to whether and how Mayo applies to composition claims.  Unlike Lourie, who regarded Mayo as not controlling on composition claims other than providing “valuable insights and illuminat[ing] broad, foundational principles,” Judge Moore believes the opposite:  “the Prometheus discussion of laws of nature (process claims) clearly ought to apply equally to manifestations of nature (composition claims).”

Judge Bryson’s dissent

Finally, Judge Bryson provided a dissenting opinion, which mainly relies upon analogies to extraction of minerals from the earth, removing a leaf from a tree and removing an organ from a human.  Judge Bryson argued that the isolated DNA claims (excluding cDNA claims) should not be patent eligible.  Bryson again likened the structural differences of isolated vs. native DNA to alterations which are attendant to extractions of minerals, stating that alterations that are attendant to extraction do not give the extractor the right to patent products of nature.  Bryson dismissed the structural differences relied upon by Judge Lourie as being “incidental to” isolation, and dismissed the functional difference relied upon by Judge Moore as being “dictated by” a naturally-occurring sequence.

As to the impact of Mayo, Judge Bryson stated that Mayo “does not decide this case, but the Court’s analysis is nonetheless instructive.”  Bryson interprets Mayo as requiring that “a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product.”  Bryson further stated that the structural differences between isolated and native DNA “does nothing to add any inventive character to the claimed molecules.”

Unlike Judges Lourie and Moore, Judge Bryson provided few comments about deference to Congress on the question of patent eligibility of isolated DNA.  On the contrary, Bryson criticized Lourie and Moore for their deference to USPTO practice, arguing that this effectively gives the USPTO lawmaking authority which Congress has not given it.

Conclusion

It was fairly widely expected that the panel would reach the same conclusion as last year, for similar reasons, and this is indeed how the case turned out.  It is also expected that this case will proceed to the Supreme Court eventually, possibly with a Federal Circuit en banc rehearing first.  As such, perhaps the only true take-away from this decision is that the decision is almost certainly not final.  However, in the meantime, this case gives us our first detailed view of the CAFC’s interpretation of Mayo.  Although there is clearly a fragmented view as to how Mayo applies to composition claims, the panel’s comments about claim 20 may prove to curtail the possible over-application of Mayo in the context of method claims.

Full Opinion

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