AMP v. USPTO Remand: Déjà Vu as Federal Circuit Majority Reaffirms Myriad’s Isolated DNA Sequences Are Patent-Eligible*
|Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: August 17, 2012 @ 3:03 pm
When the Supreme Court remanded the Federal Circuit’s original panel decision in AMP v. USPTO for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I said that nothing would change in that remand. In particular, I predicted that the same two-to-one majority from that Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) would again rule that the claimed isolated DNA sequences were patent-eligible under 35 U.S.C. § 101. My primary reason for my confidence in that prediction was that the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) would control on that claimed subject matter, not Mayo Collaborative Services. See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*.
So guess what happened in the AMP remand of? As I predicted, simply “déjà vu”: the same two-to-one majority ruling for essentially the same reasons, as well as confirming that Chakrabarty (not Mayo Collaborative Services) controlled on the patent-eligibility of the claimed isolated DNA sequences. For the full decision see AMP v. USPTO II (August 16, 2012).
With two notable exceptions to be discussed below, I’m not going to repeat what was said by the various judges in the AMP remand (as I said, it was essentially the same reasoning as in the original panel opinions), but will simply summarize what the final outcome was and by what vote:
1. Claimed isolated DNA sequences are patent-eligible under 35 U.S.C. § 101. Judges Lourie and Moore said “yea,” Judge Bryson again said “nay.”
2. Claimed cDNA (i.e., depicting the coding region for the nucleotide sequence of the BRCA1 DNA) are patent-eligible under 35 U.S.C. § 101. Judges Lourie, Moore and Bryson all said “yea.”
3. Claimed method for screening potential cancer therapeutics using trans-formed eukaryotic host cell containing an altered BRCA1 gene are patent-eligible under 35 U.S.C. § 101. Judges Lourie, Moore and Bryson all said “yea.”
4. Claimed methods directed to “comparing” or “analyzing” DNA sequences are patent-ineligible under 35 U.S.C. § 101. Judges Lourie, Moore and Bryson all said “yea.”
Now what do I feel bears repeating (and quoting) from the AMP remand? First, what Judge Lourie said the appeal in the AMP case is not about, and especially what it really is about:
Before reviewing the applicability of the Supreme Court’s Mayo holding to the claims of the Myriad patents, however, 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.
How refreshing! After all of the disingenuous rhetorical nonsense spewed by the ACLU, PubPat, and others as to what the AMP case is supposedly about, it’s good to hear that Judge Lourie hasn’t lost sight of what this appeal is really about: patent-eligibility under 35 U.S.C. § 101, not patentability under 35 U.S.C. §§ 102 or 103. We’re also not talking about whether the defendants (i.e., University of Utah or Myriad) should/could have acted differently in “licensing or enforcing” their patent rights. We’re especially not talking about whether it’s good from a policy standpoint “for one company to hold a patent or license covering a test that may save people’s lives.” As Judge Lourie correctly observed, “disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress,” not to the courts, be it the Federal Circuit or the Supreme Court.
The other point that also bears repeating (and quoting) from the majority opinion in the AMP remand is Judge Lourie’s response to the so-called “preemption” question:
Plaintiffs argue here that they are preempted from using the patented DNA molecules. The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature. Moreover, as indicated earlier, a limited preemption is inherent in every patent: the right to exclude for a limited period of time.
Touché! As I’ve observed before, “preemption” really isn’t a patent-eligibility question under 35 U.S.C. § 101. Instead, “preemption” is really a question of “written description,” and especially “enablement,” under 35 U.S.C. § 112, first paragraph (and potentially “definiteness” under 35 U.S.C. § 112, second paragraph). As Judge Lourie correctly observes, some “preemption” is inherent in every patent, no matter how broad (or narrow) the patent claim scope is. And unlike trade secret rights which may potentially exist in perpetuity, any such patent “preemption” is further limited in time, i.e., by the 20 year term (from filing date) of the patent.
As I said in my earlier IPWatchdog article cited above, the plaintiffs’ belief that the remand in AMP would change the Federal Circuit panel’s view on the patent-eligibility of the claimed isolated DNA sequences was “no more than very wishful thinking.” I’m also certain the AMP remand decision will not end the efforts by the ACLU, PubPat (and others) to blow more “smoke” on what this case is really about. But as Judge Lourie correctly observes, this case is solely about “patent eligibility.” We can only hope that an en banc Federal Circuit, and potentially the Supreme Court, will heed Judge Lourie’s warning, and not allow the ACLU, PubPat (and others) to further obfuscate what the real question to be decided in the AMP case is. We can also only hope that these courts will decide that question based on a proper understanding of the claimed subject matter, as well as the applicable law, and not some inapt “plucking a leaf” or “magic microscope” analogy.
*© 2012 Eric W. Guttag. Posted August 17, 2012 on IPWatchdog.com.
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