Today's Date: November 22, 2014 Search | Home | Contact | Services | Patent Attorney | Patent Search | Provisional Patent Application | Patent Application | Software Patent | Confidentiality Agreements

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
Tell A Friend!

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.


- - - - - - - - - -

For information on this and related topics please see these archives:

Tags: , , , , , , , , , , ,
Posted in: Biotechnology, Eric Guttag, Federal Circuit, Guest Contributors, IP News, IPWatchdog.com Articles, Patentability, Patents

 

 


Tags & Categories

Tags: , , , , , , , , , , ,
Posted in: Biotechnology, Eric Guttag, Federal Circuit, Guest Contributors, IP News, IPWatchdog.com Articles, Patentability, Patents

11 comments
Leave a comment »

  1. To all:

    One point that I should have elaborated on was Lourie’s comment that “disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress,” not to the courts. At page 50 of the slip opinion, Lourie importantly observed that “Congress is presumed to have been aware of the issue, having enacted a comprehensive patent reform act [i.e., the America Invents Act] during the pendency of this case, and it is ultimately for Congress if it wishes to overturn case law and the long practice of the PTO to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function.” In other words, during the pendency of the AMP case, Congress was aware this issue but chose to do nothing about it when enacting the America Invents Act. That’s one point that the AMP remand decision adds which the ACLU, PubPat and others are going to have a very hard time rebutting with their “policy” arguments.

  2. Eric,

    There is little doubt that this 3-judge panel decision will be re-visited by way of en banc review and/or a Supreme Court review. I have a feeling that the anti-inventor judges/justices on the CAFC and on the Supreme Court are just itching at the trigger to take those uppity inventors down a notch or two and explain to them why they need an un-articulated “something more” if they want to get a patent in an area that involves a “law of nature”.

    I for one am always thrilled to get a lecture from the Supreme minds of our land on how science works, on how the invention process works and on how inventors must figure out on their own what amazing new theories the judges will come up with 10-20 years from now as the inventors deviously “craft” their patent specifications and claims.

  3. SB,

    Thanks for the comment (and sarcasm about how the SCOTUS mind works when it comes to science and patent law). But I would hope the en banc Federal Circuit, as well as SCOTUS would take a careful look at what Congress has said or chosen not to say about what is or isn’t patent-eligible under 35 USC 101. Afterall, as Judge Lourie pointed out in citing the ObamaCare decision, “policy questions” are for Congress to decide, not the courts, especially where Congress has clearly spoken (or chose not to speak) on the “policy question.”

  4. Eric,

    These are the mere platitudes of insignificant mortals.
    The Titans who inhabit Mount SCOTUS do not trifle over such concerns.
    If they deem in their final and absolute wisdom that “something more” is required, then by golly and by gee whiz, that “something more” is required. End of story. Please do not confuse us with any gobbledygook like that involving logic and rational thinking. You simply do not comprehend the grander plan that those on Mount SCOTUS have in store for us lower part of the 99/1% divide. ;-)

  5. Stan,

    How is that drink Nectar of the SCOTUS Gods coming along? It might need another dash of the Fire of Prometheus…

  6. SB,

    Oh yes, I’m a just “mere mortal” (and happy to be one). But even the Chief Justice in the ObamaCare case said that “policy questions” are for Congress to decide. OK, so for those like the philosophers, the ACLU, PubPat and others who want turn this case into a “policy question,” let them bring it on, and especially explain where Congress has said that such isolated DNA sequences are to be excluded from the scope of 35 USC 101? In fact, Congress has said explicitly and even implicitly the opposite (unless you buy into the disingenuous logic at Stevens expressed on what 35 USC 273 said about the patent-eligibility of business methods).

    Moreover, Congress has had more than one opportunity to change the USPTO’s policy on granting such patents, and has, apparently deliberately, chosen not to do so (e.g., the Becerra bills which proposed similar exclusions and have gone absolutely nowhere). How do you explain that refusal as evidencing other than a “policy” not to exclude such subject matter from patent-eligibility? But you’re right, I digress with “logic and rational thinking.”

  7. Eric,

    You might find this external link to be interesting reading:
    http://newsandinsight.thomsonreuters.com/Legal/News/ViewNews.aspx?id=54979

    “The majority resists the Supreme Court’s unanimous directive to apply the patentable subject matter test with more vigor,”

    (SB comment: Did line come from Bill Murray’s movie, “Lost in Translation”? Drink the Kook-Aid but with more vigor? Like this? Yes, like that; but it needs even more vigor!)

  8. “How is that drink Nectar of the SCOTUS Gods coming along? It might need another dash of the Fire of Prometheus…”

    SB,

    I almost fell over laughing!

  9. SB,

    Thanks also for the link to the Thomson Reuters article. I see they essentially bought into Ravicher’s rhetorical nonsense hook, line and sinker. I suggest you tell Stan to send a tank car load of Nectar of the SCOTUS Gods (with another dash of the Fire of Prometheus) over to Ms. Alison forwith.

  10. Eric,

    We mortals laugh and frolic now.
    However the Titans of Mount SCOTUS will have their vengeance soon enough.

    I hope they ask Bill Murray to star in that new movie commemorating the event, “Lost in the Patent Translation” where he plays a famous inventor drinking from a glass of True Inventor’s Nectar and proclaiming that it does something “significantly more” and with “more vigor” than does your plain vanilla, Froth of the Ineligible and Obvious Subject Matter. Do you think Scarlet Johansen will agree to play the role of Judge Newman (a forlorn science major who is ignored by the torch bearers of the new and improved laws of nature movement)? I sure hope so.

  11. […] As Myriad has correctly pointed out in its brief in opposition to the grant of certiorari, the question posed by the ACLU/PubPat (“Are Human Genes Patentable”) is absolutely the wrong one to answer:  “The first question presented [by the ACLU/PubPat] bears no relation to the uncontroverted facts of this case.”  (Myriad’s brief in opposition has also pointed out at least 4 other significant factual and legal “misstatements” made in the petition for certiorari by ACLU/PubPat.)  As much as the ACLU/PubPat (and others) want to make the Myriad case into about “Who Owns You,” what Myriad has claimed does nothing of the sort.  In fact, a “yes” answer to the question posed by the ACLU/PubPat does not automatically lead to Myriad’s claimed “isolated” DNA sequences being patent-ineligible.  Those claimed “isolated” DNA sequences are not “genes” by any standard molecular biology definition of what that term actually means.  Instead, and as accurately characterized by Judge Lourie, these claimed “isolated” DNA sequences are “novel biological molecules.”  See The AMP v. USPTO Remand:  Déjà Vu as Federal Circuit Majority Reaffirms that Myriad’s Isolated …. […]