USPTO Guidelines Blur “Natural” And “Novel” Products

I seldom comment on fellow bloggers’ posts, but Kevin Noonan’s recent article in PatentDocs deserves some attention. He basically has taken the recent PTO Guidelines to their “logical” extreme. The Guidelines contain an example that suggests that the Myriad ruling should be applied to “natural products” other than isolated pieces of genomic DNA. In Kevin’s view the roof has fallen in on isolated, purified natural products of any kind. In other words, if a substance like insulin or quinine occurs in nature so that its isolation does not change its chemical formula, it is not patent eligible. To be fair, the example directs examiners to reject claims to natural products, such as “purified amazonic acid” since “there is no structural difference between the purified acid in the claim and the acid in the leaves [of the tree from which it is obtained].”

That simplistic standard, if taken to its extreme would, as Kevin writes, render almost any purified natural product patent ineligible. But there are some brakes that can be applied to halt this runaway train of rejections. As Hal Wegner has argued in detail, In re Bergy, 596 F.2d 952 (1979) was never vacated or reversed by the Supreme Court when it took up Chakrabarty. After the holding of Bergy was reaffirmed by the CCPA in a consolidated decision with Chakrabarty, the Commissioner sought certiorari, and the writ was granted as to both cases. Before the decision, Bergy was dismissed as moot “leaving only Chakrabarty for decision.” 447 U.S. at 306. Judge Lourie’s analysis of the posture of Bergy in the August 16th Myriad decision (fn. 11) is just incorrect. Bergy is precedential; the second CCPA decision was not vacated by the Supreme Court.

Bergy is a very important decision since, without it, there is little historical guidance from the courts as to which natural products are patent-eligible as “new and useful” as required by section 101, and which natural products are produced by Mother Nature, without our assistance (the gold nugget plucked from the stream, as the ACLU might say). Bergy was directed to a pure strain microorganism isolated from soil samples. It had been brought back alive from the jungle of nature, where it benefitted no one, and cultured into an antibiotic producing biofactory.

Hal Wegner points out that the decision in Funk Bros. was based on the obviousness of combining different strains of known bacteria in a single package, not on whether or not the mixture was a composition of matter under s.101. I have read all of the early decisions, and almost all of them are based on lack of s.102 novelty, not on s.101.

In re Bergstrom, 427 F.2d 1394 (CCPA 1970), the prostaglandin decision, may also be of some help. Since no one had obtained a prostaglandin in pure, crystalline form, although it was known to be present in semen in tiny amounts, the claim to the purified PGE2 was approved as “new.” The court takes a broad view of the requirement for newness, and finds no difference between “new” in s.101 and “novel” in s.102. The Solicitor relied on Funks Bros. to no avail. Interestingly, Judge Lourie reviewed Bergstrom in the same footnote mentioned above in the Myriad decision and got it wrong again. Bergstrom is no fun to read but the decision was clearly based on s.101, since that was the basis of the Board’s decision rejecting the claims.

On the other hand, the oft-cited adrenalin decision by Learned Hand—cited and distinguished by the Fed. Cir. in Myriad—has been extensively analyzed and criticized as erroneous or, at best, dicta. See Jon M. Harkness, Guest Post: Myriad Misunderstandings of Parke-Davis v. Mulford, PatentlyO, May 23, 2012.

The Supreme Court’s Myriad decision was based on policy and politics, not on the law. I don’t know why the PTO felt it needed to extend its reach far beyond the question presented and resolved. Yes, I know that the Guidelines do not have the force of law, but they are going to force or encourage Examiners to reject a lot more claims than they would have pre-Guidelines. An Examiner recently called me to say he would allow a claim to the use of a combination of two natural products (both commercially available polypeptides), wherein the activity of one of the compounds was greatly extended by the co-administration of the second. However, he demanded that I cancel a composition of matter claim to a mixture of the two compounds in a simple solvent vehicle, since it was clear that I was trying to patent natural products. Of course, here I have an unobvious result due to the combination, and so should be able to distinguish Funk Bros., but I wanted to give you an idea of “what rough beast, its hour come round at last, slouches towards [Alexandria] to be born.”

3 Responses to “USPTO Guidelines Blur “Natural” And “Novel” Products”

  1. EG says:

    Warren,

    You’re correct that In re Bergy should be controlling precedent on “products of nature,” but these USPTO Guidelines have totally mucked up the understanding of this area of the law/technology, and Our Judicial Mount Olympus is very much to blame for this mess. BTW, I speak from personal knowledge as I wrote a law review article shortly after I graduated from law school on In re Bergy, In re Chakrabary, and the whole “living subject matter”/”products of nature” controversy before the SCOTUS decision in Diamond v. Chakrabarty. What Our Judicial Mount Olympus has done, especially in Mayo, is a travesty, amounting to a judicial fiat that ignores both precedent, as well as the patent statutes.

  2. Paul Cole says:

    It would be ungracious to cite 35 USC 102 against Kevin Noonan and better to be glad that he has reached independently much the same conclusions for much the same reason as in my earlier posting. Two voices are stronger than one.

    It occurs to me that my earlier posting had much underestimated the need for legal certainty and avoiding disturbance of settled expectations. John Harkness may be correct to point out that the opionion of Judge Learned Hand was doubtful at the time that it was made. However, it was acted on and regaarded as settled law for over a century. Claims to a host of natural product molecules, many of them of great medical benefit, have been granted over that period, an pointed out by both Kevin Noonan and myself. The abilition of the facility to claim such molecules is a serious and unwarrnted detriment to the pharmaceutical and other industries and is not warranted by the opinion in Myriad.

    I differ from EG in attributing this error to the Supreme Court. As argued in previous postings, if Myriad is read with close attention and is carefully interpreted in the light of the factual matrix and the opinions below, its holding is narrower than supposed and there are opportunities for distinguishing it where the facts are different. In my view, the error arises wholly from over-zealousness within the USPTO.

  3. EG says:

    Paul,

    I agree that the primary problem lies with the “from over-zealousness within the USPTO” with respect to these guidelines. But we may have to “agree to disagree” with respect to the impact of Our Judicial Mount Olympus. My primary beef is with the Mayo decision which is rhetorical nonsense, inconsistent with prior SCOTUS precedent (especially Diehr), and driven by Breyer’s almost pathological hatred of any patent (much like Justice Douglas). Myriad is the least troubling of the SCOTUS precedents, but it also suffers from the same common problem that Our Judicial Mount Olympus simply “doesn’t get” or chooses to ignore: the failure to articulate “bright line rules” lead non-legally trained government personnel to apply those rules subjectively, and in the case of these new guidelines, absurdly, contrary to other controlling legal precedent (e.g., In re Bergy which the USPTO has now apparently chosen to ignore), and in a manner that will drive up the cost of patent prosecution on such subject matter significantly.