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May 12 --The mostly critical consensus of the Patent and Trademark Office's forum on subject matter eligibility May 9 was that the PTO guidance's interpretation of U.S. Supreme Court decisions affecting life sciences patents was overly broad and selective and its emphasis on structure over function wasn't supported by precedent.
There were very few “atta boys” to the agency during the forum in the PTO's offices in Arlington, Va. Leslie Fischer, senior patent attorney for Novartis Pharmaceuticals Corp., told PTO officials at the meeting that, contrary to the PTO's contention, Supreme Court decisions from the 19th century to today have indicated that function rather than structure is the most important claim requirement for patent eligibility.
“Why would you choose the broadest interpretation of the cases that would do the greatest harm and invalidate antibiotics and vaccines?” Fischer asked. “Why would you choose that if you don't have to?”
Others commenting on the PTO's guidance during the forum said that the PTO had confused the Supreme Court's holdings with its dicta, should have held meetings with patent practitioners before issuing its guidance rather than after, determined patent eligibility by considering claim elements and not the claims as a whole and created guidance that its own examiners don't believe in.
Attorney Warren D. Woessner, of Schwegman Lundberg & Woessner asked: “What were you thinking when you developed this guidance?”
During the question-and-answer session, one attendee predicted to the PTO representatives, “The court is going to hand you your head for what you did in this guidance.”
Drew Hirshfeld, PTO's deputy commissioner for patent examination policy, responded, “One sure way a federal agency gets its head handed to it, is for it to ignore its own reasonable interpretation of Supreme Court precedent.”
Hirshfeld did advise those who wanted to submit comments on the guidance to the PTO to do so by the end of June, suggesting that the agency isn't intending to let the concerns about the guidance drag on indefinitely.
The PTO's March 4 guidance (52 PTD, 3/18/14) was prompted by the Supreme Court's rulings in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 2012 BL 66018, 101 U.S.P.Q.2d 1961 (2012) (54 PTD, 3/21/12) and the Ass'n for Molecular Pathology v. Myriad Genetic Inc., 133 S. Ct. 2107, 2013 BL 155804, 106 U.S.P.Q.2d 1972 (2013) (115 PTD, 6/14/13).
In Mayo, the court held that claims directed to a method of administering a drug weren't patent-eligible because they covered products or laws of nature, while in Myriad it found that claims for isolated DNA aren't patent-eligible but claims for complementary DNA (cDNA) were because they weren't naturally occurring.
In its guidance in response to these decisions, the PTO indicated that its examiners will now be asked to consider whether the claim recites or involves a judicial exception to patent eligibility--laws of nature/natural principles, natural phenomena and/or natural products--and, if it does, whether the claim as a whole recites something “significantly different” than the judicial exceptions.
Under this approach, the PTO said that the effects of the Myriad ruling wouldn't be limited to clams for isolated DNA and could extend to bacteria, peptides and primers. The guidance focuses on the structural rather than the functional characteristics of the product.
The reaction to the PTO's guidance was so strong that the agency scheduled the forum and welcomed comments (75 PTD, 4/18/14)
In her welcoming remarks, PTO Deputy Director Michelle Lee told the forum that the Supreme Court “has reminded us of the role of judicial exceptions in Section 101 (patent eligibility). The subject matter eligibility guidance is the result of eight months of examination. We are seeking feedback to resolve conflicts of law where the Supreme Court had not yet spoken.”
Hirshfeld then outlined three basic principles that are the backbone of the guidance:
• case law prevents issuing patents to claims that cover judicial exceptions;
• there are two pathways to patent eligibility if there is a judicial exception: the “markedly different” pathway of Diamond v. Chakrabarty, 447 U.S. 303 (1980) and the “significantly more” pathway of Mayo; and
• there are no “bright line rules” and the word “isolated” doesn't have a magic meaning.
PTO representatives explained that the guidance is comprehensive because the relevant Supreme Court's opinions are interwoven. They stated that for 65 years the Supreme Court has been saying that the discovery of the handiwork of nature isn't patent-eligible but it may be eligible when it is practically applied.
PTO representatives noted that there are other options to patent eligibility beyond the two pathways: combine the product that recites a judicial exception with something else and draft the claim to embody what is markedly different or combine a natural product with something else that adds significantly more.
The forum then was opened up to presentations from speakers representing the life sciences industry.
Hans Sauer, deputy general counsel for intellectual property for the Biotechnology Industry Organization, said there has been no opportunity for public comment on the guidance before it was drafted as there had been for the PTO's utility guidance.
“The new guidance's expanding of Myriad's holding to reinterpret prior Supreme Court cases to now apply to all claims for antibiotics and vaccines and any combination thereof will prospectively block inventors from acquiring protection for products never mentioned by the Supreme Court,” Sauer said.
More importantly, the guidance casts a shadow over thousands of currently issued patents U.S. patents that the PTO now says would never be issued if they were examined today and implicitly says should never have been issued in the first place, Sauer said.
“Such policy statements matter,” he said. “BIO believes that Supreme Court precedent stands in tension with itself. There is no unified reading of [Supreme Court precedent] that's fully coherent. We need the PTO to acknowledge that reality. We need a dialogue not only on how to interpret the case law but whether the interpretation of a case leads us to the right place.”
Attorney Courtenay Brinckerhoff, of Foley & Lardner LLP, acknowledged that Myriad did invalidate the PTO's practice of granting patents for isolated DNA. “But the guidance extends Myriad to areas the Supreme Court wasn't addressing. And the court warned against overly broad applications of subject matter eligibility requirements because they could stifle innovation.”
Where did the PTO go wrong? Brinckerhoff asked. “Through an overly narrow interpretation and an overly broad application of Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), parsing the claim elements rather than considering the claims as a whole.” She said she sees functionality discussed in Funk that the PTO ignored.
For an alternative test for compositions whose patent eligibility the Supreme Court hasn't questioned, Brinckerhoff said the examiners may look for structure but also may look for a different use and enlargement of the utility, a different effect and empowerment in effect.
As to method claims, Brinckerhoff said, “The Supreme Court in addressing method claims has only done so under the judicial exceptions of law of nature and natural phenomenon. The guidance lumps together all the judicial exceptions We have received calls that the PTO is rejecting methods of manufacture and of method of treatment claims as products of nature. There is no basis in the Supreme Court decisions under Section 101 for invalidating a method of manufacture or of a method of continuing different products as a law of nature. It's just wrong”
She noted the PTO's statements that applicants can and should respond to the examiner's rejections under the guidance. “The problem is the examiners are issuing these rejections without believing in them in their hearts. So it's hard to know how to formulate a response to a rejection when nobody believes in the guidance.”
Novartis's Fischer said that what is missing from the PTO's citing of Supreme Court precedent is any reference to the court's tariff cases, especially Hartranft v. Wiegmann, 121 U.S. 609 (1887).
“It was a case about sea shells whose structure was changed--they were chemically altered and brought to the U.S. where people made things out of them--and the court said the structural alteration did not matter because the shells were not changed into an article having a distinct name, character or use,” Fischer said. “We learn from the tariff cases that conversion of raw materials into a manufacture is dictated by function and structure is subservient. We learn that to convert raw material into something patent-eligible we need to change the function.”
Fischer said the tariff cases are important because they lead into Funk and Chakrabarty, which refers back to Hartranft. “We had always understood that function is important when considering patent eligibility. And then Myriad came along. But Myriad doesn't tell us to throw out function. Myriad uses the term information when it refers to the function of DNA. The court saw that this is a case about a molecule isolated from nature that had no difference in structure and no difference in function. The justices asked, is the DNA sequence different from what is seen in nature.”
Fischer said, “I'd suggest that nothing has changed in our understanding of patent eligibility. The older cases address structure and function. Myriad addressed structure and function. We should consider structure and function.”
She asked the PTO why it would choose the broadest interpretation of the cases that would do the greatest harm and invalidate antibiotics or vaccines? “I ask you to reconsider your guidance and the idea that structure is the only thing that matters and please begin to teach examiners that for natural products function matters.”
Attorney Anthony D. Sabatelli, of Dilworth IP LLC, asked, “The PTO says there will be no 'bright line.' Do we need a bright line? Will the factor analysis bring in Sections 102 (novelty) and 103 (obviousness) considerations through the back door? The factors are asking Section 102 and 103 types of questions. There are too many factors. I really had to slog through them.”
He added, “While the guidance is clearly a step in the right direction, it must become clear that the determination is for patent eligibility, not patentability. We need some assurance that there are safeguards to prevent this misapplication.”
Attorney Kenneth H. Sonnenfeld, of King & Spalding, who represents clients focused on purified products, said, “Purified products are crucial to providing strong patent protection for therapeutics. The legal basis to obtain patents for claims covering purified products is sound, going back 100 years and includes such products as adrenaline, digitalis and Vitamin B12. The argument that they should not be patent-eligible runs against the fact that they always have been because they are valuable and the law does not exclude such non-DNA product from patent protection. Until Myriad, there was no real issue in the patent eligibility of purified natural products. The PTO's own 2011 utility guidelines provides a basis for purified natural product claims. Myriad, which was limited to isolated genes and the information they encode, should not change that course.”
Attorney Barbara Fiacco, of Foley Hoag LLP, speaking on behalf of the American Intellectual Property Law Association for which she is chair of the patent law committee, said, “We are concerned that the guidance extends the reach of the Supreme Court cases far beyond the reach of the holdings. The factor-based test is inconsistent with the long-standing principle articulated and re-articulated that patent eligibility must be determined by considering the claims as a whole, not by describing elements. The absence of one factor should not weigh against patent eligibility.”
Gregory A. Cox, assistant general patent counsel for Eli Lilly& Co., speaking on behalf of the American Bar Association Section on Intellectual Property Law, said, “The ABA supports the principle that the inquiry into subject matter for Section 101 should not import requirements from Sections 102, 103 and 112 (written description). These are separate and distinct requirements and should be resolved independently from the conditions for patent eligibility.”
In the question-and-answer period, attorney David A. Gass, of Marshall, Gerstein & Borun, said that the “significantly different” language that has prompted the PTO to create a “significantly different” standard isn't in Supreme Court opinions. “The Myriad holding is 'naturally occurring' and not 'markedly different,' not 'significantly different.' In setting out to interpret Supreme Court cases, you need to be mindful of what the holdings are and what dicta is.”
Another audience member said, “The process failure in your issuing this guidance was not to include at a much earlier stage the commentary of practitioners who could have commented and had a diligent conversation back and forth about the PTO's interpretation of these cases.”
Hirshfeld responded, “What we have done is consistent with what we have done in prior situations.”
Hirshfeld concluded the meeting by saying that, although the PTO would accept comments on the guidance at any time, people who want to submit comment should aim to get them in by the end of June. He did add that, in spite of requests that the PTO do so, “it is highly unlikely that the guidance will be withdrawn. But renovations will occur.”
Brinckerhoff told Bloomberg BNA after the forum, “People were pushing for a withdrawal of the guidance because rejections are happening. In some cases, such as rejection of methods of manufacture as products of nature, the guidance is just wrong. And some companies and inventors don't have the resources to wait it out until the PTO gets it right, and they will lose their patent protection. People have to have their voices heard and tell the PTO that it has to fix this.”
Comments on the guidance can be submitted to firstname.lastname@example.org.
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Brinckerhoff and Fiacco are members of this journal's advisory board.
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