Attorneys Debate Risk of Cancer ‘Moonshot'Patent Claims Facing Rejection

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The White House's Cancer “Moonshot” initiative and the Patent and Trademark Office's program to fast-track approval of cancer immunotherapy patent claims have garnered much attention. But one attorney asks whether the PTO would reject many fast-tracked cancer treatment patent applications under Supreme Court precedent and PTO practice. Attorneys interviewed by Bloomberg BNA had differing views on the risk of such rejections.

By John T. Aquino

Aug. 30 — Applicants using the PTO's Cancer “Moonshot”-inspired fast-track initiative for cancer immunotherapy patent claims often could face agency rejections, an attorney contended.

“Based on my experience and my data analysis, patent examiners have been saying that when you treat cancer, the body’s reaction to that is a natural relationship and so they reject the claims based on the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.,” Robert R. Sachs of Fenwick & West LLP, San Francisco, told Bloomberg BNA in an Aug. 25 phone interview.

“As I have said before, when you have a scientifically incoherent definition of law of nature, which the court gave in Mayo, then all bets are off,” he added.

Immunotherapy is a type of cancer treatment designed to boost the body's natural defenses by using substances either made by the body or in a laboratory to improve or restore immune system function. The treatment's reliance on natural products of the body is why the Mayo decision, in which the court found the claims invalid because they were derived from a law of nature, could affect Cancer Moonshot-related claims.

Some Disagree, PTO Notes Concern

Hans Sauer, deputy general counsel for the Biotechnology Innovation Organization, told Bloomberg BNA in an Aug. 26 e-mail, “There is no question that the USPTO is rejecting applications on important, even potentially life-saving inventions under 35 U.S.C. §101,” which covers patent eligibility. He added, though, that he had no specific information on the number of cancer-related patent applications affected.

Other attorneys downplayed the cancer moonshot- Mayo connection.

Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, in an Aug. 25 phone interview with Bloomberg BNA, acknowledged that Sachs had raised legitimate concerns. But he stressed that Mayo is focused on diagnostic patent claims and the Obama administration's Cancer Moonshot initiative and the Patent and Trademark Office's Cancer Immunotherapy Pilot Program are directed to treatments and cures for cancers, claims that shouldn't face rejection under Mayo.

Sachs responded that some examiners aren't drawing the distinction between therapeutics and diagnostics.

On Aug. 18, Sachs' initial presentation of his arguments in a June 30 blog became the focus of an exchange between Robert Bahr, the PTO's deputy commissioner for patent examination policy, and intellectual property attorney and strategist Wayne Sobon at the PTO's Patent Public Advisory Committee meeting.

Sobon cited Sachs' blog, and Bahr said he had read it and that he had concerns. “I certainly hope we tread carefully in that area, and I’ve tried to take pains in our guidance to examiners to do that,” Bahr said.

Applicants on Road to Rejection?

President Obama announced a national effort to find a cure for cancer during his Jan. 20 State of the Union address, and the creation of a Cancer Moonshot Task Force on Jan. 28. The task force is designed to “focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives and other mechanisms to support cancer research and enable progress in treatment and care.”

On June 28, in support of this project, the PTO launched its cancer immunotherapy pilot initiative, also known as “Patents 4 Patients.” It is an initiative to “free fast-track review for cancer treatment-related patents” by “complet[ing] the examination of an application containing a claim(s) to a method of treating a cancer using immunotherapy within twelve months of special status” being granted (10 LSLR 14, 7/8/16).

Sachs noted in his blog that the Supreme Court's Mayo ruling and the way the PTO's patent examiners apply it may pose problems for applicants using the PTO's initiative.

On May 20, 2012, the Supreme Court held in Mayo that Prometheus Laboratories' process claims for adjusting a drug dosage after observing a patient's reaction to a drug blood test aren't eligible for a patent because they incorporate laws of nature, which is a court-established exception to patent eligibility (6 LSLR 404, 4/6/12) .

Sachs wrote in his blog that the court essentially ruled in Mayo that any natural relationship or correlation that “exists in principle apart from any human action” sets forth a law of nature, and thus isn't patent eligible without the addition of “significantly more.” He called the court's definition of law of nature “not scientifically correct, as mere correlations of naturally occurring conditions do not rise to the level of ‘laws of nature' just by dint of the statistical relationship.”

He told Bloomberg BNA that he had looked at 19,000 abandoned patent applications for the last two years, categorized them by reason for rejection—patent ineligible under 35 U.S.C. §101, lack of novelty under Section 102, obviousness under Section 103 and lack of written description and enablement under Section 112—and by disease. He said he found a growing number of Section 101 rejections for cancer-related claims.

In his blog, Sachs said that “if the USPTO continues in this manner, what Patents 4 Patients offers for a large number of cancer researchers is a fast track to a Section 101 rejection, and possibly abandonment or years of waiting on appeal. And on appeal, the likelihood of reversing a Section 101 rejection is less than 10 percent.”

He urged the PTO to “re-calibrate how it applies Section 101 to patents in this field. Yes, the USPTO is bound by the Supreme Court, but that does not preclude it from interpreting the Court in a way that is scientifically coherent. The USPTO should focus on the Supreme Court’s stated concern—avoiding preemption of actual laws of nature, ‘the basic tools of scientific and technological work'—and adopt a more nuanced and scientifically accurate definition of what counts as a law of nature.”

Some Find Eligibility Rejections Unlikely

Noonan told Bloomberg BNA that he agreed with Sachs that “bad science makes bad law” and that the PTO should focus on the Supreme Court’s stated concern—avoiding preemption of actual laws of nature, which Sachs defines as the basic tools of scientific and technological work.

Sachs “is right that the court has gone down the wrong path, primarily because it has done its analysis in a piecemeal manner,” Noonan said. “But according to the Federal Register notice for Patents 4 Patients, the focus is not to diagnose cancer, which is the focus of Mayo, but to treat it.”

Noonan said that what the Supreme Court has been concerned about is preventing situations where patenting interferes with the practice of medicine. “When it comes to a drug genetically engineered to treat cancer, the Supreme Court shouldn't find that ineligible under Section 101.”

Deborah L. Lu of Vedder Price LLP, New York, told Bloomberg BNA in an Aug. 25 e-mail, “I don’t think that the initiative is necessarily doomed to a Mayo roadblock. I believe the initiative is directed to treating cancer, which still remains patent eligible subject matter. Diagnosing cancer is another story, which may run into a Mayo roadblock. However, Example 29 of the PTO's May 6, 2016 update of the supplemental 101 Guidance to examiners issued by the PTO provides some guidelines as to what may be considered patent eligible for diagnostic claims.”

Sachs told Bloomberg BNA that it could be argued that Prometheus's claims were therapeutic. “They say they are for a method of improving therapeutic efficacy. They involve administering a drug, making a determination based on that administration, and increasing or decreasing the dose based on that determination. If the claims were for patients with cancer rather than a gastrointestinal disorder, wouldn't that be part of a treatment for cancer, wouldn't it be therapeutic? But having said that, what's really important is how the examiners are applying Mayo to cancer treatment claims.”

Not Enough Trickle Down

Gene Quinn in an Aug. 24 posting on his blog IP Watchdog discussed Sachs' blog and described the exchange between Bahr and Sobon at the PPAC meeting about the blog. Like Sachs in his comments to Bloomberg BNA, Quinn focused his attention on the patent examiners. He wrote, “Unfortunately, there are patent examiners who routinely announce to patent attorneys and applicants that they are not following the guidance, or that they are not allowed to follow the guidance by their direct supervisors. So while I have no doubt that Bahr and others in the PTO's commissioner’s Office do want to tread carefully, that message is simply not filtering down in any meaningful or actionable way to PTO Art Units and ultimately to examiners.”

Quinn added, “Is the way examiners are applying 101 in keeping with the [PTO's] guidance? Absolutely not. Is this one big mess? You bet!”

Noonan said, “I don’t think it profitable to put the ‘blame' on the examiners. Leadership and consistency come from PTO management, and it can be effective. Twenty-five years ago, Commissioner [Bruce] Lehman stemmed a tide of recalcitrant examiners in the biotech arts by putting out a memo that the PTO was there to grant patents within the law, and not to be a barrier to worthwhile inventions getting patent protection. The Supreme Court has made that message harder to send, but the Patent Office has the ability to do so.”

Sachs told Bloomberg BNA that Bahr and the PTO leadership are trying to provide clear guidance to the examiners. He also acknowledged, as Lu noted, that, among the examples the PTO has provided to examiners for life sciences-related patents, Example 29.6 provides appropriate guidelines for the patent eligibility of a method for detecting the presence of a disease in a plasma sample. “But some examiners aren't following Example 29.6,” Sachs said.

What Applicants Might Discover

BIO's Sauer told Bloomberg BNA, “I think Bob Sachs’s well-researched post does pick up on a certain irony that I’ve heard echoed by biotech company colleagues: On the one hand, the White House and the USPTO stress the importance of stimulating research and investment through patents and create special programs to accelerate the grant of these rights.

“But at the same time,” Sauer continued, “patent owner confidence in these rights is definitely declining due to changing patentability standards, unstable jurisprudence, as we see in the Section 101 area, and a Patent Trial and Appeal Board [the PTO's trial division] that will enthusiastically subject patents to de novo review after large investments have been made, with no presumption of validity, and no presumption that the original patent grant was administratively correct.”

Sachs said, “The bottom line is that examiners will likely make a rejection under Mayo for cancer treatments and diagnostics until the PTO recalibrates what examiners are really doing. Natural relationships are not laws of nature. Nature would not have known or anticipated—forgive the anthropomorphism—the body’s reaction to a man-made intervention that did not exist in nature. But some examiners will just say, how a tumor responds to a drug is a natural relationship and therefore not eligible under Mayo. And that is what applicants under the PTO's cancer immunotherapy initiative may have to worry about.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

Sachs' June 30 blog is at http://www.bilskiblog.com.

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