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Sept. 18 — The approval rate for biotechnology patents has dropped significantly, and applicants should take lessons from the claims that are being accepted, panelists Sept. 18 told a biotech conference.
Jennifer Fox of Brinks Gilson & Lione, Research Triangle Park, N.C., said the number of rejections of biotech claims has doubled since the Supreme Court clarified its test for patent eligibility from Mayo Collaborative Servs. v. Prometheus Labs. in Alice Corp. Pty. Ltd. v. CLS Bank Intl. in June 2014.
Giving a specific type of claim as an example, Fox said that according to case studies from the Patent and Trademark Office's art unit 1634, which covers predominantly nucleic acid claims, there was a 38 percent allowance (approval) rate before 2012, and 9 percent after 2012, which is the year the court issued Mayo.
Fox spoke during a panel session titled “The Next Phase: How the USPTO and PTAB Are Identifying Patent Eligible Subject Matter” at the 2015 BIO IP & Diagnostics Symposium in Alexandria, Va.
Fox described case studies from the PTO's art unit 1634 on claims that were rejected, revised and then allowed (approved), saying that they could serve as lessons for patent applicants.
She cited U.S. Patent Application No. 13/418,310, whose first claim initially read that it was for a method of treating an addictive disease or disorder that comprised administering various steps.
“It received a rejection under 35 U.S.C. §101 as patent ineligible subject matter because it was ‘routine, well understood and conventional' under Mayo, in which the Supreme Court held that diagnostic patent claims for methods for optimizing the efficacy of a drug were directed to the judicial exception to patent eligibility of laws of nature.”
“The claim was ultimately revised to add more specificity,” Fox said.
The beginning of claim 1 now reads, “A method of treating an alcohol-related disease or disorder, comprising: administering to a patient in need thereof a therapeutically effective amount of ondansetron […].”
Fox said, “In addition to specifying that the method was for an alcohol-related disease or disorder rather the broader ‘addictive disease and disorder,' the claim was revised to specifically cover a new use for an old drug—adding an effective amount of ondansetron.”
The revised claim was allowed, and the patent was issued as U.S. Patent No. 8,753,815 on June 17, 2014, Fox said.
Fox also cited the prosecution history of U.S. Patent Application No. 13,349,877. She said that the first claim originally described a method for “determining” the myopic potential of a patient. It received a Section 101 rejection as not allowable subject matter based on Mayo.
Fox said, “The claim was allowed after it was changed from a ‘method for determining' to ‘a method of treating myopia.' Examiners are more comfortable with a method of treatment and a depiction of steps.”
The patent was issued as U.S. Patent No. 8,951,729 on Feb. 10, Fox said.
Fox noted that the PTO's Patent Trial and Appeal Board recently affirmed an examiner's rejection of diagnostic method claims for obtaining a small interfering (si) RNA sequence for a target gene in Ex Parte Khvorova and specifically cited Mayo in its decision.
The board wrote that the claims represented unpatentable subject matter because they didn't recite a specific algorithm, Fox noted.
Michael P. Tierney, lead administrative patent judge for the PTAB, said he couldn't discuss the specifics of Khvorova but noted that the board is working on cases from 2012 and 2013 because of its backlog of 2,200 cases.
“We're just seeing cases that deal with patent eligibility that are rooted in Mayo and other recent court decisions. So we'll be dealing with the issue more and more,” Tierney said.
Panelists said during the question-and-answer period that, when they have received claim rejections from the PTO, the examiners seldom have given detailed explanations and suggestions.
“I don't blame them,” Fox said. “They don't have enough guidance to give us guidance. The court decisions on patent eligibility are still relatively new, and they're still figuring them out.”
Bernard Brown, also with Brinks Gilson & Lione, agreed, but noted that some examiners can be especially helpful.
He told a story of how, after he had received a number of office actions rejecting particular claims, his client decided not to keep spending money on the patent and to file a provisional application. A provisional application establishes an early filing date but doesn't mature into an issued patent unless the applicant files a regular nonprovisional patent application within one year.
Brown said he later received a phone call from the examiner asking him why he was abandoning the claims. “When I explained the reason for my client's decision, the examiner said, ‘Why don't you argue? Why don't you fight it?' Some examiners are really willing to work with you,” Brown said.
“But, as for very detailed reasons for rejection or suggestions beyond the formula rejection language,” he said, “they are infrequently given, the examiners' volume of work is pretty high and it's up to you to figure out what to do next.”
“And so, you need to study what claims are getting through,” Fox said.
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