Turns out drug patents survive IPR proceedings at a higher rate than patents for other technologies.
A recent Fitzpatrick, Cella, Harper & Scinto Study “Drug Patents May Fare Better Than Other Technologies in IPR Proceedings,” reveals that drug patents survive IPR proceedings at a much higher rate than patents for other technologies.
PTAB statistics from March 2017 show that in 81 percent of final written decisions, at least some instituted patent claims were found unpatentable, raising concerns that the PTAB is a patent “death squad.” However, data gathered from BiologicsHQ, Fitzpatrick’s newly-launched database, reveals the opposite is, in fact, true for drug patents. For pharmaceutical companies, the research is a welcome rebuke to the prediction made soon after the PTAB was established in 2012 that the forum would become a patent death squad.
“Over recent years, several assumptions have been made about how patent disputes will be resolved by the PTAB—and some have turned out to be wrong. Our BiologicsHQ database allows Fitzpatrick to provide up-to-date information that we believe will provide added value to our clients and BiologicsHQ users,” said Robert Schwartz, Ph.D., a partner at Fitzpatrick and chair of the firm’s Biotechnology and Biologics industry group, who sat down with Inside Counsel in an interview.
Fitzpatrick’s key findings include: across all technologies, all patent claims survived IPR in 19 percent of final written decisions; for Orange Book listed drug patents, all claims survived IPR in 50 percent of final written decisions; for CDER listed biologic drugs, all claims survived IPR in 37.5 percent of final written decisions and; IPRs were instituted at a rate of 53 percent; for Orange Book listed drug patents IPRs were instituted at a rate of 44 percent; and for CDER listed biologic drugs IPRs were instituted at a rate of 41 percent.
Today, there is no simple answer to why drug patents survive IPR proceedings at a higher rate than other patents. According to Schwartz, it may be that patent claims in drug patents are more carefully drafted or those patents contain objective evidence of non-obviousness. Or, it could be partially due to the recognition that the pharmaceutical, biotechnology and chemical arts are more unpredictable fields than other technologies as pharmaceutical, biotechnology and chemical patent claims are less likely to be found to be obvious compared to patent claims in those other technologies.
“In IPR patent claims can only be challenged because they are anticipated (not novel) or obvious,” he explained. “Patent claims are determined to be unpatentable in an IPR if the PTAB finds that, based on the evidence in the record, their subject matter is either not novel or it is obvious. Challenges to the claimed priority benefit may also be made in an IPR. For novelty and obviousness challenges in an IPR a petitioner may only rely on patents or printed publications. So, the scope of IPR is relatively limited.”
So, why has the PTAB been nicknamed the patent “death squad”?
Schwartz said that Judge Randall Rader (former Chief Judge of the Federal Circuit) said at the AIPLA annual meeting in October 2013, that the PTAB was a death squad killing patent rights - this label has continued to concern patent owners.
But, an article published by Fitzpatrick Associates Corinne Atton and April Breyer titled “Drug Patents May Fare Better Than Other Technologies in IPR Proceedings” shows this label is not fair, at least for drug patents. Fitzpatrick’s analysis revealed that the IPR statistics for drug patents are significantly more favorable than the statistics reported by the PTAB for all technologies: a smaller percentage of drug patent IPRs are instituted; and of those that reach a final written decision, a higher percentage of patents survive with at least some claims remaining patentable.
He said, “While the dataset for biologic drug IPRs remains small (only 29 IPR petitions were resolved as of March 31, 2017), a significantly higher percentage of drug patents are surviving IPR with all challenged claims remaining intact (patentable).”