Drug patents fare better at PTAB


While the Patent Trial and Appeal Board (PTAB) has not been friendly to patent owners in general, the PTAB has not been inhospitable to pharma patent owners according to a report issued by BiologicsHQ, a searchable database of drugs, patents, and companies involved in PTAB inter partes review (IPR) proceedings developed by attorneys at Fitzpatrick, Cella, Harper & Scinto. The BiologicsHQ report shows a much different story in terms of drug patents facing IPR challenges at the PTAB. The report looks at a combination of data sources, including the Orange Book, Center for Drug Evaluation and Research (CDER) listed biologics and statistics on America Invents Act (AIA) trials published by the PTAB. The BiologicsHQ report draws the conclusion that, despite widespread concerns about the PTAB operating as a patent death squad in IPRs, “such concern is not justified for drug patents.”

According to the March 2017 IPR statistics issued by the PTAB, 53 percent of IPRs resolved as of March 31, 2017 were instituted; the rest were either denied institution or reached some other resolution prior to the institution decision. 35 percent of all resolved IPRs resulted in final written decisions and 23 percent led to findings of all claims unpatentable. Only 7 percent of all resolved IPRs led to final written decisions finding that no claim was unpatentable, and 5 percent led to mixed claim findings.

By contrast, drug patents fare better under PTAB scrutiny in terms of having claims upheld. Of the 4,563 resolved IPRs, BiologicsHQ reports that 222 petitions (5 percent) involved patents covering drugs listed in the Orange Book. Focusing on just the IPRs involving Orange Book patents, 44 percent were instituted and 38 percent reached a final written decision, but only 16 percent led to final written decisions where all claims were found unpatentable. No instituted claim was found unpatentable in 50 percent of final written decisions (19 percent of the total number of resolved Orange Book IPRs).

CDER-listed biologic drug patents also survive PTAB challenges better than patents not directed to pharmaceutical drugs, although the number of resolved challenges is quite small by comparison. By March 31, 2017, BiologicsHQ reports that a total of 29 resolved IPR petitions involved patents covering CDER-listed biologics. 41 percent of those petitions were instituted and 28 percent reached final written decisions. 17 percent of all resolved CDER-listed biologic drug IPRs led to final written decisions of all claims unpatentable, and 10 percent led to final written decisions of no claims unpatentable.

When comparing final written decisions among all IPRs, IPRs relating to Orange Book patents, and IPRs relating to CDER-listed biologic drug patents, Orange Book and CDER-listed biologic drug patents are more likely to escape with all claims intact. For all resolved IPRs, 23 percent led to final written decisions of all claims unpatentable. That’s a higher percentage than the 16 percent of Orange Book IPRs, and 17 percent of CDER-listed biologic drug IPRs that led to final written decisions where all claims are unpatentable. The 7 percent of all IPRs that led to final written decisions of no claims unpatentable is less than the 10 percent of CDER-listed biologic drug IPRs, and the 19 percent of Orange Book IPRs, that met the same fate.

Overall, 58 percent of IPRs involving drug patents resolved by the PTAB resulted in some claims remaining patentable: 60 percent for Orange Book IPRs and 45 percent for CDER-listed biologic IPRs.

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