Greenblum & Bernstein, P.L.C.
REEXAMINATION AND POST-GRANT
PRACTICE GROUP NEWSLETTER
keePingTABs No. 35
In This Issue:
· Taking Stock of AI Petitions
· Developments in the Law
· In the News
Jill M. Browning
Taking Stock of AIA Petitions
The PTAB reports a total of 9,646 AIA petitions filed through December 31, 2018. Inter Partes Review (“IPR”) petitions continues to make up 92% of the total petitions. Covered Business Method (“CBM”) petitions comprise 6% of the total and Post-Grant Review (“PGR”) petitions make up the remaining 2%.
The institution rate for all proceedings declined to 60% for FY18; however, FY19 is so far showing an institution rate of 64%.
With respect to settlements, the pre-institution settlement rate was around 12% for FY18, and has jumped significantly to 21% for FY19, although it is still early in the fiscal year so this may return to lower numbers as the year progresses. Post-institution settlements remained steady at about 24%. This rate has hovered between 22 and 24% since FY2016.
The PTO reports that all claims are found unpatentable in 64% of instituted proceedings, and some claims found unpatentable in another 17% (making the total 81% of all instituted proceedings with one or more claims rendered unpatentable). All claims escape unscathed in about 19% of instituted proceedings, according to the PTO’s records.
Recent Developments In The Law
Secret Sale Meets AIA On-Sale Bar
Helsinn Healthcare SA v. Teva Pharmaceuticals USA Inc.
The Supreme Court, in a unanimous decision, ruled that, under the America Invents Act (AIA), an inventor’s “sale” of an invention to a third party (even if secret) qualify as prior art. In this case, Helsinn’s patent covered methods for administrating Aloxi®. Teva asserted the patent was invalid for the sale of the product prior to the patent’s filing date. Specifically, 35 U.S.C. §102(a)(1) states that “a person shall be entitled to a patent unless – (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public”. (Emphasis added). The Court emphasized that Congress, in the AIA, did not change the meaning of “on sale” in the prior statute and that prior Federal Circuit precedent clearly established that a secret sale could serve to invalidate a patent.
PTAB Denied Admissibility of New Argument
Pfizer v. Chugai Pharmaceutical (IPR2017-01358) (PTAB Nov. 28, 2018).
The PTAB rejected arguments presented by petitioner that were absent from the petition, noting that, in IPR proceedings, the Petitioner is obligated to establish why claims are unpatentable in the petition. The Decision pointed out that IPRs differed from district court litigation in this regard, as parties before a district court can introduce a new argument or clarify original positions in response to the discovery of new information. However, due to the expedited nature of IPR proceedings, such shifting of arguments is impermissible.
In this case, Pfizer filed a petition against a Chugai Pharmaceutical patent covering a method for purifying proteins. In its petition, Pfizer asserted that the prior art explicitly disclosed the claim limitation “eluting the antibody with an acidic aqueous solution of low conductivity having a molarity of 100 mM or less”. The claim term “molarity” was construed, however, as meaning the total concentration of solute present in the solution as opposed to the concentration of one particular solute. Based on this, Pfizer changed its position and argued that the prior art reference met the claim limitation “inherently.”
The PTAB rejected this shift in position.
PTAB Issued Final Written Decision Despite Parties’ Settlement
Micro Labs Ltd. v. Santen Pharmaceuticals Co., IPR2017-04134 (Nov. 27, 2018).
The PTAB issued a final written decision despite the parties’ reaching a settlement agreement and asking that the proceedings be terminated. While a rare occurrence, this does happen occasionally, particularly in situations like this one, where the settlement case very late in the proceedings (two days before the statutory deadline for issuing a final written decision). The PTAB, in view of the late stage of the proceedings, proceeded to issue a final written decision anyway, although the Board did dismiss the petitioner from the case. The decision upheld the patent, determining that the petitioner failed to demonstrate by a preponderance of evidence that the claims of the patent would have been obvious.
ANDA With Paragraph III Certification Has Standing For Appeal
Amerigen Pharmaceuticals v. UCB Pharmaceuticals, (Fed. Cir. Jan. 22, 2019). The Federal Circuit made clear that ANDA filers that included a “paragraph III” certification to the Orange-Book listed patent that was also the subject of the IPR has standing to appeal an IPR decision. A “Paragraph III certification is where the filer of an Abbreviated New Drug Application (ANDA) indicates to the New Drug Application (NDA) holder that it will wait to market/sell its drug until after the patent expires or is otherwise rendered invalid or unenforceable. If the ANDA filer files a Paragraph IV certification, indicating to the NDA holder that it intends to market/sell the ANDA product before the Orange Book listed patents expire/are invalid, the NDA holder may file suit against the ANDA holder. In this case, the ANDA holder filed a Paragraph III certification but then challenged the patent via an IPR Petition. On appeal, the NDA holder argued that the ANDA holder should not have standing to pursue the appeal, but the Federal Circuit disagreed, concluding that the listing in the Orange Book of an invalid patent may well create a “cognizable injury” that is independent of the “prospect of infringement.”
In the News
The U.S. PTO issued a final rule, effective for all petitions filed on or after November 13, 2018, doing away with the “broadest reasonable interpretation” standard for claim construction and replacing it with the claim construction standard that is applied by the district courts. Most of the comments received by the PTO supported this change.