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Greenblum
& Bernstein, P.L.C. REEXAMINATION AND POST-GRANT PRACTICE GROUP NEWSLETTER keePingTABs No. 35 |
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February 2019
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In This Issue: · Taking
Stock of AI Petitions · Developments
in the Law · In
the News Contact Us: Jill M. Browning www.gbpatent.com JBrowning@gbpatent.com 703-716-1191 (phone) |
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. |
