By Suresh Pillai --
DC District Court Remands Pfizer PTA Suit to USPTO
Last week, the U.S. District Court for the District of Columbia remanded
Pfizer Inc.'s challenge of the USPTO's calculation of patent term adjustment
(PTA) back to the U.S. Patent and Trademark Office. This action by
the District Court, following the Federal Circuit's decision in Wyeth v. Kappos, suggests that the agency will now be responsible
for reconsideration of all patent term adjustments requested for patents that
issued prior to March 2. Pfizer
had originally filed suit in December seeking to have the District Court change
the patent term by increasing the USPTO's calculated PTA from 100 days to 207
days for U.S. Patent No. 7,544,362. Although Pfizer had previously unsuccessfully petitioned the USPTO to
reconsider its PTA determination, that petition was considered under the USPTO's pre-Wyeth formula for calculations.
In the wake of the Wyeth decision, the
USPTO has established an interim procedure to recalculate PTA in accordance with the
Federal Circuit's decision in Wyeth. As part
of the implementation of this interim procedure, the USPTO announced that for all patents that issued before March 2 (but after August 1, 2009), the agency will process
recalculation requests for no fee (see "USPTO Announces Interim Procedure for Requesting PTA Recalculations").
Read the Joint Motion to Remand here and the District Court's Order here.
Settlement in ADHD Patent Infringement Suits Announced
The U.S. District Court for the District of New
Jersey has signed off on orders to stay patent infringement litigation among
plaintiffs Celgene Corp. and Novartis AG against defendants KV Pharmaceutical Co.
and IntelliPharmaCeutics Corp. over defendants' alleged infringement of plaintiffs' patents covering
treatments for attention deficit hyperactivity disorder (ADHD). Celgene originally filed suit against
KV in 2007 after KV's filing of an Abbreviated New Drug Application (ANDA) with the
FDA in which KV sought regulatory approval to market and manufacture a generic
version of Celgene's blockbuster drug, Ritalin® (see "Court Report,"
October 14, 2007). In its complaint, Celgene alleged
that KV's proposed generic infringed two Celgene patents, U.S. Patent Nos.
5,837,284 and 6,635,284.
Celgene also filed a concurrent
complaint with Novartis, Celgene's exclusive licensee, against
IntelliPharmaCeutics over IntelliPharmaCeutics' efforts to market a generic
version of Focalin® XR (see "Court Report," October 14, 2007). Celgene and Novartis alleged that, in
addition to the patents-in-suit in the KV litigation, IntelliPharmaCeutics
infringed U.S. Patent Nos. 5,908,850,
6,355,656,
and 6,528,530. In both cases, the defendants
filed counterclaims alleging that all patents-in-suit were invalid and
unenforceable. Terms of the
settlement have not been disclosed.
Read the District Court's Order here and Court's Order and Stipulation here.
Sanofi/Sun Deal over Generic Eloxatin® Deemed
Enforceable
The U.S. District Court for the District of New
Jersey has ruled that Sanofi-Aventis' agreement with Sun Pharmaceutical Industries Ltd. resolving an
ongoing patent dispute over the colon cancer drug Eloxatin® was enforceable
in spite of Sanofi's efforts to have the District Court declare the contrary. The agreement puts an end to litigation
between the two companies over Sun's alleged infringement of Sanofi's HPLC
method of synthesizing optically pure oxaliplatin (covered by U.S. Patent No.
5,338,874,
the active ingredient in Eloxatin® (see "Court Report," July 30,
2007). The parties had first entered into a
letter of intent in January 2009, with Sanofi confirming on June 16 that Sun
had fully executed Sun's portion of the written settlement agreement. Sanofi, however, failed to obtain the
remaining 20% of signatures needed to complete the agreement. The District Court determined that
Sanofi's actions were sufficient to render the agreement binding
on both parties (see "Biotech/Pharma Docket," October 7, 2009).
Sanofi's efforts to negate the
agreement came on the heels of the Court's granting of summary judgment to four
other parties (Sandoz Inc.,
Mayne Pharma Inc.,
Hospira Inc.,
and Teva Pharmaceutical Industries Ltd.),
having concluded that the parties all used methods for obtaining purification
of oxaliplatin that differed from that disclosed in the '874 patent. The Court concluded that because these
resolutions reduced the value of Sanofi's settlement agreement with Sun, Sanofi
neglected to turn over a signed copy. However, because all essential terms of the agreement were set forth in
the original January 2009 letter of intent and term sheet, the Court concluded
that the contract was still enforceable.
Read the District Court's Opinion here.
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