By Suresh Pillai —

Mayo Seeks Supreme Court Review in Prometheus Labs
Case

Following the U.S. Court of Appeals for the Federal
Circuit's ruling that Prometheus Laboratories'
method patents were valid under In re
Bilski, the Mayo Clinic has petitioned the U.S. Supreme Court to review the ruling.  The patents-in-suit, U.S. Patent Nos.
6,355,623
and 6,680,302,
claim methods for calibrating dosages of drugs used in the treatment of autoimmune
diseases.  The Mayo Clinic had
originally used tests obtained from Prometheus, but Mayo, having designed
its own test internally and intending to sell this test to other hospitals,
stopped using the Prometheus test.  Prometheus sued for patent infringement.

The U.S. District Court for the Southern District
of California held that Mayo had not infringed the patents, as the patents
claim the correlations between drug metabolite levels and therapeutic
efficacy.  The District Court concluded
that because the steps involving drug administration and the determination of
metabolic levels were unpatentable data-gathering steps for use in correlations, such non-transformative steps were invalid and, therefore, claims containing these steps were not
infringed by Mayo.

The Federal Circuit, however, disagreed and
reversed the holding of the District Court.  The Federal Circuit concluded that the claims were
transformative in nature and not mere data-gathering steps.  The CAFC reasoned that, as the steps
were transformative, the steps were patentable subject matter under In re Bilski.

Mayo's petition, which argues that the claims of
the patents-in-suit "attempt to turn a physician's thought processes into
infringement," represents the second time such an issue has been appealed
to the Supreme Court.  In Laboratory Corp. v. Metabolite Labs., Inc. (LabCorp), the same issue went up on appeal and was granted certiorari, yet the Supreme Court did not resolve the case on the merits because the petitioner had failed to
preserve the issue on appeal.

For a more detailed analysis of the Federal Circuit's
decision, please see "Prometheus Laboratories, Inc. v. Mayo Collaborative
Services (Fed. Cir. 2009)."

Warner Chilcott Suit Dismissed in Maryland; To Be
Heard in Delaware

The U.S. District Court for the District of Maryland
has granted Warner Chilcott's request for voluntary dismissal of its patent infringement suit against Lupin
Ltd. over
Warner-Chilcott's patents covering the birth control medications Loestrin® 24
Fe and Femcon® Fe.  The case,
however, will proceed in the District Court for the District of Maryland.  Warner Chilcott claimed to drop the
suit in Maryland because of the parallel litigation pending in Delaware (see "Court
Report," September 13, 2009).  The Maryland suit, filed on September
11, 2009 (two days after the filing of the Delaware suit) was filed as a
protective action in the event that Lupin challenged jurisdiction in Delaware
(see "Court Report," September 27, 2009).  As Lupin failed to file such a
challenge, Warner Chilcott dropped the parallel suit.

The original suits were filed on the heels of Lupin's submissions of Abbreviated New Drug Applications with the FDA seeking permission to
market and manufacture generic versions of Loestrin® and Femcon®.  Both applications included Paragraph IV
certifications stating that the patent for each drug was invalid,
unenforceable, or would not be infringed by the proposed generic versions of the drugs.  The patents-in-suit are U.S. Patent
Nos. 5,552,394 and
6,667,050,
with Loestrin® covered by the '394 patent and Femcon® covered by the '050
patent.  Earlier this year, Warner Chilcott
settled litigation with Watson Pharmaceuticals over the same patents by
entering into a licensing agreement with Watson that granted Watson a
non-exclusive license to market generic equivalents of the disputed products (see "Biotech/Pharma Docket," February 2, 2009).

Settlement Announced in Oxytrol® Litigation

Watson Laboratories has announced a
settlement in its patent infringement suit against Barr Pharmaceuticals.  The patents-in-suit, U.S. Patent Nos.
5,601,839,
5,834,010,
6,743,441,
7,081,249,
7,081,250,
7,081,251,
7,081,252,
and 7,179,483,
cover Oxytrol®, Watson's drug for overactive bladder control.  The original suit was filed in October
2008 after Barr's filing of an Abbreviated New Drug Application with the FDA seeking
permission to market and manufacture a generic version of Watson's drug (see "Court
Report," November 2, 2008).

Under the terms of the settlement, Watson has
agreed to provide Barr with a royalty-bearing license to all of the
patents-in-suit.  This allows Barr
to bring their generic version of the drug to market in 2015, or earlier if
certain conditions are met.

Apotex and Purdue Settle Suit over Oxycontin®

The U.S. District Court for the Southern District
of New York has signed off on a consent order between Purdue Pharma and
Apotex Inc., ending the litigation between the two companies over Purdue's painkiller drug,
Oxycontin®.  Purdue filed the
original complaint in September 2007 following Apotex's filing of an Abbreviated New Drug Application with the FDA seeking permission to manufacture
and market a generic version of Oxycontin® (see "Court Report,"
September 24, 2007).  The ANDA included a Paragraph IV
certification stating that Purdue's patent, U.S. Patent No. 5,508,042,
was invalid, unenforceable, or would not be infringed by the proposed generic
product.  Apotex filed a
counterclaim stating that the patent was invalid on grounds of being procured
through inequitable conduct in the form of failing to disclose relevant prior
art during prosecution.  Apotex
also claimed that Purdue engaged in antitrust activity by engaging in an
anti-competitive scheme designed to delay Apotex from marketing a generic
version of the drug.

Under the terms of the settlement agreement, Apotex
has acknowledged that its ANDA, if approved, would infringe
the '042 patent and that the '042 patent is valid and enforceable.  This acknowledgement of patent validity
also extends to related patents from Purdue:  U.S. Patent Nos. 5,549,912,
5,266,331,
and 5,656,295.  The settlement agreement also enjoins
Apotex from selling its generic product until after expiry of the '042 patent
in April 2013.  Finally, the
settlement agreement dismisses all counterclaims made by Apotex challenging
patent validity and alleging antitrust activity on the part of Purdue.  A copy of the consent order can be
found here.