In This Issue
· Federal
Circuit Affirms District Court Ruling That Section viii Statement Avoids
Infringement Under 35 U.S.C. §271(e)(2)
· Delaware
District Court Holds That Paragraph IV Certification Not Required for
Jurisdiction
Contact Us:
www.gbpatent.com
gbpatent@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax) |
Greenblum & Bernstein is proud to announce
that we are hosting a pre-conference workshop titled: Biosimilars In America:
IP Strategy and Due Diligence at the 10th EGA International Symposium on
Biosimilar Medicines that will take place April 19-20, 2012 in London. Please contact us for additional
information and/or with any questions.
Federal Circuit Affirms District Court Ruling That
Section viii Statement Avoids Infringement Under 35 U.S.C. §271(e)(2)
In AstraZeneca v. Apotex, the United
States Court of Appeals for the Federal Circuit affirmed the ruling by the
United States District Court for the District of Delaware holding that
submission of ANDAs with a paragraph VI certification and Section viii statement
by Apotex and Teva Pharmaceuticals did
not constitute patent infringement, under 35 U.S.C. §271(e)(2), of
AstraZeneca’s Crestor® (rosuvastatin calcium) method of use
patents, i.e., AstraZeneca’s U.S.
Patent Nos. 6,858,618 and 7,030,152 (respectively ”the ‘618 and ‘152 patents”),
listed in the Orange Book for Crestor® because the ANDAs sought
approval for unclaimed methods of use. (See, e.g., Greenblum &
Bernstein January 2011 Update).
By way
of explanation, Crestor® is approved for the treatment of various
cholesterol-related conditions, including hyperlipidemia,
hypertriglyceridemia, homozygous familial hypercholesterolemia (HoFH) and
heterozygous familial hypercholesterolemia (HeFH), and for the prevention of
cardiovascular disease in patients with elevated levels of C-reactive
protein. The ‘618 and ‘152 patents are
directed to the last two indications, but do not cover the first three
indications, and the ANDAs did not seek approval to market the generic version
of Crestor® for the patented methods of use, i.e., indications. AstraZeneca, nonetheless, filed suit alleging that the ANDAs,
containing the Section viii statement (carving out the claimed methods of
use, infringed the ‘618 and ‘152 patents.
In
affirming the Delaware District Court, the Federal Circuit initially noted
the below language of Section 271(e)(2), with a discussion of the term “use”:
It shall be an act of
infringement to submit--(A) an application [i.e., an ANDA] under section
505(j) of the Federal Food, Drug, and Cosmetic Act [codified at 21 U.S.C. §
355(j)] for a drug claimed in a patent or the use of which is claimed in a
patent…
The
Federal Circuit then noted that it had already held, in Warner-Lambert v. Apotex, that the term "use" within
the rubric of Section 271(e)(2) meant “the use listed in the ANDA," and
reiterated "that it is not necessarily an act of infringement under §
271(e)(2) to submit an ANDA for a drug if just any use of that drug is
claimed in a patent; rather, infringement of method claims under § 271(e)(2)
requires filing an ANDA wherein at least one 'use' listed in the ANDA is
claimed in a patent."
The
Federal Circuit then addressed AstraZeneca’s argument that Warner-Lambert was not relevant to the
instant situation because the patent-in-suit, in that case, claimed an
off-label use, and rejected it stating that what the patent claims is
"irrelevant for purposes of § 271(e)(2)" in this analysis; rather
the question is "the scope of approval sought in the ANDA."
The
Federal Circuit likewise rejected AstraZeneca’s argument that “filing an ANDA
for a drug having any patented use automatically constitutes infringement
under § 271(e)(2)…,” on the grounds that “a patented
method of using a drug can only be infringed under § 271(e)(2) by filing an
ANDA that seeks approval to market the drug for that use.”
Delaware District Court Holds That Paragraph IV
Certification Not Required for Jurisdiction
The United States District
Court for the District of Delaware recently held, in Cephalon v. Sandoz, that a paragraph IV certification is not
required to confer jurisdiction to hear a Hatch-Waxman patent infringement
action.
This case stems from Sandoz’
January 2010 submission of an ANDA containing a paragraph IV certification against
Cephalon’s U.S. Patent Nos. 6,200,604 and 6,974,590 (respectively “the ‘604
and ‘590 patents”) listed in the Orange Book for Fentora® (fentanyl citrate)
buccal tablets, and Cephalon thereafter timely filed an infringement
action. The action was then stayed on
May 5, 2011 in accordance with Cephalon’s motion to stay the proceedings
pending the Cephalon v. Watson appeal
which involved the same patents-in-suit.
Subsequently, on January 4,
2011, U.S. Patent Nos. 7,862,832 and 7,862,833 (respectively “the ‘832 and
‘833 patents”) issued to Cephalon, but Cephalon failed to list the patents in
the Orange Book within thirty (30) days of issuance as required by the
Hatch-Waxman Act. Because Cephalon
“late-listed” the patents, Sandoz did not file an amended paragraph IV
certification to these patents.
Because there was no
paragraph IV certification with respect to the '832 and '833 patents,
Cephalon requested that Sandoz stipulate to amend the pleadings to include
the patents on June 3, 2011, but Sandoz declined to do so. Cephalon then filed an amended complaint
asserting infringement of the '832 and '833 patents as well as claims under
the under the Declaratory Judgment Act. In response, Sandoz filed a motion to dismiss the complaint for lack
of subject matter jurisdiction and failure to state a claim.
The Delaware District Court
denied the motion to dismiss. In so
doing, the Court first observed that "Sandoz, relying primarily on the
opinion issued in Eisai v. Mutual (D.N.J. 2007), argues that the court's authority to exert subject matter
jurisdiction over the instant dispute is narrowly limited” and noted that “put
more simply, [Sandoz’ argument is that] no Paragraph IV certification, no
jurisdiction." The Delaware
District Court was not persuaded stating that, in Eisai, "the patent holder's conduct was so egregious that
its ability to take advantage of § 271(e)(2) was forfeited," and noting
that the patent in Eisai was not
listed in the Orange Book such that the "patentee could not maintain an
infringement action pursuant to the Declaratory Judgment Act because '§
271(e)(2) provides the jurisdictional peg for infringement actions brought
prior to ANDA approval and, in the absence of the jurisdictional hook,
jurisdiction is lacking.'"
As such, the Delaware
District Court dismissed Sandoz’ “sweeping” argument “that the absence of a
Paragraph IV certification limits, as a matter of law, the court's subject
matter jurisdiction under both 35 USC § 271(e)(2) and Declaratory Judgment
Act.” The Court continued that “with respect to § 271(e)(2), the sole purpose
of the Paragraph IV certification in the artificial world of the Hatch-Waxman
Act is to provide notice of what patents may be implicated by the ANDA, in
order to trigger suit. In reality,
however, the inquiry truly begins because the ANDA filer seeks approval to
market a patented drug prior to the expiration of the relevant patent.”
Based upon
this reasoning, the Delaware District Court stated that it “declined to
elevate form over substance” as urged by Sandoz and held that, because in the
instant fact pattern, “the jurisdictional trigger was properly pulled by the
filing of an ANDA and the initial Paragraph IV certification by Sandoz, the
court's jurisdiction should not be confined simply because Sandoz was not
required to file an amended Paragraph IV certification. Clearly, Sandoz was put on notice of the
'832 and '833 patents.” |