Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                              February 2012   

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

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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.”

The GREENBLUM & BERNSTEIN NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property.  The NEWSLETTER provides monthly updates on recent issues of general interest in this field.  The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  Information regarding the contents of the Newsletter can be obtained by contacting P. Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2012 GREENBLUM & BERNSTEIN, P.L.C. [01300582.DOC