Is subject matter jurisdiction under the Hatch-Waxman Act expanding?

35 U.S.C. § 271(e)(2) establishes subject matter jurisdiction for an action of infringement against an Abbreviated New Drug Application (ANDA) applicant who has not yet committed traditional statutorily defined acts of infringement – the making, using, selling or importing into the United States of a patented product.[1]  The Hatch-Watchman Act states in relevant part:

“It shall be an act of infringement to submit an [ANDA]…for a drug claimed in a patent or the use of which is claimed in a patent,…if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug…which is claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.”[2]

Although it is clear from this language that under the Hatch-Waxman Act submitting an ANDA for a drug claimed in a patent is a technical “act of infringement,” questions have arisen regarding the scope of subject matter jurisdiction granted by the Act – specifically, can non-Orange Book patents be asserted? 

Recently, the US District Court for the District of New Jersey, in Celgene Corp. v. Sun Pharma Global FZE, addressed the issue of whether subject matter jurisdiction exists under the Hatch-Waxman act when the asserted patents are not listed in the Orange Book and the ANDA filer did not submit a paragraph IV certification.[3] 

Celgene sues Sun for infringement under § 271(e)(2) for Orange Book listed patents, files separate suit for additional patents not listed in the Orange Book

Celgene is the maker of the cancer treatment drug Revlimid®, an FDA-approved drug for which several patents are listed in the Orange Book.[4]  On May 30, 2018, Sun provided Celgene with notice that it had filed an ANDA containing paragraph IV certifications against three of Celgene’s Revlimid® Orange Book listed patents, asserting that its generic drug lenalidomide would not infringe the Revlimid® patents and/or that the Revlimid® patents were invalid.[5]  Celgene sued Sun for infringement of the three listed patents on July 13, 2018.[6]  On April 16, 2019, Celgene filed a second action under the Hatch-Waxman Act, asserting that Sun’s proposed ANDA product would infringe three additional patents that are not listed in the Orange Book for Revlimid® nor subject to Sun’s paragraph IV certifications.[7]  These newly asserted patents cover different crystalline or polymorphic forms of lenalidomide, the active pharmaceutical ingredient in Revlimid®. 

Sun moved to dismiss the second infringement action for lack of subject matter jurisdiction under the Hatch-Waxman Act, arguing that a complaint for patent infringement under the Act must allege (1) that the asserted patents are listed in the Orange Book and (2) that the defendants have submitted a paragraph IV certification to all asserted patents.

Sun argued that, pursuant to § 271(e)(2), Congress established it is an act of infringement “to submit an application under 505(j) of such Act for a drug claimed in a patent or the use of which is claimed in a patent.”[8]  In other words, to raise a valid claim under §271(e)(2), it is necessary to show that an ANDA applicant seeks FDA approval to produce a product or use a method that is claimed in an existing patent.  In a traditional Hatch-Waxman suit, where an Orange Book-listed patent is asserted, this requirement is met by referencing an ANDA applicant’s paragraph IV certification.[9]  Sun claimed that the basis for jurisdiction was therefore not available to Celgene because none of the asserted patents were listed in the Orange Book and Sun did not submit a paragraph IV certification.  Without a paragraph IV certification, Sun argued that Celgene’s complaint must set forth factual allegations that Sun, through submission of its ANDA, seeks to produce a product or use a method that infringes one or more claims of the asserted patents.

Celgene relied on precedent from the Federal Circuit and New Jersey District Court, which held that a paragraph IV certification is not necessary to confer subject matter jurisdiction under § 271(e)(2).[10]  Celgene cited to Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd. and AstraZeneca Pharm LP v. Apotex Corp. for the proposition that nothing more is required to establish subject matter jurisdiction other than an allegation of infringement under § 271(e)(2) based on the filing of an ANDA.[11] 

Sun argued that these cases were distinguishable because, although each case involved scenarios in which jurisdiction was found even though the defendants did not submit a paragraph IV certification, in each case the court found that plaintiffs’ complaint contained sufficient factual allegations to meet the jurisdictional requirements of § 271(e)(2). Sun claimed that Celgene’s complaint, unlike the cited cases, was “completely devoid of facts establishing how Sun’s ANDA product might possibly fall within the scope of any claim(s) of the asserted patents.”[12]  Sun additionally alleged that Celgene did not meet the requirements of declaratory judgement jurisdiction or meet the general pleading standards required to state a claim under federal rules. 

The decision: subject matter jurisdiction under § 271(e)(2) is satisfied by filing an ANDA

The court sided with Celgene and held that in order to satisfy subject matter jurisdiction, a complaint under § 271(e)(2) need only allege that the defendant infringed the asserted patent(s) by filing its ANDA application.[13]  Neither a paragraph IV certification nor listing of the asserted patents in the Orange Book is required to establish subject matter jurisdiction.[14]  The court found support in the absence of Sun’s paragraph IV certification and Orange Book listing jurisdictional requirement in the plain text of § 271(e)(2).  The court also found Celgene’s reliance on Vanda and AstraZeneca to be persuasive, stating that “subsequent decisions from the Federal Circuit have explicitly held that a Paragraph IV Certification is not necessary to confer subject matter jurisdiction under § 271(e)(2).[15]  As such, the court found subject matter jurisdiction over the suit to be proper under the Hatch-Waxman Act and denied Sun’s motion to dismiss.

Impact of the Celgene decision

As the Federal Circuit explained in Vanda, jurisdiction is “met once a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2).” This holds true whether or not the patent is identified by the patent owner in the Orange Book, according to the Celgene court.  Subject matter jurisdiction exists even if a patent is late-listed and/or not listed at all. 

As a result, subject matter jurisdiction will arguably exist over those patents that “should not” be listed per FDA regulations; such as, “[p]rocess patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates . . .” and patents that only “claim unapproved uses of a drug.”

Thus, generic companies may now want to consider conducting due diligence that goes beyond the Orange Book, investigating the entirety of the branded company’s patent portfolios. 

To learn more about the implications of this decision on your patent portfolio, please contact any of the authors.