Source: https://www.orangebookblog.com/2012/03/index.html
Timestamp: 2019-04-20 06:55:23+00:00

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The Court's decision was that this claim was not eligible for patent protection because it merely recites laws of nature. In arriving at this decision, the Court stated that a claim to "a process that focuses upon the use of a natural law [must] also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."
In addition to making an obviousness inquiry part of the patent-eligibility analysis, the Court also recognized that there may be an "overlap" between the § 101 patent-eligibility inquiry and the § 102 novelty inquiry. The United States government filed an amicus brief in which it urged the Court to find the patent claim eligible for patent protection, but also unpatentable based on prior art grounds. The Supreme Court declined to accept the government's position in preference of the "better established inquiry under §101," hence making the "law of nature" exception a strong defense against diagnostic method claims. It appears that this decision subsumes the patentability requirements from §§ 102, 103 and possibly 112 as well into the initial patent-eligibility inquiry under § 101.
While raising the patent-eligibility bar for diagnostic method claims by making it clear that additional steps are needed to render such claims patent-eligible, the decision includes very little guidance as to what type of steps would be "significant" enough to pass muster in converting a law of nature to a patent-eligible application. The decision did categorically note that claims to "a new drug" or "a new way of using an existing drug" are patent-eligible.
This decision has significant ramifications for diagnostic companies and the field of personalized medicine. The decision may push such companies towards trade secret protection for diagnostic methods. The Court noted that "we must recognize the role of Congress in crafting more finely tailored rules where necessary . . . . We need not determining here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable."
The decision decreases the protections available to the diagnostic methods industry as compared to all other industries and takes away rights that were previously available to a valuable economic sector of the biotechnology industry. The decision also may influence the Supreme Court's decision whether to review AMP v. Myriad Genetics, which is pending the Court’s decision on petition for certiorari.
I will have the honor of speaking at American Conference Institute's 6th annual Paragraph IV Disputes conference in New York next month. I'll be part of a panel discussion entitled, "Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges."
Additionally, ACI is offering two pre-conference workshops on Monday, April 23rd: "Hatch-Waxman and BPCIA 101--A Primer on IP Basics and Regulatory Fundamentals" and "Working Group Session: The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation." Finally, a post-conference session will be offered on Thursday, April 26th: "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics."
In January 2010, Sandoz sent a Paragraph IV notice letter to Cephalon in connection with its ANDA for a generic version of Cephalon's FENTORA (fentanyl citrate) buccal tablets. Cephalon responded by filing suit against Sandoz under 35 USC § 271(e)(2), alleging infringement of U.S. Patent Nos. 6,200,604 and 6,974,590 based on Sandoz's Paragraph IV certifications on the two patents.
(vi)Late submission of patent information. If a patent on the listed drug is issued and the holder of the approved application for the listed drug does not submit the required information on the patent within 30 days of issuance of the patent, an applicant who submitted an abbreviated new drug application for that drug that contained an appropriate patent certification before the submission of the patent information is not required to submit an amended certification.
Notwithstanding that Sandoz did not file a Paragraph IV (or any) certification with respect to the '832 and '833 patents, on September 15, 2011, Cephalon filed suit against Sandoz alleging infringement of the patents under § 271(e)(2). Cephalon also included claims under the Declaratory Judgment Act in its complaint. Sandoz responded by filing a motion to dismiss the complaint for lack of subject matter jursidiction and failure to state a claim.
In an Order today, the district court denied Sandoz's motion. According to the court, "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 . . . put more simply, no Paragraph IV certification, no jurisdiction." The Delaware court distinguished Eisai, stating that in that case, "the patent holder's conduct was so egregious that its ability to take advantage of § 271(e)(2) was forfeited." Further, the Eisai court "went on to hold 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.'"
I respectfully disagree with the sweeping conclusion 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 [the Declaratory Judgment Act]. 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.
Where, as here, 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. It would be ironic, indeed, if the absence of an amended Paragraph IV certification precluded suit, when the certification provisions exist for the benefit of the patentee.
Finally, the court concluded that there is no connection between § 271(e)(2) and the Declaratory Judgment Act: "so long as there is an actual controversy, that is, there is a 'sufficient allegation of immediacy and reality,' 'the exercise of jurisdiction over such an action is within the discretion of the district court.'"

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