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Vanda Pharm. Inc. v. W.-Ward Pharm. Int'l Ltd. - 887 F.3d 1117 (Fed. Cir. 2018)


A patentee does not need to prove an actual past instance of direct infringement by a physician to establish infringement under 35 U.S.C.S. § 271(e)(2)(A)Section 271(e)(2)(A) makes it possible for a patent owner to have the court determine whether, if a particular drug were put on the market, it would infringe the relevant patent. A § 271(e)(2)(A) infringement suit differs from typical infringement suits in that the infringement inquiries are hypothetical because the allegedly infringing product has not yet been marketed. Similarly, patentees in Hatch-Waxman litigations asserting method patents do not have to prove that prior use of the NDA-approved drug satisfies the limitations of the asserted claims.

The Supreme Court has established a two-step framework to determine patent subject matter eligibility under 35 U.S.C.S. § 101: First, a court determines whether the claims at issue are directed to one of those patent-ineligible concepts. If so, the court then asks, what else is there in the claims before it? To answer that question, the court considers the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application. Step two of this analysis has been described as a search for an "inventive concept"—i.e., an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.

Step one two-step framework to determine patent subject matter eligibility under 35 U.S.C.S. § 101 requires determining whether the claims at issue are directed to one of those patent-ineligible concepts. The Supreme Court has cautioned that too broad an interpretation of ineligible subject matter could eviscerate patent law because all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Accordingly, at step one, it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is directed to. If the claims are not directed to a patent ineligible concept at step one, we need not address step two of the inquiry. 


Plaintiff Vanda Pharmaceuticals owns the ‘610 patent issued on November 9, 2013. The ‘610 patent relates to a method of treating schizophrenia patients having lower cytochrome P450 2D6 gene (CYP2D6) than a normal person with a lower dose of iloperidone to prevent cardiac problems. Vanda also owns New Drug Application for Fanapt (iloperidone), a drug based on the ‘610 patent, approved by the U.S. Food and Drug Administration in 2009.

In 2013, prior to the issuance of ‘610 patent, West-Ward filed an Abbreviated New Drug Application (ANDA) which stated the same contents as that of the ‘610 patent. The ANDA sought to commercially manufacture a generic version of Fanapt. The ‘198 and ‘610 patents were listed in connection with Fanapt in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.

In 2014, Vanda sued West-Ward for infringement. West-Ward notified Vanda that it amended its ANDA by filing a Paragraph IV which contained a certification that the ‘610 patent is invalid and/or not infringed. The District Court found that West-Ward’s proposed products induce infringement of the ‘610 patent. It ruled that the ‘610 patent was valid because the claims included CYP2D6 genotyping tests to determine the appropriate dose of iloperidone which West-Ward failed to prove as routine or conventional tests. Although the ANDA was filed earlier than the ‘610 patent, the District Court granted an injunctive relief in favor of Vanda on equitable grounds.


Was West-Ward liable for inducement of infringement of Vanda’s ‘610 patent?




The Court ruled that although the patent was approved subsequent to the filing of the ANDA, it remained to be an infringement case under the Hatch-Waxman Act. The Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act and patent laws to enable generic drugs to be approved easily and respond to loss of effective patent life resulting from the required pre-market testing and FDA review. Under the Act, there is an artificial act of infringement where an application for either a drug or use of which is claimed in a patent if the purpose is to obtain approval for the commercial manufacture, use, or sale of such before the expiration of such patent. The resolution of infringement claims for patents that issue after an ANDA is submitted, but before it is approved, facilitates the early resolution of patent disputes between generic and pioneering drug companies.

The Court found that West-Ward’s products induce infringement regardless of its non-infringing uses. Actual evidence of direct infringement is not necessary in Hatch-Waxman litigations since they pertain to ANDA applications and not the actual use and marketing of a drug. Vanda was able to prove that if the proposed ANDA product were marketed, it would infringe the ‘610 patent as the proposed label recommends that physicians perform the claimed steps of Vanda’s genotyping tests.

The Court ruled that the asserted claims are not directed to patent-ineligible subject matter. Vanda’s claims under the ‘610 patent merely recognized the natural relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation as the claim was in fact an application of such relationships. The ’610 patent pertains to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. The ‘610 patent is different from the patent in the Mayo Collaborative v Prometheus Labs case as that pertained to a method that was not novel and was merely a diagnostic method describing a relation set forth by natural law.

As to the argument that Vanda’s patent is invalid for inadequate written description, the Court ruled that the disclosure of a dose outside of the claimed range does not compel a finding that the asserted claims lack adequate written description. Furthermore, West-Ward has already waived arguments regarding inadequate written description for failure to present it before the trial court. 

In sum, the Court sustained the District Court’s finding of infringement and the grant of injunctive relief in favor of Vanda.

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