No. 18-817

Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc.

Lower Court: Federal Circuit
Docketed: 2018-12-27
Status: Denied
Type: Paid
CVSGAmici (3)Relisted (2) Experienced Counsel
Tags: generic-drugs inventive-concept medical-patent medical-treatment method-of-treatment natural-law patent-eligibility routine-and-conventional section-101
Key Terms:
Antitrust Trademark Patent JusticiabilityDoctri
Latest Conference: 2020-01-10 (distributed 2 times)
Question Presented (AI Summary)

Whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps

Question Presented (OCR Extract)

QUESTION PRESENTED This Court has repeatedly held that “natural phenomena|[] and abstract ideas are not patentable” under Section 101 of the Patent Act. E.g., Alice Corp. Pty. Ltd. v. CLS Bank, Int'l, 573 U.S. 208, 216 (2014). Thus, “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.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72-73 (2012). Mayo, for example, invalidated a medical diagnosis method patent that was just “an instruction to doctors to apply the applicable laws when treating their patients.” Id. at 79. In the decision below, a divided Federal Circuit panel did exactly what Mayo forbids: it exempted all patent claims that are drafted as reciting a method of medically treating patients from this analysis. Citing the ruling, the Patent and Trademark Office has directed its examiners that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under * * * the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under [Section 101].” The question presented is whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.

Docket Entries

2020-01-13
Petition DENIED.
2019-12-26
Letter of December 26, 2019 from counsel for petitioner received. (Distributed)
2019-12-23
Supplemental brief of respondent Vanda Pharmaceuticals USA, Inc. filed. (Distributed)
2019-12-23
DISTRIBUTED for Conference of 1/10/2020.
2019-12-20
Supplemental brief of petitioners Hikma Pharmaceuticals USA Inc., et al. filed.
2019-12-06
Brief amicus curiae of United States filed.
2019-05-22
Amendment to Rule 29.6 Corporate Disclosure Statement filed with respect to brief in opposition of respondent Vanda Pharmaceuticals Inc.
2019-03-18
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
2019-03-15
Letter of Hikma Pharmaceuticals USA Inc., et al. received.
2019-02-27
DISTRIBUTED for Conference of 3/15/2019.
2019-02-26
Reply of petitioners Hikma Pharmaceuticals USA Inc., et al. filed.
2019-02-12
Brief of respondent Vanda Pharmaceuticals USA, Inc. in opposition filed.
2019-01-28
Brief amici curiae of The Association for Accessible Medicines and Certain Individual Companies filed.
2019-01-28
Brief amici curiae of Intellectual Property and Innovation Professors, Engine Advocacy, et al. filed.
2019-01-23
Motion to extend the time to file a response is granted and the time is extended to and including February 12, 2019.
2019-01-22
Motion to extend the time to file a response from January 28, 2019 to February 12, 2019, submitted to The Clerk.
2018-12-27
Petition for a writ of certiorari filed. (Response due January 28, 2019)
2018-10-31
Application (18A461) granted by The Chief Justice extending the time to file until December 27, 2018.
2018-10-26
Application (18A461) to extend the time to file a petition for a writ of certiorari from November 12, 2018 to December 27, 2018, submitted to The Chief Justice.

Attorneys

Hikma Pharmaceuticals USA Inc., et al.
Charles Bennett KleinWinston & Strawn LLP, Petitioner
Charles Bennett KleinWinston & Strawn LLP, Petitioner
Intellectual Property and Innovation Professors, Engine Advocacy, and The R Street Institute
Phillip Robert MaloneJuelsgaard Intellectual Property and Innovation Clinic, Amicus
Phillip Robert MaloneJuelsgaard Intellectual Property and Innovation Clinic, Amicus
THE ASSOCIATION FOR ACCESSIBLE MEDICINES AND CERTAIN INDIVIDUAL COMPANIES
Douglas Clifford HochstetlerKelley Drye & Warren LLLLP, Amicus
Douglas Clifford HochstetlerKelley Drye & Warren LLLLP, Amicus
United States
Noel J. FranciscoSolicitor General, Amicus
Noel J. FranciscoSolicitor General, Amicus
Vanda Pharmaceuticals USA, Inc.
Nicholas GroombridgePaul, Weiss, Rifkind, Wharton & Garrison LLP, Respondent
Nicholas GroombridgePaul, Weiss, Rifkind, Wharton & Garrison LLP, Respondent