Celgene Corp. v. Peter

• Decision Date: 30 July 2019
• Docket Number: 2018-1171,2018-1167, 2018-1168, 2018-1169
• Citation: 931 F.3d 1342
• Parties: CELGENE CORPORATION, Appellant v. Laura A. PETER, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Intervenor Celgene Corporation, Appellant v. Laura A. Peter, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Intervenor
• Court: U.S. Court of Appeals — Federal Circuit

931 F.3d 1342

CELGENE CORPORATION, Appellant

v.Laura A. PETER, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Intervenor

Celgene Corporation, Appellant

v.Laura A. Peter, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent and Trademark Office, Intervenor

2018-1167, 2018-1168, 2018-1169

2018-1171

United States Court of Appeals, Federal Circuit.

Decided: July 30, 2019

Gregory A. Castanias, Jones Day, Washington, DC, argued for appellant. Also represented by Jihong Lou, Jennifer Loraine Swize ; Gasper LaRosa, New York, NY; Anthony Insogna, San Diego, CA; Frank Charles Calvosa, F. Dominic Cerrito, Andrew Chalson, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY.

Amy J. Nelson, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor. Also represented by Meredith Hope Schoenfeld, Thomas W. Krause. Also argued by Katherine Twomey Allen, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC. Also represented by Mark R. Freeman, Scott R. Mcintosh, Joseph H. Hunt.

Before Prost, Chief Judge, Bryson and Reyna, Circuit Judges.

Prost, Chief Judge.

The Coalition for Affordable Drugs VI LLC ("CFAD") filed a petition for inter partes review ("IPR") challenging the validity of all of the claims of U.S. Patent No. 6,045,501 ("the ’501 patent") and three petitions for IPR challenging the validity of all of the claims of U.S. Patent No. 6,315,720 ("the ’720 patent"). The Patent Trial and Appeal Board ("Board") determined that all of the claims of the ’501 patent and claims 1–9 and 11–32 of the ’720 patent were obvious. Celgene Corporation ("Celgene") appeals the Board’s decisions.

For the reasons explained below, we affirm the Board’s decisions finding the appealed claims obvious. We also hold that the retroactive application of IPR proceedings to pre-AIA patents is not an unconstitutional taking under the Fifth Amendment.

I

A

A teratogen is an agent known to disturb the development of an embryo or fetus. Teratogenic drugs can cause birth defects

or other abnormalities following fetal exposure during pregnancy. One example of a teratogenic drug is thalidomide. Thalidomide, first synthesized in 1957, was originally marketed for use as a sedative in many countries, not including the United States. See ’501 patent col. 1 ll. 19–22. Following reports of serious birth defects, thalidomide was withdrawn from all markets by 1962. Id. at col. 1 ll. 22–24. Despite these teratogenic effects, thalidomide has proven to be effective in treating other conditions. See id. at col. 1 ll. 24–35. The ’501 patent and the ’720 patent are generally directed to methods for safely distributing teratogenic or other potentially hazardous drugs while avoiding exposure to a fetus to avoid adverse side effects of the drug.

B

In order to obtain FDA approval to sell and distribute thalidomide

, Celgene developed a system to safely distribute thalidomide to patients, which it called the System for Thalidomide Education and Prescription Safety ("Original S.T.E.P.S."). Appeal No. 18-1171, Appellant’s Br. 8–9. According to Celgene, the ’501 patent is directed to its Original S.T.E.P.S. program. See id. at 10.

Celgene’s ’501 patent relates to "methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug." ’501 patent at Abstract. Claim 1 is representative and states:

1. A method for delivering a teratogenic drug to patients in need of the drug while avoiding the delivery of said drug to a foetus comprising:

a. registering in a computer readable storage medium prescribers who are qualified to prescribe said drug;

b. registering in said medium pharmacies to fill prescriptions for said drug;

c. registering said patients in said medium, including information concerning the ability of female patients to become pregnant and the ability of male patients to impregnate females;

d. retrieving from said medium information identifying a subpopulation of said female patients who are capable of becoming pregnant and male patients who are capable of impregnating females; e. providing to the subpopulation, counseling information concerning the risks attendant to fetal exposure to said drug;

f. determining whether patients comprising said subpopulation are pregnant; and

g. in response to a determination of non-pregnancy for said patients, authorizing said registered pharmacies to fill prescriptions from said registered prescribers for said non-pregnant registered patients.

Id. at claim 1. Claim 2 recites "[t]he method of claim 1 wherein said drug is thalidomide

." The remaining claims depend from claim 1 and are not limited to thalidomide.

CFAD filed a petition for IPR challenging all ten claims of the ’501 patent. The Board instituted review of claims 1–10 on a single ground—obviousness based on Powell,¹ Mitchell,² and Dishman.³ Coalition for Affordable Drugs VI LLC v. Celgene Corp. , No. IPR2015-01092, Paper 20 (P.T.A.B. Oct. 27, 2015).

In its final written decision, the Board held that CFAD had shown by a preponderance of the evidence that claims 1–10 of the ’501 patent are unpatentable as obvious over the combination of Powell, Mitchell, and Dishman. Coalition for Affordable Drugs VI LLC v. Celgene Corp. , No. IPR2015-01092, Paper 73, at 33 (P.T.A.B. Oct. 26, 2016) (" ’501 Final Written Decision "). The Board denied Celgene’s request for rehearing.

C

In the interim, Celgene "overhaul[ed]" its Original S.T.E.P.S. program to create what it called an "Enhanced S.T.E.P.S." program. Appeal No. 18-1167, Appellant’s Br. 8–9. According to Celgene, the ’720 patent is directed to its Enhanced S.T.E.P.S. program. See id. at 10.

Celgene’s ’720 patent relates to "[i]mproved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug." ’720 patent at Abstract. Claim 1, written in Jepson format, states:

1. In a method for delivering a drug to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by said drug, wherein said method is of the type in which prescriptions for said drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber is registered in said medium and qualified to prescribe said drug, that the pharmacy is registered in said medium and qualified to fill the prescription for said drug, and the patient is registered in said medium and approved to receive said drug, the improvement comprising:

a. defining a plurality of patient risk groups based upon a predefined set of risk parameters for said drug;

b. defining a set of information to be obtained from said patient, which information is probative of the risk that said adverse side effect is likely to occur if said drug is taken by said patient;

c. in response to said information set, assigning said patient to at least one of said risk groups and entering said risk group assignment in said medium;

d. based upon said information and said risk group assignment, determining whether the risk that said adverse side effect is likely to occur is acceptable; and

e. upon a determination that said risk is acceptable, generating a prescription approval code to be retrieved by said pharmacy before said prescription is filled.

CFAD filed three petitions for IPR, each challenging all 32 claims of the ’720 patent. The Board instituted review of claims 1–32 in all three cases. In the first IPR, the Board instituted review based on obviousness over the Thalomid Package Insert,⁴ Cunningham,⁵ Zeldis,⁶ and other prior art. Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01096, Paper 21 (P.T.A.B. Oct. 27, 2015). In the second IPR, the Board instituted review based on obviousness over Powell and Dishman, in view of Cunningham, and further in view of Mann⁷ and other prior art. Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01102, Paper 21 (P.T.A.B. Oct. 27, 2015). In the third IPR, the Board instituted review based on obviousness over the same references as the second IPR but using Mitchell instead of Powell as the base reference. Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01103, Paper 22 (P.T.A.B. Oct. 27, 2015).

In each of its final written decisions, the Board held that CFAD had shown by a preponderance of the evidence that claims 1–32 of the ’720 patent were unpatentable as obvious over the instituted ground. Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01096, Paper 73 (P.T.A.B. Oct. 26, 2016) ("-01096 Final Written Decision "); Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01102, Paper 75 (P.T.A.B. Oct. 26, 2016) ("-01102 Final Written Decision "); Coalition for Affordable Drugs VI, LLC v. Celgene Corp. , No. IPR2015-01103, Paper 76 (P.T.A.B. Oct. 26, 2016) ("-01103 Final Written Decision "). Following Celgene’s request for rehearing, the Board modified its final written decisions to uphold the patentability of claim 10 because CFAD failed to prove that claim obvious by a preponderance of the evidence.

D

Celgene timely appealed all four IPRs. We consolidated the appeals from the three IPRs on the ’720 patent (Appeal Nos. 18-1167, 18-1168, 18-1169) and designated the appeal from the IPR on the ’501 patent (Appeal No. 18-1171) as a companion case. CFAD did not participate in these appeals. The Director of the United States Patent and Trademark Office ("PTO") intervened pursuant to 35 U.S.C. § 143.

We have jurisdiction over these appeals pursuant to 28 U.S.C. § 1295(a)(4)(A).

II

On appeal, Celgene argues that the Board erred in finding all claims of the ’501 patent and claims 1–9 and 11–32 of the ’720 patent obvious. Celgene also argues that the retroactive...