Hatch-Waxman Practice in the Supreme Court of the United States

• Author: Kenneth L. Dorsney
• Pages: 517-532

517

chapter 21

Hatch-Waxman Practice

in the Supreme Court

of the United States

As the U.S. judiciary’s ultimate arbiter of “what the law is,”1 the Supreme

Court has addressed issues involving the Hatch-Waxman Amendments to

the Food, Drug, and Cosmetics Act (FDCA) on six occasions. Two of these

cases involved the scope of the FDCA’s experimental-use exception to pat-

ent infringement; one involved the act’s counterclaim provision, which

authorizes the courts to require brand-name drug makers to correct inac-

curate patent information filed with the Food and Drug Administration

(FDA); two involved “preemption” issues involving the effect of Hatch-

Waxman’s requirements on conflicting state tort law; and one involved the

potential antitrust implications of cases settled under the Hatch-Waxman

framework. The Supreme Court also will occasionally use pharmaceutical

cases to delve into general patent law issues, as in 2015’s Teva v. Sandoz

decision. This chapter summarizes these cases.

I. Eli Lilly & Co. v. Medtronic, Inc. (1990)

The first Hatch-Waxman case to reach the Supreme Court was Eli Lilly &

Co. v. Medtronic, Inc.2 The Court there considered the “safe harbor” provi-

sion of 35 U.S.C. §271(e)(1), which says it is not “an act of infringement” to

use “a patented invention . . . solely for uses reasonably related to the devel-

opment and submission of information under a Federal law which regulates

the manufacture, use, or sale of drugs or veterinary biological products.”3

David S. Bloch, Steffen N. Johnson, and Charles B. Klein, Winston & Strawn LLP. The

authors thank Matthew J. Mezger for helpful research assistance.

1. Marbury v. Madison, 5 U.S. (1 Cranch) 137, 177(1803).

2. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).

3. 35 U.S.C. § 271(e)(1) (2012); Eli Lilly, 496 U.S. at 663.

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All agreed that this provision protected generic drug companies conduct-

ing the research necessary to submit Abbreviated New Drug Applications

(ANDAs) to the FDA from infringement claims brought by brand-name

drug makers.4 The question was whether the safe harbor also extended

to medical devices. The answer would be no, of course, if “a Federal law”

referred only “to those individual provisions of federal law that regulate

drugs.”5 But devices would be covered if “a Federal law” referred to “the

entirety of any Act . . . at least some of whose provisions regulate drugs.”6

Advocating the first of these possible interpretations of Hatch-Waxman, Eli

Lilly argued that Medtronic’s testing of an allegedly infringing device—an

implantable cardiac defibrillator—was not covered. But the Supreme Court

disagreed, holding instead that the experimental-use exception applies to

any product subject to FDA approval under the FDCA.7

Faced with the conflicting textual signals in §271(e)(1)—indeed, the

Court candidly described that provision as “not plainly comprehensible on

anyone’s view”8—the Court found its answer in “the structure of the 1984

Act taken as a whole.”9 As the Court explained, Congress enacted the rel-

evant Hatch-Waxman’s provisions to cure twin patent-term “distortions.”10

On the one hand, during the infancy of a patent, a manufacturer might

spend years developing a device and waiting for FDA approval.11 On the

other hand, as the patent aged, competitors were forced to wait for the

patent’s expiration even to begin research and development.12 To correct

these “dual distorting effects,” the Court observed that Hatch-Waxman

established, on the front end, a term extension for patents relating to prod-

ucts that are subject to lengthy regulatory delays and, on the back end,

a safe harbor for experimentation.13 Since these provisions were “meant

generally to be complementary,” the Court found that “[a]ll of the products

eligible for a patent term extension,” including medical devices, were “sub-

ject to [the safe harbor].”14

4. See 21 U.S.C. § 360(e) (2012); see also, e.g., Eugene Trogan, Balancing the Need for

Innovative Drugs While Providing Lower Cost Alternatives to Consumers: Hatch-Waxman

Reviewed, 24

MED. & L.

355, 358–59 (2005).

5. Eli Lilly, 496 U.S. at 665.

6. Id. at 665–66.

7. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended in 21 U.S.C. §§ 301–399

(2012)).

8. Eli Lilly, 496 U.S. at 669.

9. Id.

10. Id. at 672.

11. See id. at 669–70.

12. See id. at 670.

13. Id.

14. Id. at 673–74.

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