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benefit to generic drug companies, they received an exemption from patent infringement on the novel drug counterpart, provided that the use of the patent developed information that would reasonably lead to pre-expiration FDA approval of a generic version of a drug.62 This facilitated availability of generic drugs immediately upon the expiration of the patent on the pioneer drug.
In light of the changes to the patent statute, the Hatch-Waxman Act also modified the FDCA to give pioneer drug companies the ability to resolve patent disputes prior to the generic entry into the market. The Hatch-Waxman Act included a provision, which requires pioneer drug companies to submit patent information on novel drugs to the FDA. The FDA lists these patents in a publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.63 Generic manufacturers, in addition to their ANDA, must certify the patents listed in the Orange Book upon which they rely in order to show bioequivalence.64
Finally, the Hatch-Waxman Act benefited the public through increased competition in the marketplace, which resulted in lower consumer costs for drugs and insurance.
Additionally, generic drugs were available immediately upon expiration of the relevant patents. Indeed, the Hatch-Waxman Act effectively removed bathers to generic drugs in the marketplace, while still retaining sufficient incentives to pioneer drug manufacturers to develop new and useful drugs.
B. Judicial Interpretations
Since the passage of Hatch-Waxman, the courts are consistently inconsistent in their interpretations of § 271(e)(1), thereby withholding from the legal community a vehicle to predict how problems such as the research tool patent problem should be resolved. Indeed, outcomes in the courts with respect to § 271(e)(1) are unpredictable, with inconsistent holdings and dicta from case to case and court to court, and even opinions, which in light of today's technology, are logically invalid.65 Until recently, the general trend expanded the scope of the Hatch-Waxman Act.66 With respect to the application of § 271(e)(1) to patented
62 35 U.S.C. § 271(e)(1), Infringement of patent.
63 Weiswasser & Danzis, supra note 43, at 599.
64 § 355(b)(2)(A) (requiring that a generic manufacturer certify that a drug is either not patented, based on an expired patent, patented, or based on a patent that is invalid). Certifications with respect to patent invalidity cause significant controversy that can lead to litigation. Weiswasser & Danzis, supra note 43, at 600.
65 AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1029 (Fed. Cir. 1997) (showing the holdings of Eli Lilly to be inconsistent with each other in light of application to Class I and II medical devices). See also Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp 1269 (N.D. Cal. 1991), aff'd, 991 F.2d 808 (Fed. Cir. 1993); Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860 (Fed. Cir. 2003), vacated, 545 U.S. 193 (2005).
66 Paul Fehlner, Not Such a Safe Harbor After All, 10 No. 6 ANDREWS INTELLECTUAL PROPERTY
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research tools, five cases address the topic directly, and all have slightly different applications of § 271(e)(1).
1. Eli Lilly & Co. v. Medtronic, Inc.
The first case addressing the problems arising from § 271(e)(1) was Eli Lilly & Co. v.
Medtronic, Inc.67 The Supreme Court grappled with the problem of whether the language of
§ 271(e)(1) applied to a cardiac defibrillator, a Class III medical device.68 Like drugs, the FDA requires that Class III medical devices undergo safety and efficacy testing prior to marketing.69 Although § 271(e)(1) broadly applies to the term “patented invention,”
Congress narrowed it with respect to the scope of its applicability by requiring that the use be “reasonably related to the development and submission of information under a federal law which regulates the manufacture, use, or sale of drugs. ...”70 The Supreme Court held that a Class III medical device was considered a “patented invention” because it met the requirement that it be pursuant to FDA approval under a federal statute regulating drugs.71
The Supreme Court came to this conclusion based on the “patented invention” standard.
The Court held that the issue turned on the meaning of the term “Federal law” in the statutory language, not the term “drug.”72 Justice Scalia wrote for the Court that § 271(e)(1)
“more naturally summons up the image of an entire statutory scheme. ...”73 Thus, the scope of § 271(e)(1) applies not only to drugs, but potentially to any invention, provided its use is related to a requirement imposed under a federal law related to drugs.74
The Supreme Court also addressed the “symmetry principle” inherent in the Hatch-Waxman Act. The symmetry principle requires that the “patented invention” of § 271(e)(1) be an invention eligible for term extension under 35 U.S.C. § 156.75 The Court held that § 156 and § 271(e) are meant “generally to be complementary.”76 Thus, the Court
LITIGATION REPORTER 18 (July 22, 2003) (the Hatch-Waxman Act has been construed broadly to include medical devices and experiments).
67 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).
68 Id. at 664.
69 21 U.S.C. § 355 (2003).
70 35 U.S.C. § 271(e)(1).
71 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 666 (1990).
72 Id. at 666-667.
73 Id. at 666.
74 Id. at 666-670. Justice Scalia pointed out that there were two possible ways of reading this statute. First, it could be viewed as referring to any “statutory scheme of regulation” that included as one of its components drugs, or conversely, that it could be read to apply to sections of federal statutes dealing with drugs. The Court suggested that if Congress intended § 271(e)(1) to read as only those sections of federal statutes dealing with drugs, the statutory language more naturally would have read, “It shall not be an act of infringement to make, use, or sell a . . . patented invention for [a] drug product, drug composition, or drug use.”
75 Id. at 669-70.
76 Id. at 673.
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suggested that if a device is not eligible for term extension, then the safe harbor of § 271(e)(1) should not apply either.77 Despite the Supreme Court’s good intentions with respect to the so-called symmetry principle, later cases show that symmetry is not compatible with a broad application of the term “patented invention” in § 271(e)(1) that extends the safe harbor to all medical devices, including Class I or Class II medical devices.
2. Intermedics, Inc. v. Ventritex, Inc.
Intermedics, a Northern District of California case affirmed by the Federal Circuit, addressed the question of intent in the application of § 271(e)(1).78 Here, the court refused to subjectively consider specific uses for which the § 271(e)(1) exemption was granted.79 Rather, the court held that Congress intended the test for determining whether § 271(e)(1) applies to be an objective test, “focusing on conduct rather than motive or ultimate aim.”80 To that end, the court set out the relevant factors to test whether a particular use is reasonably related to the pursuit of FDA approval:
[W]ould it have been reasonable, objectively, for [the allegedly infringing]
party to believe that there was a decent prospect that the ‘use’ in question would contribute (relatively directly) to the generation of kinds of information that was likely to be relevant in the processes by which the FDA would decide whether to approve the product?81
This test allows all patents the benefit of § 271(e)(1), provided the uses are “reasonably related.” Even ancillary uses are permitted if reasonably related to FDA approval under Intermedics.82
3. AbTox, Inc. v. Exitron Corp.
AbTox extended Eli Lilly to Class I and Class II medical devices.83 The Federal Circuit resolved the issue of whether medical devices, which were not eligible for term extensions under § 156(a),84 enjoyed the protection of the safe harbor of § 271(e)(1).85 The Federal Circuit decided between the two disparate holdings in Eli Lilly: whether § 271(e)(1) applied as part of an entire statutory scheme of regulation, or whether § 271(e)(1) required
77 Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 671-673 (1990).
78 Intermedics, Inc. v. Ventritex, Inc., 775 F. Supp. 1269 (N.D. Cal. 1991), aff'd, 991 F.2d 808 (Fed. Cir. 1993).
79 Id. at 1278.
80 Id.
81 Id. at 1280.
82 Id.
83 AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1029 (Fed. Cir. 1997).
84 35 U.S.C. § 156(a)(4) (2000), Extension of patent term.
85 AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1028-1029 (Fed. Cir. 1997).
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symmetry.86 The court noted that the FDA did not require pre-marketing approval for Class I and Class II medical devices. Thus, these devices were not eligible for term extensions under
§ 156(a). The Federal Circuit held, “Ultimately, this court must follow the Supreme Court's broader holding, which remains in force despite a potential conflict with its own narrower reasoning . . . the Supreme Court commands that statutory symmetry is preferable but not required.”87 Consequently, under § 271(e)(1), otherwise infringing acts need only be reasonably related to FDA approval to be entitled to the safe harbor.88
4. Infigen, Inc. v. Advanced Cell Technology, Inc.
Infigen was a decision that cut against the precedent of the Federal Circuit with respect to § 271(e)(1).89 In Infigen, the Western District Court of Wisconsin opined that the only patents to which § 271(e)(1) applies to were those which qualified for the term extension in
§ 156(f).90 However, food and color additives are not eligible for term extensions, because they are not subject to a stringent pre-market approval process as required under § 156(a), though they are technically listed in § 156(f) as being eligible for term extension. Thus, the holding of Infigen is somewhat contradictory. On one hand, the court asserted that the safe harbor in § 271(e)(1) is available for all products defined in § 156(f).91 On the other hand, not all products defined in § 156(f) as eligible to receive term extensions may actually receive a term extension because of the regulatory review requirement of § 156(a). Thus, the Infigen court broke from earlier holdings of the Federal Circuit that rejected symmetry between § 156 and the safe harbor in § 271(e)(1).