Source: http://www.chanrobles.com/usa/us_supremecourt/496/661/case.php
Timestamp: 2019-12-15 10:42:06
Document Index: 484103477

Matched Legal Cases: ['§ 271', '§ 271', '§ 271', '§ 10', '§ 706', '§ 7', '§ 106', '§ 271', '§ 271', '§ 201', '§ 271', '§ 271', '§ 201', '§ 202', '§ 201', '§ 201', '§ 156', '§ 271', '§ 201', '§ 271', '§ 360', '§ 151', '§ 201', '§ 202', '§ 271', '§ 201', '§ 202', '§ 360', '§ 348', '§ 376', '§ 355', '§ 357', '§ 262', '§ 201', '§ 202', '§ 355', '§ 355', '§ 355', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 572', '§ 42', '§ 355', '§ 355', '§ 812']

This case presents the question whether 35 U.S.C. § 271(e)(1) renders activities that would otherwise constitute patent infringement noninfringing if they are undertaken for the purpose of developing and submitting to the Food and Drug Administration information necessary to obtain marketing approval for a medical chanroblesvirtualawlibrary
On appeal, the Court of Appeals for the Federal Circuit reversed, holding that, by virtue of 35 U.S.C. § 271(e)(1), respondent's activities could not constitute infringement if they had been undertaken to develop information reasonably related to the development and submission of information necessary to obtain regulatory approval under the FDCA. It remanded for the District Court to determine whether, in fact, that condition had been met. 872 F.2d 402 (1989). We granted certiorari. 493 U.S. 889 (1989). chanroblesvirtualawlibrary
The phrase "patented invention" in § 271(e)(1) is defined to include all inventions, not drug-related inventions alone. See 35 U.S.C. § 10O(a) ("When used in this title unless the context otherwise indicates . . . [t]he term invention' means invention or discovery"). The core of the present controversy is that petitioner interprets the statutory phrase, "a Federal law which regulates the manufacture, use, or sale of drugs," to refer only to those individual provisions of federal law that regulate drugs, whereas respondent interprets it to refer to the entirety of any Act (including, of course, the chanroblesvirtualawlibrary
On the basis of the words alone, respondent's interpretation seems preferable. The phrase "a Federal law" can be used to refer to an isolated statutory section -- one might say, for example, that the judicial review provision of the Administrative Procedure Act, 5 U.S.C. § 706, is "a Federal law." The phrase is also used, however, to refer to an entire Act. The Constitution, for example, provides that "Every Bill which shall have passed the House of Representatives and the Senate, shall, before it becomes a Law, be presented to the President of the United States." U.S. Const., Art. I, § 7, cl. 2 (emphasis added). And the United States Code provides that "[w]henever a bill . . . becomes a law or takes effect, it shall forthwith be received by the Archivist of the United States from the President." 1 U.S.C. § 106a (emphasis added). This latter usage, which is probably the more common one, seems also the more natural in the present context. If § 271(e)(1) referred to "a Federal law which pertains to the manufacture, use, or sale of drugs," it might be more reasonable to think that an individual provision was referred to. But the phrase "a Federal law which regulates the manufacture, use, or sale of drugs" more naturally summons up the image of an entire statutory scheme of regulation. The portion of § 271(e)(1) that immediately precedes the words "a Federal law" likewise seems more compatible with reference to an entire Act. It refers to "the development and submission of information under a Federal law" (emphasis added). It would be more common, if a single section rather than an entire scheme were referred to, to speak chanroblesvirtualawlibrary
Petitioner contends that the terms "patented drug," or "drug invention" (or, presumably, "patented drug invention") would have been "potentially unclear" as to whether they covered only patents for drug products or patents for drug composition and drug use as well. Brief for Petitioner 22. If that had been the concern, however, surely it would have been clearer and more natural to expand the phrase constituting the object of the sentence to "patented invention for drug product, drug chanroblesvirtualawlibrary
On the other side of the ledger, however, one must admit that while the provision more naturally means what respondent suggests, it is somewhat difficult to understand why anyone would want it to mean that. Why should the touchstone of noninfringement be whether the use is related to the development and submission of information under a provision that happens to be included within an Act that, in any of its provisions, not necessarily the one at issue, regulates drugs? The first response is that this was a shorthand reference to the pertinent provisions Congress was aware of, all of which happened to be included in Acts that regulated drugs. But since it is conceded that all those pertinent provisions were contained within only two Acts (the FDCA and the Public Health Service Act (PHS Act), 58 Stat. 682, as amended, 42 U.S.C. § 201 et seq. (1982 ed. and Supp. II)), that is not much of a time-saving shorthand. The only rejoinder can be that Congress anticipated future regulatory submission requirements that it would want to be covered which might not be included in the FDCA or the PHS Act, but would surely (or probably) be included in another law that regulates drugs. That is not terribly convincing. On the other hand, this same awkwardness, in miniature, also inheres in petitioner's interpretation, unless one gives "under a Federal law" a meaning it simply will not bear. That is to say, if one interprets the phrase to refer to only a single section or even subsection of federal law, it is hard to understand why the fact that that section or subsection happens to regulate drugs should bring within § 271(e)(1) other products that it also regulates; and it does not seem within the range of permissible meaning to interpret "a Federal law" to mean only isolated portions of a single section or subsection. The answer to this, presumably, is that Congress would not expect two products to be dealt with chanroblesvirtualawlibrary
35 U.S.C. § 271(a). The parties agree that the 1984 Act was designed to respond to two unintended distortions of the 17-year patent term produced by the requirement that certain products must receive premarket regulatory approval. First, the holder of a patent relating to such products would, as a practical matter, not be able to reap any financial rewards during the early years of the term. When an inventor makes a potentially useful discovery, he ordinarily protects it by applying for a patent at once. Thus, if the discovery relates to a product that cannot be marketed without substantial testing and regulatory approval, the "clock" on chanroblesvirtualawlibrary
Under respondent's interpretation, there may be some relatively rare situations in which a patentee will obtain the advantage of the § 201 extension but not suffer the disadvantage of the § 202 noninfringement provision, and others in chanroblesvirtualawlibrary
which he will suffer the disadvantage without the benefit. [Footnote 4] Under petitioner's interpretation, however, that sort of disequilibrium becomes the general rule for patents relating to all products (other than drugs) named in § 201 and subject to premarket approval under the FDCA. Not only medical devices, but also food additives and color additives, since they are specifically named in § 201, see 35 U.S.C. § 156(f), receive the patent-term extension; but since the specific provisions requiring regulatory approval for them, though included in the FDCA, are not provisions requiring regulatory approval for drugs, they are (on petitioner's view) not subject to the noninfringement provision of § 271(e)(1). It seems most implausible to us that Congress, being demonstrably aware of the dual distorting effects of regulatory approval requirements in this entire area -- dual distorting effects that were roughly offsetting, the disadvantage at the beginning of the term producing a more or less corresponding advantage at the end of the term -- should choose to address both those distortions only for drug products; and for other products named in § 201 should enact provisions which not only leave in place an anticompetitive restriction at the end of the monopoly term but simultaneously expand the monopoly term itself, thereby not only failing to eliminate but positively aggravating chanroblesvirtualawlibrary
35 U.S.C. § 271(e)(1). Although new animal drugs and veterinary biological products are subject to premarket regulatory licensing and approval under the FDCA, see 21 U.S.C. § 360b (new animal drugs), and the Act of March 4, 1913, see 21 U.S.C. §§ 151, 154 (veterinary biological products) -- each "a Federal law which regulates the manufacture, use, or sale of drugs" -- neither product was included in the patent-term extension provision of § 201. They therefore were excepted from § 202 as well. Interpreting § 271(e)(1) as the Court of Appeals did chanroblesvirtualawlibrary
here appears to create a perfect "product" fit between the two sections. All of the products eligible for a patent term extension under § 201 are subject to § 202, since all of them -- medical devices, food additives, color additives, new drugs, antibiotic drugs, and human biological products -- are subject to premarket approval under various provisions of the FDCA, see 21 U.S.C. § 360e (medical devices); § 348 (food additives); § 376 (color additives); § 355 (new drugs); § 357 (antibiotic drugs), or under the PHS Act, see 42 U.S.C. § 262 (human biological products). And the products subject to premarket approval under the FDCA and the Act of March 4, 1913, that are not made eligible for a patent term extension under § 201 -- new animal drugs and veterinary biological products -- are excluded from § 202 as well. [Footnote 6] chanroblesvirtualawlibrary
These abbreviated drug-application provisions incorporated an important new mechanism designed to guard against chanroblesvirtualawlibrary
This certification is significant, in that it determines the date on which approval of an ANDA or paper NDA can be made effective, and hence the date on which commercial marketing may commence. If the applicant makes either the first or second certification, approval can be made effective immediately. See 21 U.S.C. §§ 355(c)(3)(A), 355(j)(4)(B)(i). If the applicant makes the third certification, approval of the application can be made effective as of the date the patent expires. See 21 U.S.C. §§ 355(c)(3)(B), 355(j)(4)(B)(ii). If the applicant makes the fourth certification, however, the effective date must depend on the outcome of further events triggered by the Act. An applicant who makes the fourth certification is required to give notice to the holder of the patent alleged to be invalid or not infringed, stating that an application has been filed seeking approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent, and setting forth a detailed statement of the factual and legal basis for the applicant's opinion that the patent is not valid or will not be infringed. See 21 U.S.C. §§ 355(b)(3)(B), 355(j)(2)(B)(ii). Approval of an ANDA or paper NDA containing the fourth certification may become effective immediately only if the patent owner has not initiated a lawsuit for infringement within 45 days of receiving notice of the certification. If the chanroblesvirtualawlibrary
This scheme will not work, of course, if the holder of the patent pertaining to the pioneer drug is disabled from establishing in court that there has been an act of infringement. And that was precisely the disability that the new § 271(e)(1) imposed, with regard to use of his patented invention only for the purpose of obtaining premarketing approval. Thus, an act of infringement had to be created for these ANDA and paper NDA proceedings. That is what is achieved by § 271(e)(2) -- the creation of a highly artificial act of infringement that consists of submitting an ANDA or a paper NDA containing the fourth type of certification that is in error as to whether commercial manufacture, use, or sale of the new drug (none of which, of course, has actually occurred) violates the relevant patent. Not only is the defined act of infringement artificial, so are the specified consequences, as set forth in paragraph (e)(4). Monetary damages are permitted only if there has been "commercial manufacture, use, or sale." 35 U.S.C. § 271(e)(4)(C). Quite obviously, the purpose of (e)(2) and (e)(4) is to enable the judicial adjudication upon which the ANDA and paper NDA schemes depend. It is wholly to be expected, therefore, that these provisions would apply only to applications under the sections establishing those schemes -- which (entirely incidentally, for present purposes) happen to be sections that relate only to drugs, and not to other products. [Footnote 7] chanroblesvirtualawlibrary
The Court asserts that Congress could have specified this result in a clearer manner. See ante at 496 U. S. 667-668. That is all too true. But we do not tell Congress how to express its intent. Instead, we discern its intent by assuming that Congress employs words and phrases in accordance with their ordinary usage. In this case, even if Congress could have clarified § 271(e)(1), the Court ascribes a most unusual meaning to the existing language. Numerous statutory provisions and court decisions, from a variety of jurisdictions, use words almost identical to those of § 271(e)(1), and they never mean what the Court says they mean here. chanroblesvirtualawlibrary
Mo.Rev. Stat. § 572.100 (1986) (emphasis added), I doubt that it meant to invalidate local enactments in their entirety whenever some portion of them regulates gambling. Countless other examples confound the Court's method of reading the operative language in this case. See, e.g., N.C.Gen. Stat. § 42-37.1 (1984) (prohibiting retaliatory eviction by landlords for complaints about violations of any "State or federal law that regulates premises used for dwelling purposes") (emphasis added); Cochran v. Peeler, 209 Miss. 394, 408, 47 So.2d 806, 809 (1950) ("the violation of a law which regulates human conduct in the operation of vehicles on the roads becomes, by legislative fiat, negligence") (emphasis added); Local 456, Int'l Brotherhood of Teamsters v. Cortlandt, chanroblesvirtualawlibrary
Congress did not act in an irrational manner when it drew a distinction between drugs and medical devices. True, like medical devices, some drugs have a very high cost. See ante at 496 U. S. 673, n. 5. Testing a patented medical device, however, often will have greater effects on the patentholder's rights than comparable testing of a patented drug. As petitioner has asserted, manufacturers may test generic versions of patented drugs, but not devices, under abbreviated procedures. See 21 U.S.C. § 355(j). These procedures, in general, do not affect the market in a substantial manner, because manufacturers may test the drugs on a small number of subjects, who may include healthy persons who otherwise would not buy the drug. See § 355(j)(7)(B) (stating the requirements of a showing of the "bioequivalence" of drugs). By contrast, as in this case, manufacturers test and market medical devices in clinical trials on patients who would have purchased the device from the patent holder. See App. 39-42; see also 21 CFR § 812.7(b) (1989) (permitting manufacturers to recover their costs in clinical trials). Although the Court gives examples of high-cost drug dosages, it does not demonstrate that the testing of these drugs detracts from a patentholder's sales. Congress could have determined that the differences chanroblesvirtualawlibrary