MOORE, Circuit Judge.
Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc., and Watson Pharma., Inc. (collectively, Amphastar) appeal the district court's order denying the Emergency Motion to Dissolve or Stay the preliminary injunction entered in this case. Because the district court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1), we vacate the grant of a preliminary injunction and remand for further proceedings consistent with this opinion.
This case is a patent litigation involving a generic version of Lovenox (enoxaparin), a drug that prevents blood clots. Enoxaparin is a low molecular weight version of heparin, a naturally occurring molecule. Heparin is a polymer, known as a polysaccharide, made up of long chains of sugar molecules. Heparin is not a single defined molecule. Instead, heparin molecules have considerable diversity in (1) the length of the polysaccharide chain and (2) in the component disaccharide units and the corresponding distribution of disaccharide unit sequences in the polysaccharide chains. FDA Letter to Aventis Pharmaceuticals, Inc., July 23, 2010, FDA Docket No. FDA-2003-P-0273 (FDA Letter), J.A.
Enoxaparin is produced by breaking the heparin polysaccharide into smaller pieces, called oligosaccharides. Because the heparin starting material is a diverse set of molecules, enoxaparin is also made up of different chain lengths and disaccharide units corresponding to the diversity in the original mix of heparin molecules. Id. Additional diversity is introduced based on the way in which the heparin molecule is broken down into the low molecular weight heparin product. Id., JA 292-93. Thus, unlike a typical small molecule drug like penicillin, enoxaparin is made up of a range of different molecules.
This molecular diversity raises a potential problem in light of the Food and Drug Administration's (FDA's) abbreviated new drug application (ANDA) approval process. ANDAs are typically used by generic companies to obtain approval to market a generic version of an existing drug. Unlike a new drug application (NDA), an ANDA applicant is not required to submit the same extensive clinical studies typically needed to prove the drug's safety and efficacy. Instead, the ANDA applicant must submit studies to establish that its drug is bio-equivalent to the reference drug. The ANDA must also include sufficient information to establish that the generic drug has the same active ingredients as the reference drug.
The obvious complication with using an ANDA application to gain approval for enoxaparin is that it is a mixture of a number of different low molecular weight heparin molecules. In fact, Aventis, which marketed Lovenox, asked the FDA to deny approval for a generic version of enoxaparin via an ANDA unless the applicant either (1) completely characterized enoxaparin by isolating, purifying, and sequencing each of its unique polysaccharide chains, which Aventis claimed was impossible; (2) used Aventis's manufacturing process; or (3) conducted clinical trials to prove safety and efficacy (the very type of duplicative studies the ANDA approval process was designed to avoid). FDA Letter, J.A. 286. The FDA rejected Aventis's arguments, and instead explained that the ANDA "statutory provisions do not describe the type or amount of information that an ANDA applicant must submit to demonstrate that the active ingredient in the generic drug product is the same as the active ingredient in the [reference drug]." Id., J.A. 294. As a result, the FDA concluded that Congress recognized that the FDA has "broad discretion with respect to the information [it] may consider in making a finding on the `sameness' of an active ingredient." Id.
Consistent with this discretion, the FDA identified five criteria, or "standards for identity," that "together provide sufficient information to conclude that generic enoxaparin has the `same' active ingredient as Lovenox." Id., J.A. 295. These criteria included, inter alia, "[e]quivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species." Id. The FDA explained that such equivalence is proven by "exhaustive digestion of enoxaparin with purified heparin digesting enzymes (heparinases I, II, III) and nitrous acid, among other means, to yield the constituent disaccharide building blocks comprising enoxaparin." Id., J.A.
The FDA also suggested the identity of the disaccharides could be determined via standard techniques, including mass spectroscopy, NMR spectroscopy, modifying reagents, or modifying enzymes. These techniques identify the nature of the constituent sugars and their substitution patterns, including the sulfation and acetylation patterns, as well as "whether the disaccharide possesses, among other structures, a ... 1, 6 anhydro ring" structure. Id., J.A. 300-01. Detecting the presence of a 1, 6 anhydro ring structure is particularly important for proving equivalence because "[e]quivalence in disaccharide building blocks together with equivalence in molecular weight distribution shows that generic enoxaparin contains the 1, 6 anhydro ring structure at the reducing ends of between 15 percent and 25 percent of its poly(oligo)saccharide chains." Id. n. 68, J.A. 301.
Amphastar was the first company to file an ANDA for a generic version of enoxaparin. It submitted its ANDA to the FDA in March 2003, and subsequently engaged in a lengthy patent litigation with Sanofi-Aventis. Amphastar received FDA approval to market its generic enoxaparin on September 19, 2011. Despite the fact that Amphastar was the first company to file an ANDA, Momenta Pharmaceuticals, Inc. and Sandoz, Inc. (collectively Momenta), who collaborated to develop a generic enoxaparin product, were the first to bring generic enoxaparin to the market-place. Momenta received FDA approval to market enoxaparin in July 2010, more than a year before Amphastar's approval. Being the only generic version of enoxaparin has it benefits: its sales generated revenues of $260 million per quarter. J.A. 189. The approval of Amphastar's version of enoxaparin, and the resultant ruinous competition of another generic version of the drug, threatened this unique market position. Understandably unwilling to give up a billion dollars in yearly revenue, Momenta initiated the present litigation two days after Amphastar received final FDA approval to market its generic enoxaparin.
Momenta is the assignee of United States Patent No. 7,575,886 ('886 patent). The '886 patent generally relates "to methods for analyzing heterogeneous populations of sulfated polysaccharides, e.g. heparin [and] ... LMWH [e.g., enoxaparin.]" '886 patent col.4 ll.53-55. Claim 6 is typical. It is a method for analyzing an enoxaparin sample "for the presence or amount of a non naturally occurring sugar... that results from a method of making enoxaparin that included β-eliminative cleavage with a benzyl ester and depolymerization." Id. col.64 ll.35-39. Momenta also asserted independent claims 15, which assesses the level of non-naturally occurring sugar, and 53, which allows selection of an appropriate batch. These claims are similar to claim 6. The asserted claims generally require digestion of an enoxaparin sample with a heparin degrading enzyme, followed by the use of a separation method to detect the presence of the non-naturally occurring sugar resulting from the B-eliminative cleavage. The signal corresponding to the non-naturally occurring sugar can then be used to analyze the test sample based on a comparison with a reference standard. Id. col.64 ll.40-57.
Amphastar sequentially appealed the preliminary injunction and the two denials for relief from the preliminary injunction. These three appeals were consolidated. We have jurisdiction to hear these appeals pursuant to 28 U.S.C. § 1292. After hearing oral argument in this case, we stayed the preliminary injunction. This stay, however, was not a final decision on the merits of Amphastar's appeal. We now explain why the district court incorrectly concluded that Momenta was likely to succeed on the merits of its infringement claim, and conclude that the preliminary injunction must be vacated.
"The issuance of a preliminary injunction... is a matter of discretion for a district court. That discretion, however, is not absolute and must be reviewed in light of the equitable standards governing the issuance of injunctions." Intel Corp. v. ULSI Sys. Tech., Inc., 995 F.2d 1566, 1568 (Fed.Cir.1993). To determine whether a preliminary injunction is appropriate, the district court weighs factors including "(1) whether the movant has sufficiently established a reasonable likelihood of success on the merits; (2) whether the movant would suffer irreparable harm if the injunction were not granted; (3) whether the balance of hardships tips in the movant's favor; and (4) the impact, if any, of the injunction on the public interest." Id. The grant of a preliminary injunction can be overturned "by showing that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings." Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed.Cir. 1997). As the party seeking the injunction, the burden is on Momenta to establish it is entitled to this extraordinary relief. Id. In order to prove a likelihood of success on the merits, Momenta must prove that Amphastar likely infringes its patent. Id. Conversely, if Amphastar establishes that Momenta is unlikely to succeed on its claim of infringement, a preliminary injunction is likely not appropriate. Id.
In its opposition to the preliminary injunction, Amphastar argued, among other things, that its testing falls within the scope of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1). Section 271(e)(1) indicates that "[i]t shall not be an act of infringement to ... use ... a patented
On appeal, Amphastar argues that the district court took an unduly restrictive view of the safe harbor, and that its activities fall within the plain language of 35 U.S.C. § 271(e)(1). Momenta counters that the district court correctly held that the safe harbor does not apply to Amphastar's testing for two reasons. First, Momenta argues that the safe harbor does not apply to post-approval activity: "In Classen, this court squarely held that `[t]he [safe harbor] does not apply to information that may be routinely reported to the FDA long after marketing approval has been obtained.'" Appellee's Br. at 43 (quoting Classen, 659 F.3d at 1070, alterations made by Momenta). Because Amphastar's batch testing is carried out as a condition for the post-FDA approval sale of enoxaparin, Momenta argues it falls outside the scope of the safe harbor.
Second, despite its allegations and concessions, Momenta asserts the safe harbor does not apply because "the FDA does not require the use of the particular procedure that is claimed in the '886 patent." Id. at 41. Instead, Momenta claims that the FDA's interpretation of its statutory mandate in its letter response to Aventis's petition, J.A. 300-01, allows a variety of testing methods to be used to establish equivalence, both for the submission of an ANDA and for the undisputedly required batch testing. Appellee's Br. at 41. Momenta argues that the availability of other acceptable testing methods means that Amphastar's alleged use of the patented method is not required by the FDA, and is therefore outside of the safe harbor provision.
The parties thus present us with conflicting views about the scope of the safe harbor. If Amphastar is correct that its post-approval activities actually fall within the scope of 35 U.S.C. § 271(e)(1), Momenta is unlikely to succeed on its claim of infringement and the preliminary injunction is likely inappropriate. Genentech, 108 F.3d at 1364. In order to determine whether the preliminary injunction was appropriate in this case, we must first ascertain the scope of the Hatch-Waxman safe harbor provision, 35 U.S.C. § 271(e)(1).
"[A]ll statutory construction cases ... begin with the language of the statute." Barnhart v. Sigmon Coal Co., 534 U.S. 438,
The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), Public Law No. 98-417 (1984) (codified in relevant part at 35 U.S.C. § 271(e)) set up a statutory system to "balance the need to stimulate innovation against the goal of furthering the public interest." H.R. Rep. 98-857, pt. 2, at 2714 (Aug. 1, 1984), 1984 U.S.C.C.A.N. 2686, 2714. This balance is embodied, in part, in the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which provides (with emphasis added) that:
Congress could not have been clearer in its choice of words: as long as the use of the patented invention is solely for uses "reasonably related" to developing and submitting information pursuant to "a Federal law" regulating the manufacture, use, or sale of drugs, it is not "an act of infringement."
Although the Hatch-Waxman safe harbor provision was enacted in the context of the then-novel ANDA approval process, 35 U.S.C. § 271(e)(1) does not reference the portion of the Federal Food, Drug, and Cosmetic Act describing the ANDA requirements, e.g., 21 U.S.C. § 355(j). Instead, Congress used more flexible and expansive language to define the scope of § 271(e)(1), referring generally to "the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs." This broad language unambiguously applies to submissions under any federal law, providing that the law "regulates the manufacture, use, or sale of drugs." Limiting the scope of 35 U.S.C. § 271(e)(1) to just the submission of information pursuant to the Federal Food, Drug, and Cosmetic Act generally, or to the ANDA provision of the Federal Food, Drug, and Cosmetic Act in specific, would read words into the statute in violation of the express language chosen by Congress.
This interpretation is also consistent with the rest of the statutory scheme. When Congress wanted to impose a limitation
Unlike the closely related infringement provision, 35 U.S.C. § 271(e)(2), Congress did not link the safe harbor to the submission of an application for approval under the Federal Food, Drug, and Cosmetic Act. Compare 35 U.S.C. § 271(e)(1) (not an act of infringement when used for "the development and submission of information under a Federal law") with 35 U.S.C. § 271(e)(2)(A) (it is an act of infringement to submit "an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act"). We cannot change the statutory language. We will not import the limitation of § 271(e)(2) into § 271(e)(1). "[O]ur obligation is to take statutes as we find them." Diamond v. Chakrabarty, 447 U.S. 303, 315, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980); see also, e.g., Reiter v. Sonotone Corp., 442 U.S. 330, 344, 99 S.Ct. 2326, 60 L.Ed.2d 931 (1979) ("We must take the statute as we find it."). The statute here applies to any use of a patented invention as long as the use is "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs...." 35 U.S.C. § 271(e)(1).
In light of these provisions, the only coherent and consistent interpretation of "a Federal law which regulates the manufacture, use, or sale of drugs" is that it must be broad enough to encompass submissions made pursuant to the Federal Food, Drug, and Cosmetic Act. Since there is no ambiguity in the language used by Congress in 35 U.S.C. § 271(e)(1), our inquiry into the scope of the safe harbor is complete. Robinson, 519 U.S. at 340, 117 S.Ct. 843. When the intent of Congress is expressed so clearly and consistently throughout the statute, there is neither the need nor the occasion to refer to the legislative history. Id. The scope of the Hatch-Waxman safe harbor does not stop at activities reasonably related to development of information submitted in an ANDA. Instead, the safe harbor applies "to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." As long as the allegedly infringing use is "for uses reasonably related" to the development and submission of that information it is not an act of infringement, regardless of where that requirement resides in the law.
This analysis is not groundbreaking: the Supreme Court came to essentially the same conclusion in 1990. In Eli Lilly & Co. v. Medtronic, Inc., the Court explained that "the phrase `a Federal law which regulates the manufacture, use, or sale of
The Court later reaffirmed this expansive view, explaining: "we think it apparent from the statutory text that § 271(e)(1)'s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA [(Food, Drug, and Cosmetic Act)]." Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202, 125 S.Ct. 2372, 162 L.Ed.2d 160 (2005) (citing Eli Lilly, 496 U.S. at 665-69, 110 S.Ct. 2683). Merck KGaA expressly rejected the notion that the safe harbor only applies to information developed during a clinical trial. 545 U.S. at 202 n. 6, 125 S.Ct. 2372. Instead, "the statutory text makes clear that it provides a wide berth for the use of patented drugs in activities related to the federal regulatory process." Id. at 202, 125 S.Ct. 2372 (emphasis added). In light of the unqualified exemption for uses reasonably related to the development and submission of information, "[t]here is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included." Id. (emphasis added). The use of the word "under" in the statute is expansive. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. ___, 132 S.Ct. 1670, 1683-84, 182 L.Ed.2d 678 (2012). "Under a federal law" extends beyond just the "most barebones information" required by the FDA, and instead encompasses all "materials the FDA demands in the regulatory process." Id.
While it is clear that the safe harbor applies to a broad set of "activities related to the federal regulatory process," Merck KGaA, 545 U.S. at 202, 125 S.Ct. 2372, there is an important limitation: the use must be "for uses reasonably related to the development and submission of information," 35 U.S.C. § 271(e)(1). "Reasonably related," however, does not mean that the use of the patented invention must necessarily result in submission of information to the FDA: "Congress did not limit § 271(e)(1)'s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug." Merck KGaA, 545 U.S. at 206, 125 S.Ct. 2372. Instead, the Court explained that the safe harbor "exempted from infringement all uses of patented compounds `reasonably related' to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs." Id. (emphasis in original). Thus, the Court explicitly rejected the notion that § 271(e)(1) was limited "to the activities necessary to seek approval of a generic drug." Id. As long as the accused infringer "has a reasonable basis for believing" that use of the patented invention might yield information that "would be appropriate to include in a submission to the FDA, that use is `reasonably related' to the `development and submission
At the outset we are met with the contention that the information in question was not "submitted" to the FDA, see 35 U.S.C. § 271(e)(1) ("... solely for uses reasonably related to the development and submission of information ..."), but rather was retained by the ANDA holder. We do not agree. Amphastar, as a generic drug manufacturer under an ANDA, cannot sell a batch of enoxaparin unless it has established that its strength and quality is consistent with the standards set forth in the relevant official compendium. See 21 U.S.C. §§ 331(a), 351(b). FDA regulations require that all records associated with a produced batch of drugs, including these batch records, "be retained for at least 1 year after the expiration date of the batch." 21 C.F.R. § 211.180(a). These records "shall be readily available for authorized inspection" by the FDA at any time. 21 C.F.R. § 211.180(c). We think that the requirement to maintain records for FDA inspection satisfies the requirement that the uses be reasonably related to the development and submission of information to the FDA. It is not disputed by the parties that these records are produced in order to develop and submit to the FDA proof that the Amphastar products comply with a Federal law. The fact that the FDA does not in most cases actually inspect the records does not change the fact that they are for the "development and submission of information under a Federal law." 35 U.S.C. § 271(e)(1); cf. Merck KGaA, 545 U.S. at 207, 125 S.Ct. 2372 (holding that uses which are not ultimately included in a submission to the FDA are nonetheless exempted by the safe harbor). Thus, we consider this information "submitted" for purposes of the statute. We turn then to the question of whether these submissions are within the safe harbor.
In Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 125 S.Ct. 2372, 162 L.Ed.2d 160 (2005), the Supreme Court held that uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the FDA, are nevertheless exempted from infringement by the safe harbor provision. Id. at 208, 125 S.Ct. 2372. The Court explained that
Id. at 206, 125 S.Ct. 2372. Thus, it was not an act of infringement to use patented compounds in preclinical studies which were not ultimately submitted to the FDA where "there [was] a reasonable basis for believing that the experiments [would] produce the types of information that are relevant to an IND or NDA." Id. at 208, 125 S.Ct. 2372.
However, in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1070 (Fed.Cir.2011), we held that § 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."
This case, however, fits well within Classen because the information submitted is necessary both to the continued approval of the ANDA and to the ability to market the generic drug. Here, the submissions are not "routine submissions" to the FDA, but instead are submissions that are required to maintain FDA approval. Amphastar is required to conduct a laboratory determination of identity and strength of the active ingredient for each batch of enoxaparin. See 21 C.F.R. § 211.165(a). This test must be done according to the patented methods described in an official compendium, in this case the United States Pharmacopeia (USP). See 21 U.S.C. § 351(b) (Any "determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium."). Moreover, as described above, FDA regulations require that all such batch records "be retained for at least 1 year after the expiration date of the batch," 21 C.F.R. § 211.180(a), and that such records "shall be readily available for authorized inspection" by the FDA at any time, 21 C.F.R. § 211.180(c); see also 21 C.F.R. §§ 211.186, 211.188, 211.194 (requiring "master production and control records," "batch production and control records," and "laboratory records"). Failure to comply with these requirements could result in suspension or revocation of Amphastar's ANDA approval to market the drug. See 21 U.S.C. §§ 335a(g), 355(e). Furthermore, such testing is "a condition for [the drug's] approval and release" into commerce, 21 C.F.R. § 211.165(d), thus acting as a predicate to the ability to market the ANDA-approved drug to the public.
The submissions to the FDA in this case are anything but "routine" — they implicate Amphastar's very ability to continue its FDA approval for its ANDA and to continue manufacturing and marketing enoxaparin under its ANDA. We also note that, unlike in Classen where the patented studies performed were not mandated by the FDA, the information here is not generated voluntarily by the manufacturer but is generated by FDA requirements the manufacturer is obligated under penalty of law to follow. Under such circumstances, the information can be said to have been gathered solely for submission to the FDA and not, as in Classen, primarily for non-FDA purposes. While Momenta urges us to adopt the pre-/post-approval distinction used by the district court, we cannot: Classen did not turn on this artificial distinction, and the plain language of the statute is not restricted to pre-approval
In this case, Momenta concedes that Amphastar's tests "are conducted in order to satisfy the FDA's requirements that each batch of enoxaparin that is sold commercially after FDA approval is actually the same as the brand name drug." Appellee's Br. at 40-41 (emphasis added); see also J.A. 56 (allegation that the "FDA requires" the accused testing). Under a proper construction of 35 U.S.C. § 271(e)(1), the fact that Amphastar's testing is carried out to "satisfy the FDA's requirements" means it falls within the scope of the safe harbor, even though the activity is carried out after approval. Unlike Classen, where the allegedly infringing activity "may" have eventually led to an FDA submission, there is no dispute in this case that Amphastar's allegedly infringing activities are carried out to "satisfy the FDA's requirements." The district court's interpretation of § 271(e)(1) was erroneous. Under the correct construction, Momenta cannot establish a likelihood of success on infringement and the preliminary injunction must be vacated. Genentech, Inc., 108 F.3d at 1364.
Momenta also argues that even if 35 U.S.C. § 271(e)(1) extends to post-approval activities, Amphastar's testing is not protected because there are FDA endorsed non-infringing alternatives available. The safe harbor, however, does not mandate the use of a noninfringing alternative when one exists. The only limitation in the safe harbor is that the use must be "reasonably related to the development and submission of information" pursuant to a federal law regulating the "manufacture, use, or sale of drugs or veterinary biological products." 35 U.S.C. § 271(e)(1). The safe harbor's protection is not limited to the dire situation where the patented invention is the only way to develop and submit the information. Instead, the safe harbor expressly allows the submitter the freedom to use an otherwise patented means to develop the necessary information demanded by the "Federal law." This makes good sense because it eliminates liability for infringement when that act of infringement is, in effect, required by the federal government as part of the continuing safety and efficacy monitoring of an approved drug. It also avoids the situation here, where a drug has received approval, but is nevertheless kept from the market based on an FDA mandated testing requirement.
Momenta's interpretation is predicated upon the incorrect assumption that "solely" in the context of 35 U.S.C. § 271(e)(1) means that the patented invention must be the "sole" means of providing the information for the safe harbor to apply. This is not the language of the statute: under 35 U.S.C. § 271(e)(1), as long as the use is "reasonably related to the development and submission of information" under a relevant statute, it is not an act of infringement. "Solely" modifies "uses reasonably
Even if Momenta's strained reading of the statute was supportable, Amphastar's allegedly infringing activities are clearly carried out according to the dictates of the Federal Food, Drug, and Cosmetic Act. Under the Act, Amphastar is prohibited from selling a drug if it is adulterated. 21 U.S.C. § 331(a). A drug is adulterated if it purports to be a drug listed in an official compendium, for example the USP, but in actuality differs in composition. 21 U.S.C. § 351(b); see also 21 U.S.C. § 321(j) (defining "official compendium"). In order to demonstrate that a drug is not adulterated, testing must be carried out pursuant to the methods articulated in the compendium, in this case the USP. See 21 U.S.C. § 351(b) (Any "determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium."). "For each batch of drug product, there shall be appropriate laboratory determination of ... the identity and strength of each active ingredient...." 21 C.F.R. § 211.165(a). FDA regulations characterize this testing as "a condition for [the drug's] approval and release" into commerce. 21 C.F.R. § 211.165(d). The FDA also mandates maintenance of appropriate records related to this type of testing. See 21 C.F.R. § 211.180(a) (production, control, and distribution records associated with a batch of drug must be retained for at least one year after the expiration date of the batch); see also 21 C.F.R. §§ 211.186, 211.188, 211.194 (requiring "master production and control records," "batch production and control records," and "laboratory records").
The USP entry for enoxaparin, the drug at issue in this litigation, states: "About 20 percent of the materials contain a 1, 6-anhydro derivative on the reducing end of the chain, the range being between 15 and 25 percent." J.A. 365 (USP Revision Bulletin, Official December 1, 2008). Thus, in order to be "enoxaparin" as defined in the
Finally, the dissent suggests that we must reject any disequilibrium between sections 201 and 202 of the Hatch-Waxman Act, that is, the safe harbor should not be available unless a patent term extension is also available. Dissenting Op. at 1370-71. This is not correct. The Supreme Court in Eli Lilly noted that equilibrium was not always achieved. See Eli Lilly, 496 U.S. at 671-72, 110 S.Ct. 2683. We too have rejected this strict interpretation of the safe harbor, explaining that "statutory symmetry is preferable but not required." Abtox, 122 F.3d at 1029 (holding that Class II medical devices, which are not subject to a "rigorous premarket approval process" and thus cannot receive patent term extensions, are nonetheless covered by the safe harbor).
Under the correct interpretation of 35 U.S.C. § 271(e)(1), Momenta's admission that Amphastar's testing is carried out to "satisfy the FDA's requirements," Appellee's Brief at 40-41, makes it unlikely that Momenta will succeed on the merits of its infringement claim. The district court's findings with respect to the irreparable harm, balance of the hardships, and public interest factors were all, to some extent, predicated on its erroneous conclusion that Momenta's patent was likely infringed by Amphastar's product. See J.A. 24 (applying a presumption of irreparable harm in view of Momenta's "showing of infringement and validity"); J.A. 29 (explaining that in light of the "showing of likelihood of success on the merits, the balance of hardship tips in [Momenta's] favor"); J.A. 30 (public interest favors protection of patent rights secured by valid patents). Because Momenta has not established a likelihood of success on its claim of infringement, the preliminary injunction must be vacated.
On remand, the district court may want to consider whether Momenta's admission that Amphastar's use of the patented invention is to "satisfy the FDA's requirements" makes this case amenable to summary judgment of non-infringement in favor of Amphastar. Because the safe harbor issue is dispositive, we need not reach the other arguments on appeal.
Costs to Appellants.
RADER, Chief Judge, dissenting.
By definition, a patent defines a right to exclude. Consistent with property principles, an infringer of a valid patent is an unlawful trespasser. The remedy for trespassing,
The public readily applauds the role of patents in the development and delivery to the marketplace of life-saving drugs or modern technology products like smartphones. At the same time, many incremental advances contribute to these monumental advances or, as in this case, enhance their delivery to the public. These incremental inventions also represent difficult and expensive advances in technology. For example, in this case, Amphastar had a strong incentive to invent this patented manufacturing method. As the first-filer, it would have obtained 180 days of market exclusivity as the only seller of the generic drug — a right worth $260 million per quarter. Nevertheless, Amphastar could not make that invention. Instead, the patentee Momenta made the investment, did the research, and engineered the new method disclosed in the '886 patent.
At that point, Amphastar stepped in and took Momenta's patented invention without permission and used it to manufacture each commercial batch it sells on the market. Indeed Amphastar continues to trespass and promises to trespass for years to come. In fact, as the court repeatedly acknowledges, Amphastar is only able to compete with Momenta by taking its patented invention. Amphastar has not developed its own method, but instead delights in trespassing and refuses to pay a reasonable royalty to make the trespass lawful.
This court would allow this arrogance to continue by expanding the limited reach of 35 U.S.C. § 271(e)(1). This expansion of the law circumvents the purpose of the law and ignores the binding precedent of Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed.Cir.2011). Sadly this result will render worthless manufacturing test method patents. Accordingly, I must respectfully dissent.
The Supreme Court has observed that the text alone of § 271(e)(1) can be "not plainly comprehensible." Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). The purpose of this text, which ought to inform its application, however, is evident from the legislative history. The legislative history of § 271(e)(1) includes more than 2 House reports, 25 statements and letters, and many pages of Congressional testimony. A review of this extensive material shows that section 202 of the Hatch-Waxman Act, enacted as § 271(e)(1), had the sole purpose of overruling this court's holding in Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir.1984). In particular, § 271(e)(1) applied only in limited situations, namely pre-approval experiments to obtain FDA approval:
H.R.Rep. No. 98-857, pt. 1, at 45-46 (1984), 1984 U.S.C.C.A.N. 2647, 2678-2679 (emphases added).
H.R.Rep. No. 98-857, pt. 2, at 27 (1984), 1984 U.S.C.C.A.N. 2686 at 2711. See also Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on Courts, Civil Liberties and the Admin. of Justice of the H. Comm. on the Judiciary, 98th Cong. 742 (1984) (statement of Laurence H. Tribe, Professor of Law, Harvard Law School) ("Section 202, the thrust of which is to overturn Roche v. Bolar legislatively"); Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on Courts, Civil Liberties and the Admin. of Justice of the H. Comm. on the Judiciary, 98th Cong. 826 (1984) (letter from Bernarr R. Pravel, President, American Intellectual Property Law Association) ("Section 202 is intended to reverse the April 23, 1984, decision of the Court of Appeals for the Federal Circuit in Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed.Cir. 1984)."); Memorandum from Congressional Research Service, The Library of Congress, American Law Division to House Judiciary Committee, located at H.R.Rep. No. 98-857, pt. 2, at 27 n.18 (1984), 1984 U.S.C.C.A.N. 2686 at 2711.
Roche v. Bolar held that the limited pre-approval experiments to obtain FDA approval still infringed a valid patent. See 733 F.2d at 861 ("The district court correctly recognized that the issue in this case is narrow: does the
130 CONG. REC. 23060 (1984) (statement of Rep. Robert W. Kastenmeier, Chairman of the Subcommittee on Courts, Civil Liberties and the Administration of Justice, Committee on the Judiciary) (emphases added).
The Pharmaceutical Manufacturers Association echoed the Chairman's analysis of the purpose of the bill:
Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on Courts, Civil Liberties and the Admin. of Justice of the H. Comm. on the Judiciary, 98th Cong. 696 (1984) (letter from Pharmaceutical Manufacturers Association) (emphases added).
On the other side of the industry, the Generic Pharmaceutical Industry Association agreed that section 202 is only for limited pre-approval experiments:
Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on Courts, Civil Liberties and the Admin. of Justice of the H. Comm. on the Judiciary, 98th Cong. 926 (1984) (memorandum of Alfred B. Engleberg, Patent Counsel, Generic Pharmaceutical Industry Association) (emphases added).
The executive branch favored an even more limited exception than the one proposed in section 202 and enacted as § 271(e)(1). Nevertheless, it clearly understood the boundaries of section 202 to be pre-approval experimental use.
Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on Courts, Civil Liberties and the Admin. of Justice of the H. Comm. on the Judiciary, 98th Cong. 812 (1984) (letter from David A. Stockman, Director, Office of Management and Budget, to Rep. Edward R. Madigan, Subcomm. on Health and the Environment, H. Comm. on Energy and Commerce) (emphasis added).
The pharmaceutical industry expressed concern about permitting trespass on exclusive rights, but this concern dissipated with promises that § 271(e)(1) only allowed "limited testing of drugs." See H.R.Rep. No. 98-857, pt. 2, at 29 (1984), 1984 U.S.C.C.A.N. 2686 at 2714.
Id. at 30 (emphases added).
Specifically, § 271(e)(1) won approval because it was limited in time, quantity, and type. First, as to time, § 271(e)(1) only applies to
Second, as to quantity and type, § 271(e)(1) only applies to experimentation — and therefore would have limited impact on the patentee's exclusivity during
In particular, the authors made clear that section 271(e)(1) would not apply to commercial sales, i.e., the "infringing" product would not enter the market until after the patent's life. H.R.Rep. No. 98-857, pt. 1, at 45 (1984), 1984 U.S.C.C.A.N. 2647 at 2678 ("This section
The authors of this section (and I hesitate to add that I was present through this legislative process) did not imagine that § 271(e)(1) would allow continuous, commercial infringing sales during any portion of the life of the patent. As discussed below, Amphastar has already obtained FDA regulatory approval, and today this court rewrites the law to allow Amphastar to infringe Momenta's patent throughout the entire life of Momenta's patent and for the purpose of obtaining profits on commercial sales of a product that competes with the patentee.
Nowhere in the legislative history can this court find any suggestion that § 271(e)(1) would apply other than in the limited scenario of conducting de minimis experiments pre-approval (i.e., to obtain FDA approval). Nowhere in the legislative history can this court find a hint that an "infringer" could continue to use its competitor's patented method in manufacture of each commercial batch for contemporaneous sale. Nowhere in the legislative history can this court find any mention of the post-approval, continuous, commercial sales allowed by this decision. Nowhere in the legislative history can this court find any suggestion that the mere maintenance or retention of information as part of a company's records is considered a submission that would trigger § 271(e)(1). In fact, this court makes no attempt to examine the legislative history of this section at all — a very telling silence.
To facilitate a post-approval, continuous, commercial use, the court discounts the word "solely." Indeed, throughout its opinion, the court cites the language of the statute yet omits the word "solely." See Majority Op. 1355, 1355-56, 1356, 1356-57, 1359, 1359-60. If one properly reads "solely" as the statute says, the result must be that Amphastar's activity is not within the statute. Its infringing activity is
Second, the court claims that the mere retention of records can satisfy the "submission" requirement in § 271(e)(1). By essentially stating that "submission" can mean not really submitting, this new interpretation reads this requirement out of the statute as well.
Specifically, despite the plain meaning of "submission of information" to mean the company actually submitting information to the FDA, the court interprets "submission of information" to mean the mere retention of information as part of a company's records. Majority Op. 1357 ("We think that the requirement to
This new interpretation would allow almost all activity by pharmaceutical companies to constitute "submission" and therefore justify a free license to trespass. The FDA can inspect records of any drug manufacturer and seller. See 21 U.S.C. § 374. Thus, the drug manufacturer need only make a record, which could potentially be inspected by the FDA, and then any activity could satisfy this new meaning of "submission."
Therefore, a reading of all the words in the statute and a reading of those words in light of their legislative history shows that § 271(e)(1) only permits a limited amount of pre-approval experiments to obtain FDA approval. Thus, the statute limits the exception to "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products."
This court has already decided the meaning of this statute in Classen. The Classen majority held "§ 271(e)(1) provides an exception to the law of infringement in order
Classen also looked to Supreme Court precedent, such as Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990) and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 125 S.Ct. 2372, 162 L.Ed.2d 160 (2005): "Every decision examining the statute has appreciated that § 271(e)(1) is directed to
Id. at 1072 n. 4 (bold emphasis added).
Here, Amphastar uses Momenta's patented method in the manufacture of each commercial batch it sells. By definition, its use is not to obtain FDA approval. One can only market a drug that the FDA has already approved. Amphastar is not using Momenta's patented method for pre-approval, limited experimental use. It is not pre-approval because Amphastar has already obtained approval. See Appellant Br. 7 (Amphastar received FDA approval on September 19, 2011.); Majority Op. 1359 ("It also avoids the situation here, where a drug has received approval ..."). Thus, its activity is post-approval. It is not limited because Amphastar uses Momenta's invention on a continuous basis in the manufacture of each commercial batch and during the life of Momenta's patent. It is not experimental because Amphastar uses Momenta's invention in manufacturing each commercial batch of its product for contemporaneous sale on the market (in commerce) to obtain profits and to compete with Momenta. This is a commercial use of an invention by a competitor to compete and trespass on the inventor's exclusive right. Amphastar's use is not for premarketing FDA approval and therefore Classen definitively holds that § 271(e)(1) does not apply here.
To come out the exact opposite way, the court first claims Classen did not turn on the pre-/post-approval distinction. Majority Op. 1358. Second, the court claims Classen merely held that § 271(e)(1) does not apply to "routine" submissions. Therefore, this court opines: "This case, however, fits well within Classen because the information submitted is necessary both to the continued approval of the ANDA and to the ability to market the generic drug. Here, the submissions are not `routine submissions' to the FDA, but instead are submissions that are required to maintain FDA approval." Majority Op. 1358.
At the outset, this court must stretch too far to claim Classen did not turn on a pre-/post-approval distinction. The dissent actually helps identify the holding in Classen.
Further, the parties and the amici certainly thought Classen turned on a pre-/post-approval distinction. See, e.g., Classen's Opposition to Petition for Rehearing En Banc, at *1 ("Plaintiff-Appellant agrees with Hatch-Waxman, The United States Supreme Court and the Federal Circuit: 35 U.S.C. § 271(e)(1) applies only to
Moreover, this court in Classen did not at any point state that § 271(e)(1) applies to information "necessary both to the continued approval of the ANDA and to the ability to market the generic drug." Majority Op. 1358. Indeed, this post-approval, continuous, commercial use is the exact opposite of the Classen rule. Classen rested its holding on "premarketing approval," 659 F.3d at 1070, 1071, "limited amount of testing," id. at 1071, and "experimentation," id.
This decision ("post-approval studies"; "after approval"; "not restricted to pre-approval activities") cannot be genuinely reconciled with Classen ("pre-marketing approval"). Instead, the court in this decision uses the same language as the dissent in Classen ("post-approval"; "I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the FDCA, including information regarding post-approval uses"). This decision should instead request the entire court to resolve the issue en banc.
The court distinguishes Classen by characterizing the activities in that case as not "mandated by the FDA," while the activities here are. Some context is in order. The patented method here is "mandated" only in that Momenta thus far has created and developed the only successful method by which one can show the FDA's requirement has been met. Amphastar is free to invent its own method to satisfy these requirements. Instead it chooses to trespass. Because it has not ventured to find another way to perform these tests, it is unfair to suggest that Amphastar's hands are tied. Indeed, to the extent the court is creating a new expansion of the statute that covers anything "mandated" by the FDA, this would unfairly attack inventors of the newest and most successful method. Such a method would be adopted or "mandated" by the FDA and then trigger the court's new infringement exception. Needless to say, that would be the exact opposite from a system that incentivizes creation and improvement.
This court's interpretation of § 271(e)(1) would essentially render manufacturing method patents worthless. This court repeatedly states that the FDA's adoption of Momenta's patented method as a standard means that § 271(e)(1) should apply. Majority
In essence, this reasoning repeals the incentives and protections of the patent act in this area. A patentee invents the first and (at the time) best method. Because of the success and utility of the inventive method, the FDA adopts that method as a standard. Because that method is "required by the FDA," this court would permit copiers to infringe. What incentive remains to invest in inventing a better test? Imagine a teacher who rewards the top student by allowing her peers to copy her exam answers. Needless to say, this approach does violence to patent law and future research incentives in this field.
And what happens if a second, less effective (patented) method appears? Will copiers be allowed to infringe that method, too? Or, instead, because it is not as good and the FDA does not adopt it as the standard, then the court's new interpretation of § 271(e)(1) does not apply and copiers can infringe the first, best method but not the second, less effective method?
The Supreme Court cases Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990) and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 125 S.Ct. 2372, 162 L.Ed.2d 160 (2005) support the holding in Classen and do not support this decision. Both holdings in Eli Lilly and Merck dealt with pre-approval activity and submissions, meaning before obtaining FDA approval. Further, neither even suggested that the mere maintenance or retention of information as part of a company's records could be a "submission" to the FDA. Nevertheless, the court takes phrases from those opinions out of context to allege that its new interpretation of § 271(e)(1) is consistent with those cases.
In Eli Lilly, the Supreme Court addressed whether § 271(e)(1) applies to medical devices in addition to drugs. 496 U.S. at 663-64, 110 S.Ct. 2683 ("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 (FDA) information necessary to obtain marketing approval for a medical device under § 515 of the Federal Food, Drug, and Cosmetic Act (FDCA), 90 Stat. 552, 21 U.S.C. § 360e.").
The Supreme Court described how §§ 201 and 202 should be read together. Section 201 concerns activity in the early years of a patent's life. Section 202 concerns the latter years. Each section is a reciprocal counter to the other. Importantly, Congress intended the sections to deal with "premarket regulatory approval":
496 U.S. at 669-670, 110 S.Ct. 2683 (emphases added). Therefore:
Id. at 670-71, 110 S.Ct. 2683 (emphasis added).
The 1984 Act enacted the two sections to create a balance. The Supreme Court rejected the party's attempt to create a "disequilibrium" between the two sections. Id. at 672, 110 S.Ct. 2683.
This court's new interpretation in this case would apply the disadvantage of § 202 to a patentee who would not be able to obtain the benefits of § 201. The patentee of a manufacturing patent does not obtain the patent extension created in § 201, yet this court's new expansion of § 202 would allow its competitors to infringe during the life of its patent. The Supreme Court rejected this sort of disequilibrium. See Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed.Cir.2008) (relying on Merck to hold that § 271(e)(1) does not apply to infringement of patented product not eligible to obtain patent extension).
This court's new interpretation does not reserve § 202 for the "end of the patent term." Instead, its interpretation allows infringing activity continuously throughout the life of the patent, including the "early years" reserved for § 201. If, as the court claims, § 202 was meant to cover the continuous, commercial use throughout the
And, as already discussed, this new interpretation expands beyond "premarket regulatory approval." See 496 U.S. at 669-670, 110 S.Ct. 2683. Its interpretation allows infringing activity after the product has already been approved for sale on the market.
Surprisingly, the court claims that its "analysis is not groundbreaking: the Supreme Court came to essentially the same conclusion in 1990" and cites Eli Lilly. Majority Op. 1355-56. It has been quoted that "Words are easy, like the wind." Saying that something "is not groundbreaking" does not make it so.
Nowhere in Eli Lilly does the Supreme Court come to "essentially the same conclusion" as the majority here. The Supreme Court does not say that the mere maintenance or retention of records — with no intention to submit to the FDA but that only could potentially be viewed by the FDA if the FDA requested it — would satisfy as a "submission" to the FDA. The Supreme Court does not sanction post-approval activity. The Supreme Court does not read the word "solely" out from the statute.
It is more telling what the court's reasoning omits than what it cites. The court only relies on a single sentence from Eli Lilly, which it quotes out of context. 496 U.S. at 666, 110 S.Ct. 2683 ("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 Supreme Court was not even referencing the same phrase that is at issue here: "a Federal law," not "submission." In fact, that sentence is not even in the section in the Supreme Court's opinion that discusses the basis on which the Court decided the case. Instead, that sentence is in a prior section discussing the text of the statute, which the Supreme Court found "somewhat more naturally reads as the Court of Appeals determined, but that is not plainly comprehensible on anyone's view." Id.
The sentence cited by this court is not even a definitive holding of the Supreme Court but instead a discussion of the parties' arguments. In looking at the paragraphs following the one cited by this decision, the Supreme Court states the case for the opposing side: "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?" Id. at 668, 110 S.Ct. 2683. On other occasions, the Federal Circuit advises against this type of slanted wordsmithing.
In Merck, the Supreme Court addressed whether § 271(e)(1) applies to research intended for submission for FDA approval but ultimately not submitted to the FDA. 545 U.S. at 195, 125 S.Ct. 2372 ("This case presents the question whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U.S.C.
Nowhere does Merck suggest that post-approval, commercial, continuous infringing use would be permitted. Indeed, Merck clearly lays out that § 271(e)(1) is intended for pre-approval, experimental, limited use.
545 U.S. at 207, 125 S.Ct. 2372 (emphases added).
This court relies on some text from Merck that appears superficially to suggest an expansive interpretation of § 271(e)(1). But, read in context, that language has another meaning entirely. This language appears to suggest that § 271(e)(1) covers any sort of information or submission. But, this language actually appears in the context of the issue in Merck of whether information intended for submission to the FDA for approval should be covered when the information was ultimately not submitted because the drug candidate in that case lacked potential. This context is apparent in the sentences next to the sentence quoted by the majority, which state:
Id. at 207, 125 S.Ct. 2372 (emphases added).
Merck does not reduce the importance of the limitation that § 271(e)(1) is reserved
As another point, this court claims that "the Court explicitly rejected the notion that § 271(e)(1) was limited `to the activities necessary to seek approval of a generic drug.'" Majority Op. 1356. But, it is important to understand what Merck was trying to distinguish. Read in context, that phrase is referring to allowing § 271(e)(1) to include pre-approval activities for a branded drug. It was
Just because Merck held that § 271(e)(1) could cover pre-approval activities for not only the ANDA but also the NDA and IND, does not mean that the mere retention of documents as part of a company's records could be considered a "submission" to the FDA. In other words, if a house owner allows a hired painter to paint his house any and all shades of brown, that is not permission to choose neon orange or turquoise.
Thus, while Merck said that as long as an activity was intended for submission to obtain approval, then § 271(e)(1) applies even if the information is not actually submitted (because it is difficult to predict which drug candidates ultimately will be successful), it did not say that § 271(e)(1) applies even if the activity was never intended to obtain approval at all. Or if the information was not even intended for submission to the FDA. This court's interpretation (that the mere retention of information as part of a company's records can be a "submission" to the FDA) is indeed "groundbreaking" and the Supreme Court did not "come to essentially the same conclusion."
The safe harbor provision at issue in this case, due to its origin and purpose in reversing Roche v. Bolar, receives attention as an exception that permits experimentation. This link to experimentation and its role in advancing the progress of technology requires some commentary as well. Too often patent law is misunderstood as impeding more than promoting innovation. This academic proposition, called the tragedy of the Anti-commons in some scholarly presentations, suggests that exclusive rights impede the flow of information and limit experimentation that might lead to the next generation of technological advance. Michael A. Heller & Rebecca S.
In the first place, in an era of empirical research, one might ask the reason that this academic notion has never actually been verified. Although studied, no research has substantiated this alleged attack on the patent system. In fact, "the effects predicted by the anti-commons hypothesis are not borne out in the available data." Timothy Caulfield, Human Gene Patents: Proof of Problems?, 84 Chi.-Kent L.Rev. 133, 137 (2009); see also American Association for the Advancement of Science, INTERNATIONAL INTELLECTUAL PROPERTY EXPERIENCES: A REPORT OF FOUR COUNTRIES 12 (2007) (finding the results of a 2006 survey of U.S. and Japanese researchers "offer very little evidence of an `anticommons problem'" and that "IP-protected technologies remain relatively accessible to the broad scientific community"). Surveys of academic researchers have revealed that "only 1 percent ... report having to delay a project, and none abandoned a project due to others' patents." Wesley M. Cohen & John P. Walsh, Real Impediments to Academic Biomedical Re search, in 8 INNOVATION POLICY AND THE ECONOMY 1, 10-11 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds. 2008), available at http://www.nber. org/&mtilde;arschke/mice/Papers/cohenwalsh.pdf (citing John P. Walsh et al., The View from the Bench: Patents, Material Transfers and Biomedical Research, 309 SCIENCE 2002 (2005)). In other words, patents on research tools and biomedical innovations do not significantly slow the pace of research and do not deter researchers from pursuing promising projects.
The reason that patents have not been proven to impede more than stimulate technological advance is simple: it does not happen. It does not happen for several reasons. First, experiments advancing technology rarely, if ever, generate commercial value. Thus patent owners have little, if any, incentive to license or inhibit research. Stated otherwise, even if a patent owner wanted to sue or license potential researchers, experiments do not produce income or a source of damages. See id. at 12.
Second, in the modern age of technology, the character of technological advance has changed. The era when the Bell Labs or some other tech center could hire the most promising engineers and essentially invent everything for the world has passed. With the vast specialization of all fields of research, advances in technology require great cooperation. A new product or a new direction in biotechnology or electronics will be produced by cooperation between a professor in Chengdu, China, a young programmer in Bangaluru, India, an engineer at a large corporation in Munich, Germany, a graduate student at Tokyo University, and a team at a small start-up company in Silicon Valley. The patent system can help inform each of them of the other and bring together their incremental advances to achieve the next generation of progress in some tiny corner of human progress.
Thus, patents properly remain a tool for research and experimentation because the system encourages publication and sharing of research results. Disclosure of how to make and use the invention is the "quid pro quo" of the patent grant. See JEM Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 142, 122 S.Ct. 593, 151 L.Ed.2d 508 (2001). In exchange for disclosure, the inventor receives a limited term of exclusivity to benefit from commercialization
Every day, Amphastar, a competitor of Momenta, is infringing Momenta's patent. This decision allows that trespass. Moreover, to reach that result, this court must ignore its own prior decision in Classen and the purpose of the statute explained in the legislative history. Sadly this decision abrogates Momenta's hard-achieved property right and reallocates that entitlement to its competitors — a sad day for property owners and an undeserved victory for those who decline to invest in the expense and difficulty of discovery and invention.
