T. S. Ellis, III, United States District Judge.
In this Administrative Procedure Act ("APA")
The parties filed cross-motions for summary judgment, which have now been fully briefed and argued. Accordingly, the motions are now ripe for disposition.
At the outset, a brief overview of the pertinent statutory and regulatory framework is useful. The FDA oversees the review and market approval of new drugs and medical devices pursuant to the Federal Food, Drug, and Cosmetic Act ("FDCA").
FDA review of a new drug or medical device is often a lengthy process, not uncommonly requiring years to complete. The time-consuming nature of this process can impose certain significant costs on the holders of patents claiming new drugs or medical devices. Specifically, federal law generally provides a twenty-year term for a patent, starting from the date on which the patent application is filed. See 35 U.S.C. § 154(a)(2). This general rule places patents claiming FDA-regulated drugs or medical devices (or methods of using or manufacturing such drugs or medical devices) at a disadvantage, as many years of the patent's term can pass while the product awaits FDA approval. Because the patent owner cannot market the claimed product commercially without FDA approval, several years of the patent monopoly can be entirely unprofitable. See, e.g., Glaxo Operations UK Ltd. v. Quigg, 706 F.Supp. 1224, 1225 (E.D.Va.1989) (observing that FDA review and approval "often require[s] years to complete, thereby diminishing the commercial rights provided by the patent"), aff'd, 894 F.2d 392 (Fed.Cir.1990). Thus, an important policy concern in this area is that inventors may well not have sufficient incentive to expend the resources necessary to develop new
Title II of the Hatch-Waxman Act represents Congress's solution to this problem by seeking to ease the tension between ensuring safe drugs and medical devices on the one hand and incentivizing the development of new drugs and medical devices on the other. The mechanism for doing so involves extending the terms of certain patents claiming products (or methods of using or manufacturing products) subject to FDA review and approval. See Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 396 (Fed. Cir.1990) (The Hatch-Waxman Act "encourage[s] new drug research by restoring some of the patent term lost while drug products undergo testing and await FDA pre-market approval."). Thus, once the FDA's regulatory review of a product has concluded, the owner of a patent "which claims [the] product, a method of using [the] product, or a method of manufacturing [the] product" can apply to the PTO for an extension of the patent's term pursuant to the Hatch-Waxman Act. See 35 U.S.C. § 156(a). If the product and the patent meet certain statutory criteria, the PTO "shall" extend the term of the patent. Id. In other words, term extensions are mandatory for patents that qualify under § 156.
The PTO's final decision on a patent term extension application is an "agency action" subject to judicial review under the APA. As such, the PTO's final decision on whether to grant or to deny a patent term extension application may be "set aside" if it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A).
The '447 patent — titled "Therapeutic Inhibitor of Vascular Smooth Muscle Cells" — issued on September 22, 1998. See U.S. Patent No. 5,811,447, at ,  (filed May 25, 1995). As relevant here, claim 12 of the '447 patent recites "[a] method for biologically stenting a mammalian blood vessel, which method comprises administering to the blood vessel of a mammal a cytoskeletal inhibitor in an amount and for a period of time effective to inhibit the contraction or migration of the vascular smooth muscle cells." Id. col. 76, ll. 41-46.
In addition to being the exclusive licensee of the '447 patent, plaintiff also manufactures the Zilver PTX, which performs both physical and biological stenting of blood vessels. Specifically, the Zilver PTX is a self-expanding nitinol
In June 2010, plaintiff applied for FDA approval to market the Zilver PTX commercially. The Zilver PTX is a combination product in that it comprises device and drug components, and the FDA determined that its primary mode of action is that of a device. Accordingly, the FDA agency center charged with premarket review of devices had primary jurisdiction to review the Zilver PTX. See 21 U.S.C. § 353(g)(1)(B). The FDA granted the premarket approval application for the Zilver PTX on November 14, 2012.
On December 7, 2012, shortly after FDA approval of the Zilver PTX, plaintiff filed with the PTO an application for a patent term extension for the '447 patent.
In October 2015, the PTO issued an initial decision denying plaintiff's application for a patent term extension. Thereafter, plaintiff unsuccessfully sought reconsideration of the initial decision, and the PTO issued its final decision denying plaintiff's application on December 11, 2015. The PTO's final decision explained that the Zilver PTX was reviewed and approved by the FDA as a medical device, and hence, in the PTO's view, in order for a patent to claim a method of using the medical device, the patent must recite one or more structural elements of the device. The PTO reached this conclusion by referencing the definition of "device" in the FDCA, which focuses on structural features to the exclusion of chemical features.
On December 21, 2015, plaintiff filed the instant action seeking judicial review of the PTO's final decision denying the application for a patent term extension.
As this case involves a federal agency's interpretation of a federal statute, an important threshold consideration is whether the PTO's interpretation of the Hatch-Waxman Act, which in relevant part amended the Patent Act, is entitled to any deference. Judicial deference to administrative interpretations of federal law manifests in two separate doctrines, namely Skidmore deference
The PTO correctly does not request Chevron deference for the statutory interpretation advanced in the final decision denying plaintiff's patent term extension application. Indeed, "Chevron deference is generally reserved for agency interpretations set forth after notice-and-comment rulemaking or a formal adjudication," and patent term extension decisions are mere "informal adjudications." Meds. Co. v. Kappos, 731 F.Supp.2d 470, 475 (E.D.Va.2010) (applying, inter alia, Mead Corp., 533 U.S. at 231-34, 121 S.Ct. 2164, and concluding that patent term extension decisions are not entitled to Chevron deference). The informal nature of the PTO's patent term extension decisions is sufficient, standing alone, to preclude Chevron deference. See id. But on an even broader level, "[b]ecause Congress has not vested the [PTO] with any general substantive rulemaking power ... the rule of controlling deference set forth in Chevron does not apply."
Yet, the PTO argues that its interpretation is entitled to the weaker form of deference under Skidmore. This argument must be welcome news for Skidmore, which has had a rough go of it ever since the birth of Chevron. Like the figurative older child neglected in the wake of a new sibling's arrival, in 1984 Skidmore was relegated to the status of an administrative law sideshow while the federal courts fawned over Chevron. Indeed, by the age of just three and a half years, courts had cited Chevron over six hundred times,
But Skidmore still has at least one friend — the Federal Circuit — where "Skidmore deference carries more force than in other circuits." Exelixis, Inc. v. Kappos, 906 F.Supp.2d 474, 483 n. 21 (E.D.Va. 2012), vacated and remanded on other grounds sub nom., Exelixis, Inc. v. Lee, 550 Fed.Appx. 894 (Fed.Cir.2014). Indeed, although the Supreme Court has not provided much guidance on the application of Skidmore other than to suggest that "some deference" or "respect" is due to any reasonable agency interpretation of a statute the agency administers,
Yet, even under the Federal Circuit's approach to Skidmore deference, the PTO's interpretation of the Hatch-Waxman Act here is entitled to no deference for at least two reasons. First, the PTO's interpretation of § 156(a) in this case does not qualify for Skidmore deference under the Federal Circuit's Cathedral Candle decision. To begin with, on this record it is unclear that the PTO's position represents an "agency-wide policy" rather than a determination limited to this case. Cf. Meds. Co., 731 F.Supp.2d at 477 (observing that patent term extension decisions are non-precedential). Without such an assurance, Skidmore deference is inappropriate under Cathedral Candle, 400 F.3d at 1366. Moreover, the PTO's statutory interpretation here cannot fairly be characterized as "careful," which the Federal Circuit also requires before Skidmore deference is appropriate. Id. The PTO's analysis of § 156 makes at least two critical assumptions, namely (i) that the FDA's determination of a product's primary mode of action is relevant to whether a product is a drug or a device for purposes of § 156 and (ii) that the FDCA's definition of "device" applies to § 156. Regardless whether these assumptions are right or wrong — and as Part III, infra, shows, they are mistaken — the PTO's analysis is not "careful" because the PTO never sought to justify these critical assumptions. See id. Rather, the PTO's final decision merely asserts the assumptions as foregone conclusions. See A872 ("Because the review of the [Zilver PTX] was under section 515 of the [FDCA] and not section 505 of the [FDCA], the method of using the approved product (medical device) must be a method of using [a device as defined in the FDCA]."). Thus, no Skidmore deference is due under Cathedral Candle.
But more fundamentally, even assuming that the PTO's interpretation satisfied Cathedral Candle, it is doubtful that the PTO should be afforded Skidmore deference for an interpretation of a substantive provision of the Patent Act, such as § 156. Indeed, the Federal Circuit in Cathedral Candle discussed deference to the U.S. International Trade Commission's interpretation of a statute, not the PTO's interpretation of the Patent Act. Id. at 1366-67. To be sure, there are cases in which courts have suggested that Skidmore deference may apply to PTO interpretations of the Patent Act in some instances,
To elucidate this point, although the Supreme Court has acknowledged that Skidmore may well apply "where statutory circumstances indicate no intent to delegate general authority to make rules with force of law, or where such authority was not invoked," this observation was made in the context of an agency's administration of a "regulatory scheme" characteristic of the administrative state. See Mead Corp., 533 U.S. at 235, 237, 121 S.Ct. 2164. Yet, the nation's patent law regime is not a regulatory scheme in the typical administrative law sense; rather, the Patent Act operates much more like a traditional common law unilateral contract offer by Congress. Specifically, Congress has offered that if an inventor makes a discovery meeting certain criteria, then the United States will grant the inventor an intangible property right in that discovery. See 35 U.S.C. §§ 101-03 (criteria for patentability). Importantly, it is Congress that has stated the terms of the offer, and the PTO's job is merely to determine whether any given inventor purporting to have accepted the offer has, in fact, done so. In this respect, the PTO is not engaged in a regulatory function, but instead serves as Congress's
In light of the foregoing, when the PTO litigates a dispute under the Patent Act like the instant case, the PTO essentially stands as an offeror's agent in a contract dispute. In the law of unilateral contracts, which provides a conceptually helpful analogy, there is no background rule that an offeror (or an offeror's agent) receives a thumb on scale on interpretative matters merely by advancing a "careful," "consistent," and "reasonable" argument about the contract's meaning. See Cathedral Candle, 400 F.3d at 1366 (interpreting Skidmore as requiring deference where these criteria are present). Nor is there a background presumption that a party to a contract is more likely to understand the contract's terms by virtue of having been a party to many similar contracts in the past. In short, Skidmore deference — or something akin to such deference — is never due to an offeror in a contract dispute merely by virtue of his status as offeror or as a repeat player with a certain type of contract. And there is no compelling, rational reason to conclude that the PTO should be treated any differently from an ordinary contract litigant merely by virtue of the fact that the PTO is an agency. In other words, what should matter for purposes of judicial deference under Skidmore is the substance of what an agency does. Where, as here, the agency is more fairly viewed as a contracting party's agent than a regulator, this must surely be a relevant "factor" bearing on the PTO's "power to persuade." Skidmore, 323 U.S. at 140, 65 S.Ct. 161. To conclude otherwise would be to accept a form of categorical administrative agency exceptionalism in which anything reasonable that an agency says about a statute relevant to its work is entitled to some respect simply because the agency says it. At bare minimum, such respect should be limited to agencies functioning in a regulatory capacity, as the status as regulator is at least arguably reflective of the agency's specialized expertise.
Nothing stated here should be understood as an attack on the authority of Chevron or Skidmore when applied in the proper circumstances. To the contrary, the purpose of this discussion has been to suggest that federal courts should not decouple deferential doctrines from the justifications for those doctrines. There is no dispute that Chevron and Skidmore are limited to "an agency's construction of a statute it is charged with administering." Cathedral Candle, 400 F.3d at 1365. The conclusion here is simply that, properly understood, the PTO is not "charged with administering" the Patent Act in a regulatory sense. Id. Thus, the logic of Skidmore does not fit comfortably with the functions of the PTO. Specifically, because the PTO's functions, as relevant here, are more analogous to those of an agent engaged in the ordinary private law task of complying with contract-like agreements affecting the disposition of property rather than those of a public law entity engaged in regulation, the indicia of expertise that warrant Skidmore deference are not present here. Put more simply, given
In sum, (i) because the PTO's interpretation of § 156 here is neither carefully reasoned nor constitutes agency-wide policy and (ii) because the logic of Skidmore does not apply to PTO interpretations of substantive provisions of the Patent Act like § 156, no deference is due here to the PTO's interpretation of § 156 as reflected in the final decision denying plaintiff's application.
Analysis now turns to the merits of the precise question presented. Although the parties disagree with one another on multiple issues, the dispute between the parties boils down to a single question: Does the '447 patent "claim ... a method of using" a "medical device" as those terms are used in the Hatch-Waxman Act? See 35 U.S.C. § 156(a), § 156(f)(1)(B). In essence, plaintiff's position is that claim 12 of the '447 patent is an open method of biologically stenting a mammalian artery, and therefore the method may well include the use of the Zilver PTX. The PTO, in opposition, stands by its administrative determination that because the FDA reviewed the Zilver PTX as a device, the Zilver PTX is also a device for purposes of § 156, and in light of the definition of "device" in the FDCA, the '447 patent can claim a method of using the Zilver PTX only if the patent recites one or more structural elements of the product.
The task here is to determine the correct interpretation of § 156. If the PTO denied plaintiff's application "based on an erroneous interpretation of law," then the PTO committed an abuse of discretion under the APA. See Arnold P'ship v. Dudas, 362 F.3d 1338, 1340 (Fed.Cir.2004). At the same time, if the PTO's erroneous interpretation resulted in no "prejudicial error," then affirmance of the PTO's decision may still be appropriate. See 5 U.S.C. § 706; Shinseki v. Sanders, 556 U.S. 396, 406, 129 S.Ct. 1696, 173 L.Ed.2d 532 (2009) ("[T]he APA's reference to prejudicial error is intended to sum up in succinct fashion the harmless error rule applied by the courts in the review of lower court decisions as well as of administrative bodies.") (internal quotations and alterations omitted).
As a preliminary matter, the PTO argues that certain of plaintiff's statutory arguments have been waived and cannot be considered. These arguments fail.
As the Federal Circuit has observed, "a party generally may not challenge an agency decision on a basis that was not presented to the agency." In re DBC, 545 F.3d 1373, 1378 (Fed.Cir.2008). This rule finds its roots in "considerations of practical justice," which include (i) allowing an agency to correct its own mistakes and (ii) promoting judicial efficiency by keeping out of court claims that could be quickly and economically resolved before the agency. See id. at 1378-79 (internal quotations omitted). These principles point conclusively to the absence of a waiver on this record.
Plaintiff's position throughout the patent term extension application process has been that the PTO is misreading the Hatch-Waxman Act by imposing as a limitation on patent term extension eligibility
Precisely this occurred here. Every statutory argument plaintiff advances in this lawsuit, although perhaps not "ardently and cogently" presented to the PTO, relates directly to plaintiff's fundamental premise as that premise was presented to the PTO during the administrative process. Id. The PTO's position, in effect, is that plaintiff can argue in federal court only the precise statutory arguments presented to the PTO. Yet, to accept the PTO's position would be to run roughshod over the purposes of the waiver doctrine. Plaintiff's statutory arguments about the meaning of the Hatch-Waxman Act gave the PTO ample opportunity to adopt an interpretation that would satisfy plaintiff. An agency is not entitled, as a matter of course, to pre-screen any and all arguments that might support a proposition; rather, the agency is entitled only to the reasonable opportunity to address the proposition itself. See In re DBC, 545 F.3d at 1378 (noting that a purpose of the waiver doctrine is to discourage disregard of agency procedures by giving the agency an opportunity to correct its own mistakes). There can be no doubt that the PTO had sufficient opportunity to — and did in fact — confront plaintiff's fundamental statutory argument that § 156 encompasses claim 12 of the '447 patent.
Accordingly, plaintiff has not waived any of the arguments presented in this litigation, as every statutory argument relates to the single question of statutory interpretation at the heart of the dispute: For purposes of the Hatch-Waxman Act, what does it mean for a patent to "claim ... a method of using" a "medical device"? Analysis therefore proceeds to answer this question.
When resolving the meaning of a statute, "the starting point ... is the language of the statute itself." Consumer Prod. Safety Comm'n v. GTE Sylvania, Inc., 447 U.S. 102, 108, 100 S.Ct. 2051, 64 L.Ed.2d 766 (1980). Indeed, it is axiomatic that "[i]f the statutory language is plain," a court "must enforce it according to its terms." King v. Burwell, ___ U.S. ___, 135 S.Ct. 2480, 2489, 192 L.Ed.2d 483 (2015). Moreover, it is "fundamental" that "unless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning." Perrin v. United States, 444 U.S. 37, 42, 100 S.Ct. 311, 62 L.Ed.2d 199 (1979). Only in "rare and exceptional circumstances" will unambiguous statutory language not end the analysis. See Wyeth, 591 F.3d at 1369. Of course, some ambiguities are evident only when the words are viewed "in their context and with a view to their place in the overall statutory scheme." King, 135 S.Ct. at 2489 (internal quotations omitted). Thus, although the analysis properly focuses on the text, the analysis is not necessarily limited to the text.
The parties do not dispute that the Zilver PTX is a qualifying "medical device" under § 156(f)(1)(B). They hardly could. As generally understood, a "device" is a contraption, contrivance, or similar physical article. See, e.g.,
The dispositive question then becomes whether the '447 patent claims a method of using the Zilver PTX, a question the PTO answered in the negative. The PTO's reasoning in this regard begins
Plaintiff's objections to the PTO's reasoning may be succinctly summarized: How the FDA reviews a product under § 353(g) and how § 321(h) defines a "device" for purposes of the FDCA are irrelevant to whether a patent "claims ... a method of using" a "medical device," an inquiry that should focus exclusively on the text of § 156. Plaintiff's objection is well taken; the PTO improperly wandered afield from the text of § 156. Yet, the PTO's foray into the FDCA was a harmless detour, as the PTO ultimately arrived at the correct destination, albeit in a roundabout way.
As previously noted, it is "fundamental" that "unless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning." Perrin, 444 U.S. at 42, 100 S.Ct. 311. Thus, the baseline presumption is that "medical device" as used in § 156(f)(1)(B) refers to any contraption, contrivance, or related article that serves a purpose related to the diagnosis, treatment, or prevention of disease.
The PTO nonetheless argues that the definition from § 321(h) applies to § 156 because § 156(f)(1)(B) refers to medical devices "subject to regulation under the [FDCA]." Yet, this language does not warrant or invite an importation of § 321(h)'s definition of "device" into § 156; rather, it merely narrows the scope of the ordinary meaning of "medical device," such that the only contraptions, contrivances, and related articles with purposes relating to the diagnosis, treatment, and prevention of disease that are covered are those that the FDCA regulates. Thus, a physical contraption with a drug component that achieves its primary therapeutic effect through chemical action is still a medical device for purposes of § 156 as long as the contraption is subject to FDCA regulation in some respect. And this is so whether the FDA regulates the product as a device, as a drug, or as a biological product.
Context further supports this conclusion, insofar as where Congress intended to color the meaning of terms under § 156(f) according to the definitional provisions of the FDCA, it did so unambiguously. Thus, § 156(f)(5) gives the term "informal hearing" "the meaning prescribed for such term by section 201(y) of the [FDCA]," which is codified at § 321. See also H.R. Rep. No. 98-857(II), 1984 U.S.C.C.A.N. 2686, 2709 (1984). In fact, the House Report on the Hatch-Waxman Act cites § 321 several times, but never in connection to what constitutes a "device" for purposes of § 156(f)(1)(B). See id. at 2694, 2696, 2698, 2709. That there is no unambiguous link between § 156(f)(1)(B) and § 321(h) in either the text or the legislative history of the Hatch-Waxman Act — despite the fact that such links exist with regard to other terms in §§ 156 and 321 — points all the more persuasively to the conclusion that a "medical device" for purposes of § 156(f)(1)(B) should not be construed to have the same meaning as "device" under § 321(h), but should instead take its ordinary meaning.
The fact that the FDA reviewed the Zilver PTX as a medical device does nothing to change this analysis. When the FDA determines a combination product's primary mode of action for purposes of FDCA review, the FDA is not identifying the nature of the product itself. Rather, the FDA's determination of a primary mode of action is merely an identification of the predominate means by which the product achieves its therapeutic effect. See 21 C.F.R. § 3.2(k) (defining "mode of action"),
In short, the PTO's statutory analysis of § 156 is flawed. Section 156's language is adequate (i) to classify the Zilver PTX as a drug or as a medical device for purposes of the Hatch-Waxman Act and (ii) to analyze the '447 patent's eligibility for a patent term extension. There is no need or warrant to refer to the FDCA or the actions of the FDA to reach these conclusions. Yet, it does not necessarily follow that the PTO's ultimate conclusion must be set aside. As the analysis that follows demonstrates, the PTO's interpretative error was ultimately harmless.
Distilled to its essence, the PTO's justification for denying plaintiff's patent term extension was that the '447 patent does not recite any structural elements of the Zilver PTX. In plaintiff's view, the PTO's structural element requirement is atextual and amounts to the administrative addition of a patent term extension eligibility criterion. This characterization is not accurate, however, as the PTO's requirement that the '447 patent must recite a structural element of the Zilver PTX derives from two statutory sources, namely (i) the definition of "device" in § 321(h) and (ii) the meaning of "claims" in § 156(a), as the Federal Circuit interpreted that term in Hoechst-Roussel Pharms., Inc. v. Lehman, 109 F.3d 756 (Fed.Cir. 1997). As already discussed, the PTO's reliance on § 321(h) rather than on the ordinary, contemporary, and common meaning of "medical device" was in error. But if the same outcome obtains by synthesizing the ordinary, contemporary, and common meaning of "medical device" together with the holding of Hoechst-Roussel, then the PTO's error is harmless. It remains, therefore, to apply § 156(a) to claim 12 of the '447 patent in light of the ordinary, contemporary, and common meaning of "medical device" and the requirements of Hoechst-Roussel.
In Hoechst-Roussel, 109 F.3d at 757, the Federal Circuit affirmed the PTO's denial of a patent term extension for U.S. Patent No. 4,631,286 ("the '286 patent"). The '286 patent made two relevant claims, (i) the compound 1-hydroxy-tacrine and (ii) a method of treating a patient in need of memory enhancement by administering an effective amount of 1-hydroxy-tacrine. See id. In 1990, approximately four years after the '286 patent issued, a company that was neither the owner nor licensee of the '286 patent submitted for FDA approval a new drug, the active ingredient of which was tacrine hydrochloride. See id. Upon ingestion, tacrine hydrochloride metabolizes into, inter alia, 1-hydroxy-tacrine, which then performs the function of memory enhancement in patients with Alzheimer's disease, the target population of the tacrine hydrochloride drug. See id. Thus, the administration of the tacrine hydrochloride drug allegedly infringed the '286 patent in that "when administered, tacrine hydrochloride metabolizes into another product, 1-hydroxy-tacrine, which [the '286 patent] has claimed." Id. at 759. Because the administration of the tacrine hydrochloride drug would infringe the '286 patent's claimed method of administering 1-hydroxy-tacrine, the plaintiff in Hoechst-Roussel argued that the '286 patent claimed a method of using the tacrine hydrochloride drug and therefore qualified
Importantly, Hoechst-Roussel stands for the proposition that for purposes of § 156(a), a patent does not claim all products that directly infringe the patent claims.
Understanding Hoechst-Roussel as requiring the analysis to focus sharply on the particular product allegedly claimed also finds support in the text of § 156(a), which repeatedly employs the language "a product." In this context, the indefinite article "a" serves its usual and expected purpose "as a function word before most singular nouns ... when the individual in question is undetermined, unidentified, or unspecified."
Hoechst-Roussel well illustrates this point. The applicant there had a method claim that gave it the right to exclude others from administering 1-hydroxy-tacrine as a treatment for memory deficiencies. See 109 F.3d at 759. That right to exclude encompassed any number of means or methods of administering 1-hydroxy-tacrine and was not limited to the administration of the specific tacrine hydrochloride drug that underwent FDA approval and prompted the patent term extension application. Thus, the '286 patent's claims were profitable even in the absence of FDA approval of the tacrine hydrochloride drug because the '286 patent allowed the patent owner to exclude other directly infringing products from the outset of the patent term. Indeed, in Hoechst-Roussel the product that served as the alleged basis for the patent term extension was not even submitted for FDA review until almost four years after the '286 patent issued. See id. at 757. In the approximately four preceding years, the owner of the '286 patent was presumably able to profit from the ability to exclude others, absent payment of a royalty, from administering 1-hydroxy-tacrine as a treatment for memory deficiencies. Thus, the '286 patent was not the type of patent about which Congress was concerned when it enacted Title II of the Hatch-Waxman Act to ensure that medical innovators were sufficiently incentivized to continue investing in medical innovations, in that the '286 patent never sacrificed a period of profitability to the regulatory process.
The instant case is analogous to Hoechst-Roussel in at least two crucial respects. Like the '286 patent, claim 12 of the '447 patent does not claim a method of using the particular product that underwent FDA review. To the contrary, claim 12 of the '447 patent claims a method that can be performed by a number of products, of which the Zilver PTX is but one. Cf. Hoechst-Roussel, 109 F.3d at 759 n. 4 (concluding that a qualifying method claim must claim the precise product undergoing FDA review). Indeed, the fact that claim 12 of the '447 patent does not recite structural features of the Zilver PTX, a deficiency
Further, the '447 patent is similar to the '286 patent in that both patents could have been profitably exploited well before the products allegedly triggering term extension eligibility underwent FDA review. Indeed, the Zilver PTX was not submitted for FDA review until June 2010, nearly twelve years after the '447 patent issued. In this respect, the '447 patent, like the '286 patent in Hoechst-Roussel, falls beyond the reach of the policy problem that Title II of the Hatch-Waxman Act was designed to address. Specifically, the profitability of claim 12 of the '447 patent does not turn on the ability to use the Zilver PTX, in that claim 12 sweeps broadly enough that the use of any number of products could infringe the claim.
Plaintiff's objection to what it views as an atextual eligibility requirement — that the '447 patent must recite some structure
For the foregoing reasons, the PTO's final decision denying plaintiff's application for a patent term extension for the '447 patent was not arbitrary, capricious, an abuse of discretion, or otherwise contrary to law in a manner that warrants setting the denial aside. Accordingly, plaintiff's motion for summary judgment must be denied, and the PTO's motion for summary judgment must be granted.
An appropriate order will issue.