Precedential Patent Cases From the Federal Circuit in the Past Week
Clearcorrect – In a case that has been closely followed by publishers, motion picture companies and software and internet business enterprises, a divided Circuit provides three different opinions covering almost 60 pages, ruling that the ITC's authority to ban imports of infringements of U.S. patents extends only to tangible goods and not to electronic transmissions. The Circuit overrules the ITC's holding that the importation of "articles" as described in 19 U.S.C. § 1337(a) should be construed to include electronic transmission of digital data. Chief Judge Prost acknowledges that the Circuit must give deference to the ITC's interpretation of its rules but holds that the ITC's decision to expand the scope of its jurisdiction to include electronic transmissions of digital data runs counter to the unambiguously expressed intent of Congress.Moreover, the opinion notes that the Commission improperly deleted a portion of a quote from the legislative history of the Tariff Act it cites to support its position, without even noting that the phrase was deleted. The fact that the deleted phrase undercuts the Commission's analysis provides further support for the decision that the Commission's conclusion as to "articles" was unreasonable.
In dissent, Judge Newman argues that the ITC correctly applied the Tariff Act and prior case law to encompass today's forms of infringing technology. She cites many examples of federal law being interpreted in such a way as to keep up with current technologies, including copyright law. Finally, she notes that the majority failed to provide the deference to which the ITC is entitled on issues within its jurisdiction.
Momenta – Section 271(g) prohibits the unauthorized importation, or sale or use within the U.S., of a product which is made by a process patented in the U.S. Teva's generic enoxaparin is manufactured outside of the U.S. However, within the U.S., Teva evaluates the quality of its enoxaparin by selecting and separating batches that conform to the U.S. Pharmacopoeial Convention requirements from batches that do not. In a divided opinion the majority finds that it is more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual "making" of a product, rather than extend its reach to methods of testing the quality of a drug product.
Amphastar is also a generic manufacturer of enoxaparin. Unlike Teva, however, Amphastar manufactures its enoxaparin within the U.S. The panel unanimously reverses and remands summary judgment of non-infringement, ruling that Amphastar's use of the patented method in the U.S. as part of the manufacture of enoxaparin does not fall within the safe harbor of § 271(e)(1). The panel finds that Amphastar's routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process is not "reasonably related to the development and submission of information" to the FDA. Therefore, the panel holds that Amphastar is not within the safe harbor provision of § 271(e)(1).
In so holding, the panel rejects Amphastar's argument that law of the case requires affirmance of summary judgment of non-infringement because the Circuit had previously, in affirming denial of Momenta's motion for preliminary injunction, determined that Amphastar was within the safe harbor. The panel notes that, for the law of the case doctrine to apply, the issue must have actually been decided, and that rulings made in the preliminary injunction context are not binding.
Imaginal – This case involves a patent directed to the way box springs are made. Imaginal filed suit against L&P and Simmons, alleging that L&P's TopOff automatic box spring stapling machine infringes its patent. The district court granted summary judgment of noninfringement on grounds that the accused machine includes a "vision guidance system," which is explicitly excluded from coverage in the claims. Imaginal argued that the negative claim limitation should be a narrow one, limited to the vision guidance system depicted in a ‘789 patent that was incorporated by reference in the patent in suit. The Circuit holds that the patentee might have defined the excluded "vision guidance system" to reference only the ‘789 system, but did not do so. Accordingly, the Circuit affirms the district court's claim construction and summary judgment based on it.
Prometheus – The Circuit affirms a determination of obviousness of a patent directed to treating irritable bowel syndrome. While acknowledging that a prior art genus patent would not necessarily preclude a non-obviousness determination as to a species claim limiting the prior art genus to a more specific patient group, in the present case the panel finds that the claims merely recite an obvious variation of the invention disclosed in the earlier patent. The panel also determines that there was no clear error by the district court in finding that commercial success was due to Prometheus' marketing and not due to the merits of the claimed invention. Finally, the Circuit notes that the district court did not improperly shift the burden of proof as to commercial success to Prometheus, as the district court's opinion clearly states that defendants must prove obviousness by clear and convincing evidence.
Clearcorrect Operating, LLC v. Int'l Trade Comm'n, Fed. Cir. Case 2014-1527
(November 10, 2015)
The Tariff Act of 1930 provides the ITC with authority to remedy unfair acts that involve the importation of "articles" as described in 19 U.S.C. § 1337(a). Here, the Commission concluded that "articles" should be construed to include electronic transmission of digital data. However, according to the majority of the panel, the Commission's decision to expand the scope of its jurisdiction to include electronic transmissions of digital data runs counter to the "unambiguously expressed intent of Congress."
The Commission instituted the present investigation based on a complaint filed by Align Technology, Inc. Align alleged a violation of 19 U.S.C. § 1337 by reason of infringement of various claims of seven different patents. The respondents to the investigation were various ClearCorrect companies. The technology at issue in this case relates to the production of orthodontic appliances, also known as aligners.
ClearCorrect US scans physical models of the patient's teeth and creates a digital recreation of the patient's initial tooth arrangement. This digital recreation is electronically transmitted to ClearCorrect Pakistan, where the position of each tooth is manipulated to create a final tooth position. ClearCorrect Pakistan then creates digital data models of intermediate tooth positions. One intermediate tooth position is created for each incremental aligner. ClearCorrect Pakistan then transmits these digital models electronically to ClearCorrect US. ClearCorrect US subsequently 3D prints these digital models into physical models. Then an aligner is manufactured by thermoplastic molding using the physical model. Here, the accused "articles" are the transmission of the "digital models, digital data and treatment plans, expressed as digital data sets, which are virtual three-dimensional models of the desired positions of the patients' teeth at various stages of orthodontic treatment," from Pakistan to the U.S.
The claims involved in this appeal were found by the Commission to be infringed and not invalid.
Section 337 declares certain activities related to importation to be unlawful trade acts and directs the Commission to grant prospective relief if it has found an unlawful trade act to have occurred. Section 337(a)(1) reads in pertinent part as follows:
[T]he following are unlawful,…:
(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that- (i) infringe a valid and enforceable United States patent….
Thus, when there is no importation of "articles," there is nothing for the Commission to remedy. Here, the only purported "article" found to have been imported was digital data that was transferred electronically, i.e., not digital data on a physical medium such as a compact disk or thumb drive.
When dealing with the interpretation of Section 337, the ITC is entitled to appropriate deference. We review the Commission's interpretation pursuant to Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984). Under Chevron, in reviewing an agency's construction of its organic statute, we address two questions:
The first is whether Congress has directly spoken to the precise question at issue. If the answer is yes, then the inquiry ends, and we must give effect to Congress' unambiguous intent. If the answer is no, the second question is whether the agency's answer to the precise question at issue is based on a permissible construction of the statute. The agency's interpretation governs in the absence of unambiguous statutory language to the contrary or unreasonable resolution of language that is ambiguous.
A. Chevron Step One
In construing a statute, we begin with its literal text, giving it its plain meaning. If the statutory language is plain, we must enforce it according to its terms. The term "articles" is not defined in the Act. In the absence of such a definition, we construe a statutory term in accordance with its ordinary or natural meaning. When looking to the term's plain meaning we must look first not to the 1930 Tariff Act but instead its predecessor, the 1922 Tariff Act.
The Commission relies on the 1924 edition of Webster's that defines "article," in pertinent part, as "something considered by itself and as apart from other things of the same kind or from the whole of which it forms a part; also, a thing of a particular class or kind; as an article of merchandise; salt is a necessary article." Id. (citing Article, WEBSTER'S NEW INTERNATIONAL DICTIONARY OF THE ENGLISH LANGUAGE (1924)). Based on this and other similar definitions, the Commission concluded that "the term 'article' was understood at the time of the enactment of the Tariff Act to carry the meaning of an identifiable unit, item or thing, with examples indicating that such articles may be traded in commerce or used by consumers" and thus would include digital data. However, the contemporaneous dictionary definition upon which the Commission relied, the 1924 edition of Webster's, does not aid our search for the definition of "articles" because it is imprecise at best. It is notable, however, that both examples provided in Webster's dictionary are of material things, indicating that the vague language used was in reference to tangible items.
More modern dictionaries also support the conclusion that an "article" is a tangible thing, including the three that are referenced by the Commission in footnotes 20 and 21 of its final opinion. The Commission refers to WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY which defines "article" as "one of a class of material things . . . piece of goods; COMMODITY." Article, WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY (1966). The Commission additionally refers to the 2002 edition of WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY which defines "article" as "a material thing . . . ." Article, WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY (2002).
Defining "articles" as "material things" is further consistent with the Tariff Commission's own definition of the term "articles" as laid out in its DICTIONARY OF TARIFF INFORMATION, issued September 1924. While this dictionary is not a "regular dictionary"— because it was published by the Commissioners—nor perfectly contemporaneous—as it was published in 1924— it does provide us with guidance as to how a person in the field would have interpreted "articles" close to the time of the passage of the Tariff Act.
Every dictionary referenced by the Commission, with the exclusion of one imprecise definition, along with all the other relevant dictionaries, point to the fact that "articles" means "material things." As we "must presume that the legislature says in a statute what it means and means in a statute what it says," we conclude that "articles" does not cover electronically transmitted digital data.
As the presence of ambiguity in the meaning of a term "may only become evident when placed in context" with the statute, we also need to look to how "articles" is used throughout Section 337. We conclude that the use of the word "articles" in other sections of the 1930 Tariff Act reinforces the conclusion that Congress's unambiguously expressed intent was for "articles" to mean "material things."
The clarity of the statutory context obviates the need to turn to the legislative history. However, the Tariff Act's legislative history further confirms the conclusion that "articles" is limited to "material things," however, and thus not inclusive of electronic transmissions of digital data. This is supported by two distinct points in the Tariff Act's legislative history: (1) the period of time when "articles" first appeared in Section 337 of the Tariff Act of 1930, inclusive of Section 316 of the 1922 Tariff Act; and (2) the legislative history from 1988 in which for the first time the Tariff Act was expanded to explicitly cover IP infringement.
In sum, the literal text, the context in which the text is found within Section 337, and the text's role in the totality of the statutory scheme all indicate that the unambiguously expressed intent of Congress is that "articles" means "material things" and does not extend to electronically transmitted digital data.
B. Chevron Step Two
As Congress's expressed intent is unambiguous, we need not address step two of Chevron. However, even if we were to address step two, it is clear that the Commission's interpretation of the term "articles" was unreasonable. Step two of Chevron requires us to determine "whether the Commission's answer is based on a permissible construction of the statute." Because the Commission failed to properly analyze the plain meaning of "articles," failed to properly analyze the statute's legislative history, and improperly relied on Congressional debates, the Commission's analysis does not warrant deference. Moreover, the Commission improperly deletes a portion of a quote from the legislative history of the Tariff Act it cites to support its position, without even noting that the phrase was deleted. The fact that the deleted phrase undercuts the Commission's analysis provides further support for the decision that the Commission's conclusion as to "articles" was unreasonable.
Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., Fed. Cir. Cases 2014-1274,
-1277, (November 10, 2015)
Momenta appeals the district court's decision finding that Teva does not infringe the '886 patent. In a companion case, Momenta appeals the decision finding that Amphastar Pharmaceuticals and Actavis Pharma (collectively, "Amphastar") do not infringe the '886 patent.
Enoxaparin is an anticoagulant that helps to prevent blood clots that was first approved for marketing in the U.S. in 1993 under the trade name Lovenox. In 2010, Momenta became the first company to market a generic version of enoxaparin. Momenta is assignee of the '886 patent, directed to a process used to ensure each batch of generic enoxaparin meets certain quality standards.
Teva, another generic manufacturer, sought to enter the enoxaparin market. It does not manufacture enoxaparin itself, but sources the product from an Italian company that manufactures, analyzes, tests, packages, and labels Teva's generic version of enoxaparin, which Teva then imports into the U.S. Momenta sued Teva on the grounds it intended to market in the U.S. an enoxaparin product that was manufactured using a process covered by the '886 patent.
The district court found Teva's conduct did not infringe because it fell within the safe harbor from infringement provided by 35 U.S.C. § 271(e)(1), which states it is not infringement for a party to use a patented invention "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." The court also rejected Momenta's contention that Teva's sales in the U.S. constitute infringement under § 271(g), which prohibits selling within the U.S. a product which is made by a process patented in the U.S. The court reasoned that the patented process related to quality control testing and was not a method of making enoxaparin.
Amphastar is also a generic manufacturer of enoxaparin. Unlike Teva, Amphastar manufactures its enoxaparin product in the U.S. Momenta asserts the court erred in granting summary judgment of non-infringement in favor of Amphastar. According to Momenta, Amphastar's use of the patented method in the U.S. as part of the manufacture of enoxaparin infringes the '886 patent, and this infringement does not fall within the safe harbor of § 271(e)(1). It further argues Amphastar's sale of enoxaparin in the U.S. infringes under 35 U.S.C. § 271(g).
Teva's and Amphastar's Enoxaparin Products Are Not
"Made By" Momenta's Patented Process
Section 271(g) prohibits the unauthorized importation, or sale or use within the U.S., of a product which is made by a process patented in the U.S. The issue on appeal is whether Teva's and Amphastar's enoxaparin products are "made by" Momenta's patented process within the meaning of § 271(g).
Momenta argues that "made" means "manufactured," and that its patented method is a crucial interim step used directly in the manufacture of Teva's products. Specifically, Momenta asserts its method is used by Teva to select and separate batches of intermediate drug substance that conform to U.S. Pharmacopoeial Convention requirements for enoxaparin from batches that do not, and that selected batches are then further processed. Momenta also notes the FDA's Good Manufacturing regulations define "manufacture" and "processing" as including testing and quality control of drug products.
Although Momenta's arguments are not without merit, it is more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual "making" of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made. In patent law, as in all statutory construction, unless otherwise defined, words will be interpreted as taking their common meaning. Dictionaries define the verb forms of "make" to involve the creation or bringing into existence of something. This court has previously equated the word "made" in § 271(g) with "manufacture." As with the word "make," dictionaries define the verb form of "manufacture" to involve the creation or bringing into existence of something.
In light of the foregoing, the ordinary meaning of "made" as used in § 271(g) means "manufacture," and extends to the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties. However, "making" does not extend to testing to determine whether an already synthesized drug substance possesses existing qualities or properties.
Our conclusion finds support in this court's precedent. In Housey, we held a product was not "made by" a process patented in the U.S. for purposes of § 271(g) where the patented process was not used in the actual synthesis of the drug product. Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367 (Fed. Cir. 2003). Housey involved patents directed to "a method of screening for substances which specifically inhibit or activate a particular protein." The screening method enabled the identification of a particular drug as "useful," which drug could then be manufactured. The court determined the process was too far removed from the actual making of the product.
Similarly, a product is not "made by" a patented process within the meaning of § 271(g) if it is used merely to determine whether the intended product of a separate and perhaps separately-patented process has in fact already been manufactured. All of the asserted claims of the '886 patent are directed to "[a] method for analyzing an enoxaparin sample." Use of the word "analyzing" indicates practicing the claimed invention requires that the enoxaparin already be "made."
It is true the FDA's regulations define "manufacture" and "processing" of drug products as including "testing and quality control," as Momenta asserts. However, § 210.3 explicitly states that its definitions apply when the terms are used in other parts of the C.F.R, and do not control the interpretation of § 271(g), which is part of a separate statutory scheme directed to patented inventions. Nor is this a case where the FDA has interpreted § 271(g) and deference under Chevron U.S.A. Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984) is owed. The ordinary meaning of "made by"—rather than an FDA definition of "manufacture" crafted for purposes unrelated to incentivizing invention—therefore controls.
The § 271(e)(1) Safe Harbor Does Not Shield the
Accused Use by Amphastar
Unlike Teva, Amphastar does not assert it manufactures its enoxaparin product abroad. Momenta argues Amphastar's use of the patented method within the U.S. infringes under § 271(a) and is not protected by the § 271(e)(1) safe harbor. Section 271(e)(1) provides that it is not infringement for a party to use a patented invention "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." Though the contours of § 271(e)(1) are not exact in every respect, there is no dispute as to the statutory purpose, namely, to facilitate market entry upon patent expiration. The legislative history also makes this purpose clear.
The language of § 271(e)(1) is sufficiently broad to leave adequate space for experimentation and failure on the road to regulatory approval. The breadth of the exemption extends even to activities the actual purpose of which may be "promotional" rather than regulatory, at least where those activities are consistent with the collection of data necessary for filing an application with the FDA for approval. Moreover, notwithstanding the legislative focus on activities occurring prior to the approval of generic drugs, the § 271(e)(1) exemption is not restricted to pre-approval activities. Section 271(e)(1) thus provides a wide berth for the use of patented drugs in activities related to the federal regulatory process.
Despite the broad contours of the exemption, some activities are outside its protection. For example, § 271(e)(1) does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. Here, Amphastar's routine quality control testing of each batch of generic enoxaparin as part of the post-approval, commercial production process is not "reasonably related to the development and submission of information" to the FDA, and it was clearly erroneous to conclude otherwise. Therefore, we find that Amphastar is not within the safe harbor provision of § 271(e)(1).
Law of the Case Does Not Apply to Determinations Like the Present on Preliminary Injunctions
We preliminarily addressed the issue of Amphastar's eligibility for the § 271(e)(1) safe harbor in Momenta I, holding that, in light of the safe harbor and for purposes of granting a preliminary injunction, the district court incorrectly concluded that Momenta was likely to succeed on the merits of its infringement claim. Amphastar argues this court in Momenta I "already decided that Amphastar's safety testing is protected by the Section 271(e)(1) safe harbor" and that this determination is law of the case. However, for the doctrine to apply, the issue must have actually been decided. Findings of fact and fact-intensive conclusions of law made by a court in the preliminary injunction context are not binding.
With the benefit of additional briefing in the current appeals, which reflects the full district court record developed by all parties after the preliminary injunction phase, we conclude Amphastar's submissions are appropriately characterized as "routine," and the conclusion in Momenta I that Amphastar's commercial use of Momenta's patented method falls within the safe harbor of § 271(e)(1) would result in manifest injustice. Amphastar points to no case, until Momenta I, extending immunity under § 271(e)(1) to encompass activities related to ongoing commercial manufacture and sale.
Imaginal Systematic, LLC v. Leggett & Platt, Inc. , Fed. Cir. Case 2014-1845 (November 10, 2015)
L&P manufactures equipment used to assemble bedding components, such as the TopOff machine, which automatically staples wire grids to wood frames to make mattress foundations. Simmons, which manufactures and sells bedding products, purchased eleven TopOff machines. Simmons' use of those TopOff machines gave rise to an earlier lawsuit between the parties. In this earlier action Imaginal alleging that L&P and Simmons infringed three of its patents, including the '402 Patent at issue in this appeal. The district court granted summary judgment that the asserted claims were not invalid and that the TopOff machines infringed. The case went to trial, and the court entered judgment in favor of Imaginal and the Circuit affirmed without opinion.
Subsequently, L&P redesigned the TopOff machines by removing the positioning software and mechanical devices that were used in the original TopOff machines to control alignment. In their place, the redesigned TopOff machines use a computer system that uses an optical sensor to control the movement of both a gripper carriage on which a wood frame and one grid of modules are placed, and the stapling device.
Before the redesign of the TopOff machines was complete, Imaginal filed a second suit (that gave rise to this appeal), based on L&P's and Simmons' continued use of the original TopOff Machines following the judgment in the first lawsuit. Imaginal subsequently amended the complaint to allege that the redesigned TopOff machines also infringe the '402 Patent.
The district court ruled on summary judgment the continued use of the original TopOff machines was an infringement but determined that the redesigned TopOff machines do not infringe. Looking to the ordinary meaning of the words "vision" and "guidance" the district court concluded that the claim phrase "vision guidance system" is a "system that uses a vision or sight based method to control or direct the movement or direction of something."
The Circuit Affirms the Construction of "Vision Guidance System"
On appeal, Imaginal argued that the district court erred in its construction of "vision guidance system" because it: (1) ignored the written description and claim language; (2) relied too heavily on general purpose dictionaries; and (3) improperly excluded a preferred embodiment.
Claim 1 of "402 Patent requires "moving the fastening tool without the use of a vision guidance system in a direction generally perpendicular relative to the base and through the open access area of a module until the fastening tool is located at a target fastening location." Nothing in the claim language purports to restrict the term "vision guidance system" to one particular system.
Imaginal argues that the written description of the '402 patent manifestly excludes only the vision guidance system of a '789 patent, which is incorporated by reference into the ‘402 patent. According to Imaginal, the written description of the '402 Patent specifically defines the meaning of the claimed negative limitation "without the use of a vision guidance system" where it states that "the present invention provides a fastener apparatus which does not require the vision guidance system of the '789 patent." However, the panel concludes that, while the patentee could have defined "vision guidance system" to mean "the vision guidance system of the '789 Patent," it did not do so. Although the '402 patent uses the '789 patent in its preferred embodiments as a general point of reference, it does not express any manifest exclusion or restriction as it pertains specifically to the meaning of "vision guidance system." Nothing in the written description of the '402 Patent indicates that the claims should be read to refer only to the vision guidance system of the '789 Patent. Indeed, the specification of the '402 Patent recognizes that there are different types of vision guidance systems and discusses two separate examples.
Imaginal submits that the written description of the '402 Patent and the '789 Patent taken together "make clear that the excluded 'vision guidance system' is one that uses a camera to adjust the aim of the fastening tool to a target fastening location." But neither patent even uses the phrase "adjust the aim." There is no support for Imaginal's attempts to narrow the negative claim limitation so that it disclaims only one particular vision guidance system.
Imaginal argues that the district court relied too heavily on dictionary definitions. When construing claim terms, courts can rely on dictionaries "so long as the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents." Citing the same dictionary Imaginal relied upon in its briefing, the district court explained that "vision" means "the ability to see: sight or eyesight" and "guidance" means "the act of directing or controlling the path or course of something." The court then looked at definitions of the words "path" and "course": a "course" is a "path or direction that something or someone moves alone," and a "path" is a "continuous series of positions or configurations that can be assumed in any motion." Taking these terms together, the court construed "vision guidance system" to mean a "system that uses a vision or sight based method to control or direct the movement or direction of something."
Imaginal argues that the district court's addition of the term "movement" changed the definition of "guidance" in a meaningful way. However, Imaginal's objection to use of the term movement makes little sense given that the claim term itself speaks in terms of motion: " moving the fastening tool without the use of a vision guidance system." The specification likewise is replete with references to movement and alignment. Imaginal's objection to the court's use of the term "movement" is unfounded.
Imaginal argues that "the district court's construction improperly excludes a preferred embodiment where vision is used in the module alignment step." According to Imaginal, the court's construction "precludes using a vision system that first aligns the modules beneath the staplers, and then controls merely the up and down movement of the staplers without guiding them." The negative limitation at issue on appeal is in element 7 of Claim 1, and disclaims use of a vision guidance system during the step of "moving the fastening tool." Nothing in the district court's construction with respect to element 7 has any effect on the use of a vision guidance system in connection with the other claimed elements, as is contemplated in the specification.
In summary, the Circuit concludes that the district court's claim construction is consistent with the claim language and specification, and that Imaginal's attempts to restrict the "vision guidance system" to the system disclosed in the '789 Patent are without merit. Summary judgment of noninfringement is affirmed.
Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc. , Fed. Cir. Cases 2014-1634, -1635, (November 10, 2015)
Prometheus was issued its '770 patent directed to a method of treatment for diarrhea-predominant irritable bowel IBS ("IBS-D"), utilizing alosetron (known by the brand name Lotronex). Shortly after the '770 patent issued, Prometheus initiated an ex parte reexamination, during which Prometheus amended one claim and added two others.
Roxane filed an ANDA with the FDA, seeking to market a generic version of Lotronex. Cipla manufactures the active ingredient used in Roxane's ANDA products. Following completion of the reexamination, Prometheus filed suit against Roxane and Cipla based on the ANDA filing and alleging that Roxane's label would encourage doctors to prescribe alosetron in a manner that infringes the claims of the ‘770 patent.
Following a bench trial, the district court found the asserted claims to be invalid based upon obviousness. Specifically, the court found that it was not unexpected for alosetron to exhibit greater efficacy in IBS-D patients who have exhibited symptoms for greater than six months, and who have experienced at least moderate pain. The evidence at trial did not establish that there is an unexpected result of greater efficacy in women, concluding that, at best, the combination of known elements produced expected results. Moreover, the court found that any commercial success of Lotronex could be attributed to Prometheus' marketing practices, and not as a result of the claimed invention. Finally, the court found that the method claimed in the '770 patent did not satisfy a long-felt but unmet need.
In the alternative, the district court held that the claims were invalid for obviousness-type double patenting in light of the claims of Prometheus' ‘800 patent. Given its invalidity rulings, the panel did not reach the infringement issue.
The Disclosures in the ‘800 Patent Rendered Obvious the Methods Claimed in the ‘770 Patent
The '800 patent discloses the use of alosetron to treat patients suffering from IBS. The '770 patent claims treating a subset of those IBS patients—those who (1) are women (2) with IBS-D (3) who have experienced symptoms for at least six months and (4) who have had moderate pain. A narrow species can be non-obvious and patent-eligible despite a patent on its genus, and an earlier disclosure of a genus does not necessarily prevent patenting a species member of the genus. The genus-species distinction has particular relevance in the field of personalized medicine, where, for example, singling out a particular subset of patients for treatment may reflect a new and useful invention that is patent eligible despite the existence of prior art or a prior art patent disclosing the treatment method to patients generally.
In AbbVie Inc. v. Mathilda & Terence Kennedy Inst. Of Rheumatology Tr., 764 F.3d 1366 (Fed. Cir. 2014), for example, a prior art genus patent claimed a method of co-administering two drugs to treat rheumatoid arthritis. The later patent contained a species claim limiting the prior art genus to a more specific patient group: individuals with "active disease." Borrowing from "the law of obviousness generally," AbbVie noted that "if the later expiring patent is merely an obvious variation of an invention disclosed and claimed in the reference patent, the later expiring patent is invalid."
Here, however, the panel holds that it would have been obvious for a person having ordinary skill in the art reading the '800 patent to treat female patients with IBS-D who had symptoms for at least six months and who had experienced at least moderate pain. While the present case, unlike AbbVie, involves a few different variables, the panel finds that the record contains abundant evidence, including properly relied-upon scientific and medical publications, that there were a limited number of known parameters and it would have been obvious to combine the teachings as to each parameter.
The District Court's Findings as to Secondary Considerations were not Clearly Erroneous
Further, the panel holds that the court properly considered secondary considerations of non-obviousness, as required by In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012). The district court properly found those considerations did not support a conclusion of non-obviousness in this case.
Prometheus first argued that Lotronex's commercial success can be attributed directly to the '770 patent, noting that from 2003 to 2007, net sales of Lotronex increased each year and the original patent owner was able to sell the Lotronex franchise to Prometheus for $120 million. The district court recognized that sales revenue of Lotronex increased from 2002 until 2012, but observed that "by 2011, there were just over 42,000 prescriptions of Lotronex written per year for about 10,000 patients." This was only about 2,100 more prescriptions compared to the peak year of sales by the original patent owner. The district court determined that the commercial success of Lotronex was due to Prometheus' actions in marketing, increasing the price of Lotronex, and introducing a series of rebates to stimulate sales of the drug, rather than from the treatment method claimed in the '770 patent. The district court also noted that Prometheus did not submit an analysis that would show the commercial success for the '770 patent on its own merits,"controlling for other variables and separating the treatment instructions from the drug compound and the method in the '800 patent that already existed, nor any analysis to control for other changing variables, such as marketing campaigns, new drug warnings, pricing changes, etc."
Finally, the Circuit finds no clear error in the district court's factual conclusions regarding the ‘770 patent's meeting an unmet need. Rather, the district court's finding made complete sense that "it is clear that many of the benefits touted by Prometheus were attributable to the compound disclosed in the ‘800 patent rather than the '770 patent's method of treatment."
The panel also finds that the district court did not improperly shift the burden of proof as to the nexus between Lotronex's commercial success and the ‘770 patent onto Prometheus. Although the district court described and rejected Prometheus' attempts to "prove commercial success of Lotronex and that Lotronex fulfilled a long-felt but unmet need," the panel understands those statements to be in reference to Prometheus' burden of production, but such imperfect language is not ground for reversal.