IP Update, Vol. 6, No. 11, November 2003
November 2003
Presumption of Surrender Applies When Broader Claim Canceled in Favor of Narrower One
By Matthew F. Weil
The U.S. Court of Appeals for the Federal Circuit has ruled that canceling broader claims and retaining narrower ones re-written in independent form is effectively a Festo-type narrowing amendment and presumptively results in no range of equivalents for the effectively narrowed limitation. Deering Precision Instruments, L.L.C. v. Vector Distribution Systems, Inc., Case Nos. 02-1013, -1197 (Fed. Cir. Oct. 17, 2003).
Deering’s patent is directed to a compact pocket scale. An important aspect of the invention is a sliding counterweight that can move closer to the plane of the scale’s fulcrums, thereby minimizing the overall weight of the scale. In the application originally filed with the U.S. Patent and Trademark Office (USPTO), independent claim 1 was the broadest, with no limitation drawn to the exact location of the counterweight. Claim 3 of the application, dependent on claim 1, included an additional limitation concerning the location of the sliding weight (a limitation that the parties referred to as the “zero position limitation”). In response to an USPTO rejection of claim 1, the applicants canceled claim 1 and submitted a new claim 11, which was the original claim 3 rewritten in independent form.
In summary judgment papers, Vector conceded that the accused VX-10 literally met every limitation of the asserted claims except for the zero position limitation. Vector argued that the zero position limitation was absent literally because the key claim term (substantially) required the weight to actually penetrate the plane of the fulcrums. Moreover, based on the prosecution history, Vector argued that the zero position limitation was entitled to no range of equivalents under the Federal Circuit’s first en banc Festo opinion (decided in 2000).
The district court adopted Vector’s construction and its view of the prosecution history, entering a summary judgment of non-infringement.
The Federal Circuit agreed with the district court’s claim construction and analysis that Festo applied on the facts of the case. However, in light of the Supreme Court’s 2002 ruling that the Festo presumption is not absolute, the Federal Circuit remanded for the district court to consider whether Deering can rebut the Festo presumption that it gave up the right to claim as an equivalent everything between the narrower claims granted and the broader ones canceled.
New Festo Decision Applied to Preclude Doctrine of Equivalents
By Paul Devinsky and Arturo E. Sandoval
In a post-Festo decision, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision and held a plaintiff patentee was precluded from proving infringement under the doctrine of equivalents due to prosecution history estoppel. Talbert Fuel Systems Patents Co. v. Unocal Corp., Case No. 99-1421 (Fed. Cir. Oct. 28, 2003).
Talbert sued Unocal for the infringement of U.S. Pat. No. 5,015,356 (the `356 patent). The `356 patent is directed to certain reformulated gasolines that reduce emissions while maintaining their performance boundaries. The infringement issue focused on a limitation found in all of the claims requiring the gasoline boiling point to be within of a range of 121°F to 345°F. In the original suit between Talbert and Unocal that reached the Federal Circuit in 2002, the Court relied on the absolute bar established by the first Federal Circuit Festo decision (decided in 2000) to deny Talbert access to the doctrine of equivalents. The Supreme Court’s vacatur of that decision led to the remand of this case on the issue of prosecution history estoppel.
As initially filed, claim 1 of the `356 patent recited no temperature range and was rejected based on references that showed gasolines of various hydrocarbon contents and boiling ranges with an upper boiling range of 390°F to 420°F. Unocal’s accused fuels had a boiling point range of 373.8°F to 472.9°F. Finding that the “temperature limit was placed in the claims at the examiner’s insistence, to distinguish over prior art that … showed hydrocarbon fuels with an endpoint ‘within the range of 390°F and about 420°F,’” the Court found there was no “reasonable explanation” of how the “designated endpoint of 345°F is correctly construed to include fuels with endpoints of 373°F and higher” and held that there was no literal infringement.
Talbert requested a remand to the district court for retrial on the issue of infringement under the doctrine of equivalents in view of the Supreme Court’s Festo decision, arguing that the 345°F limit does not describe the actual composition that is distilled, at least for carbonated fuels, and would be so recognized by one of skill in the art. Talbert further argued that the evidence would show he did not disclaim coverage of gasolines having an endpoint higher than 345°F, except for gasified fuels.The Court had little trouble finding that Talbert’s amendment was “a presumptive surrender of gasolines boiling in the range” between Talbert’s endpoint and the endpoint taught in the prior art that had been cited and applied by the examiner. The Court also noted that the record demonstrated that Talbert could not meet the “rebuttal criteria” as articulated by the Supreme Court to avoid the Festo presumption.
The Court noted that the Unocal fuels were foreseeable at the time of the application since the accused gasolines’ boiling point (373.8°F) fell between the highest range of the `356 patent (345°F) and the prior art (endpoint 390°F). Moreover, the Court noted that by amending the claim during prosecution, Talbert specifically disclaimed fuels at higher boiling points to get its patent approved, and it could not be credibly argued now that it was unforeseeable that fuels with higher boiling ranges than 345°F would be equivalent to the fuels as limited by the amendment.
The Court further noted that the amendment was not tangential to the alleged equivalent (the Unocal fuel) because the boiling point range of the patented fuels was at issue during prosecution, i.e., it was the direct, not tangential, reasons for narrowing.
Finally, the Court found Talbert had proffered no “other reason” for avoiding estoppel.
Similar Claim Terms May Have Different Meanings—It All Depends
By Paul Devinsky and Firasat M. Ali
The U.S. Court of Appeals for the Federal Circuit reiterated that a claim term should be construed according to its plain language and ordinary meaning and should be limited in scope only if a clear and unmistakable disavowal is manifested by the patent applicant. The result here is that three similar claim terms, “each field,” “each of plurality of fields” and “a plurality of different fields,” are properly construed to have different meanings. ResQNet.com Inc v. Lansa Inc., Case No. 03-1163 (Fed. Cir. Oct. 16, 2003).
ResQnet sued Lansa for infringement of three ResQnet patents U.S. Pat No. 5,530,961 (the `961 patent), 5,831,608 (the `608 patent) and 6,295,075 (the `075 patent). The specification of the `608 patent a continuation-in-part (CIP) of the `961 patent and the `075 patent each referenced the `961 patent. All three patents were directed to software for analyzing field attributes downloaded from a mainframe computer to a PC for permitting multiple PC users to access one mainframe and display a unique graphical user interface (GVI) for each user.
The district court analyzed claim 1 of the `961 patent that recites, in part, “said ID being generated as a function of the number, location and length of each field” (emphasis supplied) and concluded that claim term “every field” means “all fields.” The Federal Circuit, noting that the claim element in question was presented in means-plus-function format, first identified the claimed function and the corresponding structure (“an algorithm that recognizes the screen layout and the fields therein…”). Then, considering the claim language as a whole, the Federal Circuit agreed with the district court “that the claimed algorithm evaluates each (and every) field in the information to be displayed.” The Court then noted that “the specification sets forth only one embodiment of the algorithm” and that the description of that algorithm “suggests that characteristics of all, not just some, fields are input …” and that “the specification [nowhere] suggests otherwise.”
However, the Federal Circuit reversed the district court’s decision regarding the construction of the term “each of a plurality of fields” as found in claim 1 of the `608 patent, finding that in the context of the `608 patent claim (also a means-plus-function claim element), the subject term only required use “of at least two fields”—not every field. In this regard, the Court noted that the `608 patent was the result of a CIP of the application for the `961 patent and the slightly different algorithm disclosed in the `608 patent could select for analysis “potentially a subset of all fields.”
Finally, turning to claim 1 of the`075 patent (not a means-plus-function claim but a pure method claim), the Court invoked the plain meaning rule and construed the term “a plurality of specific screen identifying information” to only require “at least two pieces of information, finding no ‘clear and unmistakable’” prosecution history to the contrary.
Method of Treatment Interpreted to Include a Pharmaceutical Formulation of the Claimed Compound
By David A. Gay, PhD.
In a case turning on claim construction, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s ruling of infringement construing a claim directed to a treatment for bone reabsorption and urolithiasis to encompass the use of a pharmaceutical formulation of the active agent. Merck & Co., Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 03-1168 (Fed. Cir. Oct. 30, 2003).
The drug Fosamax is marketed by Merck & Co. (Merck) and approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoporosis and Paget’s disease. The active agent of the product is formulated as a salt having the common name alendronate salt. The Merck patent in issue was U.S. Patent No. 4,621,077 (the `077 patent), which contained a single claim directed to a method of treating bone reabsorption and urolithiasis through the administration of the non-salt form of the compound, alendronic acid.
Alleging that the delivery of the acid as recited in the claimed method includes the delivery of the salt form, Merck sued the generic drug maker Teva Pharmaceuticals (Teva) for infringing the `077 patent claim when Teva filed for regulatory approval to sell the alendronate salt form. Teva defended its actions on the basis that the alendronate salt is distinct from the claimed acid form. The district court found that the method administering alendronic acid was infringed by the administration of alendronate salt.
In construing the claim, the Federal Circuit took notice that while extrinsic evidence cannot change the meaning of a term as it is used in the specification, expert opinion is not prohibited to explain the meaning of claim language used in the patent as it would be understood by those skilled in the field of the invention. Here, the Court framed the issue to be decided as whether a person skilled in pharmacology would understand from the specification that the claimed method of treatment by administering alendronic acid encompasses administering alendronate salt.
Affirming the lower court’s finding of infringement, the Federal Circuit found that the claimed acid form was exemplified in the specification in formulations that included the salt, and usage of the active agent in the salt form for the treatment of bone disorders was presented in the specification. The Court further found extensive evidence in the record that persons experienced in the field refer to the active ingredient in the form of the salt and that qualified witnesses in the field of pharmacology understood that the acid, which is administered in the form of the salt, is the active agent.
Test Results Showing Invention Failed to Satisfy Commercial Standards Are Not Material to Patentability
By Christopher D. Bright
The U.S. Court of Appeals for the Federal Circuit has vacated a district court’s summary judgment of lack of enablement and reversed its finding of inequitable conduct, holding instead that an applicant does not necessarily have a duty to disclose disappointing test results. CFMT, Inc. v. Yieldup Int’l Corp., No. 01-1452 (Fed. Cir. Nov. 12, 2003). The two patents in suit were directed to systems for cleaning semiconductor wafers. While the applications were still pending, the inventors tested the patented machine at a Texas Instruments (TI) facility, where it failed to meet TI’s cleanliness standards for removing particulates. In response, the inventors came up with improvements for which they sought and obtained another patent.
The district court found the claims of the patents in suit were not enabled because the claimed invention failed to remove particulates. The court also held that the issuance of the improvement patent showed that undue experimentation was required to practice the patents in suit. The district court further found the inventors had committed inequitable conduct by failing to disclose the negative TI test results to the U.S. Patent and Trademark Office.
Construing the claims to require any level—not some specific level—of contaminant removal, the Federal Circuit found the claims were enabled by the specification because the inventors’ prototype removed penciled grease marks. The Federal Circuit observed that the enablement requirement “does not require that a patent disclosure enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect.” Moreover, the Federal Circuit found that even if the prototype did not achieve “complete cleaning,” the claimed invention would not be inoperative on that ground alone. The Federal Circuit rejected the district court’s holding that the improvement patent demonstrated that undue experimentation was required to enable the claims of the two patents in suit.
As to unenforceability, the Federal Circuit held the negative TI test results were not material to the patentability of the claimed invention because the TI data “reflects a commercial, not a statutory, standard for enablement.”
PATENTS / INTERFERENCES
“Substantial Evidence” Includes That Not Relied on by the Board
By Thomas A. Haag, Ph.D.
In a case involving an interference between a patent and an allowed patent application, both directed toward the production of human fibrinogen protein in non-human milk, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office Board of Patent Appeals and Interference (the Board) that the claims were obvious, as being supported by “substantial evidence.” Even though a determination of obviousness is a question of law to be decided de novo, the Federal Circuit deferred to the underlying factual determinations made by the Board regarding reasonable expectation of success in support of its obviousness determination. In doing so, the Court considered references not relied on by the Board. Velander et al. v. Garner et al., Case No. 02-1366 (Fed. Cir. Nov. 5, 2003). Fibrinogen is a serum protein synthesized by the liver and utilized in the blood to form a clot. The production and isolation of recombinant fibrinogen provides a potentially unlimited source of the naturally scarce protein. The count in interference related to mammals capable of producing “recoverable amounts” of biocompetent human fibrinogen protein in the milk of transgenic non-human mammals carrying heterologous DNA segments encoding each of fibrinogen’s
Aa, Bb and g chains and methods of making biocompetent fibrinogen therefrom.
Garner moved for a finding that Velander’s claims were obvious over a reference disclosing the commercial desirability of producing human serum proteins in non-human milk (Hennighausen) in view of a reference disclosing methods for the production of heterologous protein in the milk of transgenic mammals (Meade). Velander admitted that the combination of prior art references contained all the limitations in its claims and one of skill in the art would be motivated to combine them. Thus, the only issue for the Board to decide was whether one of ordinary skill in the art would glean from the prior art a reasonable expectation of success to make and use the claimed mammal.
The Board heard from a number of Velander’s expert witnesses who generally opined that a skilled artisan would not have reasonably expected to succeed. However, the Board discounted those expert opinions because they were not corroborated by any published references. The Board also discounted other opinions specifically relating to issues of heterologous protein and hormone purification from, and expression in, milk, as not sufficiently calling into question whether the claimed “recoverable amounts” of fibrinogen could be expressed. The Board noted that absolute predictability is not a requirement for obviousness. Velander appealed.
The Federal Circuit dismissed Velander’s argument that the Board had erred by placing the burden on Velander to prove an expectation of failure beyond Garner’s alleged expectation of success. The Court determined that the Board was aware of the proper legal standard, but was simply not swayed by Velander’s arguments, noting the arguments were either uncorroborated opinions or failed to consider problems relevant to the invention as claimed. Rather, the Court found that in discounting Velander’s experts, the Board acted as a proper trier of fact, determining the weight and credibility to be given to uncorroborated, conclusory statements. The Court indicated that under the “substantial evidence” standard, it would not reverse the Board in situations where the evidence supports several reasonable, but contradictory, conclusions.
In support of its conclusion, the Court considered Garner’s citation of several new references not relied on by the Board that went to the issue of whether several proteins with similar structural characteristics had successfully been produced in transgenic milk systems. The Court relied, at least in part, on these new references in refusing to second guess the Board’s assessment of the evidence.
In his dissenting opinion, Judge Gajarsa, argued that the Court’s review of substantial evidence should be limited to the record relied on by the Board. The dissent indicates that the Board had not taken into account the new references relied on by Garner in the appeal and that without these references, the Board’s opinion is not supported by substantial evidence as it makes unwarranted assumptions with regard to differences between the prior art and the claims at issue as seen by a person of skill in the art. By considering such evidence, Judge Gajarsa asserted that the Federal Circuit is simply substituting for the grounds for administrative action, those the Court would consider to have a more adequate and proper basis.
Written Description Requirement Not Satisfied Under Principles of Inherency
By Lawrence T. Cullen
In affirming an award of priority by the U.S. Patent and Trademark Board of Appeals and Interferences (the Board), the U.S. Court of Appeals for the Federal Circuit held that a product that is inherently produced by a disclosed process does not satisfy the written description requirement for claims directed to the product when one of skill in the art, reading the application, would not have been aware that the product is produced. Chen v. Bouchard, Case No. 03-1037 (Fed. Cir. Oct. 22, 2003).
The Board declared an interference between U.S. Pat. No. 5,254,580 to Chen, which claimed priority back to July 1, 1992, via a continuation in part, and a pending application of Boucher that had a priority date of December 9, 1992. Chen’s 1992 parent application disclosed a process to produce taxol derivatives and precursors of taxol. The disclosed method did not explicitly state that cyclopropataxols were produced as required by the interference count. Chen argued that cyclopropataxols were inherently described since the process described in examples will “inevitably” result in those compounds. Chen also attempted to establish conception and actual reduction to practice using notebooks that were witnessed by others skilled in the art and a contemporaneous test conducted by a third party for the existence of the product in a compound. The Board rejected Chen’s evidence of conception and actual reduction to practice based on a failure to corroborate the notebooks and on the grounds that the test was not an independent verification of the product because the third party was informed that the product existed in the compound prior to the test. Chen appealed.
The Federal Circuit, noting that compliance with the written description requirement is a factual issue, concluded that there was substantial evidence supporting the Board’s determination, and thus Chen was not entitled to the benefit of his earlier applications. The Federal Circuit noted that there was no explicit description of the claimed product in the 1992 parent application and, as the parent did accurately describe another product (fluorotaxol derivatives) made by the process, there was no error in the disclosure. The Court noted that the 1992 parent application did not describe any physical characteristics of the claimed product and the Federal Circuit also noted that there was no evidence that a person of ordinary skill in the art would have recognized that the product of the count would have been produced from the disclosed process.
The Federal Circuit also held that the Board did not abuse its discretion in failing to consider the inventor notebooks since, even though available, the author of the notebooks did not testify. Thus, the Federal Circuit agreed with the Board that the notebooks were properly excluded under hearsay rules.
However, the Federal Circuit rejected the Board’s exclusion of an independent test for the product conducted by a third party, holding that a tester need not be “kept in the dark” regarding the material being tested in order to corroborate the existence of the material. Holding the error harmless, the Federal Circuit went on to find that Chen had not established that the material tested had all of the limitations of the count and hence, Chen did not meet his burden to establish priority.
Judge Newman dissented on the grounds that the inventor’s own testimony was enough to allow the notebooks to be considered as evidence. Judge Newman noted that the reason that an inventor’s testimony must be corroborated related to the frailties of memories regarding acts relating to conception and reduction to practice, and this concern does not relate to whether notebooks were kept. Judge Newman argued that to require corroboration of everything to which an inventor testifies amounts to a rebuttable presumption of dishonesty simply because he is an inventor.
Functionality of a Design Trademark Determined in Part by Availability of Alternatives
By Paul Devinsky
Affirming a ruling that the shape of the plaintiff’s bottle was functional and its registered mark on the design was invalid, the U.S. Court of Appeals for the Ninth Circuit looked to the existence of alternatives to help determine whether the design was functional. Talking Rain Beverage Co. v. South Beach Beverage Co., Case No. 02-35845 (9th Cir. Nov. 4, 2003).
Talking Rain Beverage Co. brought a suit against South Beach Beverage Co., claiming that South Beach’s SoBe beverage bottles were confusingly similar to Talking Rain’s trademarked bottle. Both Talking Rain’s and SoBe’s bottles resembled a bottle designed to fit into a holder on a bike. The only other common feature between the bottles was “a recessed grip area approximately two-thirds of the way up from the bottoms of the bottles.”
The Court noted that although Talking Rain’s bottle design was registered and presumed valid, the presumption was rebuttable. The Court went on to find that South Beach had successfully rebutted the presumption by establishing the functionality of the design. Addressing the Supreme Court decision in TrafFix Devices, the Court noted a design is functional and, therefore, cannot be protected as a trademark when the design “is essential to the use or purpose of the device or when it affects the cost or quality of the device.”
The court acknowledged that under TrafFix Devices, once a design has been found to be functional, the fact there might be alternative designs available was not relevant. However, according to the Ninth Circuit, “the existence of alternative designs may indicate whether the trademark itself embodies functional or merely ornamental aspects of the product.”
The Court noted that Talking Rain’s advertisements promoted the utilitarian features of the bottle design, using the slogan “Get a Grip.”
The Court also noted that Talking Rain itself acknowledged that its own product development process had determined that the bottle design provided an easier grip and offered structural support.
Finally, the Court noted that “recessed/grip areas appear to be common in the beverage industry tends to corroborate SoBe’s assertion that the grip area is indeed functional and not arbitrary.”
Double Your Pleasure: “Doublemint” Mark Refused CTM Registration
By Larry Cohen
In a case relating to the test to be applied in deciding whether a work mark is capable of distinguishing the goods of one from another, the European Court of Justice (ECJ) reversed the lower court ruling that mark “Doublemint” was not registrable for chewing gum in the European Union (EU) absent evidence of distinctiveness. OHIM v. Wm Wrigley Company (DOUBLEMINT), ECJ Case C-191/01P.
Under Community Trade Marks (CTM) practice marks, which “consist exclusively of signs or indications which may serve in trade to designate the kind, quality, quantity intended purpose, value … or other characteristics of the goods or services” (emphasis added) are not registrable.
The question before the ECJ involved the correct test to apply to determine if the mark “Doublemint” for chewing gum was capable of distinguishing the gum of one maker from those of another. The correct test was held to be that the mark must be refused registration if at least one of its possible meanings designates a characteristic of the goods or services concerned.
In this case, Doublemint was found to be two conjoined English words. It might have a primary use when used by other traders to designate a characteristic of their gum, i.e., has the taste of double mint, and it had to be kept free of that purpose. There was no evidence of record that the mark had, in fact, become distinctive of Wrigley’s gum. The case was remanded by the ECJ to the European Court of First instance (CFI) to review the facts of the basis of the ECJ’s guidance as to the law.
Practice Note: If a word mark is semi-descriptive of the character of some other attribute of the goods, the National Route for registration may be better than the CTM route, as the mark in at least some countries may get through to registration even where the language does not convey a utility for the product. Also, the best evidence of distinctiveness in fact should be made part of the record. Where possible, evidence that the mark does not convey any features of the goods to a native speaker of the language of the mark should be presented, recognizing the difficulty of proving a negative. Note that the ECJ did not hold that “Doublemint” was unregistered for chewing gum, only that the CFI applied the wrong legal test.
It’s Off to the Races as Far as Striping on Gear Is Concerned
In a case concerning the limits of trademark protection, and where it impinges on commonplace designs features open to everyone, the European Court of Justice (ECJ) has now found that a two parallel stripe logo does not infringe the Adidas three stripe logo. Adidas Soloman AG v. Fitness Trading Ltd, ECJ Case C-408/01.
The plaintiff, Adidas-Soloman, and its Dutch licensee, Adidas Benelux BV, are owner and exclusive licensee of certain Benelux trademarks, which consisted of three parallel stripes of equal width that appear down the whole length of pieces of clothing; i.e., down the length of a sleeve or a pair of trousers and contrasts with the main colour of the clothing. The defendant’s alleged infringement consisted of two parallel stripes of equal width that contrast with the
main colour and are applied to the side seams of the clothing.
There are three tests for infringement of a registered trademark under the EC Trade Marks Directive (89/104/EC), which is a harmonizing directive that approximates the trademark law of the EU member states for nationally granted trademarks. The exclusivity granted by registration has three features:
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Where the goods and mark are the same as that recited into the registration, the registrant has the right to prevent use of the mark (Art. 5(1)(a)).
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Where there is a likelihood of confusion including a likelihood of association between the accused mark and the registered mark, the registrant has the right to prevent use of a mark identical to or similar to the registered mark for use on goods identical to or similar to those recited in the registration (Art. 5(1)(b)).
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Where a registrant has a reputation in a member state and where that mark in question takes advantage or is detrimental to the distinctive character or reputation of registered mark, the registrant has the right to prevent the use of a mark identical to or similar to the registered mark even for goods which are not similar to those recited in the registration (Art. 5(2)).
While not all member states of the EU have adopted the wider protection of Article 5(2), a member of consequences flow from its adoption:
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Marks with sufficient reputation are infringed where the infringing mark takes advantage of or it is detrimental to the distinctive character or reputation of the registered mark.
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The relevant public must find some nexus between the registered mark and the defendant’s mark for there to be infringement liability.
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Where a national court finds, as a factual matter, that the alleged mark (in this case the two stripes design) is viewed by the public purely as an embellishment, there is no infringement as no nexus between the similarity of the allegedly infringing mark and source confusion with the registered mark can be established.
In this case, Adidas failed on whether the alleged infringement was viewed by the public as more than a design embellishment.
Practice Note: The practical lesson is that infringement is inherently more difficult to prove when confronted with a non-word than with a word mark, as in the latter case the allegedly infringing mark may be viewed as purely ornamental, and not a designation of origin. Thus, in order for a trademark owner to rely on the added protection of Article 5(2) for “similar” goods, it must be able to establish the necessary reputation and linkage in the mind of the public between the mark and the allegedly infringing design, as well as the unfair advantage or detriment to the reputation of the registered mark.
Federal Circuit Upholds FDA Practices in Suit Involving Patents for Paxil Antidepressant
By Astrid Spain
In a case that turned on statutory interpretation and involved Apotex’s application to market a generic version of SmithKline Beecham Corporation’s (SmithKline) antidepressant Paxil, the U.S. Court of Appeals for the Federal Circuit upheld various U.S. Food and Drug Administration (FDA) practices relating to implementation of the Hatch-Waxman Act (Act). Apotex, Inc. v. Thompson et al. , Case No. 02-1295 (Fed. Cir. Oct. 27, 2003).
The Hatch-Waxman Act authorizes a company to obtain FDA permission to market a generic version of an approved drug by filing an Abbreviated New Drug Application (ANDA). The Act requires New Drug Application (NDA) applicants to identify and the FDA to list any patent that claims the drug that is the subject of the NDA or that claims “a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted” against a party who made, used or sold the drug. In turn, ANDA applicants are required to certify as to each patent listed by the FDA in what is referred to as the Orange Book, either that no patent information has been filed with the FDA; the patent has or will expire on a particular date; or that the patent is invalid or will not be infringed by the generic drug.
Apotex, Inc., filed an ANDA for a generic bioequivalent of Paxil. At the time of filing, only one patent was listed relating to SmithKline’s NDA for Paxil. Because the active ingredient in Apotex’s proposed generic drug was an anhydrous form of Paxil’s active ingredient, Apotex filed a certification asserting its generic would not infringe the listed patent. SmithKline responded with an infringement action, triggering an automatic 30-month stay for an ANDA regulatory approval. SmithKline was subsequently issued five additional patents relating to the anhydrate form of Paxil’s active ingredient and submitted each for listing by the FDA. Apotex filed certifications for each of the newly listed patents and SmithKline in turn responded with separate infringement actions, each triggering a separate 30-month stay.
Apotex filed a complaint alleging, inter alia , that the five subsequently issued patents do not claim Paxil or a method of using Paxil as approved in the original NDA and do not satisfy the statutory requirements for listing in the Orange Book; the FDA was required to determine whether patents qualify for listing; the FDA’s practice of requiring an ANDA applicant to certify patents listed after the ANDA has been submitted violates the Hatch-Waxman Act; and the FDA’s regulation permitting the listing of patents as part of NDA supplements violates the Act.
Construing the plain statutory language as well as interpreting congressional intent, the Federal Circuit concluded that nothing in the Hatch-Waxman Act obligates the FDA to screen Orange Book submissions and refuse patent listings that do not satisfy the statutory requirements for listing. The Federal Circuit also concluded that the statutory language shows clear congressional intent to require certification whenever an ANDA applicant seeks approval of a drug that is claimed by a listed patent and upheld the FDA’s practice of requiring certifications in response to patent information submitted after an ANDA is filed. The Federal Circuit further upheld the FDA regulation requiring that patents submitted as part of a NDA supplement be listed in the Orange Book as consistent with the procedures for submitting patent information for both pending and approved NDAs.
