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7 January 2009

IP Update - December 2008

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Almost exactly two years after affirming a district court decision that granted a preliminary injunction against Apotex.
United States Intellectual Property
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Contents

Desirable Enantiomer Unobvious Over Racemate
By Astrid R. Spain

Almost exactly two years after affirming a district court decision that granted a preliminary injunction against Apotex, the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's decision that Sanofi's patented isomer was unobvious over its known racemate described in Sanofi's own prior art patents. Sanofi-Synthelabo v. Apotex, Inc.., Case No. 07-1438 (Fed. Cir., Dec. 12, 2008) (Newman, J.).

Sanofi markets Plavix®, a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. The active ingredient in Plavix® is the bisulfate salt of the d-enantiomer of a free base referred to by the parties as MATTPCA and is specifically claimed in Sanofi's patent-in-suit.

Apotex filed an Abbreviated New Drug Application (ANDA) pursuant to the Hatch-Waxman Act seeking U.S. Food and Drug Administration (FDA) approval to manufacture and sell a generic version of clopidogrel bisulfate. Apotex filed a Paragraph IV certification with its ANDA asserting that the patent-in-suit is invalid. Sanofi sued Apotex and Apotex counterclaimed, asserting that the patent is invalid and unenforceable in view of Sanofi's United States and Canadian reference patents, which both derive from the same French priority filing.

Stereoisomers are molecules that have the same atomic composition but different spatial arrangements. Enantiomers are a pair of stereoisomers, referred to as (+) and (-), that are non-superimposable mirror images of each other and often have distinct physical properties. A racemate (or racemic mixture) is an equal mixture of two enantiomers. The active ingredient in Plavix® displays the rare chemical property of "absolute stereoselectivity"—one enantiomer (the dextrorotatory enantiomer) provided all of the favorable activity without any significant degree of the unfavorable characteristics.

On appeal, the Federal Circuit rejected the argument that Sanofi's earlier patent that disclosed the racemate anticipated the claims of the patent-in-suit, which were directed to the desirable d-enantiomer. The Court concluded that the prior art patent lacked a specific description and enablement of the enantiomeric form. The Court noted that anticipation requires the specific description as well as enablement of the claimed subject matter. A properly anticipating reference must disclose all elements of the claim within the four corners of the document and must also disclose those elements arranged as in the claim. The Court pointed out that the Plavix® d-enantiomer is shown in the prior art only as one of several compounds with desirable biological properties. Accordingly, the Court concluded that the district court did not clearly err in finding that the reference disclosure would not have led one of ordinary skill to recognize either an explicit or inherent disclosure of its d-enantiomer, as well as the bisulfate salt.

With respect to obviousness, the district court "held that the unpredictable and unusual properties of the dextrorotatory enantiomer, and the therapeutic advantages thereby provided, weighed in favor of nonobviousness, and that Apotex had not met its burden of establishing otherwise." In affirming the district court's holding, the Federal Circuit cited numerous instances in which Apotex's expert witnesses appeared to admit the unexpected properties of clopidogrel. The Court pointed out that experts for both sides agreed that, while it was generally known that enantiomers can exhibit different biological activity, this degree and kind of stereoselectivity is rare and could not have been predicted. In addition, the Court noted that the opposing experts further agreed that the event of a pharmaceutically suitable crystalline salt forming from a particular acid-base combination is unpredictable. Finally, the Court noted that Sanofi presented evidence that the prior art taught away from the use of sulfuric acid with an enantiomer, because the strong acid could encourage re-racemization.

FDA's Rejection of Paragraph IV Certification Valid in Light of Prior Delisting by NDA Holder
By Peter Schuyler

Deciding an issue of first impression regarding the Hatch-Waxman Act, the U.S. Court of Appeals for the District of Columbia Circuit recently vacated a lower court's injunction that had ordered the Food and Drug Administration (FDA) to relist a patent in the FDA's Orange Book and to restore an Abbreviated New Drug Application (ANDA) filer's Paragraph IV patent certification. Teva Pharmaceuticals, USA, Inc. v. Leavitt, Case No. 08-5141 (D.C. Cir., Nov. 7, 2008) (Brown, J.; Williams, J., concurring).

On August 21, 2001, Teva submitted an ANDA that contained a Paragraph IV certification for U.S. Patent No. 5,158,952 (the '952 patent), for a generic version of Risperdal, a schizophrenia drug marketed by Janssen Pharmaceuticals. The FDA informed Teva that the '952 patent had been delisted and asked Teva to submit a revised ANDA. Teva voluntarily complied. Six years later, however, Teva filed a citizen petition requesting that the FDA relist the '952 patent and confirm Teva's eligibility for a 180-day period of marketing exclusivity based on its original ANDA. After the FDA denied Teva's request, Teva asked the D.C. district court for a preliminary injunction, which it granted. The FDA appealed the district court's decision to the U.S. Court of Appeals for the D.C. Circuit.

Teva claimed its certification was valid because the printed version of the Orange Book still listed the '952 patent as of the filing date of its ANDA. Prior to the filing date, Janssen had requested the delisting of the '952 patent, and the FDA updated its online Orange Book at least a month prior to Teva's filing date to reflect the delisting. Thus, the unique question raised by this case is the effect of a Paragraph IV certification made after a patent has been withdrawn by the NDA holder, but before the patent has been deleted from the printed version of the Orange Book.

On appeal, the D.C. Circuit held that Teva failed to meet the "clear and unambiguous requirements" of the Hatch-Waxman statute because its certification did not identify a patent that claimed Risperdal, since the '952 patent had been previously withdrawn by Janssen. The Court noted that the statute requires the NDA (New Drug Application) holder to ascertain whether a patent covers its drug. The Court accepted the FDA's explanation that it operates in a purely ministerial role when listing patents in the Orange Book according to instructions from the NDA holder. In a concurring opinion, Judge Williams concluded that while the statute does not mandate a ministerial role, the FDA's adoption of that role is not unreasonable. This decision did not disrupt this Court's early decision in Ranbaxy v. Leavitt, 469 F.3d 120 (D.C. Cir., Nov. 14, 2006) (previously discussed in IP Update Vol. 9, No. 12), which held that the FDA may not delist a patent after a valid Paragraph IV certification has been submitted.

Baseless Paragraph IV Certification Letters Lead to Exceptional Case
By Brian Baker

Concluding that a district court did not abuse its discretion, the U.S. Court of Appeals for the Federal Circuit upheld the lower court's finding of an exceptional case under 35 U.S.C. § 271(e)(4) and award of $16,800,000 for attorneys' fees, expenses and expert fees. Takeda Chemical Industries, Ltd. v. Mylan Laboratories, Inc., Case Nos. 07-1269, -1270 (Fed. Cir., Dec. 8, 2008) (Lourie, J.; Bryson, J., concurring).

Alphapharm and Mylan sought approval under the Hatch-Waxman Act to produce generic versions of pioglitazone. Takeda sells pioglitazone under the trademark Actos®, which is approved for treating Type 2 diabetes. The Abbreviated New Drug Applications (ANDAs) related to pioglitazone included Paragraph IV certification letters claiming that Takeda's patent covering pioglitazone was invalid for obviousness. Takeda sued both companies for infringement. At trial, Alphapharm and Mylan each changed the focus of their invalidity arguments from those advanced in their certification letters. Alphapharm shifted its theory of obviousness and prior art focus, while Mylan abandoned the defense in its certification and advanced inequitable conduct arguments. After an extensive bench trial, the district court found the patent-in-suit non-obvious and enforceable.

Takeda then moved for an award of attorneys' fees against both Mylan and Alphapharm on the theory that this was an exceptional case. When a patent has been infringed by the filing of an ANDA, 35 U.S.C. § 271(e)(4) provides for the grant of attorneys' fees under 35 U.S.C. § 285, which in turn allows the court to award reasonable attorneys' fees to a prevailing party in exceptional cases. Takeda contended that Mylan and Alphapharm each lacked a good-faith basis for their respective Paragraph IV letters and engaged in misconduct throughout the litigation. "In making a Paragraph IV certification, applicants are statutorily required to 'include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid.'" The district court found numerous "shortcomings in Alphapharm's Paragraph IV letter, which were made obvious by Alphapharm's 'constantly shifting set of arguments,' that supported the finding that the certification was baseless." The district court catalogued scientific errors in Alphapharm's certification letter that the lower court regarded as "insidious" and as underscoring that Alphapharm "did not act with due care or in good faith." As for Mylan, the district court determined that the initial certification letter was completely baseless and that the claims Mylan offered as substitutes were similarly frivolous. The district court agreed with Takeda that both companies lacked a good-faith basis for their certification filings and had engaged in litigation misconduct. The court ordered Alphapharm to pay $5.4 million and Mylan to pay $11.4 million.

On appeal, the Federal Circuit noted that a decision by a district court on whether to award attorneys' fees is within that court's discretion, but the conclusion that a case is "exceptional" is a finding of fact reviewable for clear error. With respect to Alphapharm, the Federal Circuit observed that the district court correctly found that Alphapharm's filing would amount to litigation misconduct supporting an exceptional case finding if it were baseless and if it failed to present even a prima facie case of invalidity in filing the paragraph IV certification. With respect to Mylan, the Court noted that, "the finding that Mylan engaged in litigation misconduct was well-supported and explained by the district court." The Court was unpersuaded by Mylan's argument that the district court took issue with the mere fact that Mylan changed its theory of invalidity and then lost. Rather, the Court noted that Mylan's initial certification letter was completely baseless and that the claims Mylan offered as substitutes were similarly frivolous. The Court concluded that in view of the lower court's "reasoned analysis" and familiarity with the litigation, "[w]e do not believe the court abused its discretion with its award of attorney fees and related expenses."

Practice Note: In an amicus filing, the Generic Pharmaceutical Association argued, ultimately unsuccessfully, that the district court ruling would deter generic applicants from presenting defenses at trial that were not included in their certification letters and preclude the ability to litigate the best available theories at trial regardless of their inclusion in the certification letters.

Narrow Claim Construction Based on Clear Specification
By Alissa Misun

The U.S. Court of Appeals for the Federal Circuit affirmed the district court construction of a claim limitation that the parties agreed, as construed, the defendants did not infringe. Based on its construction, the district court also granted summary judgment of non-infringement. In affirming the district court, the Federal Circuit relied on basic claim construction principles set forth in its en banc Phillips decision. Netcraft Corp. v. eBay, Inc., Case No. 2008-1263 (Fed. Cir., Dec. 9, 2008) (Prost, J.).

Netcraft sued eBay and PayPal (collectively "defendants") for infringement of two patents related to internet billing methods. The asserted patents claim priority to the same earlier patent and share the same specification. The asserted claims require "providing a communications link through equipment of the third party." The district court concluded that "the specification makes it unmistakably clear that the invention requires that the third party provide internet access to the customer" and proceeded to construe the phase to require providing customers with internet access. All parties agree the defendants do not provide internet access to customers. Netcraft appealed.

Netcraft asserted the proper term for construction was simply "communications link." The Federal Circuit agreed that while the term "communications link" viewed in isolation may have a broader construction, when viewed in light of the entire clause in dispute, the district court got it right. The Federal Circuit also cited numerous examples in the specification which describe the "object of the present invention." It found the examples presented describe the invention as a whole and require that the third party provide customers with internet access. The Federal Circuit rejected Netcraft's claim differentiation arguments, noting that even if they had been helpful, they are not necessarily dispositive.

Finally, Netcraft argued the prosecution history supported its claim construction by offering alternative embodiments. The defendants countered that the prosecution history supported a narrow construction. As it turned out during prosecution, in order to overcome prior art, Netcraft amended the claims from "providing a communications link over the internet" to "providing a communications link through equipment of the third party." Ultimately, the Federal Circuit found the prosecution history was not particularly helpful to either party, concluding that it wasn't clear whether the examples Netcraft cited were optional functions or alternative embodiments. The Federal Circuit determined this was inconsequential because the patent specification itself was clear. Thus, the Federal Circuit affirmed the district court's claim construction and grant of summary judgment of non-infringement.

The Twin Axioms of Claim Construction
By John Burr

Over a strong dissent from the "front lines," the U.S. Court of Appeals for the Federal Circuit recently vacated a grant of summary judgment for non-infringement, holding that the district court had improperly narrowed the scope of the allegedly infringed claims to the embodiments illustrated in the figures. Medegen MMS, Inc. v. ICU Medical, Inc., Case No. 07-1513 (Fed. Cir., Nov. 20, 2008). (Dyk, J.; Walker, J., dissenting).

Medegen's patent-in-suit claims an intravenous catheter (IVC) adapter valve configured to work with a needleless syringe. The needleless syringe substantially reduces retrograde flow observed when the needle of a conventional syringe is removed from the adapter through the self-sealing rubber septum. Such retrograde flow often contains blood that can clot in the IVC and impede fluid flow. All embodiments illustrated in the figures of Medegen's patent show a valve in which an elastomeric plug blocks fluid flow between the valve's inlet port and outlet port, which connects to the IVC tubing. The written description regarding plugs suitable for use in the IVC valves of Medegen's patent overwhelmingly focuses on elastomeric plugs. But several claims of Medegen's patent recite valves comprising plugs, without limiting the plugs to having elastomeric properties. After a Markman hearing, the district court issued a claim construction order construing the term "plug" as an elastomeric part that buckles and pivots to establish a fluid flow path. Because the allegedly infringing valve has a rigid plug, the district court granted summary judgment for non-infringement.

On appeal, the Federal Circuit noted that the ordinary meaning of "plug" is not restricted to objects having elastomeric properties. The Court also noted that neither a general description of plugs in the patent nor its prosecution history limited the claimed plugs to having elastomeric properties, even though all illustrations and written description of preferred embodiments describe valves having elastomeric plugs. The Court then relied on the rule that it is improper to import limitations from the specification into the claims in finding too narrow the district court's construction of "plug" as having elastomeric properties. On this rationale, the Court vacated the grant of summary judgment for non-infringement.

In dissent, the Honorable Vaughn R. Walker, Chief Judge in the U.S. District Court for the Northern District of California (sitting by designation), noted "a conundrum often faced by district courts when construing" claim terms. Judge Walker cited the "twin axioms" of claim construction that produced the conundrum. On the one hand, claims must be read in view of the specification, of which they are a part. On the other hand, it is improper to read a limitation from the specification into the claims. The dissent then pointed out that the district court had engaged in a fact-intensive and well-reasoned analysis in construing "plug" and found it improper to reverse that construction, especially given the lack of rationale in the majority's opinion as to how the ordinary meaning of "plug" was determined. Judge Walker commented on the Federal Circuit's practice under Cybor Corp. of giving no deference to claim construction by district courts: "[a]s a jurist more accustomed to working on the front lines of patent litigation than reviewing decisions from above, it is my experience that claim construction—determining how one of ordinary skill in the art would understand the patent at the time of invention—often requires making fact-like determinations not well suited to appellate review."

Earlier Granted Genus Claim Bars Later-Filed Species Claims
By Kevin P. Shortsle

In affirming an obviousness-type double-patenting rejection, the U.S. Court of Appeals for the Federal Circuit held that pending species claims were barred because they were obvious variants of and not patentably distinct from genera claimed in an earlier issued patent to the same inventors. In re Basell Poliolefine Italia S.P.A., Case No. 07-1450 (Fed. Cir., Nov. 13, 2008) (Lourie, J., Newman, J., dissenting).

The U.S. Patent and Trademark Office (USPTO) initiated a reexamination of U.S. Patent 6,365,687 (the '687 patent), assigned to Basell Poliolefine Italia, directed to processes for polymerizing alpha-olefins with other olefins using a titanium halide aluminum alkyl catalyst, which was filed as a continuation in 1992 and claimed priority to a pair of Italian applications filed in 1954. On appeal from the reexamination, the Board of Patent Appeals and Interferences (the Board) found the pending claims unpatentable based on obviousness-type double patenting in view of four expired patents, including U.S. Patent 3,582,987 (the '987 patent), which was issued to the same inventors as the '687 patent. Basell appealed.

The Federal Circuit affirmed, relying on the '987 patent claims to uphold the double-patenting rejection. The Court concluded that the pending claims were obvious variants of the broader genera claimed in the '987 patent: "the claims of the '987 and '687 patents consist of various permutations of polymerization of olefins with various numbers of carbon atoms using catalysts of titanium halides and aluminum alkyls." The Court noted that while "a generic expression does not render obvious all of the species that it encompasses, these claims are both generic and specific to each other in interchangeable ways, involving the same groups of species." The Court noted that the '987 patent specification, which disclosed species claimed in the '687 patent, supported its conclusion that these species were intended to fall within the scope of the '987 claims, and therefore were obvious variants of the '987 patent.

One-Way vs. Two-Way Obviousness Test

Basell argued that the Board erred in failing to apply the "two-way" obviousness test for double patenting. In rejecting this argument the Federal Circuit explained the one-way test of In re Berg—i.e., whether the application claims are obvious over the patent claims—is normally applied. In some circumstances, where the first-filed application has not issued due to a USPTO delay, the two-way test for obviousness-type double patenting may be used, where the additional inquiry of whether the patent claims are obvious over the application claims is also imposed. However, where (as here) the Court found the delay to be attributable to applicant, there was no basis to apply the (more restrictive) two-way test.

Graham Factors

As for Basell's argument that, even applying the one-way obviousness test, the Board failed to present an analysis of the factors required by Graham v. John Deere, the Federal Circuit found that in the context of a double patenting rejections, there was no reversible error in failing to expressly set forth each of the Graham factors.

In dissent, Judge Newman argued that expert testimony indicated that the invention claimed in the '687 patent would not have been predicted by the '987 patent. According to expert testimony, the '987 patent was too broad and incomplete to have motivated one of ordinary skill in the art to prepare a catalyst and have a reasonable expectation that a polymer could have been prepared in the presence of a higher olefin, as recited in the '687 patent. This lack of guidance or enablement from the '987 patent to polymerize alpha-olefins higher than polypropylene, argued Judge Newman, is "relevant to whether the later invention would have been obvious in light of the earlier, or whether the asserted obvious variant could have been patented in both patents." Because the longer chain hydrocarbons behave differently and their synthesis is unpredictable, in Judge Newman's opinion, the '687 patent was patentably distinct from the '987 patent.

Wake Up and Smell the Coffee: Reexamination Stays Can Effectively Deny a Preliminary Injunction Motion
By Todd Hales

In a patent infringement suit involving Folgers and Maxwell House coffee brands, the U.S. Court of Appeals for the Federal Circuit held that the district court abused its discretion by effectively denying Proctor & Gamble Company's (P&G) motion for preliminary injunction without consideration of the merits when granting Kraft Foods Global, Inc.'s motion for a stay pending an appeal in an inter partes re-examination. Proctor & Gamble Company v. Kraft Foods Global, Case No. 08-1105 (Fed. Cir., Dec. 5, 2008) (Gajarsa, J.).

P&G owns the Folgers brand of ground and roast coffee, and Kraft owns the competing Maxwell House brand. Shortly after issuance of P&G's plastic coffee container patent in 2007, Kraft filed a request for inter partes reexamination of the patent. The U.S. Patent and Trademark Office (USPTO) granted Kraft's request for reexamination, but essentially simultaneously confirmed the patentability of the coffee container. Soon after Kraft introduced its plastic coffee containers, P&G filed suit seeking a preliminary injunction against Kraft. Kraft sought to stay the case pending an appeal of the USPTO decision in the reexamination. The district court granted Kraft's motion to stay the case and concluded that "plaintiff's pending motion for preliminary injunction is moot." P&G appealed, asserting that the district court abused its discretion in denying its motion without considering the four-factor preliminary injunction balancing test.

The Federal Circuit agreed, noting that the district court action effectively denied P&G's motion without considering and balancing the required four factors: the likelihood of the patentee's success on the merits, irreparable harm if the injunction is not granted, the balance of hardships between the parties and the public interest. The Court confirmed that the district court had inherent powers to grant a stay pending a patent reexamination but remanded the case to the district court for a determination on the merits of whether P&G is entitled to a preliminary injunction during the stay.

On remand, the district court was instructed to consider the current posture of the inter partes reexamination proceedings when evaluating P&G's likelihood of success on the merits. The Federal Circuit observed that a district court ordinarily should not grant both a preliminary injunction and a stay, stating that a preliminary injunction should not be granted if there is a substantial issue of patent validity and a stay should ordinarily not be granted unless there is a substantial patentability issue raised in the inter partes reexamination proceeding. The Court reasoned that a grant of a preliminary injunction motion followed by a stay of the district court proceedings could subject an accused infringer to an unfair and undesirable delay in reaching a final resolution. In a footnote, the Court suggested the better course (if a stay is granted and a preliminary injunction is denied) is to lift the stay (even if the USPTO proceeding is not concluded) if it appears that the invalidity challenge is "insubstantial."

PTO Announces a New Test for Claim Indefiniteness
By Leigh J. Martinson

The Board of Patent Appeals and Interferences (the Board) announced a new standard for determining compliance with 35 USC § 112, ¶ 2 during examination of a patent application. In a precedential opinion, a five-member panel of the Board determined that a rejection under § 112, ¶ 2 for indefiniteness is proper if a claim has multiple "plausible" interpretations. Ex Parte Miyazaki, Appeal No. 2007-3300, (PTO Bd. App. and Interf. 2008) (Horner, APJ) (precedential).

Miyazaki filed a patent application claiming a large printer and various components of that printer. The examiner rejected various claims, asserting that recitations in the claims relating the height of the paper feeding unit and the sheet feeding area to a user's height were unclear. Miyazaki appealed

In deciding the appeal, the Board considered an exemplary claim which recited (in part) as follows: "a sheet feeding area positioned at a height at which a user, who is approximately 170 cm tall, standing in front of the printer can set up a printing medium without having to bend substantially at the waist, wherein the sheet feeding area is positioned at the height when the printer is placed substantially at ground level."

The Board focused on "sheet feeding area." After reviewing the discussion of the sheet feeding area in the specification and the ordinary meaning of the terms "sheet" and "area," the Board determined that the term was amenable to two plausible definitions. However, neither of these definitions made sense in view of the remainder of the claims. Thus, the Board concluded that neither the specification, nor the claims nor the ordinary meanings of the words provided any guidance as to what Miyazaki intended to cover. In a departure from prior precedent, the Board announced that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite."

In support of its action, the Board cited the Federal Circuit's suggestion in Halliburton Energy Servs. v. M-ILLC (see IP Update, Vol. 11, No. 2) that: "the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.

In connection with its analysis of other, purely functional claims, the Board held that a claim drafted in purely functional language, without the appropriate "means for" language available under 35 U.S.C. § 112, ¶ 6, fails to meet the requirements of 35 U.S.C. § 112, ¶ 1 and is unpatentable. The Board relied for this proposition on the Supreme Court's decision in Halliburton Oil Well Cementing Co. v. Walker.

Practice Note: As always, careful claim drafting is essential when attempting to claim the functional aspects of an invention.

Mere Use of a General Purpose Computer Does Not Sustain Eligibility
By Eric M. Shelton

In the wake of In re Bilski (see IP Update, Vol. 11, No. 11) the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences (the Board) recently addressed the eligibility of computer-based process claims under § 101 and concluded that a programmed computer method did not constitute patent eligible subject matter. Ex parte Halligan, Appeal No. 2008-1588 (BPAI, Nov. 24, 2008) (Horner, APJ).

The en banc Federal Circuit recently implemented a new test for patent eligibility for process claims. Under the Bilski process, claims are subject to a two-part "machine-or-transformation" test. Under this test, patent eligibility may be demonstrated in one of two ways: if a process is tied to a particular machine or apparatus or if the process transforms a particular article into a different state or thing. For computer-related claims, a "particular article" is satisfied by data representing physical and tangible objects. In the Bilski decision the Federal Circuit expressly reserved the question as to "whether or when recitation of a computer suffices to tie a process claim to a particular machine." Now the Board has rejected the proposition that use of a general purpose computer in an otherwise ineligible process claim will confer eligibility.

The process claims on appeal recited a "programmed computer method" for identifying trade secrets, in which the programmed computer was recited as performing each of the method steps. Considering the transformation prong of the test, the Board quickly dispatched the claim concluding trade secrets are not physical or tangible. As to the "specific machine" prong, the Board decided that "a general purpose computer that has been programmed in an unspecified manner to implement ... functional steps" fails to provide a "specific machine" that confers eligibility. Rather the BPAI concluded that the mere recitation of such a computer "fails to impose any meaningful limits," seeks to "exalt form over substance" and is a "field-of-use limitation [that] is insufficient to render an otherwise ineligible process claim patent eligible."

Other claims were directed to a "programmed computer" with a number of means-plus-function elements. Noting the recent Federal Circuit opinion, Aristocrat Technology (see IP Update, Vol. 11, No. 4), the Board found that by merely describing the outcome without providing a sufficient description of an algorithm performed by the computer to obtain the outcome, the application did not disclose the "corresponding structure" required for means-plus-function claiming and that the claims were therefore indefinite under § 112, ¶ 2.

Practice Note: Going forward, applicants are cautioned not to rely on the mere recitation of a general purpose computer to satisfy the "specific machine" prong of the Bilski test for patent eligibility. Something more specific, such as an algorithm performed by the computer, may be needed to establish patent eligibility. One possibility suggested by the opinion, although unlikely to occur in practice, is a step-plus-function computer-implemented claim, in which an algorithm is sufficiently described in the specification. In some cases, applicants may be successful under the transformation prong, where it can be argued that a computer-related method uses data representing physical and tangible objects, such as image-processing methods.

To Prove Infringement, an Accused Device Must Meet All the Limitations of a Claim
By Babak Akhlaghi

The U.S. Court of Appeals for the Federal Circuit upheld the district court's judgment permanently enjoining inventor Samy Gharb from asserting his patent against Unitronics (1989) (R"G) Ltd. and Unitronics, Inc. (collectively, Unitronics) or Unitronics' customers. Unitronics v. Gharb, Case No. 08-1442 (Fed. Cir., Dec. 2008) (Newman, J.; Linn, J. and Moore, J.) (per curiam) (non-precedential).

Gharb is an owner of a patent directed to a security system with a mobile telephone. Unitronics manufactures programmable logic controllers (PLCs) that communicate using Global System for Mobile Communications Standard (GSM). Since the Unitronics's PLCs could communicate using GSM Gharb threatened to sue Unitronics and its distributors for infringing his patent. In response, Unitronics filed suit for a declaratory judgment of non-infringement.

The district court agreed with Unitronics that its product does not infringe Gharb's patent and granted summary judgment in Unitronics' favor. Unitronics then moved for permanent injunction to prevent Gharb from any future threat of infringement litigation. The district court also granted this motion. Gharb appealed (pro se).

On appeal, Gharb argued that Unitronics infringed its patent by selling PLCs having GSM capability. The Federal Circuit disagreed, asserting that the patent requires more than a PLC with GSM capability and that the Unitronics's device could not infringe the patent because it does not meet several limitations of the claims. The Federal Circuit noted that "Gharb appears to believe that any PLC that is able to communicate over the GSM network infringes his patent, because part of his patent discloses PLCs communicating over GSM. Gharb's belief, however, is premised on an incorrect understanding of the law."

The Federal Circuit stated that to prove infringement, [Gharb] was required to show that Unitronics's devices met all of the limitations of the claim either literally or by an equivalent. However, Gharb failed to carry this obligation. For example, "[n]one of the evidence set forth by Gharb shows that any Unitronics device contains the 'digital recording device having at least one emergency message' or its equivalent, or the 'data set for transmission to the mobile telephone including alarm information' or its equivalent, of the claimed security system." Accordingly, the Federal Circuit concluded that the district court was correct to grant summary judgment of non-infringement in favor of Unitronics.

First Amendment Trumps Trademarks to Protect Video Game's Virtual Strip Club
By Rita W. Siamas

Considering whether a video game producer had a valid First Amendment defense against a Los Angeles strip club's trademark and trade dress infringement claims, the U.S. Court of Appeals for the Ninth Circuit explicitly held that the First Amendment may serve as a valid defense not only to use another's trademark within the title of a creative work, but also to use a trademark within the content of a creative work itself. E.S.S. Entertainment 2000 v. Rock Star Videos, Case. No. 06-56237 (9th Cir., Nov. 5, 2008) (O'Scannlain, J.)

Plaintiff E.S.S. Entertainment 2000 operates the Play Pen Gentlemen's Club, a strip club in East Los Angeles. Defendant Rock Star Videos manufactures the highly successful video game series "Grand Theft Auto" (GTA). The GTA video games take place in cartoon-style virtual cities that are loosely modeled after actual U.S. cities. Players assume the role of a criminal who rises through the ranks of organized crime by completing various missions. Players may roam the cities freely at any point in the game, which are populated with virtual businesses and landmarks. Many of the businesses and landmarks were created based on photographs of actual neighborhoods, but the brand names, business names and other aspects of the locations have been changed. The games include a disclaimer stating that the locations depicted are fictional.

Defendant's "GTA: San Andreas" game focuses on California gang culture and includes a fictional neighborhood "East Los Santos," the game's version of East Los Angeles. One virtual business in East Los Santos is a virtual strip club called the "Pig Pen," which is loosely based on the plaintiff's "Play Pen" club. The plaintiff sued the defendant in the Central District of California for trademark infringement, trade dress infringement and unfair competition, alleging that the defendant's use of the PIG PEN mark in the San Andreas game created a likelihood of confusion among consumers as to whether the plaintiff had endorsed or was associated with the defendant's virtual depiction of the plaintiff's "Play Pen" club. The defendant moved for summary judgment, claiming that its use of the PIG PEN mark was nominative fair use and also protected by the First Amendment. The district court rejected the defendant's nominative fair use defense but granted summary judgment based on the First Amendment defense. The plaintiff appealed.

The defendant first argued the affirmative defense of nominative fair use, which protects those who deliberately use another's mark for purposes of comparison, criticism or point of reference. The court found this defense inapplicable, however, because the defendant did not use the plaintiff's actual PLAY PEN mark or logo to identify its virtual strip club but instead used the PIG PEN variation. Concerning the defendant's First Amendment defense, the court applied the test the Ninth Circuit adopted from the Second Circuit's approach in Rogers v. Grimaldi. The Rogers test requires courts to construe the Lanham Act narrowly when considering trademark infringement claims in the context of creative works. It provides that use of another's trademark in an artistic work is not infringement unless the alleged use has no artistic relevance to the underlying work whatsoever, or, if relevance exists, the use is only infringement if the use explicitly misleads consumers regarding the source of the work. While the Rogers test has traditionally been applied to preclude liability for using trademarks in titles of creative works, the Ninth Circuit explicitly extended it in this case to apply to the use of another's trademark in the body of a creative work.

Under the Rogers framework, the plaintiff argued that the defendant's use of the PIG PEN mark in the game had no artistic relevance because the game was not "about" the strip club. The court rejected this argument, instructing that the level of relevance "merely must be above zero." Because the defendant developed a cartoon-style parody of East Los Angeles in its video game, the court found that it was reasonable to re-create businesses and buildings into the game.

Applying the second prong of the Rogers test, the court considered whether the defendant's use of the PIG PEN mark in the game "would confuse its players into thinking that the Play Pen is somehow behind the Pig Pen or that it sponsors [the defendant's] product." In finding that nothing indicated that consumers would reasonably believe that the plaintiff (a regional strip club) produced the video game or that the defendant (a well-known producer of sophisticated video games) operated a strip club, the court reasoned that the plaintiff's strip club and the defendant's video game had nothing in common other than that both offered "a form of low brow entertainment." Moreover, "[t]he San Andreas Game is not complementary to the Play Pen," the court surmised, "video games and strip clubs do not go together like a horse and carriage or, perish the thought, love and marriage." Trying another theory, the plaintiff argued that confusion was likely because the virtual strip club was a significant part of the defendant's game—alleging that it was significant based on the fact that players may ignore the game's storyline and spend unlimited amounts of time at the club. Rejecting this theory, the court explained, "fans can spend all nine innings of a baseball game at the hot dog stand; that hardly makes Dodger Stadium a butcher's shop. In other words, the chance to attend a virtual strip club is unambiguously not the main selling point of the Game."

Because the Ninth Circuit found that the defendant's use of the PIG PEN mark in the game was not explicitly misleading, it was thus protected by the First Amendment under Rogers. Accordingly, the Ninth Circuit affirmed summary judgment for the defendant.

Collegiate Color Schemes Protectable as Trademarks
By Jeremy T. Elman

Addressing the issue of trademark infringement of a color scheme, the U.S. Court of Appeals for the Fifth Circuit upheld the common-law trademark rights and unfair competition rights of four universities to trademark their color schemes against a t-shirt maker despite the absence of trademark registrations. Board of Supervisors for Louisiana State Univ., et al. v. Smack Apparel Co., et al., Case No. 07-30580 (5th Cir., Nov. 25, 2008) (Reavley, J).

An unlicensed t-shirt maker (Smack Apparel) sold its college football shirt designs alongside officially licensed t-shirts at football games. Smack's t-shirt utilized well-known college colors along with printed messages associated with its shirts such as "Beat [opposing team]" (purple and gold for Louisiana State University, crimson and cream for Oklahoma University, scarlet and gray for Ohio State University and cardinal and gold for University of Southern California) (the universities"). The Fifth Circuit upheld the trial court's summary judgment finding for the universities of common-law trademark infringement and Lanham Act unfair competition and affirmed the damages award.

The Court held that the lack of trademark registration of the color schemes was irrelevant because ownership of a trademark is established by use, not by registration. Even without a federal registration, colors may be protectable under common-law trademark principals or under Lanham Act unfair competition principles, since the Lanham Act provides that a trademark may include any word, name or symbol or "any combination therefore."

The Court classified the color schemes as descriptive trademarks, so the universities had to show that the schemes had acquired secondary meaning to be protected. The Court then proceeded to weigh the Fifth Circuit's multi-pronged secondary meaning test and found that the color schemes had achieved secondary meaning.

Having thus found a protectable trademark interest, the Court next considered whether the universities had established a likelihood of confusion. Relying on the overwhelming similarity between the universities' color schemes and the t-shirt maker's, the t-shirt maker's admitted intent to create an association with the universities and the universities' stringent licensing policies that protected the color schemes and other trademarks, the Court found no genuine issues of material fact as to consumer confusion. After it cruised through each of the Fifth Circuit confusion factors, the Court dismissed Smack's argument that the color schemes are functional since they are placed on other products such as collegiate events and university buildings as well as Smack's fair use argument, noting that a fair use defense cannot stand where the use creates consumer confusion.

It Sure Is FUN to Be Evocative – Especially If You Are a Trademark
By Désirée Fields

Addressing the issue whether the word "fun" may be seen as too descriptive and lacking in distinctive character in relation to land motor vehicles, the European Court of First Instance annulled a decision of the Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM) Board of Appeal, stating that the link between the word "fun" and land motor vehicles was too vague, uncertain and subjective to confer descriptive character on that word in relation to those goods. Ford Motor Co v. OHIM, Case No. T-67/07 (European Court of First Instance, Dec. 2, 2008).

On June 27, 2005, Ford Motor Co. filed an application with OHIM for registration of the Community Trademark FUN for "land motor vehicles and parts and fittings thereof." OHIM refused the application. On appeal, the OHIM Board of Appeal held that the mark lacked distinctiveness and was descriptive of the relevant goods stating that for the public, the word "fun" used in connection with a land motor vehicle was likely to be perceived as an indication that the vehicle had a quirky design and was particularly enjoyable to drive. The Board stated that the word "fun" was a rather banal and basic English word and that there was a clear public interest in keeping it available for other traders and competitors. Ford appealed.

On appeal, the Court of First Instance (Europe's second-highest court) reversed, finding that the case was one of evocation of one of the qualities of the relevant goods but that it did not describe them. Although in some cases the word "fun" could be a source of amusement to its driver, as a trademark, the term "FUN" did not go beyond suggestion. Unlike some indications that were descriptive of the characteristics of a vehicle, such as "turbo," "ABS" or "4x4," the term "fun" on the back of a vehicle did not serve to designate directly a motor vehicle or one of its essential characteristics. The Court concluded that the relationship between the term "fun" and land motor vehicles was not sufficiently direct and specific to enable the relevant public to immediately perceive without further thought, a description of the goods or one of its characteristics. Accordingly, the Court found that the link between the term "fun" and land motor vehicles was too vague, uncertain and subjective to confer descriptive character on that word in relation to those goods.

Practice Note: The approval of the trademark for registration may have implications for competitors who wish to use the word "fun" in advertisements, though it remains to be seen whether use of the word "fun" in a broader context, such as part of a slogan, would be regarded as trademark infringement.

Mon Dieu! Publication in a Foreign Country Without Notice Leaves No "Impressionist"
By Han (Jason) Yu

The U.S. Court of Appeals for the Ninth Circuit has determined that works did not enter the public domain by reason of pre-1978 foreign publication without copyright notice. Société Civile Succession Richard Guino v. Renoir, et al., Case Nos. 07-15582, -15583, -17209 (9th Cir., Dec. 9, 2008) (Nelson, J.).

At issue were 11 sculptures, created between 1913 and 1917 by the French impressionist Pierre-Auguste Renoir, through the hands of the Spanish sculptor, Richard Guino, who at the time served as an assistant to the ailing Renoir. The sculptures were first published in Paris under Renoir's name. In 1973, Guino succeeded in having the French Supreme Court recognize him as a "co-author" of the sculptures and found him to be entitled to a one-half ownership interest in the copyright. Guino passed away in the same year. In 1974, the sculptures were exhibited in Paris as Renoir-Guino joint creations. No copyright notice was included with any pre-1978 publication of the sculptures.

In 1982, an agreement between the families of the two artists granted the Guino estate the exclusive rights to control reproduction of the 11 sculptures, and a trust (the Société) was formed to implement those rights. In 1984, the Guino family subsequently registered the sculptures with the U.S. Copyright Office. In 2003, a descendant of Renoir sold some of the sculptures at issue to Beseder, who then advertised and sold reproductions of them at its gallery in Arizona. The present action was brought by Société on behalf of the Guino estate against the named Renoir descendant and Beseder, alleging copyright infringement.

Under the 1909 Act, a work was protected by state common law copyright until it was published. Upon publication, the work lost common-law protection but instead could secure federal protection by publication with proper copyright notice. Otherwise, the work entered the public domain. In Twin Books v. Walt Disney, the Ninth Circuit held that publication in a foreign country without a copyright notice does not put the work in the public domain in the United States. Rather, the court in Twin Books found that under the 1909 Act, a pre-1923 publication without notice neither secured copyright nor put the work in the public domain. The court in Twin Books concluded that the U.S. copyright term for the work in issue commenced in 1926, when the work was republished abroad with copyright notice.

The district court, citing Twin Books as binding precedent, ruled that the publications in France without copyright notice did not cause the Renoir-Guino sculptures to enter the public domain in the U.S., nor were the sculptures copyrighted i.e., under the 1909 Act, prior to 1978 (i.e., the effective date of the 1976 Act). Consequently, the district court concluded, the sculptures were protected by U.S. copyright under the 1976 Act for a term of 70 years following Guino's death, i.e., until 2043. Beseder and the aligned Renoir decedent appealed.

The Ninth Circuit affirmed, agreeing that the sculptures were neither in the public domain nor copyrighted in the U.S. prior to 1978 and, therefore, were entitled to protection under the 1976 Act until 2043.

The defendants contended that Twin Books was distinguishable and should not apply because there was no republication of the sculptures with notice at any time under the 1909 Act. The Court made short work of that argument, noting that Twin Books did not require republication with notice to secure copyright. Beseder also argued that, unlike the book at issue in Twin Books (Bambi, published in 1923), the sculptures in question were published before 1923 and that as a consequence of the term provisions of the 1976 Act, works published before January 1, 1923 are generally in the public domain. Rejecting these contentions, the Ninth Circuit observed that both the present case and Twin Books both dealt with the status of a pre-1978 work after foreign publication without notice and that neither the absence of republication with notice nor the pre-1923 publication would warrant a different holding from Twin Books.

Practice Note: The reasoning of Twin Books has been criticized as creating an "anomaly" category of works that were neither copyrighted nor in the public domain. However, until the Supreme Court or the Ninth Circuit itself holds otherwise, it remains the law in this circuit that foreign publication without copyright notice does not cause a pre-1978 work to enter the public domain.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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