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Heart-to-Heart on Reduction to Practice: When It Comes to Testing, How Much Is Enough?

by Thomas DaMario | Jun 1, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision that the patent owner successfully demonstrated that the claimed heart catheter invention was conceived and reduced to practice prior to the effective date of the reference, by record evidence of adequate testing to demonstrate that the invention would work for its intended purpose. Medtronic, Inc. v. Teleflex Innovations S.Á.R.L., Case Nos. 21-2356; -2358; -2361; -2363; -2365 (Fed. Cir. May 24, 2023) (Moore, C.J.; Lourie, J.) (Dyk, J., dissenting).

Teleflex Innovations owns five patents directed to guide extension catheters that use a tapered inner catheter that runs over a standard coronary guidewire to reduce the likelihood that a guide catheter will dislodge from the coronary artery’s opening. All of the patents are related and share a common specification. Around the time of the challenged patents’ priority date, the applicant was working to develop two commercial variants of similar technology: the “rapid exchange” (or “RX”) version of the GuideLiner product, which Teleflex claims practices the challenged patents, and an “over-the-wire” (or “OTW”) variant, which does not practice the challenged patents.

Medtronic petitioned for inter partes review (IPR), challenging all five patents on the basis that they were predated by a patent to Itou. During the IPR proceedings, Teleflex claimed that conception and reduction to practice occurred prior to Itou’s priority date and submitted several declarations and exhibits such as lab notebooks, internal company memoranda, presentations, invoices, sales orders, photographs, engineering drawings and documents from outside patent counsel in support of its contentions. Ultimately, the Board found that Itou did not constitute prior art and therefore Medtronic had failed to demonstrate that the challenged claims were unpatentable. Medtronic appealed.

On appeal, Medtronic did not challenge conception but argued that the Board’s findings on actual reduction to practice and reasonable diligence toward constructive reduction to practice should be reversed. To establish an actual reduction to practice, the patent owner must show that the inventors constructed an embodiment that met all the limitations of the claimed invention and determined that the invention would work for its intended purpose. Medtronic’s arguments were based on the grounds that the Board erred in three ways:

Incorrectly identifying the intended purpose of the claimed invention
Not requiring comparative testing to demonstrate that the invention worked for that purpose
Relying solely on uncorroborated inventor testimony.

On the first issue, Medtronic argued that the Board incorrectly found an over-broad intended purpose of the claimed invention by relying too heavily on extrinsic evidence. The Federal Circuit acknowledged that while “the patents themselves are the most important” evidence, “it is appropriate to consider extrinsic evidence, particularly when it does not contradict the patents themselves.” The Court went on to conclude that the intended purpose here was broader than the narrow purpose argued by Medtronic (relating to difficult occlusions)—“[t]he very title of the patents themselves, ‘Coaxial Guide Catheter for Interventional Cardiology Procedures,’ describes the purpose of the claimed inventions, and it is undisputed that the [...]

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On the Road Again: Alternative Designs May Impact Trade Dress Functionality Analysis

by Kavya Rallabhandi | May 25, 2023 | Trademarks

The US Court of Appeals for the Sixth Circuit reversed and remanded a summary judgment ruling, finding that there were genuine disputes of material fact regarding whether the plaintiff’s alleged trade dress was functional and therefore excluded from trade dress protection. DayCab Co., Inc. v. Prairie Tech., LLC, Case No. 22-5625 (6th Cir. May 11, 2023) (Moore, Clay, Stranch, JJ.)

DayCab manufactures conversion panels for tractor-trailer cabs. DayCab asserted Lanham Act and Tennessee Consumer Protection Act claims again Prairie Technology for trade dress infringement of its DayCab conversion kit. Prairie denied infringement and counterclaimed for declaratory judgment that DayCab’s trade dress was functional.

DayCab asserted that its product’s slant-back design, depth, rounded edges and gray color were protectable trade dress, explaining that it had carefully selected the angles, curves, tapers, lines, profile and appearance of the DayCab conversion kit. DayCab further argued that the 144-degree angle of the “slant-back” design, the dimensions of the depth and radius of the design, and the color were aesthetic and not functional. In support of its argument, DayCab presented competitor conversion kits to illustrate that there are many different appearances and ways to style conversion kits. DayCab attested that the only requirement for manufacturability is that the top of the fiberglass mold used for manufacturing the conversion kits must be slightly larger at the top than at the bottom. In response, Prairie presented expert testimony that the parties’ respective kits were not identical and that the panel’s depth, top body radius, lower body angle, flange/body radius and color were functional.

The parties filed cross motions for summary judgment. Prairie argued that DayCab could not prove that its trade dress was nonfunctional, had secondary meaning or that there was likelihood of confusion. The district court granted Prairie’s motion, finding that DayCab’s asserted trade dress was functional and therefore not protectable. The district court did not address secondary meaning or likelihood of confusion. DayCab appealed.

The Sixth Circuit reversed the district court’s summary judgment ruling, finding that the district court did not determine open questions about whether DayCab’s conversion kits’ slant-back design was functional. The Sixth Circuit further remanded because the district court did not consider whether Prairie’s kits infringed DayCab’s design. Regarding functionality of the conversion kit, the Court determined that existence of alternative designs and testimony from DayCab’s founder claiming that the design choices were aesthetic raised issues in the district court’s functionality ruling. The Court also noted that the existence of alternative designs was relevant to the functionality determination because they supported DayCab’s contentions that it designed the panel with aesthetic intent and that its resulting features were ornamental rather than functional.

The Sixth Circuit found that it was for the jury to determine secondary meaning and whether Prairie intentionally copied DayCab’s design. The Court also found that likelihood of confusion needed to be determined by a jury because of conflicting evidence: DayCab presented evidence that consumers inquired about ordering Prairie’s kits from DayCab because the products were similarly named and indistinguishable on [...]

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Elevate the $: Geographic Isolation Helps Defeat Trademark Infringement Claim

by Kathleen Lynch | May 25, 2023 | Trademarks

In a case between similarly named banks, the US Court of Appeals for the Tenth Circuit confirmed expert disclosure requirements, conducted a de novo likelihood of confusion analysis and ultimately upheld a finding of no trademark infringement. Elevate Federal Credit Union v. Elevations Credit Union, Case No. 22-4029 (10th Cir. May 10, 2023) (Bacharach, Moritz, Rossman, JJ.)

Elevate is a federal credit union with almost 13,000 total members, operating exclusively in three rural Utah counties. Elevations is a Colorado state-chartered credit union with more than 150,000 members. The parties’ respective logos are shown below:

Elevate filed a suit seeking declaratory judgment of noninfringement, and Elevations counterclaimed for trademark infringement. After excluding testimony from Elevations’s expert, the district court found no infringement and granted summary judgment in favor of Elevate. Elevations appealed.

Elevations raised two issues on appeal:

Did the district court abuse its discretion in excluding Elevations’s expert’s testimony?
Did the district court err in granting summary judgment to Elevate on likelihood of confusion?

The Tenth Circuit affirmed the district court on the first issue. Elevations’s expert conducted a survey that involved showing marks from internet searches to consumers and asking whether they thought any came from the same company. While this survey type is legitimate, the expert did not keep records of his searches, write down his search terms, identify his search engines, or justify why he conducted multiple internet searches but showed consumers only results from Bing and the Apple App store. The Tenth Circuit found that the district court could have reasonably considered this information “facts or data” considered by the expert that needed to be—but was not—disclosed. Because the expert failed to meet his disclosure obligations and because this failure was not excused by justification or harmlessness, the lower court did not abuse its discretion.

The Tenth Circuit also affirmed the summary judgment of no likelihood of confusion. The Court conducted a de novo review and analyzed the six factors below. The Court concluded that the following five factors weighed against the likelihood of confusion:

Level of care exercised by purchasers. When customers look to open bank accounts or borrow money, they exercise a great level of care. This is especially true here because credit unions have statutory membership restrictions, meaning consumers need to confirm they qualify for membership before applying.
Strength of senior mark. While Elevations’s marks are “suggestive” and therefore “fall[] midway in the range of conceptual strength,” many other businesses in Colorado use the root term “elevat,” which weakens Elevations’s mark. Elevations’s marks also are weak where Elevate operates in Utah due to lack of advertising.
Degree of similarity. While the marks have some similarities in appearance and sound, they differ in fonts, alignment, background colors, graphics and number of syllables. The Court also stated that the “significance of the similarities fades away” in light [...]

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First Circuit: Claim Preclusion Shouldn’t Apply to Bar Claims Under VARA

by Hannah Cohen | May 25, 2023 | Copyrights

Addressing for the first time whether federal res judicata law recognizes the alternative determinations doctrine, the US Court of Appeals for the First Circuit determined that a plaintiff’s claims under the Visual Artists Rights Act (VARA) were not precluded by a previous action in which she brought a federal copyright claim against the defendant. Foss v. Eastern States Exposition, Case No. 22-1313 (1st Cir. May 10, 2023) (Barron, Howard, Montecalvo, JJ.)

Cynthia Foss previously brought a federal copyright action against Eastern States Exposition that was dismissed. The previous action did not involve any claim under VARA. Eastern argued that claim preclusion should apply to bar the claim, and the district court agreed. Foss appealed.

To establish federal claim preclusion, a party must establish that there is a final judgment on the merits in an earlier suit, sufficient similarity between the causes of action asserted in the earlier and later suits, and sufficient identicality between the parties in the two suits. Foss did not dispute that the first and third requirements were satisfied, and thus the First Circuit’s decision turned on whether the second requirement was met.

Foss argued that the “alternative determinations” doctrine should apply. This doctrine strips a dismissal of claim preclusive effect if the dismissal rests on multiple grounds, not all of which would on their own render the dismissal claim preclusive. Whether the doctrine should apply was a matter of first impression in the First Circuit. Foss argued that the previous dismissal was in part based on “her failure to allege that she had satisfied the registration-related precondition to copyright infringement suits under § 411(a),” which was not a merits-based dismissal and therefore had no preclusive effect. Eastern argued that even if the First Circuit adopted the alternative determinations doctrine, the Court should limit the doctrine because the district court “rigorously considered” the merits-based rationale for dismissal in the previous action.

The First Circuit adopted the alternative determinations doctrine and rejected Eastern’s contention that the doctrine should not apply in the instant case because Eastern did not provide support for the contention that the district court in the previous action “rigorously considered” the merits-based grounds for dismissal of Foss’s federal copyright claims. The Court then remanded the case for further consideration, noting that Eastern might argue that the alternative disputes doctrine should be limited in this instance because of Foss’s failure to allege satisfaction of the precondition to suit, which might be prejudicial to Eastern.

Analogous Art Must Be Compared to Challenged Patent

by Alexandra Cavazos, PhD | May 25, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged patent, which related to injection devices used for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns a patent directed to a drug delivery device that can be configured to allow for the setting of different dose sizes. The main independent claim of the patent recites a spring washer element with “at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.”

Mylan initiated an inter partes review (IPR) proceeding against the patent, arguing that the challenged claims were obvious based on a combination of three prior art references: Burren, Venezia and de Gennes. Burren described a drug injection device that used a coiled spring, while Venezia described a hypodermic syringe with a spring washer having a tongue that fit into a collar to prevent the washer from rotating relative to the collar. The third prior art reference, de Gennes, disclosed a large spring-washer-like device used in automobile engines to maintain the alignment between the engine and the transmission. Sanofi argued that de Gennes was non-analogous art because it was not in the same field of endeavor as the injection devices described in the patent and was not reasonably pertinent to a problem faced by the inventor of the challenged patent.

The Board adopted Mylan’s definition of the problem to be solved, which was “axially fixing two components relative towards each other.” Under this broad definition, the Board found that de Gennes was reasonably pertinent to the challenged patent and that claims were obvious in view of Burren in combination with Venezia and de Gennes. Sanofi appealed.

Sanofi argued that the Board erred in determining that de Gennes was analogous art. The Federal Circuit explained that in evaluating whether a reference is analogous, a patent challenger must compare the reference to the challenged patent. Applying this test, the Court found that substantial evidence did not support the conclusion that de Gennes was analogous to the challenged patent. Although Mylan had mapped de Gennes to certain elements of the challenged claims, there was no evidence that de Gennes—an automobile-related patent—was analogous to the challenged patent—a drug delivery device. The Court also found that statements that de Gennes and the challenged patent were “both interested in solving the same issue . . . [of] accommodating various cartridge lengths” were insufficient to show that de Gennes was analogous to the challenged patent.

No Extra Life: Harmless Claim Construction Error Does Not Restart Invalidity Challenge

by Christian Tatum | May 18, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision, finding that under the harmless error rule, the challenged claims were invalid as obvious even if the Board erred in claim construction. Bot M8 LLC v. Sony Interactive Entertainment LLC, Case Nos. 22-1291 (Fed. Cir. May 9, 2023) (Prost, Reyna, Cunningham, JJ.).

Bot M8 owns a patent related to a gaming machine that authenticates certain data and includes both a board and a motherboard. The independent claims require that a “game program” is stored in memory on the board and written to the motherboard only after the game program has been authenticated by a central processing unit (CPU) on the motherboard (the Write Limitation). Sony Interactive Entertainment petitioned for inter partes review (IPR). Ultimately, the Board determined that the challenged claims were unpatentable as obvious. Bot M8 appealed.

The issue presented to the Federal Circuit was what data the Write Limitation precludes from being written to the motherboard prior to authentication: (1) the entire game program, (2) any portion of the game program and/or (3) any data (including data not related to the game program). It was undisputed that the claims at minimum preclude writing the entire game program to the motherboard before authentication (option 1). Both the Board and the Court rejected Bot M8’s argument that would preclude writing any data whatsoever before authentication (option 3). The question thus resolved into whether the Write Limitation also precluded writing any portion of the game program prior to authentication (option 2). Bot M8 argued that it did.

Bot M8 focused on a statement made by the Board as indicative that the Board applied an erroneous claim construction that would allow a portion of the game program to be written prior to authentication (rejecting option 2): “[Bot M8] seeks to read into claim 1 a requirement that nothing related to, or any portion of, the gaming information be read into [the motherboard’s] RAM … prior to authenticating the game program.”

The Federal Circuit rejected Bot M8’s argument, finding that even if the Board erred in construing the claim, Bot M8 failed to demonstrate that the alleged error was harmful. Specifically, the Court found that any such error was harmless because the Board never needed to apply an improper construction since it found the prior art disclosed writing only non-game program data prior to authentication, a protocol that both the Board and the Court found was not precluded by the Write Limitation. Deeming the Board’s potential claim construction error harmless, the Court affirmed the Board’s invalidity determination.

Practice Note: Parties seeking to appeal a Board decision based on an improper claim construction theory should demonstrate how the Board’s error resulted in harm.

Blunt Rejection of Attorney Fees in Stipulated Dismissal

by Lillian Spetrino | May 18, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the rejection of attorney fees, finding that neither inequitable conduct nor a conflict of interest rendered the case exceptional given the limited factual record following a stipulated dismissal in a patent case. United Cannabis Corp. v. Pure Hemp Collective Inc., Case No. 22-1363 (Fed. Cir. May 8, 2023) (Lourie, Cunningham, Stark, JJ.).

United Cannabis Corporation (UCANN) sued Pure Hemp for patent infringement. After the litigation was stayed pending bankruptcy proceedings, the parties stipulated to the dismissal. Pure Hemp then sought attorney fees based on alleged inequitable conduct by UCANN during prosecution of the asserted patent due to nondisclosure of a prior art reference used in the patent’s specification and based on a purported conflict of interest by UCANN’s litigation counsel. The district court denied Pure Hemp’s request, finding that the case was not exceptional. Pure Hemp appealed.

Pure Hemp argued that the district court erred by (1) failing to find Pure Hemp to be the prevailing party in the litigation, (2) not concluding that the undisputed facts established inequitable conduct and (3) not recognizing that UCANN’s attorneys had a conflict of interest.

The Federal Circuit found that although the district court erred in not finding Pure Hemp to be the prevailing party, this was a harmless error. The Court explained that by fending off UCANN’s lawsuit with a stipulation dismissing UCANN’s claims with prejudice, Pure Hemp is a prevailing party under § 285. However, the Court concluded that this error was harmless because the district court ultimately concluded that this case was unexceptional.

The Federal Circuit found Pure Hemp’s arguments on inequitable conduct without merit. The Court explained that it had no findings to review because Pure Hemp voluntarily dismissed its inequitable conduct counterclaim and did not seek any post-dismissal inequitable conduct proceedings. Although Pure Hemp argued that it could prevail based on the undisputed facts in the record, the Court disagreed. It explained that even the limited record demonstrated at least a genuine dispute as to both the materiality and intent prongs of inequitable conduct and, therefore, the district court properly determined that Pure Hemp did not demonstrate that this case was exceptional.

The Federal Circuit also rejected Pure Hemp’s argument that copying and pasting portions from the prior art in the patent’s specification (but not disclosing the same prior art references) was inequitable conduct. The Court explained that unlike the nonbinding cases Pure Hemp relied on, the district court here did not find that the copied prior art was material, and the record gave no reason to disbelieve the explanation provided by UCANN’s prosecution counsel. The Court was also unpersuaded by Pure Hemp’s arguments to support inequitable conduct, explaining that the Court was not free to make its own findings on intent to deceive and materiality and, further, the district court was not required to provide its reasoning for its decision in attorney fee cases.

As to Pure Hemp’s argument that the case was exceptional because UCANN’s attorneys [...]

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What’s Shakin’ Bacon? Not Inventorship—Contribution to Invention Can’t Be “Insignificant”

by James M. Oehler | May 11, 2023 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court decision and found that an asserted inventor not named in the application was not a joint inventor because in the context of the entire invention his contribution was too insignificant to constitute joint inventorship. HIP, Inc. v. Hormel Foods Corp., Case No. 22-1696 (Fed. Cir. May 2, 2023) (Lourie, Clevenger, Taranto, JJ.)

Hormel owns a patent directed to precooking bacon and meat pieces. The patent claims a two-step method that involves a preheating step using a microwave oven, infrared oven or hot air, and then a higher-temperature cooking step. Prior to filing its patent application, Hormel and HIP entered into a joint agreement to develop an oven for the two-step cooking process. Hormel evaluated an HIP oven and learned, among other things, that preheating the bacon via a microwave oven prevented condensation from washing away the salt and flavor. HIP’s David Howard suggested an infrared oven (already known in the art) as a possibility for use in the preheating step. Hormel subsequently filed a patent application that did not name Howard as a joint inventor. HIP sued Hormel alleging that Howard was a joint inventor. The district court found that Howard was a joint inventor based solely on his alleged contribution of infrared preheating. Hormel appealed.

The inventors listed on an issued patent are presumed to be the only true inventors. Thus, a party must prove a claim to correct inventorship by clear and convincing evidence. A joint inventor must do the following:

Contribute in a significant manner to the conception or reduction to practice of the invention
Make a contribution to the claimed invention that is not insignificant in quality when that contribution is measured against the dimension of the full invention
Do more than explain well-known concepts or the current state of the art.

The Federal Circuit found that Howard’s alleged contribution of using an infrared oven for preheating the bacon was insignificant in quality when measured against the full invention, which it found to be clearly focused on preheating with a microwave oven. Preheating with an infrared oven was briefly mentioned in passing as an alternative to a microwave oven in the patent’s specification and in a single dependent claim. In contrast to using an infrared oven, the patent claims, specification and figures all prominently featured using a microwave oven for the preheating step. All the independent claims required or allowed using a microwave oven for the preheating step. The specification also repeatedly referred to preheating with a microwave oven, including in the background of the invention and the summary of the invention sections. Further, the examples and corresponding figures included procedures using a microwave oven to preheat, but no mention of using an infrared oven to preheat. Accordingly, the Court found that Howard’s infrared oven suggestion was insignificant in light of the full invention.

The Federal Circuit did not address the other requirements for joint inventorship, reasoning that since all three [...]

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Hanging Patentability on Written Description Cannot Be Truss-ted

by Courtney Seams | May 4, 2023 | Patents

The US Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board finding that the claims of a patent for a truss hanger were invalid for lack of written description because they claimed an undisclosed range despite the predictable nature of the technology. Columbia Insurance Company v. Simpson Strong-Tie Company Inc., Case Nos. 21-2145; -2157 (Fed. Cir. Mar. 31, 2023) (Prost, Hughes, JJ.) (Moore, C.J., dissenting) (non-precedential).

Truss hangers secure support beams to wall frames in buildings. These hangers normally accommodate layers of fire-resistant sheathing by cutting out the sheathing that overlaps with the hanger, but this can reduce fire resistance. Columbia owns a patent claiming a truss hanger that extends through the sheathing and does not decrease fire resistance. The extension for the sheathing, illustrated below, must be “sized large enough to permit two layers of ⅝ inch thick sheathing to be received between the rear edge plane and the back flange plane, but too small to permit three layers of ⅝ inch thick sheathing to be received.”

Simpson petitioned for a post-grant review of the patent at the Board. That proceeding resulted in a mixed decision. The Board found in favor of Simpson that certain original claims and certain substitute claims of the patent were unpatentable for lack of written description and that certain claims were obvious over the prior art. However, it found in favor of Columbia with regard to one claim. Both parties appealed.

The Federal Circuit affirmed the Board’s findings regarding written description. The claimed extension portion covered a range of extension sizes between the upper limit (three layers of five-eighths-inch-thick sheathing) and lower limit (two layers of five-eighths-inch-thick sheathing). The Court affirmed the Board’s finding that nothing in the specification covered the claimed upper limit. Columbia argued that a skilled artisan would read the claims to cover exactly two layers of five-eighths-inch-thick sheathing, but the Court found that this claim construction argument was forfeited because it was raised for the first time on appeal and, even if it weren’t, it was incorrect because it was akin to rewriting the claims.

The Federal Circuit also affirmed the Board’s finding that certain claims were obvious, concluding that the Board’s determination was supported by substantial evidence. The Court rejected Columbia’s argument that the Board’s claim construction violated the Administrative Procedure Act because the construction adopted by the Board was similar enough to Simpson’s proposed construction and not raised sua sponte.

Finally, the Federal Circuit affirmed the Board’s finding that the claim on which Simpson appealed was not indefinite because the term “large enough to permit the drywall to be received” informs a skilled artisan with reasonable certainty that the scope of this claim includes any extension portion sized larger than the smallest commonly known sheathing size. The Court also found that the claim was not obvious because the Board correctly interpreted the claim language “extend [...]

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Breaking Up Is Hard to Do: Validity Upheld Based on Expert Separation Testimony

by Alexandra Cavazos, PhD | Apr 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court decision finding that two patents covering enantiomerically pure compositions of the psoriasis drug Otezla® (apremilast) were valid and one patent covering a dosage titration schedule was invalid as obvious. Amgen Inc. v. Sandoz Inc. Case No. 22-1147 (Fed. Cir. Apr. 19, 2023) (Lourie, Cunningham, Stark, JJ.)

Amgen markets apremilast, a phosphodiesterase-4 inhibitor that is used for treating psoriasis and related conditions, under the brand name Otezla®. Amgen has three patents covering Otezla®. Two of the patents are directed to orally administered pharmaceutical compositions of enantiomerically pure apremilast (composition patents), and one of the patents covers a dosage titration schedule for enantiomerically pure apremilast that ranges from a starting dose of 10 mg to a dose of 60 mg by the sixth day (dosage patent). Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of apremilast. Amgen filed suit against Sandoz for infringement of its three patents covering Otezla®.

Sandoz asserted that the composition patents were invalid based on prior art that had an example (Example 12) that described a 50%:50% racemic mixture of apremilast but did not disclose the purified apremilast (+) enantiomer recited in the claims. The prior art did state that apremilast could be isolated from this racemic mixture using chiral chromatography, a well-known technique. The district court rejected Sandoz’s argument, finding that there was insufficient evidence to conclude that a skilled artisan would have had reason to believe that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer (i.e., the (+) enantiomer). The district court also concluded that Sandoz had not demonstrated that a skilled artisan would have had a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components. Furthermore, the district court looked to objective indicia of non-obviousness, finding that apremilast unexpectedly provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability, and a nexus existed between the unexpected potency and the asserted claims.

Sandoz also argued that the dosage patent was invalid based on prior art that taught various dosage schedules and amounts for apremilast. The district court found that it would have been within the ability of a skilled artisan to titrate apremilast for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis with a drug (such as apremilast) that was known in the art to require dose titration to ameliorate side effects. The district court therefore found that the dosage patent was invalid. Sandoz appealed with respect to the composition patents, and Amgen appealed with respect to the dosage patent.

The Federal Circuit affirmed the district court’s decision with respect to the composition patents, finding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify apremilast’s (+) enantiomer from the racemic mixture disclosed in Example [...]

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