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Faulty Jury Instruction Tampered With Tamper-Proof Trial

The US Court of Appeals for the Federal Circuit affirmed in part, vacated in part and remanded a district court decision after concluding that a jury instruction on the objective indicia of nonobviousness that failed to specify all indicia on which evidence had been received constituted prejudicial legal error. Inline Plastics Corp. v. Lacerta Group, LLC, Case Nos. 22-1954; -2295 (Fed. Cir. Mar. 27, 2024) (Taranto, Chen, Hughes, JJ.)

Inline Plastics owns a patent family pertaining to containers with specific tamper-proof features and methods of producing these containers using thermoformed plastic. The invention is intended to deter unauthorized tampering with products in the containers. These tamper-proof features serve to prevent theft and product loss and maintain consumer confidence in product integrity.

Inline sued Lacerta Group for patent infringement over its tamper-proof technology. The district court made several significant pretrial rulings, including a claim construction order, and granted Inline’s motion for partial summary judgment of infringement on some of the asserted claims. During trial, Inline voluntarily withdrew certain claims, and the jury returned a verdict declaring all remaining claims (even those on which summary judgment had been granted) invalid and not infringed. After trial, Inline sought partial final judgment, which was granted, but also motioned for judgment as a matter of law and a new trial on invalidity. The district court denied Inline’s motions. Both Inline and Lacerta appealed.

Inline argued that it was entitled to judgment as a matter of law of no invalidity and that an error in the jury instructions requires a new trial on invalidity. Lacerta cross-appealed, challenging the denial of attorneys’ fees and the “without prejudice” dismissal of certain patent claims that Inline voluntarily dropped from its asserted-claims list near the end of trial.

The Federal Circuit rejected Inline’s argument for judgment as a matter of law of no invalidity but agreed with Inline that the jury instruction on the objective indicia of nonobviousness constituted prejudicial legal error. The Court determined that the jury could have reasonably found obviousness and rejected Inline’s three arguments against it. First, Inline argued deficiencies in Lacerta’s prior art references and expert testimony, but the Court found these arguments unpersuasive. Second, Inline challenged Lacerta’s evidence of motivation to combine references, but the Court found enough support to prove a motivation to combine. Third, Inline argued that Lacerta’s challenge failed because there was no rebuttal or opinion on objective-indicia evidence. The Court dismissed this argument, explaining that the absence of such testimony did not necessarily discredit the patentee’s evidence on nonobviousness. According to the Court, Inline failed to explain why the jury could not reasonably assign little weight to its objective-indicia evidence, which led the Court to reject Inline’s categorical argument based on the absence of expert testimony from Lacerta’s side.

However, the Federal Circuit agreed with Inline’s argument for a new trial on invalidity. The Court explained that jury instructions must be legally correct and sufficiently comprehensive to address disputed evidence. The Federal Circuit concluded that the district court’s objective-indicia instruction [...]

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Don’t Be So Stern: Copying Carries Significant Weight in Assessing Objective Evidence

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision invalidating a patent, finding that the Board erred in assessing nexus and weight to be accorded to objective evidence of nonobviousness. Volvo Penta of the Americas, LLC v. Brunswick Corp., Case No. 22-1765 (Fed. Cir. Aug. 24, 2023) (Moore, Lourie, Cunningham, JJ.)

Volvo Penta owns a patent directed to a tractor-type stern drive for a boat. A stern drive is a type of engine that is mounted in the hull of a boat and connected to a drive unit mounted outside of the hull, typically on the stern. In the industry, this arrangement is often referred to as an inboard/outboard drive. In 2015, Volvo Penta launched its commercial embodiment of the patent called the Forward Drive and was popular particularly for wake surfing and other water sports. The Forward Drive included forward-facing propellers that increased the distance between the propeller and swimmers or surfers compared to prior pulling-type stern drive boats.

In August 2020, Brunswick launched its own drive, the Bravo Four S, which embodies Volvo Penta’s patent. On that same day, Brunswick filed a petition for inter partes review asserting that the challenged claims were anticipated or obvious based on several references, two of which were Kiekhaefer and Brandt. In response, Volvo Penta argued that a person of ordinary skill in the art would not have been motivated to combine Kiekhaefer and Brandt with a reasonable expectation of success and that the objective indicia of nonobviousness overcame any prima facie case of obviousness. In support, Volvo Penta offered evidence of copying, industry praise, commercial success, skepticism, failure of others and long-felt but unsolved need. Volvo Penta also argued that it was entitled to a presumption of nexus between the objective indicia and the claimed invention, and, even if there was no presumption, there was still nexus.

The Board found that Kiekhaefer did not anticipate the challenged claims, but it would have been obvious to redesign the stern drive of Brandt in light of Kiekhaefer’s outboard motor to arrive at the challenged claims. After finding a motivation to combine (and prima facie obviousness), the Board turned to Volvo Penta’s objective evidence of nonobviousness. The Board first determined that Volvo Penta was not entitled to a presumption of nexus because, even though the Forward Drive and Bravo Four S indisputably embody the challenged claims, Volvo Penta did not make sufficient arguments on coextensiveness. The Board also found that regardless of the presumption, Volvo Penta did not otherwise show nexus because it failed to identify the “unique characteristics” or “merits” of the claimed invention.

Despite finding no nexus, the Board still analyzed the objective evidence and concluded that Volvo Penta’s objective evidence weighed somewhat in favor of nonobviousness but that Brunswick’s strong evidence of obviousness outweighed the objective evidence. The Board therefore concluded that the challenged claims were unpatentable. Volvo Penta appealed.

Volvo Penta raised three primary arguments on appeal:

  1. The Board’s [...]

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

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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Federal Circuit Won’t Rescue Parachute Patent

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)

Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.

Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.

Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]

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