IP UPDATE
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Exploring the latest in intellectual property law
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No Boundaries? European UPC Confirms Its International Jurisdiction

by | Oct 3, 2024 | ,

The Court of Appeal (CoA) of the Unified Patent Court (UPC) ruled that the UPC has international jurisdiction for alleged infringement actions that originate outside the UPC’s Member States. Dish and Sling v. AYLO, Case No. UPC-CoA-188/2024 (CoA UPC Sept. 3, 2024) (Grabinski, Pres. CoA; Barutel, Blok, JJ.)

In its ruling, the CoA upheld the order of the Court of First Instance Local Division Mannheim. In the main proceedings, Dish and Sling brought an infringement action against AYLO. The patent in dispute concerned a method for presenting rate adaptive streams from a media player. AYLO was accused of indirectly infringing the patent in numerous UPC Member States, including Germany, by offering and supplying the video files made available for streaming and the media players for streaming videos. AYLO lodged a preliminary objection requesting that the infringement action be dismissed for lack of UPC jurisdiction, Rule 19.1(a) of the UPC Rules of Procedure. After the preliminary objection was rejected, AYLO lodged an appeal against the order of the Local Division Mannheim.

AYLO argued that the UPC does not have international jurisdiction on the basis of Article 7(2) in conjunction with Article 71b(1) of the Brussels I Recast Regulation because the harmful event would not occur in a UPC Member State since AYLO’s servers are located in the United States. The CoA disagreed, explaining that the Article 7(2) phrase “place where the harmful event occurred or may occur” is intended to cover both the place where the damage occurred and the place of the event giving rise to the damage. Consequently, the alleged infringer can be sued in either place.

The UPC has international jurisdiction with respect to an infringement action under two conditions:

  • The European patent in suit has effect in at least one contracting Member State.
  • The alleged damage may occur in that particular Member State.

Therefore, irrespective of the location of AYLO’s server, the UPC had jurisdiction over the infringement action because AYLO’s websites are accessible in Germany where the patent has effect. This access was sufficient to satisfy the likelihood of damage, which was allegedly caused via the internet. Users in Germany can obtain means (media players and video files) that allegedly relate to an essential element of the patented invention and are suitable and intended for putting the invention into practice. The CoA clarified that it is not necessary for a website to be directed at users in the territory of the concerned Member State. The actual availability of access to the website and damage to the European patent owner in a Member State are decisive.

Practice Notes:

  • While UPC courts may consider infringement allegations in a case when evaluating UPC jurisdiction, that consideration is limited to the context of what the patent owner must prove to establish its allegations. Argument as to the specific requirements of the infringement allegations is not necessary. In the reported case, which was based on allegations of indirect infringement, it was not necessary to determine whether AYLOS’s alleged [...]

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Lower the Red Flags: Flawed Fee Award Flops

by | Sep 5, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a district court decision awarding attorneys’ fees, finding that the district court abused its discretion by failing to properly explain its basis for the fee award. Realtime Adaptive Streaming L.L.C. v. Sling TV, L.L.C., Case No. 23-1035 (Fed. Cir. Aug. 23, 2024) (Albright, Dist. J., sitting by designation; Moore, Lourie, JJ.)

Realtime Adaptive Streaming sued Sling and DISH for patent infringement related to digital data compression. The district court granted DISH’s motion for summary judgment of invalidity. While the invalidity finding was on appeal, the district court granted DISH’s motion for attorneys’ fees based on six so-called “red flags” that it found should have served as warning signs to Realtime that its case was fatally flawed.

The district court explained that the first red flag was two prior court decisions against Google and Netflix, which found similar claims of Realtime’s patent ineligible as abstract ideas under 35 U.S.C. § 101. Despite these decisions, Realtime pursued its claims. The second red flag came when the Federal Circuit ruled against Realtime in a related case. The third occurred when an inter partes review (IPR) proceeding invalidated key claims of Realtime’s patent. Following a nearly two-year stay, the district court identified the fourth and fifth red flags: a non-final office action from the US Patent & Trademark Office rejecting a key claim of the remaining patent, and a letter from DISH indicating its intention to seek attorneys’ fees if Realtime continued the case. The sixth red flag was an expert declaration from DISH that addressed invalidity of the claims at issue, and which was unfavorable to Realtime. Realtime appealed the district court’s attorneys’ fees award.

The Federal Circuit concluded that the district court erred by relying on the six so-called red flags without explaining the weight for each. Addressing the first flag, the Federal Circuit agreed with the district court’s reliance on the Google and Netflix decisions because they involved a patent with a virtually identical specification and essentially the same claims. The Court disagreed with the remaining red flags. The Court found that the second red flag related to a different technology and should not have put Realtime on notice that its patent claims were meritless. With respect to the third, fourth, and fifth flags, the Federal Circuit found that the district court did not adequately explain why these decisions supported exceptionality.

With regard to the sixth flag (the expert opinion), the Federal Circuit found that the district court’s analysis was insufficient. The Court explained that it is typical in a patent infringement case for the parties’ experts to disagree on invalidity issues. The Court found that Realtime and its expert developed critiques and counterarguments to DISH’s expert’s opinions, demonstrating that Realtime did not fail to give “serious consideration” to invalidity. While the district court may have found DISH’s expert more persuasive, that fact alone should not have put Realtime on notice that its claims lacked merit.

Accordingly, the Federal [...]

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Blurred Vision: Appeal Dismissed for Lack of Standing

by | Aug 29, 2024 |

The US Court of Appeals for the Federal Circuit dismissed a patent challenger’s appeal in an inter partes review (IPR) because the challenger could not meet the injury-in-fact requirement for Article III standing. Platinum Optics Tech. Inc. v. Viavi Solutions Inc., Case No. 23-1227 (Fed. Cir. Aug. 16, 2024) (Moore, Taranto, JJ.; Checchi, Dist. J, sitting by designation).

Viavi Solutions owns a patent directed to optical filters that include layers of hydrogenated silicon and to sensor systems comprising such optical filters. Platinum Optics Technology (PTOT) petitioned for IPR. The Patent Trial & Appeal Board found that PTOT had failed to establish that the challenged claims were unpatentable. PTOT appealed.

The Federal Circuit dismissed the appeal, finding that PTOT did not have Article III standing. The Court explained that while Article III standing is not required to appear before an administrative agency (such as the US Patent & Trademark Office), such standing is required once a party seeks judicial review in an Article III federal court. PTOT argued it had standing because of potential infringement liability due to its continued distribution of a product previously accused of infringing the patent and its development of new models of the previously accused product. The Court rejected both arguments.

First, PTOT asserted that it suffered an injury in fact because there was a likelihood that Viavi would sue again. PTOT relied on a letter from Viavi stating that it did not believe PTOT could fulfill its supply agreements with noninfringing products. The Federal Circuit disagreed with PTOT’s assertion, concluding that mere speculation about the possibility of suit, without more, is insufficient to confer Article III standing. Moreover, the Court noted that Viavi’s letter was sent prior to the patent infringement suits, which were dismissed with prejudice. Thus, the Court found that PTOT had not established an injury in fact based on potential infringement liability due to its continued distribution of a previously accused product.

Second, PTOT asserted that it suffered an injury in fact based on its development of new models of the previously accused product. PTOT’s argument was supported by a declaration from a Deputy Director of Operation Management at PTOT and the same letter from Viavi threatening future suit. The Federal Circuit did not find the declaration testimony compelling. It explained that the declaration, which generally alleged that PTOT continued to develop new models of the previously accused product, did not identify any specific concrete plans for PTOT to develop a product that might implicate the patent. The declaration did not explain the particulars of these new models or how the models might relate to the patent. The Court found that the declaration was insufficient to establish that PTOT’s development activities created a substantial risk of infringement or were likely to cause Viavi to assert infringement. The Court noted that the letter from Viavi did not specifically address models in development or foreclose PTOT’s ability to develop a noninfringing product.

Thus, the Federal Circuit concluded that PTOT failed to establish an injury [...]

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House Rules: Remote Gambling Activity Claims Go Bust

by | Jul 18, 2024 |

The US Court of Appeals for the Federal Circuit applied the Alice/Mayo framework to assess whether claims directed to remote gambling were patent eligible under 35 U.S.C. § 101 and determined that the claims were directed to a patent-ineligible abstract idea and did not otherwise recite an inventive concept. Beteiro, LLC v. DraftKings Inc., Case Nos. 22-2275; -2277; -2278; -2279; -2281; -2283 (Fed. Cir. June 21, 2024) (Dyk, Prost, Stark, JJ.)

Beteiro owned several patents related to facilitating live gaming and/or gambling activity at a gaming venue remote from the user’s physical location so that a user can participate via a communication device away from the gaming venue location. In 2021 and 2022, Beteiro filed at least six patent infringement cases against the defendants. The district court granted the defendants’ motions to dismiss the claims on the grounds that the asserted claims were patent ineligible under § 101. Beteiro appealed.

The Federal Circuit agreed with the district court’s assessment of the claims under the first step of the Alice/Mayo framework and found that the claims “exhibit several features that are well-settled indicators of abstractness”:

  • The claims “broadly recited generic steps of a kind” frequently held to be abstract, such as “detecting information, generating and transmitting a notification based on the information, receiving a message (bet request), determining (whether the bet is allowed based on location data), and processing information (allowing or disallowing the bet).”
  • Claims like these, e., drafted with largely “result-focused functional language” without specifying how the purported invention achieves those results, are “almost always found to be ineligible.”
  • Citing earlier decisions, the Court found broadly analogous claims were abstract as involving methods of providing particularized information to individuals based on their locations. The Court also noted in a footnote that several district courts have found remote-gaming patents analogous to Beteiro’s patents ineligible.
  • The claimed methods were similar to “fundamental practices long prevalent,” an indicia that they are abstract and unpatentable. For example, the Federal Circuit referred to the district court’s analogy to real-world activities, including one step in the claims where “those accepting bets have always had to confirm that the bettor with whom they were dealing was located in a place where gambling was allowed.”

The Federal Circuit also agreed with the district court’s analysis of the second step of the Alice/Mayo framework and its conclusion that the claims failed to provide an inventive concept and “simply describe[d] a conventional business practice executed by generic computer components.” The Court disagreed with Beteiro’s argument that there was genuine dispute as to whether using geolocation and global positing as an “integral data point” in processing mobile wagers was conventional technology at the time of the earliest claimed priority date, 2002. Beteiro only briefly referred to conventional use of GPS in connection with several types of conventional computers but failed to describe differences between equipping GPS on a mobile phone versus any other described conventional computers. The asserted patents did not describe any advanced GPS mobile device technology [...]

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PTO Asks Whether Legislative Action for Experimental Use Exception Is Warranted

by | Jul 18, 2024 |

The US Patent & Trademark Office (PTO) issued a request for comments concerning the public’s views on the common law experimental use exception and whether Congress should enact a statutory experimental use exception. 89 Fed. Reg. 53963 (June 28, 2024).

The experimental use defense for alleged patent infringement has been part of US jurisprudence for more than 200 years. The current state of experimental use exception jurisprudence in the United States is set forth in Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002). In that case, the Federal Circuit proffered a “very narrow and strictly limited experimental use defense” prohibiting an alleged infringer from invoking such a defense for “use that is in any way commercial in nature” or “any conduct that is in keeping with the alleged infringer’s legitimate business, regardless of commercial implications.”

The Madey decision has been met with a mix of opinions, some arguing that the Federal Circuit’s construction encourages innovation and others arguing that it impedes innovation. Limited exemptions have been carved out in the US. For example, 35 U.S.C. § 271(e)(1) established a safe harbor (the Bolar exemption) allowing for the experimental use of a patented invention by parties to collect regulatory approval data for medical devices or drugs. The Plant Variety Protection Act also provides for exemptions allowing the use of protected plant varieties for research and breeding of new varieties.

While many European and Asian nations have statutory experimental use exceptions in place, legislative efforts for codifying a statutory experimental use exception in the US have thus far failed. With the intent to promote fair competition and innovation, the PTO seeks to revisit this issue by collecting the public’s views on the impact of the experimental use exception in all technology areas. Of particular interest, the PTO seeks comments on one or more topics, including:

  • How current US experimental use exception jurisprudence impacts investment and/or research and development in any field of technology.
  • Whether certain technologies are negatively affected by the current experimental use exception jurisprudence.
  • The impact that a statutory experimental use exception would have on the innovation and commercialization of new technologies with respect to research and development, ability to obtain funding, investment strategy, licensing of patents and patent applications, product development, sales (including downstream and upstream sales), competition, and patent enforcement and litigation.
  • The impact of current experimental use exception jurisprudence on decisions made with respect to filing, purchasing, licensing, selling or maintaining patent applications and patents in the US.
  • Reasons for adopting a statutory experimental use exception or maintaining the status quo.
  • How a statutory experimental use exception should be defined to ensure that patent rights are preserved.
  • Recommendations for enhancing and facilitating experimental research on patent inventions in the US.

When responding to the questions, commenters are further asked to identify whether they represent, for example:

  • An inventor, patent owner or investor.
  • A licensee or user of patented technology.
  • An entity representing inventors or patent owners (g., law firms).
  • A recipient of [...]

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Is Pleading “Generic” Enough to Plead Inducement?

by | Jul 11, 2024 |

The US Court of Appeals for the Federal Circuit held that a branded pharmaceutical manufacturer properly pled a theory of inducement by alleging that the generic competitor promoted its product as “generic” to the branded product and referred to the branded product’s sales for patented uses. Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., Case No. 23-1169 (Fed. Cir. June 25, 2024) (Moore, Lourie, Albright, JJ.)

Amarin Pharmaceuticals sells the drug Vascepa, which the US Food and Drug Administration (FDA) approved for two uses:

  1. To treat severe hypertriglyceridemia.
  2. As an adjunct therapy to reduce certain cardiovascular risks.

In 2016, Hikma submitted an abbreviated new drug application (ANDA) to market a generic version of Vascepa, which at the time was only approved for treatment of severe hypertriglyceridemia. Hikma and Amarin then litigated patents covering Vascepa under the Hatch-Waxman Act, with Hikma invalidating the patent claims covering the severe hypertriglyceridemia indication. After Amarin obtained approval for its second indication, Hikma submitted to the FDA a “section viii carve out” (i.e., prescribing information that purposedly did not include the second indication). The FDA approved Hikma’s product, which was sold with a “skinny label.” After Hikma’s ANDA was approved, Hikma issued a series of press releases that referred to its product as a “generic” version of Vascepa, even though the product was not approved for the cardiovascular risk indication. The press releases also referred to Vascepa’s annual sales as approximately $1.1 billion – the amount of Vascepa scales for all uses – as well as its usage information.

Amarin sued Hikma again for patent infringement, this time claiming that Hikma induced infringement of patents covering the cardiovascular risk indication. The district court overruled the magistrate judge’s recommendation and concluded that Amarin’s complaint did not plead a plausible case of induced infringement. Amarin appealed.

The Federal Circuit reversed. First, it explained its view that the case was a “run-of-the-mill” inducement infringement case, rather than one governed by the Hatch-Waxman Act framework. Emphasizing the deferential plausibility standard applicable at the pleadings stage, the Court held that, combined with allegations that Hikma’s label included warnings that would promote infringement, Amarin’s averments about Hikma’s press releases were sufficient at this stage to plausibly claim that Hikma induced infringement of the cardiovascular risk limitation by its references to the branded product.

The Federal Circuit also rejected Hikma’s claim that a ruling in Amarin’s favor would “effectively eviscerate section viii carve-outs.” The Court explained that its ruling was an ordinary application of induced infringement that promotes scrutiny of generic companies’ communications for clarity and consistency.

Practice Note: This case continues the trend of inducement cases that has received renewed interest after GlaxoSmithKline v. Teva Pharmaceuticals. Branded pharmaceutical manufacturers may be emboldened to sue after launch based on theories of inducement where section viii carveouts were employed.



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The $X Factor: Demystifying Damages Calculations

by | Jun 13, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s decision to deny a defendant’s motion for a new trial on damages, finding that the plaintiff’s damages expert sufficiently showed that prior license agreements were economically comparable to a hypothetically negotiated agreement between the parties. EcoFactor, Inc. v. Google LLC, Case No. 23-1101 (Fed. Cir. June 3, 2024) (Reyna, Lourie, JJ.) (Prost, J., dissenting).

EcoFactor owns a patent directed to mitigating strain on the electricity grid by adjusting thermostat settings within HVAC systems. The patent describes a system where thermostats collect internal temperature readings and use them alongside external temperatures to estimate internal temperature change rates, including future predictions. EcoFactor sued Google alleging infringement based on Google’s Nest smart thermostat products.

After discovery, Google sought summary judgment, arguing that claims of EcoFactor’s patent were invalid as abstract ideas under 35 U.S.C. § 101. The district court denied this motion as well as Google’s Daubert motion to exclude the testimony of EcoFactor’s damages expert. At trial the jury found that Google infringed EcoFactor’s patent and awarded damages. The district court denied Google’s subsequent motions for judgment as a matter of law on noninfringement and for a new trial on damages. Google appealed.

Google raised three key issues. First, it argued that the district court erred in denying its motion for summary judgment. Second, Google asserted that the district court erred in denying its motion for judgment as a matter of law concerning the noninfringement of EcoFactor’s patent. Third, Google claimed that the district court wrongly denied its motion for a new trial on damages, arguing that EcoFactor’s damages expert opinion was based on unreliable methodology.

The Federal Circuit upheld the district court’s decision to deny summary judgment because there were genuine issues of material fact warranting a trial. The Court also affirmed the jury’s infringement verdict against Google, finding that it was supported by substantial evidence. Despite Google’s argument that its Nest thermostats did not meet the claims of EcoFactor’s patent, the Court concluded that expert testimony and corroborating documentation demonstrated otherwise.

On the damages issue, Google argued that EcoFactor’s expert testimony was unreliable because there was no evidence that the parties to the three license agreements used by the expert actually applied the royalty rate stated in the agreement. While Google acknowledged that each of the license agreements include a specified royalty rate, Google argued that each also included a “whereas” clause indicating that the licensee would pay EcoFactor a lump sum amount “set forth in this Agreement based on what EcoFactor believes is a reasonable royalty calculation of [$X] per-unit for . . . estimated past and [] projected future sales of products accused of infringement in the Litigation.” Google asserted that while the agreements may have included a stated rate, there was no evidence that the agreements actually applied the rate in calculating the lump sum payment.

The Federal Circuit rejected Google’s argument. The Court explained that the proposed royalty rate was derived from three [...]

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No Attorneys’ Fees Available for Successful IPR in Parallel Court Proceedings

by | May 30, 2024 |

The US Court of Appeals for the Federal Circuit concluded that a party that voluntarily elects to pursue parallel proceedings before the Patent Trial & Appeal Board and the district court is not entitled to recover attorneys’ fees under 35 U.S.C. § 285 (exceptional case doctrine) in connection with the Board proceedings, nor does § 285 entitle a party to hold opposing counsel jointly and severally liable for fees. Dragon Intellectual Property LLC v. Dish Network L.L.C., Case Nos. 2022-1621; -1777; -1622; -1779 (Fed. Cir. May 20, 2024) (Moore, C.J.; Stoll, J.) (Bencivengo, J., dissenting).

Dragon sued DISH Network, Sirius XM Radio (SXM) and eight others for patent infringement. The district court stayed proceedings as to DISH and SXM while they pursued inter partes review (IPR) but proceeded with claim construction for the other defendants. Following claim construction, all parties stipulated to noninfringement, and the district court accordingly entered a noninfringement judgment that was subsequently vacated following appeal to the Federal Circuit. Following the Board’s determination that the asserted claims were unpatentable, DISH and SXM filed a motion for attorneys’ fees in the district court proceeding. The district court granted the motion for time spent litigating the district court case but denied for fees incurred solely during the IPR proceedings and recovery from Dragon’s former counsel. DISH and SXM appealed the denial-in-part, and Dragon cross-appealed the grant-in-part.

The Federal Circuit affirmed the district court’s grant-in-part, finding that the district court did not abuse its discretion in declaring these cases exceptional. The Federal Circuit explained that the vacated noninfringement judgment did not require the district court to ignore its claim construction order in determining exceptionality. The Court further explained that even though Dragon was not entitled to a claim construction “do-over,” the prosecution history disclaimer issue was independently considered during the exceptionality inquiry, and Dragon did not provide any grounds for the conclusion that this constituted an inadequate inquiry.

The Federal Circuit also affirmed the denial of attorneys’ fees with regard to fees incurred during the IPR proceedings and Dragon’s former counsel’s liability for fee awards under § 285.

First, the Federal Circuit rejected DISH and SXM’s argument that § 285 allows recovery of fees incurred during parallel IPR proceedings, principally on the grounds that the IPR proceedings were pursued voluntarily. The Court reasoned that there are many advantages to leveraging IPR proceedings and, therefore, “where a party voluntarily elects to pursue an invalidity challenge through IPR proceedings, we see no basis for awarding IPR fees under § 285.”

Second, the Federal Circuit relied on the statutory text and determined that liability for attorneys’ fees awarded under § 285 does not extend to a party’s counsel. The Court explained that while other statutes explicitly allow parties to recover costs and fees from counsel, § 285 is silent as to who can be liable for a fee award, and therefore it is reasonable to conclude that fees cannot be assessed against counsel.

Sitting by designation, Judge Bencivengo of the US District Court for the Southern District of California dissented [...]

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Getting to the Core of It: Assignment Clause Is Ambiguous

by | May 30, 2024 |

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s grant of summary judgment, finding that the language used in an invention assignment clause was subject to more than one reasonable interpretation (i.e., ambiguous) and thus remand was necessary for further fact finding. Core Optical Tech., LLC v. Nokia Corp., Case Nos. 23-1001; -1002; -1003 (Fed. Cir. May 21, 2024) (Dyk, Taranto, JJ.) (Meyer, J., dissenting).

Core Optical filed complaints against three groups of defendants alleging patent infringement. The lead defendant, Nokia, moved for summary judgment, arguing that Core Optical did not have standing to bring the patent infringement suit. Nokia argued that by virtue of an invention assignment clause in an employment-related agreement signed in 1990, the inventor, Dr. Core, had assigned the patent rights to TRW, his employer at the time of the invention. In the agreement, Dr. Core “agreed to disclose to TRW and automatically assign to TRW all of his inventions that ‘relate to the business or activities of TRW’ and were ‘conceived, developed, or reduced to practice’ during his employment with TRW.” Nokia argued that by virtue of that earlier assignment, the subsequent assignment to Core Optical was ineffective. The agreement had a carveout from the assignment for inventions “developed entirely on [Dr. Core’s] own time” that was unrelated to his work for TRW. According to Nokia, based on the assignment, Core Optical did not have standing to assert the patent. The district court agreed and granted Nokia’s motion for summary judgment. Core Optical appealed.

The Federal Circuit reviewed the district court’s grant of summary judgment de novo, following Ninth Circuit and California law relating to the underlying contract dispute and related factual determinations. Under California law, the “fundamental goal of contractual interpretation is to give effect to the mutual intention of the parties” (citing City of Atascadero v. MLPF&S (1998)). In granting summary judgment, the district court had held that the 1990 invention assignment agreement’s carveout did not encompass Dr. Core’s PhD research, which undisputedly led to the invention claimed in the patent. That finding was based in part on the TRW fellowship program that supported and enabled Dr. Core’s PhD work. However, Core Optical presented evidence that “Dr. Core was careful not to work on his PhD research while ‘on the clock’ at TRW and not to use TRW equipment, facilities, or supplies when working on his PhD research.”

The Federal Circuit disagreed with the district court that the matter was subject to resolution on summary judgment. The Court agreed with Core Optical that the “entirely-own-time” phrase did not unambiguously express a mutual intent to designate all the time Dr. Core spent performing his PhD research as his own time or, as Nokia argued, to indicate that some of the time Dr. Core spent performing his PhD research was partly TRW’s time (as the district court held). The Federal Circuit walked through the undisputed facts, including that Dr. Core sought funding from TRW for his PhD research and [...]

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Testing Negative: Collateral Order Doctrine Precludes Appellate Jurisdiction

by | May 23, 2024 |

Addressing appellate jurisdiction in view of the collateral order doctrine, the US Court of Appeals for the Federal Circuit dismissed an appeal of a district court’s ruling denying a motion to dismiss because the district court’s order did “not conclusively determine any issue.” Copan Italia S.p.A. v. Puritan Med. Prod. Co. LLC, Case No. 22-1943 (Fed. Cir. May 14, 2024) (Cunningham, Bryson, Stark, JJ.)

Copan and Puritan are competing medical supplies companies. Copan filed suit against Puritan alleging infringement of Copan’s patents for “flocked” swabs, which are used “for collecting biological specimens.” While the lawsuit was filed in 2018, the circumstances surrounding the case changed significantly in March 2020 when the COVID-19 pandemic caused the demand for flocked swabs to skyrocket. In May 2020, the parties agreed to stay the proceedings until the COVID-19 crisis passed.

During the stay, Puritan entered into a contract with the US Air Force, causing Puritan to expand its manufacturing facilities and capabilities. The Air Force stated in a document associated with the contract that, under the Public Readiness and Emergency Preparedness Act (PREP Act), (1) the contract was being entered into for the purpose of covered countermeasures for responding to a public health emergency, (2) Puritan’s performance under the agreement was for recommended activities in responding to the public health emergency and (3) Puritan was a covered person under the PREP Act. Further, the Air Force “expressly acknowledge[d]” that Puritan “shall be immune from suit and liability to the extent and as long as [Puritan’s] activities fall withing the terms and conditions of the PREP Act and the PREP Act declaration.”

Puritan asserted it had immunity under the PREP Act from certain claims in Copan’s infringement suit. Puritan sought leave to amend its answer to include this affirmative defense and filed a partial motion to dismiss the claims directed to Puritan’s performance under the Air Force contract. Copan opposed the motion, arguing the PREP Act does not apply to claims for patent infringement and immunity only applies to claims for losses relating to physical harm, like products liability.

The district court denied Puritan’s motion, finding “that Puritan had not shown, as a factual matter, that its flocked swabs were ‘covered countermeasures’ under the PREP Act.” The district court pointed to “evidentiary gaps,” which prevented Puritan – at the current stage of litigation – from proving the PREP Act affirmative defense. Puritan appealed.

The Federal Circuit determined it lacked jurisdiction and dismissed the appeal. Because the denial of Puritan’s partial motion to dismiss was not a final order, appellate jurisdiction would only arise in limited circumstances under the collateral order doctrine. The collateral order doctrine allows appellate jurisdiction on rulings that (1) conclusively determine a disputed question, (2) resolve an issue completely separate (collateral) to the merits of the action and (3) are effectively unreviewable on appeal from a final judgment.

The Federal Circuit found that the district court order did not conclusively determine any issue and therefore the Federal Circuit lacked jurisdiction under the [...]

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