IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Results for "Patent approval"
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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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What Use Does § 271(e)(1) Safe Harbor “Solely” Protect?

by | Apr 4, 2024 |

The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of transcatheter heart systems while attending a trade conference, finding the importation reasonably related to submitting information to the US Food & Drug Administration (FDA) for medical device approval. Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Case No. 22-1877 (Fed. Cir. Mar. 25, 2024) (Stoll, Cunningham, JJ.) (Lourie, J., dissenting).

The fact pattern in this case is unusual. Meril, a manufacturer of a transcatheter heart system approved for sale in Europe but not in the United States, brought two demonstration samples to San Francisco with lawyer-generated instructions that the samples could not be used, sold or offered for sale in the US. Meril presented at a trade booth during a cardiovascular medical device conference. It was undisputed that the samples never left a bag that was first kept at a hotel and later brought to the conference and placed in a storage room.

Edwards Lifesciences nevertheless sued for infringement based on importation. The district court found that Meril’s importation was reasonably related to its attempts to secure regulatory approval because they were for the purposes of recruiting investigators for a clinical trial Meril had made initial efforts to commence (as required to market this type of device in the US). Accordingly, the district court granted summary judgment of noninfringement on grounds that the safe harbor under § 271(e)(1) applied. Edwards appealed.

Edwards argued that the district court erred by not finding a genuine material dispute of fact relating to Meril’s subjective intent (i.e., whether, notwithstanding some evidence, Meril actually intended the importation to relate to FDA approval). Edwards also challenged whether the importation was solely related to FDA approval and argued that the non-use of the devices to recruit investigators rendered the safe harbor inapplicable.

The Federal Circuit rejected all three challenges. Canvassing the Federal Circuit’s decades of prior case law, the Court concluded that a putative infringer’s intent is irrelevant when determining whether the safe harbor applies. Thus, even if Edwards were correct in challenging Meril’s intent, there would still be no material factual dispute. On the issue of whether the importation activity was solely related to FDA approval, the Court, discussing the use of “solely” in terms of the safe harbor provision, reiterated prior cases’ determination that the uses need not be solely related to FDA approval, but rather, that the only uses that would be protected were those within the safe harbor. Finally, the Court again deemed the non-use of the devices irrelevant, as nothing in the statute required actual use.

Judge Lourie dissented, not because he necessarily viewed the district court’s or the majority’s application as squarely incorrect under existing precedent, but because he believed that existing precedent did not expressly give proper weight to the statute’s use of the word “solely.” Applying a plain text analysis, Judge Lourie argued that the safe harbor [...]

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If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

by | Dec 14, 2023 |

The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry of generic drugs in a Hatch-Waxman suit are subject to higher scrutiny than plaintiffs asserting the same theories outside of the Hatch-Waxman context. H. Lundbeck A/S v. Lupin Ltd., Case No. 22-1194 (Fed. Cir. Dec. 7, 2023) (Dyk, Prost, Hughes, JJ.)

Lundbeck owns the approved new drug application (NDA) for Trintellix®, a drug indicated for the treatment of major depressive disorder (MDD), as well as an expired compound patent for the associated active ingredient vortioxetine. Lundbeck also owns a patent that claims the use of vortioxetine as an antidepressant that can be prescribed in place of a traditional antidepressant to alleviate a patient’s negative sexual side effects, and another patent that claims the use of vortioxetine to treat cognitive impairment symptoms in patients with MDD.

Generic pharmaceutical companies filed abbreviated new drug applications (ANDAs) seeking approval to market generic versions of Trintellix® and asserting that Lundbeck’s unexpired patents listed in its NDA were invalid and would not be infringed by the generic companies. As required by the Hatch-Waxman Act (to prevent the entry of a generic on the market), Lundbeck sued the generic companies. At the district court, the defendants prevailed on the finding of noninfringement but lost on invalidity. Lundbeck appealed.

Lundbeck pressed its induced infringement and contributory infringement theories on appeal. Lundbeck argued that the generics infringed under the plain text of Hatch-Waxman (35 USC 271(e)(2)(A)) because they filed ANDAs seeking approval to market vortioxetine, and that “some uses of vortioxetine—for the treatment of patients that have previously taken other drugs but had to cease or reduce use due to sexually related adverse events and for the treatment of cognitive impairment—are covered by [Lundbeck’s listed] patents; and the labels do not prohibit prescribing vortioxetine for those uses, even though the defendants do not propose to market the drug for those patented uses.” In other words, Lundbeck argued that in terms of its inducement allegation, it made no difference whether a drug would be sold for a use not covered by Lundberg’s NDA-listed patents because the drug could be prescribed for those patented uses.

The Federal Circuit disagreed, explaining that “‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA” and for which the ANDA was submitted.” The Court emphasized that it is not “an act of infringement under . . . § 271(e)(2)(A) to submit an ANDA for a drug if just any use of that drug were claimed in a patent.” If it were, a brand could “maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA,” which “would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer.” As the Court then held, “actions for [...]

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See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

by | Nov 16, 2023 |

The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact. Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Case No. 22-1706 (Fed. Cir. Nov. 7, 2023) (Moore, Stoll, Cunningham, JJ.)

Allgenesis Biotherapeutics filed an IPR petition challenging a patent owned by Cloudbreak Therapeutics. The challenged patent discloses compositions and methods for treating the eye condition pterygium. During the IPR proceeding, Cloudbreak disclaimed all but two of the claims. The Patent Trial & Appeal Board issued a final written decision finding that Allgenesis failed to show that the remaining two claims were unpatentable. As part of its decision, the Board made a priority decision that a Patent Cooperation Treaty (PCT) application belonging to Allgenesis was not prior art to Cloudbreak’s patent. Allgenesis appealed.

Article III of the US Constitution limits the Federal Circuit’s jurisdiction to adjudication of “cases” or “controversies,” which means the appellant must have (1) suffered an injury in fact (2) that is fairly traceable to the challenged conduct of the defendant and (3) likely to be redressed by a favorable judicial decision.

Allgenesis attempted to establish Article III standing based on two separate arguments. First, Allgenesis argued that it had standing based on potential infringement liability. To support that argument, Allgenesis offered a declaration by its vice president of finance that included information about a Phase II trial completed three years prior and a related 2020 publication. That declaration, however, did not identify any specific plan to conduct a Phase III trial or to seek US Food and Drug Administration (FDA) approval, and instead only contained generic statements that the project was not abandoned. While Allgenesis’s briefing and oral argument included statements that it planned to engage in a Phase III trial, the Federal Circuit determined that there was no record support for this claim. The Court found that the evidence before it did not constitute the necessary concrete plans to convey standing to appeal the final written decision. Allgenesis also attempted to rely on its own failed attempts at seeking a settlement from Cloudbreak, but the Court concluded that this was insufficient to show a substantial risk of infringement.

Allgenesis’s second argument was that the Board’s priority decision created an injury in fact. Allgenesis argued that the Board’s determination about the priority date of Cloudbreak’s patent affected Allgenesis’s patent rights because it would have a preclusive effect on Allgenesis’s pending applications. The Federal Circuit was unpersuaded and explained that collateral estoppel does not attach to a non-appeal priority decision from an IPR decision. To the extent that an examiner did reach the same conclusion as the Board, Allgenesis would be free to appeal that decision.

Practice Note: For Board petitioners seeking to establish standing to appeal unfavorable final written decisions, it is necessary to develop sufficient support to show standing in fact. For life sciences companies working in drug development, declarations [...]

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Sorry—No Finality, No Injunction, No Appellate Jurisdiction

by | Nov 9, 2023 |

The US Court of Appeals for the Third Circuit dismissed an appeal from the denial of a motion under the Defend Trade Secrets Act (DTSA) for an ex parte seizure order, explaining that such orders are not final, not effectively injunctive and that the DTSA does not independently provide appellate jurisdiction to review such orders. Janssen Prod., L.P. v. eVenus Pharms. Lab’ys Inc., Case No. 22-2426 (3d Cir. Oct. 17, 2023) (Porter, Freeman, Fisher, JJ.)

In 2015, the US Food & Drug Administration (FDA) approved Janssen’s drug Yondelis—a stable, injectable version of the cancer drug trabectedin—for use in certain cancer patients. Janssen asserts that its data, specifications and methods for manufacturing Yondelis are trade secrets. After Janssen received FDA approval for Yondelis, eVenus sought FDA approval for a generic version of Yondelis. Janssen filed a lawsuit against eVenus (under the Hatch-Waxman Act) for patent infringement. During discovery, Janssen obtained documents that allegedly demonstrated that eVenus misappropriated Janssen’s trade secrets. Janssen then filed the current lawsuit against eVenus seeking relief for eVenus’s alleged trade secret misappropriation under the DTSA.

During discovery, Janssen found that eVenus spoliated evidence. In response, Janssen filed a motion for an ex parte seizure under the DTSA, requesting that the district court order the seizure of eVenus’ network servers and stored data, and the laptops and cell phones of certain eVenus employees and ex-employees. The district court denied Janssen’s ex parte seizure motion. Janssen appealed.

The Third Circuit dismissed the appeal, concluding that it lacked jurisdiction over Janssen’s appeal for two reasons.

First, the Third Circuit found that it lacked appellate jurisdiction because the district court’s denial of Janssen’s ex parte seizure motion was not a final judgment and did not meet any of the limited exceptions to the final judgment rule.

One limited exception to appellate jurisdiction under the final judgment rule is review of a lower court’s refusal to order injunctive relief. However, as the Third Circuit explained, an ex parte seizure order under the DTSA is not effectively injunctive and therefore does not fall under the injunction exception. The Court explained that refusal to grant an ex parte seizure order does not satisfy the first two prongs of the Court’s three-part functional injunction test, which require that an order be “directed to a party” and may be enforced by contempt. Regarding the first prong, the Court noted that DTSA seizure orders are not “directed to a party” because the DTSA requires law enforcement officials—and not a party—to execute any ex parte seizure order. Regarding the second prong, no party can be held in contempt for failing to comply with an order that does not direct it to do anything. Therefore, the district court’s order did not effectively deny an injunction.

Second, the Third Circuit analogized DTSA seizure orders with seizure orders under the Lanham Act in terms of statutory construction. As the Court explained, in the Lanham Act, ex parte seizure provisions are part of its “injunctive relief” section. In contradistinction, Congress did not [...]

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

by | Apr 27, 2023 |

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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No Smoking Gun Here: Soliciting Input Sufficient to Satisfy Commission’s Statutory Obligation

by | Apr 6, 2023 |

Addressing a decision by the US International Trade Commission finding a violation of Section 337, the US Court of Appeals for the Federal Circuit agreed with the Commission on a slew of issues, including its determination that soliciting comments from a sister agency regarding the products at issue was sufficient consultation to satisfy the Commission’s statutory obligation to consult. Philip Morris Products S.A. v. Int’l Trade Comm’n, Case No. 22-1227 (Fed. Cir. Mar. 31, 2023) (Prost, Reyna, Stoll, JJ.)

R.J. Reynolds Tobacco Company filed a complaint at the Commission asserting a Section 337 violation by Philip Morris based on alleged infringement of three patents directed to tobacco heating products. During the course of the investigation, the administrative law judge (ALJ) granted summary determination in favor of R.J. Reynolds on the economic prong of the domestic industry requirement as to two of the asserted patents. The ALJ issued his initial determination finding that Philip Morris had violated Section 337 with respect to two of the asserted patents. On review, the Commission affirmed the ALJ’s decision with minor modifications and issued a limited exclusion order and a cease-and-desist order. Philip Morris appealed.

Philip Morris raised numerous issues on appeal. It claimed, for the first time, that the Commission erred in failing to consult with the US Food & Drug Administration (FDA), the US Department of Health & Human Services (HHS) agency exclusively tasked with regulating the tobacco products at issue. The Federal Circuit agreed with the Commission that Philip Morris forfeited this issue because, notwithstanding several rounds of briefing on the public interest factor, it never raised the issue before the ALJ nor the Commission until a motion filed after entry of the remedial orders. The Court also rejected Philips Morris’ consultation argument on the merits, finding that the Commission’s request for comments sent to the FDA was sufficient to meet the statutorily required “consult with[] and seek advice and information from” HHS, even though the FDA failed to respond.

Philip Morris next argued that the Commission abused its discretion by not concluding that the public interest in reduced-risk tobacco products at issue should have barred relief. But the Federal Circuit held that the Commission’s public interest finding had a sufficient basis in the record in the form of expert testimony, scientific articles and FDA documents regarding the products at issue to support its findings regarding the availability of alternative non-tobacco therapies and that the tobacco products were still potentially harmful.

Philip Morris also argued that the Commission erred by finding a domestic industry based on R.J. Reynolds’s competing products that had not yet received FDA approval. The Federal Circuit rejected this argument, explaining that those competing products were being sold at the time of the complaint and that the recently approved law imposing FDA regulation on those products was still in its grace period.

Finally, the Federal Circuit rejected Philip Morris’s various patent-related arguments, finding that the Commission’s determinations were based on substantial evidence.



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PTO Update: COVID-19 Prioritized Examination Extended, Non-DOCX Filing Fee Deferred and More

by | Jan 5, 2023 |

On December 22, 2022, the US Patent & Trademark Office (PTO) announced the fifth extension of the Modified COVID-19 Prioritized Examination Pilot Program. The pilot program had been set to terminate on December 31, 2022, and is now extended to February 15, 2023. The program was implemented to support the acceleration of innovations in the fight against COVID-19. Under the pilot program, an applicant may request prioritized examination without payment of the prioritized examination fee and associated processing fee if the following criteria are met:

  • The patent application’s claim(s) cover a product or process related to COVID-19.
  • The product or process is subject to an applicable US Food & Drug Administration approval for COVID-19 use.
  • The applicant meets other requirements noted in the COVID-19 Track One Notice.

For more information, see the Federal Register notice.

The PTO also announced on December 29, 2022, that the new fee for filing nonprovisional utility patent applications that do not conform to the PTO requirements for submission in DOCX format will be deferred to the new effective date of April 3, 2023. The fee was originally scheduled to become effective on January 1, 2023. For more information, see the Federal Register notice.

The PTO and the US Copyright Office announced on December 23, 2022, that the deadline for submitting written comments on intellectual property considerations related to non-fungible tokens (NFTs) has been extended from January 9, 2023, to February 3, 2023. The dates for the public roundtables directed to patents, trademarks and copyrights, respectively, also have changed as follows:

  • The first roundtable, Trademarks and NFTs, is now set for January 24, 2023 (originally scheduled for January 12, 2023).
  • The second roundtable, Patents and NFTs, has been moved to January 26, 2023 (originally scheduled for January 10, 2023).
  • The third roundtable, Copyrights and NFTs, has been moved to January 31, 2023.

The roundtables will be livestreamed, and the PTO and Copyright Office will post instructions for the public to register to view them live. Click here for more information about the topics that will be discussed. For more information about the schedule change, see the Federal Register notice.

The PTO also announced that small entity filing fee discounts are increased from 50% to 60% and micro entity filing fee discounts are increased from 75% to 80%. The discount increases went into effect on December 29, 2022, when US President Joe Biden signed into law the Consolidated Appropriations Act, 2023, which included the Unleashing American Innovators Act of 2022. The new PTO fee schedule can be found here.



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And the Band Played On: Reviewing Rule 54(b) Partial Summary Judgment Based on Who Did What to Whom and When

by | Oct 6, 2022 |

In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit (characterizing the matter as the “entrepreneurial equivalent of musical chairs”) affirmed a dismissal of a trade secret claim against a foreign defendant but not against the related US entity, and found that the case qualified under Rule 54(b) for the “narrow exception” to the finality rule. Amyndas Pharmaceutical, SA v. Zealand Pharma A/S, Case No. 21-1781 (1st Cir. Sept. 2, 2022) (Barron, Selya, Kayatta, JJ.)

Amyndas is a Greek company with a US affiliate. It is a biotechnology firm that researches and develops therapeutics targeting a part of the immune system known as the complement system. One area of Amyndas’s research deals with “complement inhibitors.”

Amyndas’s research yielded compstatin, a peptide that selectively inhibits the C3 protein (which plays a role in activating the complement system). Amyndas also developed a related peptide (AMY-101) that targets that protein. Amyndas owns trade secrets and confidential information related to this work.

Zealand Pharma, a Danish biotechnology firm, contacted Amyndas about a potential partnership for the development of complement-related therapeutics. The firms entered into a confidential disclosure agreement (CDA) regarding information-sharing “for the purposes of evaluating a possible business/services relationship between the parties and their respective Affiliates.” Amyndas started giving Zealand Pharma access to confidential information (including confidential information about AMY-101). The firms also entered into a second CDA—with added protections—for “the evaluation or formation of a possible business and/or services and/or collaborative relationship.”

Both CDAs included an identical “Governing Law” provision stipulating that the CDAs would “be interpreted and governed by the laws of the country (applicable state) in which the defendant resides” and a forum-selection clause stipulating that “any dispute arising out of th[e CDA] shall be settled in the first instance by the venue of the defendant.”

Zealand Pharma also began its own research program focused on complement therapeutics. It did not inform Amyndas of this initiative. Although negotiations continued, the firms ultimately decided not to collaborate. Amyndas later terminated its information-sharing relationship with Zealand Pharma.

Zealand Pharma later formed Zealand US, a Delaware corporation. Without Amyndas’s knowledge or consent, Zealand Pharma also filed two European patent applications for compstatin analogues and later an international patent application designating the United States and claiming priority to the earlier  EU applications.

After the international applications were published, Amyndas learned that they described “compstatin analogues that are capable of binding to C3 protein and inhibiting complement activation,” which had been the focus of Amyndas’s research and a subject of Amyndas’s confidential information-sharing with Zealand Pharma.

The other defendant, Alexion, is an established player in the complement therapeutics field and a proprietor of Soliris, a complement inhibitor that targets a protein in the complement system. Soliris is approved by the US Food and Drug Administration (FDA) and previously was the only FDA-approved and clinically available [...]

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