Patent Cases to Watch in the Second Half of 2024: Implications for IP Strategy

As we navigate through the complex landscape of intellectual property law, staying informed about significant patent cases is crucial for developing effective IP strategies. The second half of 2024 promises to be an eventful period in the world of patent litigation, with several high-stakes cases poised to shape the future of innovation across various industries. In this comprehensive analysis, we'll explore eleven patent cases that demand attention from IP professionals, tech companies, and innovators alike.

Supreme Court Cases on the Horizon

1. Cellect, LLC v. Vidal (23-1231): Challenging the Obviousness-Type Double Patenting Doctrine

The case of Cellect, LLC v. Vidal brings to the forefront a critical question about the interplay between statutory patent term adjustments and the judicially created doctrine of obviousness-type double patenting (OTDP). At its core, this case challenges whether the OTDP doctrine can invalidate a patent when the Patent Act explicitly mandates term adjustments for USPTO delays.

Background: The Patent Act requires the USPTO to adjust a patent's term to compensate for delays in issuing the patent. This can result in patents within the same family having different expiration dates. The Federal Circuit recently held that the OTDP doctrine could invalidate a later-expiring patent if it claims obvious variants of an earlier-expiring patent, even when the later expiration is due to statutory term adjustments.

Implications: This case has significant implications for patent portfolio management, particularly for companies that rely on patent families to protect their innovations. If the Supreme Court decides to hear this case and rules in favor of Cellect, it could provide greater security for patents that have received term adjustments. Conversely, if the Court upholds the Federal Circuit's decision, patent owners may need to reevaluate their strategies for maintaining patent families and consider the potential vulnerability of later-expiring patents to OTDP challenges.

2. Chestek PLLC v. Vidal (23-1217): Challenging USPTO Rulemaking Procedures

While primarily a trademark case, Chestek PLLC v. Vidal has broader implications for the USPTO's rulemaking authority, potentially affecting both trademark and patent applicants.

Background: The case centers on a USPTO rule requiring applicants to provide personal addresses. When a trademark applicant challenged this rule, citing privacy concerns, the Federal Circuit upheld the USPTO's authority to implement the rule without following standard notice-and-comment procedures.

Implications: If the Supreme Court decides to hear this case, its ruling could have far-reaching effects on the USPTO's rulemaking power. A decision in favor of Chestek PLLC could require the USPTO to adhere more strictly to administrative procedural requirements, potentially slowing down the implementation of new rules but providing greater opportunities for public input. Conversely, if the Court affirms the Federal Circuit's decision, it could grant the USPTO more flexibility in implementing rules, potentially leading to more rapid changes in patent and trademark application procedures.

3. Eolas Techs., Inc. v. Amazon.com, Inc. (23-1184): Clarifying Patent Eligibility

The case of Eolas Technologies, Inc. v. Amazon.com, Inc. presents an opportunity for the Supreme Court to revisit and potentially clarify the controversial Mayo/Alice framework for determining patent eligibility.

Background: The Mayo/Alice test, established by the Supreme Court, has been a source of confusion and criticism in the patent community for over a decade. This two-step test aims to determine whether patent claims are directed to patent-ineligible concepts (such as abstract ideas) and, if so, whether the claims contain an "inventive concept" that transforms them into patent-eligible subject matter.

Implications: If the Supreme Court agrees to hear this case, it could lead to a much-needed clarification or revision of the Mayo/Alice test. This could have profound implications for patent eligibility across various technological fields, particularly in software and business method patents. A clearer standard could provide more certainty for inventors and patent practitioners, potentially encouraging innovation in areas that have been challenging to patent under the current framework.

4. United Therapeutics Corp. v. Liquidia Techs., Inc. (23-1298): Refining Inter Partes Review Procedures

This case raises important questions about the scope of inter partes review (IPR) proceedings and the standard of review applied by the Federal Circuit.

Background: United Therapeutics is asking the Supreme Court to decide whether the Federal Circuit should defer to agency discretion or conduct a de novo review when determining if the USPTO has adjudicated a patent claim unpatentable based on grounds or publications outside the scope of the IPR petition.

Implications: The outcome of this case could significantly impact the strategy and conduct of IPR proceedings. If the Supreme Court decides to hear the case and rules in favor of a more deferential standard, it could strengthen the PTAB's authority and potentially make IPR proceedings more final. Conversely, a ruling in favor of de novo review could provide patent owners with a stronger avenue for appealing PTAB decisions, potentially making IPR a less attractive option for challengers.

Federal Circuit Cases to Watch

5. REGENXBIO Inc. v. Sarepta Therapeutics, Inc. (24-1408): Defining Patent Eligibility in Biotechnology

This case delves into the heart of patent eligibility for biotechnological inventions, specifically addressing the patentability of cultured host cells carrying recombinant nucleic acid molecules.

Background: A Delaware district court ruled that a cultured host cell carrying a recombinant nucleic acid molecule is not patent-eligible because the recombinant molecule's nucleic acid sequences do not "alter" or "change" their natural form. The patent owner argues that the cell is markedly different from naturally occurring cells because it combines DNA from two organisms to create an artificial nucleic acid molecule with unique structural and functional properties.

Implications: The outcome of this case could have far-reaching consequences for the biotechnology industry. If the Federal Circuit upholds the district court's decision, it could significantly limit the patentability of certain types of biotechnological inventions, potentially stifling innovation in areas such as gene therapy and genetic engineering. Conversely, a ruling in favor of patent eligibility could provide stronger protection for a wide range of biotechnological innovations, encouraging further research and development in this rapidly evolving field.

6. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA (23-2254): Clarifying the "Issue Date" for Reissued Patents

This case seeks to clarify the interpretation of the "issue date" for reissued patents under the Patent Act, a technicality with significant practical implications.

Background: The district court held that reissued patents inherit the "issue date" of the surrendered patent. However, Merck argues that the issue date of a reissued patent should be the actual date on which the reissued patent is issued.

Implications: The Federal Circuit's decision in this case could impact strategies for patent term extensions and the timing of patent litigation. If the court sides with Merck, it could potentially extend the effective life of certain reissued patents, providing additional value to patent holders. Conversely, if the court affirms the district court's decision, it could limit the benefits of reissuing patents in some circumstances.

7. Alnylam Pharms., Inc. v. Moderna, Inc. (23-2357): Interpreting Chemical Patent Claims

This case, centered around COVID-19 vaccine technology, highlights the importance of claim construction in patent infringement suits, particularly in the pharmaceutical and biotechnology sectors.

Background: Alnylam Pharmaceuticals has appealed the district court's interpretation of the terms "branched alkyl" and "branched C10-C20 alkyl" in its patent claims. The district court's narrow interpretation led to a judgment of noninfringement in favor of Moderna.

Implications: The Federal Circuit's decision could have significant implications for the interpretation of chemical patent claims. A broader interpretation of these terms could potentially revive Alnylam's infringement claims against Moderna, impacting not only this specific case but also setting a precedent for similar cases in the future. This case underscores the critical importance of precise claim drafting and the potential consequences of claim construction disputes in high-stakes patent litigation.

8. Regents of the Univ. of Ca. v. Broad Inst., Inc. (22-1594): Determining CRISPR-Cas9 Inventorship

This high-profile case continues the long-running dispute over the inventorship of CRISPR-Cas9 gene-editing technology, a revolutionary tool in biotechnology.

Background: The University of California is challenging the Patent Trial and Appeal Board's (PTAB) decision that the Broad Institute was the first to invent a CRISPR-Cas9 gene-editing system for use in eukaryotic cells. The University argues that the PTAB applied the wrong standard in determining when conception occurred and that it used the CRISPR-Cas9 system before the Broad Institute.

Implications: The Federal Circuit's decision in this case could have far-reaching implications for the biotechnology industry. CRISPR-Cas9 technology has numerous potential applications in medicine, agriculture, and other fields. The outcome of this case will not only determine who holds the valuable patent rights to this technology but could also set important precedents for determining inventorship in complex biotechnological inventions. Moreover, it may influence how research institutions and companies approach collaborative research and the documentation of inventive processes.

9. Arlton v. AeroVironment, Inc. (21-2049): Interpreting Government Contractor Immunity

This case raises important questions about the scope of patent infringement immunity for government contractors under 28 U.S.C. § 1498.

Background: The plaintiffs sued AeroVironment, claiming that its Mars Helicopter infringed their "Rotary Wing Vehicle" patent. The district court granted summary judgment for the defendants under 28 U.S.C. § 1498, which provides patent infringement immunity for government contractors. The plaintiffs have appealed, arguing that the district court misinterpreted the statute and misapplied legal precedent.

Implications: The Federal Circuit's decision in this case could have significant implications for government contractors and their potential liability for patent infringement. A broad interpretation of the immunity provided by § 1498 could offer greater protection to government contractors, potentially encouraging more companies to engage in government work. Conversely, a narrower interpretation could expose contractors to more patent infringement claims, potentially affecting their willingness to take on certain government projects. This case highlights the complex interplay between patent rights and government interests in technological innovation.

10. Micron Tech. Inc. v. Longhorn IP LLC (23-2007): Challenging State Anti-Patent Trolling Laws

This case brings into focus the tension between state laws aimed at preventing abusive patent assertion and federal patent law.

Background: An Idaho district court required the plaintiff to post an $8 million bond to litigate patent infringement claims against Micron, relying on an Idaho statute aimed at preventing abusive patent assertion. The appellant argues that the Idaho Act is unconstitutional and preempted by federal patent law, while Idaho and 28 other states support the district court's decision.

Implications: The Federal Circuit's ruling in this case could have far-reaching implications for state-level efforts to combat perceived patent trolling. If the court upholds the Idaho law, it could embolden other states to enact or enforce similar legislation, potentially creating a patchwork of state-level regulations affecting patent litigation. Conversely, if the court finds the law unconstitutional or preempted by federal law, it could limit states' ability to regulate in this area, potentially leading to calls for federal action to address abusive patent assertion practices.

Potential En Banc Rehearing

11. Apple Inc. v. Omni Medsci Inc. (23-1034): Clarifying PTAB Discretion in IPR Proceedings

This case, currently subject to a petition for en banc rehearing, addresses the scope of the Patent Trial and Appeal Board's (PTAB) discretion in inter partes review (IPR) proceedings.

Background: A Federal Circuit panel held that the PTAB erred in disregarding Apple's argument regarding a claim limitation in the prior art, which was made in response to Omni's patent owner response. Omni has petitioned for rehearing en banc, arguing that the panel's decision conflicts with precedent by limiting the PTAB's discretion to refuse to hear new reply arguments.

Implications: If the Federal Circuit grants en banc rehearing, its decision could have significant implications for IPR strategy and procedure. A decision affirming the panel's ruling could provide petitioners with more opportunities to respond to patent owners' arguments, potentially making IPR proceedings more dynamic and unpredictable. Conversely, a decision in favor of Omni could reinforce the PTAB's discretion to manage the scope of IPR proceedings, potentially providing more certainty and structure to these proceedings.

Conclusion: Navigating the Evolving Patent Landscape

As we move through the second half of 2024, these cases collectively represent a pivotal moment in patent law. From fundamental questions about patent eligibility and the scope of patent protection to procedural issues in patent prosecution and litigation, the outcomes of these cases have the potential to reshape the intellectual property landscape across multiple industries.

For IP professionals, tech companies, and innovators, staying informed about these cases and their potential implications is crucial. The decisions rendered in these cases may necessitate adjustments to patent prosecution strategies, portfolio management approaches, and litigation tactics. Moreover, they may influence research and development directions, particularly in fields like biotechnology and software, where the boundaries of patent-eligible subject matter continue to be tested.

As we await the outcomes of these cases, it's clear that the patent system continues to evolve in response to technological advances and changing economic realities. By staying abreast of these developments and understanding their potential impacts, stakeholders can better position themselves to protect their innovations and navigate the complex world of intellectual property law.

In this dynamic environment, working closely with experienced IP counsel becomes more important than ever. As these cases unfold, we at [Law Firm Name] are committed to providing our clients with timely insights and strategic guidance to help them adapt to the changing patent landscape and maximize the value of their intellectual property assets.

Stay tuned for updates on these cases and their implications for your IP strategy. As always, we're here to help you navigate the complexities of patent law and protect your innovations in an ever-changing legal landscape.