Last updated: August 10, 2025
Introduction
The case of Intra-Cellular Therapies, Inc. v. Matal (D.D.C. 2017) centers around a legal challenge concerning patent application rejections based on patent law statutes, particularly emphasizing Section 101—the subject matter eligibility of patent claims. This litigation underscores the ongoing balancing act between patent protection and patent law’s statutory restrictions, especially within the pharmaceutical sector. Analyzing this case offers valuable insights into patent examination practices, the influence of recent Supreme Court decisions, and strategies for patent prosecution and litigation.
Case Overview
Intra-Cellular Therapies, Inc. ("Intra-Cellular") filed a patent application related to neuropsychiatric treatment methods. The U.S. Patent and Trademark Office (USPTO) examiner rejected the application on multiple grounds, predominantly citing Section 101, asserting the claims were directed to patent-ineligible subject matter. Intra-Cellular challenged this rejection via administrative appeals and subsequent district court proceedings, ultimately seeking judicial review of the USPTO’s rejection process.
The core issue was whether the patent claims encompassed patent-eligible subject matter, given the Court’s evolving interpretation of Section 101 following decisions such as Alice Corp. v. CLS Bank (2014), which established a two-step test for patent eligibility: (1) determining whether the claims are directed to a patent-ineligible concept, and (2) whether the claims contain an 'inventive concept' that transforms the ineligible concept into a patent-eligible application.
Legal Framework
Section 101 of the Patent Act states that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter,...may obtain a patent." Courts have interpreted this broadly, but recent jurisprudence narrows patent eligibility, especially for claims that are abstract ideas, laws of nature, or natural phenomena.
The Alice decision has been pivotal, mandating a two-pronged approach to assessing patent eligibility:
- Step 1: Is the claim directed to a patent-ineligible concept, such as an abstract idea?
- Step 2: Does the claim contain an 'inventive concept'—an element or combination of elements sufficient to ensure that the patent amounts to significantly more than the ineligible concept?
Patent applicants in biologics and pharmaceutical areas have struggled with these standards, as many claims under development involve natural processes or biochemical mechanisms.
Litigation Milestones
1. Patent Rejection and Administrative Appeal
The USPTO examiner rejected Intra-Cellular’s patent application, citing that the claims were directed to a natural biological process of neurotransmitter regulation, an unpatentable natural law under Mayo and Alice. After persuasive rebuttals and further amendments, Intra-Cellular appealed the rejection to the Patent Trial and Appeal Board (PTAB).
2. District Court Proceedings
Intra-Cellular initiated a district court action challenging the USPTO’s rejection, arguing that the claims embodied specific methods that applied inventive steps to natural phenomena, thus satisfying patent eligibility standards. The court examined whether the patent claims were sufficiently transformative, considering both the language of the claims and the context provided during prosecution.
3. Court's Analysis and Decision
The district court applied the Alice framework, scrutinizing whether the claims were directed solely at natural phenomena, such as neuroreceptor mechanisms, or whether they defined specific, inventive application. The court noted that claims that merely describe natural science relationships, without additional inventive application or technological innovations, fail to meet the eligibility criteria.
Ultimately, the court upheld the USPTO’s rejection, emphasizing that the claims in question did not sufficiently incorporate an inventive concept beyond the natural law, aligning with the standards set out in Mayo and Alice.
Analysis
Implications for Pharmaceutical Patent Prosecution
The Intra-Cellular case exemplifies the difficulties faced by biotech and pharmaceutical entities in obtaining patents for claims closely tied to natural biological processes. The courts and USPTO continue to scrutinize such claims under the heightened standards established by recent Supreme Court decisions.
Legal Strategies for Applicants
Applicants must craft claims that are not only directed to natural phenomena but also demonstrate a clear technological application that embodies an 'inventive concept.' This could involve detailed process steps, specific chemical compositions, or technological improvements that distinguish the claims from mere naturals laws.
Post-Alice Landscape
This decision reinforces the importance of incorporating technological elements into patent claims related to natural laws and biological processes. It warns applicants against overly broad claims that preempt natural relationships without tangible, inventive application.
Conclusion
The litigation in Intra-Cellular Therapies, Inc. v. Matal underscores the evolving legal landscape where patent eligibility remains a challenging frontier for biotech and pharmaceutical innovations. The case clarifies the necessity for patent claims to transcend natural phenomena by including specific, inventive applications that satisfy the Alice two-step test. Navigating the Section 101 hurdles requires strategic claim drafting and thorough legal analysis to ensure robust patent protection.
Key Takeaways
- Rejections based on natural laws continue to dominate Section 101 challenges, especially in biotech/pharma industries.
- Claims must include specific, inventive applications—not merely describe natural phenomena—to withstand eligibility scrutiny.
- Prosecutors should emphasize technological improvements and concrete steps that transform natural laws into patentable inventions.
- The Alice framework remains central to patent prosecution, requiring claims to be both directed to a natural law and embody an inventive concept.
- Judicial and USPTO consistency is increasing, emphasizing the importance of precise claim language and detailed patent specifications.
FAQs
Q1: How does the Alice decision influence biotech patent applications?
A: It mandates that claims must include an inventive application beyond natural laws, discouraging overly broad claims that merely describe natural phenomena.
Q2: What strategies can applicants use to overcome Section 101 rejections?
A: Incorporate specific technological steps, detailed process claims, or tangible modifications that demonstrate a technological improvement or inventive application.
Q3: Does this case indicate a trend toward narrower patent scope in biotech?
A: Yes, courts and the USPTO are increasingly scrutinizing claims closely to prevent patents that attempt to claim natural laws or phenomena in broad terms.
Q4: How important is claim drafting in patent eligibility?
A: Extremely; well-crafted claims that explicitly tie natural principles to concrete technological applications are crucial for overcoming eligibility hurdles.
Q5: Will future legislation or Supreme Court decisions change this landscape?
A: Potentially, but current patent prosecution and litigation strategies should focus on technological specificity and inventive applications within existing legal frameworks.
Sources
[1] Intra-Cellular Therapies, Inc. v. Matal, 1:17-cv-00776 (D.D.C. 2017)
[2] Alice Corp. v. CLS Bank, 573 U.S. 208 (2014)
[3] Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012)
