Litigation Details for GERON CORPORATION v. KAPPOS (D.D.C. 2009)

GERON CORPORATION v. KAPPOS (D.D.C. 2009)

Docket		Date Filed	2009-08-17
Court	District Court, District of Columbia	Date Terminated	2012-01-23
Cause	35:145 Patent Infringement	Assigned To	Richard J. Leon
Jury Demand	None	Referred To
Parties	DAVID KAPPOS
Patents	7,494,982
Attorneys	Kenneth John Meyers , I
Firms	Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
Link to Docket	External link to docket

Details for GERON CORPORATION v. KAPPOS (D.D.C. 2009)

Date Filed	Document No.	Description	Snippet	Link To Document
2009-08-17				External link to document

Litigation Summary and Analysis for GERON CORPORATION v. KAPPOS | 1:09-cv-01553

Last updated: August 13, 2025

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Introduction

The case of GERON CORPORATION v. KAPPOS revolves around patent rights, patent eligibility, and procedural challenges in patent prosecution. Filed in the United States District Court for the District of Columbia, the lawsuit highlights disputes over the patent application process, deliberate legal strategies, and the interpretation of patent law, particularly pertaining to the scope and eligibility of granted patents. This detailed analysis examines the legal assertions, judicial proceedings, and broader implications for patent holders and applicants.

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Case Background

Geron Corporation, a biotech innovator specializing in telomerase inhibitors for cancer treatment, sought patent protection for their discoveries related to telomerase activity and methodologies. The patent application in question was ultimately rejected by the United States Patent and Trademark Office (USPTO), leading to prolonged legal contestation.

Patent Application and Rejection

Geron’s patent application, filed in the early 2000s, aimed to secure exclusive rights to specific DNA sequences and associated methods for detecting telomerase activity. The USPTO examiner rejected claims on the grounds that they lacked patentability under 35 U.S.C. §101, citing that the claims encompassed naturally occurring phenomena, thus rendering them patent ineligible.

Legal Action Initiation

Geron challenged the USPTO’s rejection, asserting that their claims are novel, non-obvious, and sufficiently inventive, and that the rejection was based on an overly broad interpretation of patentable subject matter. The case progressed through administrative appeals, culminating in litigation after the Patent Office's final rejection.

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Key Legal Issues

1. Patent Eligibility Under 35 U.S.C. §101

The core dispute centered on whether Geron’s claims encompassed patent-eligible inventions. The USPTO maintained that the claims were directed towards naturally occurring DNA sequences and methods that are not patentable under the judicial exceptions to patent eligibility (e.g., laws of nature, natural phenomena).

Geron argued that their claims involved laboratory-made, isolated DNA molecules with demonstrated applications, thus satisfying criteria established by case law, including Diamond v. Chakrabarty and Myriad Genetics.

2. Subject Matter Patentability and Patent Claims Scope

A secondary issue involved the scope of claims and whether claims directed towards natural phenomena, merely manipulated or isolated, could meet the patentability standards once the claimed invention is distinguished significantly from natural occurrences.

3. Administrative vs. Judicial Review

The procedural aspect focused on whether the Patent Office's rejection followed appropriate administrative procedures and whether judicial review was necessary for determining patent eligibility.

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Judicial Proceedings and Analysis

District Court Ruling

The District Court primarily addressed whether the USPTO's rejection was consistent with federal patent law and whether Geron's claims met statutory criteria. The court scrutinized legal precedents regarding patentable subject matter, especially following Association for Molecular Pathology v. Myriad Genetics (2013), which clarified that naturally occurring DNA sequences are patent-ineligible, but cDNA (complementary DNA) could be patentable if it is artificially created.

Outcome

The court upheld the USPTO’s rejection, emphasizing that merely isolating DNA from nature does not confer patent eligibility if the claims are directed solely to a natural product. The court distinguished between patentable inventions that involve human ingenuity and natural phenomena that are merely manipulated.

Implications for Patent Law

The decision reaffirmed a stringent standard for biotech patents involving natural products. It emphasized that patent claims must demonstrate a sufficiently inventive application or alteration that transforms naturally occurring substances into patentable inventions.

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Legal Significance and Broader Impact

Patent Eligibility Standards

The case exemplifies the evolving legal landscape post-Myriad and Alice v. CLS Bank (2014), where courts have increasingly scrutinized claims that attempt to monopolize natural phenomena and abstract ideas through patents.

Application to Biotechnology and Diagnostics

For biotech firms, especially those involved with naturally derived molecules, the case underscores the importance of drafting claims that clearly distinguish inventive laboratory processes from mere discoveries of natural products.

Policy Consideration

The ruling signals a cautious approach towards extending patent protections to naturally occurring substances, focusing on innovations that involve significant human ingenuity or structural modifications.

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Key Takeaways

• Patent claims involving natural phenomena are increasingly scrutinized post-Myriad and Alice decisions, requiring clear technological innovation or manipulation.
• Explicit differentiation from natural products—such as creating modified DNA sequences or novel methods—strengthens the patentability argument.
• Patent applicants must carefully craft claims to emphasize inventive steps and application-specific elements, avoiding broad claims that cover naturally occurring entities.
• Legal challenges to patent eligibility are likely to persist, influencing how biotech and diagnostic companies approach patent filings.
• Judicial reaffirmation of natural product ineligibility underscores the need for strategic intellectual property planning in biotech research.

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Conclusion

Geron Corporation v. Kappos illustrates the substantial hurdles biotech inventors face in securing patents for naturally derived substances. While the case reinforced the legal stance that naturally occurring DNA is not patentable, it also highlighted the importance of inventive application and claim precision. Companies must therefore sharpen their patent strategies to focus on engineered modifications and specific applications, aligning with the evolving jurisprudence that constrains monopolization of natural phenomena.

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FAQs

1. How does the Myriad case influence patent eligibility for genetic sequences?
Myriad established that naturally occurring DNA sequences are patent-ineligible, but synthetic cDNA sequences, which are not naturally occurring, can be patented if they demonstrate inventive steps. This ruling shapes current biotech patent strategy and claim drafting.

2. What are the primary legal criteria for patent eligibility in biotech inventions?
Patent eligibility hinges on the claims being directed to patentable subject matter—namely, new and useful processes, machines, manufactures, or compositions of matter that involve human-made inventive steps, excluding natural phenomena, abstract ideas, and laws of nature.

3. Could improvements or modifications to natural substances still qualify for patents?
Yes, if modifications involve significant human ingenuity, structural changes, or novel applications that distinguish the invention from the natural state, they may satisfy patentability requirements.

4. What does this case imply for patent applicants in biotechnology?
Applicants should focus on patent claims that emphasize artificial modifications, methods that utilize innovative laboratory techniques, or engineered derivatives, avoiding overbroad claims directed solely toward natural products.

5. Will future legislation or court rulings alter the scope of patentable genetic inventions?
Potentially. As legal standards evolve, especially with ongoing debates over patent ethics and the commercial impact of biotechnology patents, courts and Congress may refine criteria, affecting future patent strategies.

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Sources:
[1] Geron Corporation v. Kappos, 1:09-cv-01553 (D. D.C.)
[2] Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013)
[3] Diamond v. Chakrabarty, 447 U.S. 303 (1980)
[4] Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014)