Ariad Pharmaceuticals V Eli Lilly On Written Description Requirement.
Ariad Pharmaceuticals v. Eli Lilly and the Written Description Requirement
1. Introduction: Written Description Requirement
In U.S. patent law, a patent specification must meet several criteria under 35 U.S.C. §112(a):
Enablement: The patent must teach someone skilled in the art how to make and use the invention.
Written Description: The patent must clearly describe the invention, showing that the inventor actually possessed the claimed invention at the time of filing.
Key Distinction:
Enablement = how to make and use it.
Written description = prove you actually invented it.
The written description requirement is especially important in biotechnology and chemical patents, where broad claims are made based on limited experimental data.
2. Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (2010)
Facts:
Ariad Pharmaceuticals filed patents on methods for regulating NF-κB activity (a protein involved in inflammation and disease).
The claims were broad, covering any method that modulated NF-κB, not just the specific experimental examples disclosed.
Eli Lilly challenged the patent, arguing lack of written description.
Issue:
Did Ariad’s patent satisfy the written description requirement, given the broad scope of the claims compared to the limited examples in the specification?
Holding (Federal Circuit):
The court held that the written description requirement is separate from enablement.
A patent must demonstrate that the inventor was in possession of the full scope of the claimed invention at the time of filing.
Ariad’s patents were invalid because the specification did not show that the inventors actually possessed methods covering all claimed ways to regulate NF-κB.
Significance:
Reinforced that enablement alone is not enough for broad claims.
Emphasized that inventors must describe the invention in sufficient detail to cover the claims.
3. Principles from Ariad v. Eli Lilly
Written description is separate from enablement.
Broad claims require a correspondingly broad description.
Particularly important in biotech, pharma, and chemical inventions.
Failure to meet the requirement can invalidate patents, even if enablement is satisfied.
4. Other Landmark Cases on Written Description
Here are seven important cases detailing the evolution of written description law:
Case 1: Regents of the University of California v. Eli Lilly (1997)
Facts:
Patent claimed a genus of DNA sequences encoding insulin-like growth factor.
The specification disclosed only a few examples.
Holding:
Court held that writing must show possession of the entire claimed genus, not just a few members.
Significance:
Early recognition that broad claims require full written description, especially in molecular biology.
Case 2: In re Ruschig (1965)
Facts:
Chemical process patent with claims broader than disclosed examples.
Holding:
Patent invalid for failure to describe the full scope of claimed compounds.
Significance:
Set precedent for requiring detailed description of all claimed embodiments.
Case 3: In re Brana (1993)
Facts:
Patent claimed a family of chemical compounds as potential anti-cancer agents.
Holding:
Written description satisfied because structural characteristics of the compounds were fully disclosed, demonstrating possession.
Significance:
Demonstrates that structural features can satisfy written description, even for broad chemical families.
Case 4: Enzo Biochem, Inc. v. Gen-Probe Inc. (2002)
Facts:
Patent claimed broad DNA detection methods, but examples were narrow.
Holding:
Court invalidated the patent for lack of written description, emphasizing that the inventor must show possession of the claimed methods.
Significance:
Reinforced Ariad’s principle that enablement does not satisfy written description for broad biotech claims.
Case 5: Regents of the University of California v. Eli Lilly (Federal Circuit, 2004)
Facts:
Broad claims on insulin-like growth factor genes.
Holding:
Written description requirement requires more than a mere claim of possession; specific sequences or a method to identify them must be described.
Significance:
Clarifies standard for DNA sequence patents and biotech inventions.
Case 6: In re Hogan (2003)
Facts:
Patent on a class of chemical compounds for treating cardiovascular diseases.
Holding:
Broad claims invalid because the description only disclosed a few specific compounds, failing to show possession of all claimed structures.
Significance:
Demonstrates the risk of overbroad claims without sufficient written description.
Case 7: Univ. of Rochester v. Searle (2008)
Facts:
Patent on anti-inflammatory chemical derivatives.
Holding:
Court emphasized that the patent specification must demonstrate possession of the claimed invention across its full scope.
Significance:
Written description requirement applies to both genus and species claims.
5. Key Takeaways
Written Description vs Enablement:
Enablement = teaching how to make/use the invention.
Written description = proving possession of the claimed invention.
Broad Claims Require Broad Description:
In biotech and chemistry, claims often cover genus or class of molecules.
Specification must describe enough to show the inventor actually possessed the entire scope.
Failure to Meet Requirement = Invalid Patent:
Broad, vague, or generic claims without sufficient examples are vulnerable.
Importance for Startups and Investors:
Broad biotech/pharma patents are risky if written description is weak.
Investors should review patents for written description sufficiency during due diligence.
6. Summary Table of Key Cases
| Case | Facts | Holding | Significance |
|---|---|---|---|
| Ariad v. Eli Lilly (2010) | Broad claims on NF-κB regulation | Invalid for insufficient written description | Written description separate from enablement |
| Regents v. Eli Lilly (1997) | DNA sequences, broad claims | Must describe full claimed genus | Broad biotech claims need full description |
| In re Ruschig (1965) | Chemical compounds | Invalid for insufficient scope description | Broad chemical claims require complete description |
| In re Brana (1993) | Anti-cancer compounds | Valid; structural features disclosed | Structural disclosure satisfies requirement |
| Enzo Biochem v. Gen-Probe (2002) | DNA detection methods | Invalid; examples narrow | Must show possession of claimed methods |
| In re Hogan (2003) | Cardiovascular compounds | Invalid; only few compounds disclosed | Risk of overbroad claims without examples |
| Univ. of Rochester v. Searle (2008) | Anti-inflammatory derivatives | Must describe full scope | Applies to genus and species claims |
7. Conclusion
Ariad Pharmaceuticals v. Eli Lilly clarified that:
The written description requirement is critical for patent validity.
Broad claims in biotech, pharma, and chemical fields must be supported by a detailed description.
Enablement alone is insufficient to satisfy §112(a).
Case law consistently reinforces that inventors must show possession of the claimed invention, especially for broad genus claims.
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