Importance of Building a Detailed Factual Record for Federal Circuit Review of Obviousness Determinations
In re Brimonidine (decided 5/19/11)By: Minita G. Holloway
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What This Means to You
- Build a story in your patent application to emphasize why your claimed invention is non-obvious when you are aware of close prior art.
- Emphasize in your patent application any concerns regarding the compatibility of components of the claimed invention.
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Present supporting expert testimony/explanations on all relevant evidence at trial.
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Overview
In re Brimonidine Patent Litigation highlights the importance of having detailed arguments and supporting testimony on the record for an obviousness review by the Federal Circuit
Case Background
Apotex and its co-appellant, Exela Pharmsci, filed separate Abbreviated New Drug Applications (ANDA) seeking approval for a generic version of glaucoma drug Alphagan® P, patented by Allergan. Allergan sued both companies in separate district courts (consolidated to one), alleging infringement of five patents associated with Alphagan® P’s formulations and methods for preserving ophthalmic formulations.
The district court upheld the validity of Allergan’s asserted claims against an obviousness challenge, and enjoined both Apotex and Exela from making or selling the products described in the ANDAs. Exela appealed the finding of infringement (not covered in this case review), and Apotex appealed only the validity portion of the judgment to the Federal Circuit.
Decision Analysis
Once before the Federal Circuit, Allergan defended one of its patents (on methods for preserving ophthalmic formulations) by arguing that the cited prior art references did not teach the claimed preservative and, in fact, did teach away from the use of the claimed preservative.
The Federal Circuit found that the cited references contemplated the use of the claimed preservative and thereby negated any “teach away” arguments. However, the court upheld the validity of all asserted claims in the remaining four patents, concluding that a person having ordinary skill in the art would have concerns regarding the compatibility of components of the claimed formulations.
Takeaways
This case illustrates how the Federal Circuit will consider detailed factual arguments and evidence when reviewing obviousness determinations. This highlights the importance of building a story in the application to emphasize why a claimed invention is non-obvious.
It can also be helpful to include technical information. For example, if the inventors are aware of potential compatibility problems between the components of the claimed invention, it is advantageous to build these into the application in order to rebut any future obviousness challenge.
This case also highlights the importance of providing expert testimony at trial to support factual issues that are important to an obviousness analysis.
