Law Students

Alza Corp. v. Andrax Pharmaceuticals, LLC.

By atharkhan

Opinion: www.cafc.uscourts.gov/opinions/09-1350.pdf

Notes:

• The enablement issue reduces to factual considerations with regard to whether undue experimentation is required.
• Enablement requirement as codified in 35 U.S.C. § 112, ¶ 1: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
• Enablement is determined as of the effective filing date of the patent’s application.
• To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without “undue experimentation.”
• Whether undue experimentation would have been required to make and use an invention, and thus whether a disclosure is enabling under 35 U.S.C. § 112, ¶ 1, is a question of law that we review de novo, based on underlying factual inquiries that we review for clear error.
• Because patents are presumed valid, lack of enablement must be proven by clear and convincing evidence.
• The district court?s determination of the hypothetical person of ordinary skill in the relevant art is a finding of fact we review for clear error.
• Enablement is not precluded where a ?reasonable? amount of routine experimentation is required to practice a claimed invention, however, such experimentation must not be ?undue.?
• In Wands, we set forth the following factors that a court may consider when determining if a disclosure requires undue experimentation: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
• Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.
• The rule that a specification need not disclose what is well known in the art is merely a rule of supplementation, not a substitute for a basic enabling disclosure.
• To satisfy the plain language of § 112, ¶ 1, one is required to provide an adequate enabling disclosure in the specification; one cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification.
• The omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the condition under which a process can be carried out, undue experimentation is required.
• The specification here does not contain such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use non-osmotic oral dosage forms with ascending release rates. Instead, it provides only a starting point, a direction for further research.

Full post as published by Atharkhan on April 26, 2010 (boomark / email).