This Newsletter was originally posted to the articles section of the Harness Dickey website in May 2015. To receive the most up-to-date BioPharma news and tips, please visit www.hdp.com and subscribe to the BioPharma emails.
1. Obviousness Update:
A. Can post-filing date evidence be used to show non-obviousness? The Supreme Court has declined to reconsider this question in Bristol-Myers Squibb v. Teva.
Result: The Federal Circuit’s decision will stand, which held that post-filing date evidence remains admissible in most circumstances (except not in Bristol-Myers Squibb v. Teva). Therefore, keep submitting post-filing date evidence.
B. Should unexpected results be recited in the claims?
Recent Trend in U.S. Obviousness Law: In several recent cases the Federal Circuit considered unexpected results because the results were recited in the claims, and/or declined to consider results that were not recited in the claims. This approach to obviousness affected the outcome in Senju v. Lupin, where the court refused to consider unexpected results arguments because the asserted results were not specified in the claims. Although disclosed but unclaimed properties of a claimed drug have historically been considered part of the claim “as a whole,” it may no longer be safe to expect that surprising results will be considered when evaluating obviousness unless they are specified in the claim.
Specify any unexpected results in at least one dependent claim during prosecution. That way, the independent claims will not require proof of the result to establish infringement, but the dependent claim will be there as a back-up position against an obviousness challenge.
2. Indefiniteness Update:
On remand from the Supreme Court, the Federal Circuit in BioSig Instruments v. Nautilus, Inc. applied the new indefiniteness standard of “reasonable certainty.” The claim term at issue was “spaced relationship” between electrodes for a heart rate monitor on fitness equipment.
Result: The claim term was found definite under the new standard of reasonable certainty (as it was under the old standard of insolubly ambiguous).
The court noted that:
- A “spaced relationship” between electrodes in each pair can be no larger than the width of a user’s hand, nor so close to be only a single electrode; and
- The claim also contained a functional limitation tied to the recited “spaced relationship” structure that provided additional clarity. Namely, the electrodes in each pair must be spaced to provide electromyogram signals from each of the user’s hands that can be subtracted from one another.
While application of the reasonable certainty standard does not appear to have substantively shifted the definiteness standard, care should still be taken in drafting claims to identify and define potentially indefinite, subjective terms or functional limitations to ensure reasonable certainty of their meaning.
3. IPRs, Hedge Funds and Pharma – Oh my!
Be wary of Mr. Kyle Bass. Mr. Bass is a hedge fund manager and his firm, Hayman Capital Management, is attacking pharmaceutical patents with IPRs.
4. Do sales outside the U.S. exhaust patent rights?
The Federal Circuit will reconsider its decision in Jazz Photo v. ITC that sales outside the U.S. do not
exhaust U.S. patent rights.
Potential Consequences: If the Federal Circuit overturns Jazz Photo, sales of pharmaceuticals outside the U.S. (where prices are often capped by statute) will exhaust the rights of the patent holder to prevent importation based on U.S. patent rights. Many pharmaceutical imports to the U.S. are still prohibited by FDA regulations, but such a decision may alter the business models of innovative