Federal Circuit Review | November 2015

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Federal Circuit Declines to Reverse Invalidity, Noninfringement Holdings

In Spectrum Pharmaceuticals, Inc. v. Sandoz Inc., Appeal No. 2014-1407, the Federal Circuit affirmed the district court’s grant of summary judgement of noninfringement because Sandoz’s product would not meet the dosage claim limitation and Spectrum was estopped from invoking the doctrine of equivalents.  The Federal Circuit also affirmed the district court’s holding that other claims directed to a substantially pure compound were obvious when both the 50/50 compound mixture and the pure compound were known in the art.

Sandoz submitted an ANDA in October 2011 seeking FDA approval for a levoleucovorin drug product.  Spectrum sued Sandoz for infringement of a patent related to pharmaceutical compositions of substantially pure levoleucovorin.  The claims at issue were directed to pharmaceutical compositions comprising a mixture of (6S) and (6R) leucovorin isomers, with at least 92% or 95% of the (6S) isomer (levoleucovorin).

After construing the claims, the district court granted Sandoz’s motion for summary judgment of noninfringement for certain claims.  It later held that other claims were invalid for obviousness.  Spectrum appealed, and the Federal Circuit affirmed.  The Federal Circuit concluded that the district court did not clearly err in finding that the product Sandoz planned to sell would not literally infringe the claims.  Sandoz’s product would only contain up to 250 mg of levoleucovorin, much less than the two doses of 2000 mg required by the construed claims.  There was also no clear error in concluding that Sandoz was estopped from invoking the doctrine of equivalents.  The claims were added in an amendment and the applicants had distinguished the prior art by pointing to the claimed quantities of the specific mixtures.  

As for obviousness, the Federal Circuit again concluded that the district court did not clearly err in finding certain claims invalid.  The district court had found that two prior art references disclosed processes for separating leucovorin isomers, and these processes would have “invariably” produced a mixture containing the (6R) isomer as an impurity.  The Federal Circuit noted that both the 50/50 mixture and the pure compound were known in the art and Spectrum did not provide any evidence of unexpected results for the claimed substantially pure compound. The Federal Circuit also concluded that the district court did not err in finding that Spectrum failed to provide sufficient factual evidence of other secondary considerations (including long-felt need) to rebut the prima facie case of obviousness. 


Federal Circuit Looks to Applicant’s Own Specification as Evidence Supporting Enablement of Prior Art

In In re Morsa, Appeal No. 2015-1107, the Federal Circuit affirmed the PTAB’s judgment that a prior art reference was enabling.

In an earlier decision, In re Morsa, 713 F.3d 104 (Fed. Cir. 2013), the Federal Circuit vacated and remanded the PTAB’s determination that two claims were anticipated because the PTAB’s enablement analysis was incorrect.  On remand, the PTAB determined that the disputed anticipating reference was enabled. The PTAB found that Morsa’s specification showed that only “ordinary” computer programming skills were needed to make and use the claimed invention. The PTAB then determined that the reference’s disclosure, combined with what a skilled computer artisan would have known, rendered the reference enabling and anticipatory.

The Federal Circuit held that the PTAB properly determined the reference was enabling. The Federal Circuit focused on the fact that Morsa’s specification made numerous admissions as to what one skilled in the art at the time of invention would have known.  It concluded that the reference disclosed each claim limitation and the application’s specification indicated that a person of ordinary skill in the art would have been capable of programming the invention. The Federal Circuit also rejected Morsa’s argument that the PTAB’s statements regarding database searching being old and well known were undesignated new grounds of rejection, concluding that these statements were merely descriptive and not part of the enablement analysis.


Soft Language Such as “Approximately” Can Support Different Modes of Operation 

In Atlas IP, LLC v. St. Jude Medical, Inc., Appeal No. 2015-1190, the Federal Circuit reversed the district court’s summary judgment of noninfringement as based on an erroneous claim construction. 

In a dispute involving the same patent in Atlas v. Medtronic, the district court further construed the disputed claim to require that the hub transmit to the remotes before the communication cycle begins.  The district court granted St. Jude’s motion for summary judgment of noninfringement based on this construction.

The Federal Circuit reversed.  While the claim requires that the starting time and duration of the cycle must be communicated by the hub to the remotes before the time at which the remote may begin transmitting, nothing in the plain reading of the claim language requires such communication even earlier.  Indeed, other claims suggest that the relevant information is sent during each communication cycle, not in advance.  The specification explicitly states that remotes know “approximately” when to expect information from the hub, thus, no “pre-cycle” transmission is required. 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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