Novartis prevails at CAFC

The outcome:


West-Ward Pharmaceuticals International Ltd (“WestWard”)1 appeals
the decision of the United States District
Court for the District of Delaware holding that claims 1–3
of U.S. Patent No. 8,410,131 would not have been obvious
in view of the prior art. We conclude that the district court
did not err in its nonobviousness determination and affirm.



Of the impact of clinical trials on expectation of success:


In addition, the district court determined that the asserted prior art
would not have provided a person of ordinary skill in the art with a reasonable expectation of
success in using everolimus to treat advanced RCC. Id. It
noted Dr. Cho’s admission that a person of skill in the art
would not have reasonably expected a drug to work based
only on phase I clinical trial results, or on the fact that a
drug had entered phase II clinical trials. Id. The district
court explained that the temsirolimus phase I data disclosed in
Hutchinson had diminished weight because it resulted from small sample sizes
and because phase I clinical
trials are designed to determine safety, not efficacy. Id. It
further noted that everolimus and temsirolimus differed in
pharmacological properties relevant to treatment. These
differences, along with the high failure rate of cancer drugs
in phase II and III clinical trials, and the fact that the molecular
pathways of advanced RCC were not fully understood, all diminished the relevance of the temsirolimus
data. Based on these facts, the district court found that
West-Ward failed to establish by clear and convincing evidence that
a person of skill in the art would have reasonably expected everolimus to effectively treat advanced RCC.




Of the error of the district court:



A party seeking to invalidate a patent based on obviousness must prove “by clear and convincing evidence that
a skilled artisan would have been motivated to combine the
teachings of the prior art references to achieve the claimed
invention, and that the skilled artisan would have had a
reasonable expectation of success in doing so.” Procter &
Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994
(Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1361 (Fed. Cir. 2007)). “The presence or absence
of a motivation to combine references in an obviousness determination is a pure question of fact.” PAR Pharm., Inc.
v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014)
(quoting Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286,
1289 (Fed. Cir. 2006)). “The presence or absence of a reasonable expectation of success is also a question of fact.”
Id.
We hold that the district court erred in its analysis of
whether there was a motivation to combine. However, we
discern no clear error in the district court’s finding that a
person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC
as of February 2001. We thus agree with the district
court’s ultimate determination that the challenged claims
would not have been obvious. We address both prongs of
the obviousness inquiry below.

(...)

Yet, the district court
continued its analysis and found that West-Ward “failed to
prove by clear and convincing evidence that a POSA would
have been motivated to select everolimus.” Id. The district
court erred in applying this heightened standard. “[O]ur
case law does not require that a particular combination
must be the preferred, or the most desirable, combination
described in the prior art in order to provide motivation for
the current invention.” In re Fulton, 391 F.3d 1195, 1200
(Fed. Cir. 2004); see also Bayer Healthcare Pharm., Inc. v.
Watson Pharm., Inc., 713 F.3d 1369, 1376 (Fed. Cir. 2013).
It is thus improper to require West-Ward to prove that a
person of ordinary skill would have selected everolimus
over other prior art treatment methods.

(...)

The district court, however, appeared to apply or conflate the standard
for these types of cases by requiring clear and convincing evidence that a person of
ordinary skill “would have been motivated to select everolimus.”
Decision, 287 F. Supp. 3d at 516 (emphasis added).
To the extent the district court required a showing that a
person of ordinary skill would have selected everolimus
over other prior art compounds, it erred.
The proper inquiry is whether a person of ordinary skill would have been
motivated to modify the prior art disclosing use of temsirolimus to treat advanced
RCC with the prior art disclosing
everolimus. This question was answered affirmatively
when the district court found that a person of ordinary skill
“would have been motivated to pursue everolimus as one of
several potential treatment options for advanced solid tumors, including advanced RCC.” Id.