MEMO
TO: Prof. Risch
FROM: Mary Long
RE: Warner Lambert Co. v Teva Pharmaceuticals USA, Inc., 2007 WL 4233015 (D.N.J)
2007 U.S. Dist. LEXIS 87669
DATE: December 10, 2007
The case is brought before the District Court on appeal from a summary judgment verdict given by this Court in favor of Warner Lambert Co. granting ownership of the ‘450 patent and holding that the patent was not invalid by reason of nonenablement. Teva appealed the summary judgment verdict to the Court of Appeals. The Court of Appeals for the Federal Circuit then reversed the holding in respect to certain claims and remanded.
The patent at issue involves an invention that is directed to pharmaceutical compositions containing an ACE inhibitor that is stabilized against cyclization, hydrolysis, and oxidative discoloration, and a process for stabilizing an ACE inhibitor against cyclization. All of the controversial claims require the use of a carbonate and a saccharide for stabilization. The independent claim 1 contains a pharmaceutical composition comprising ACE inhibitor, alkali or alkaline earth metal carbonate, and saccharides. Independent claim 16 claims a process for stabilizing the ACE inhibitor using alkali or alkaline earth metal carbonates and one or more saccharides. Each claim only gives one example of an alkali carbonate and saccharide in the dosage form of a tablet.
Teva’s main objection is that the claims themselves are overly broad, but the examples given to support enablement are narrow, thus creating an undue experimental burden to determine how to reach all of the claimed stable formulations. Thus, Warner has failed to meet the enablement standard of 35 USC § 112. The Court further laid out the necessary standard to determine undue experimentation is usually done using the Wand Factors.
Most of Teva’s evidence comes from expert testimony provided by Dr. Banker who states several reasons why in 1987 undue experimentation would’ve been found. The main focus of his testimony again is on the extremely broad specifications, with only two examples. Another contention is the failure to disclose how to produce the stable formulas. Teva uses two Federal Court cases to strengthen its argument.
The first case, Pharmaceutical Res., addresses the concern that the specification only disclosed 3 examples despite the breadth of the claims. In this case, the Federal Circuit found the unpredictable nature of the invention, broad claims, and 3 examples did not meet the enabling requirement. This Court distinguishes from the Pharma case in several ways. The Court finds that Pharma’s claims were in large part directed towards inoperative embodiments and that there were unsuccessful attempts to practice the subject matter within the scope of the claims. These allegations are not supported in any of the evidence that Teva submits.
The second case, Atlas Powder Co., also is similar to the challenge that Teva brings. However, in Atlas, the court found that despite 40% of the experiments failing, Atlas was able to list all possible emulsifiers in its claims. The court further found that the list would be unnecessary because one skilled in the art would know how to select a salt and fuel and then apply Bancroft’s Rule to find the emulsifier. The failures were found to simply be not optimal under all conditions. The Court again addresses that there is no evidence to suggest that the number of inoperative combinations is so significant to force one of ordinary skill to unduly experiment to practice the claimed inventions.
As a result the Court found that the claims were sufficiently enabled. I do agree with the Court’s analysis in Pharma, but disagree with the decision in Atlas. In Atlas, I think Teva made a strong enough analogy that the claims should’ve been found to not meet the enablement requirement. I think that Teva’s downfall that ultimately tips the scale in favor of Warner is its lack of evidence to prove that the number of inoperative combinations causes and undue experimental burden.
TO: Prof. Risch
FROM: Mary Long
RE: Warner Lambert Co. v Teva Pharmaceuticals USA, Inc., 2007 WL 4233015 (D.N.J)
2007 U.S. Dist. LEXIS 87669
DATE: December 10, 2007
The case is brought before the District Court on appeal from a summary judgment verdict given by this Court in favor of Warner Lambert Co. granting ownership of the ‘450 patent and holding that the patent was not invalid by reason of nonenablement. Teva appealed the summary judgment verdict to the Court of Appeals. The Court of Appeals for the Federal Circuit then reversed the holding in respect to certain claims and remanded.
The patent at issue involves an invention that is directed to pharmaceutical compositions containing an ACE inhibitor that is stabilized against cyclization, hydrolysis, and oxidative discoloration, and a process for stabilizing an ACE inhibitor against cyclization. All of the controversial claims require the use of a carbonate and a saccharide for stabilization. The independent claim 1 contains a pharmaceutical composition comprising ACE inhibitor, alkali or alkaline earth metal carbonate, and saccharides. Independent claim 16 claims a process for stabilizing the ACE inhibitor using alkali or alkaline earth metal carbonates and one or more saccharides. Each claim only gives one example of an alkali carbonate and saccharide in the dosage form of a tablet.
Teva’s main objection is that the claims themselves are overly broad, but the examples given to support enablement are narrow, thus creating an undue experimental burden to determine how to reach all of the claimed stable formulations. Thus, Warner has failed to meet the enablement standard of 35 USC § 112. The Court further laid out the necessary standard to determine undue experimentation is usually done using the Wand Factors.
Most of Teva’s evidence comes from expert testimony provided by Dr. Banker who states several reasons why in 1987 undue experimentation would’ve been found. The main focus of his testimony again is on the extremely broad specifications, with only two examples. Another contention is the failure to disclose how to produce the stable formulas. Teva uses two Federal Court cases to strengthen its argument.
The first case, Pharmaceutical Res., addresses the concern that the specification only disclosed 3 examples despite the breadth of the claims. In this case, the Federal Circuit found the unpredictable nature of the invention, broad claims, and 3 examples did not meet the enabling requirement. This Court distinguishes from the Pharma case in several ways. The Court finds that Pharma’s claims were in large part directed towards inoperative embodiments and that there were unsuccessful attempts to practice the subject matter within the scope of the claims. These allegations are not supported in any of the evidence that Teva submits.
The second case, Atlas Powder Co., also is similar to the challenge that Teva brings. However, in Atlas, the court found that despite 40% of the experiments failing, Atlas was able to list all possible emulsifiers in its claims. The court further found that the list would be unnecessary because one skilled in the art would know how to select a salt and fuel and then apply Bancroft’s Rule to find the emulsifier. The failures were found to simply be not optimal under all conditions. The Court again addresses that there is no evidence to suggest that the number of inoperative combinations is so significant to force one of ordinary skill to unduly experiment to practice the claimed inventions.
As a result the Court found that the claims were sufficiently enabled. I do agree with the Court’s analysis in Pharma, but disagree with the decision in Atlas. In Atlas, I think Teva made a strong enough analogy that the claims should’ve been found to not meet the enablement requirement. I think that Teva’s downfall that ultimately tips the scale in favor of Warner is its lack of evidence to prove that the number of inoperative combinations causes and undue experimental burden.