Warner Chilcott Co. LLC v. Lupin Ltd.

Spring 2014

GENERICally Speaking

Case Name: Warner Chilcott Co. LLC v. Lupin Ltd., Civ. Nos. 11-5048, 12-2928, 2014 U.S. Dist. LEXIS 6228 (D.N.J. Jan. 17, 2014) (Pisano, J.)

Drug Product and Patent(s)-in-Suit: Lo Loestrin Fe® (norethindrone acetate/ethinyl estradiol); U.S. Patent No. 7,704,984 (“the ’984 patent”) 

Nature of the Case and Issue(s) Presented: The central issue in the case concerned Lupin’s obviousness defense related to the ’984 patent. The ’984 patent is directed to a method of contraception with three compositions: (i) 0.3 to about 1.5 mg progestin (norethindrone) and 5 to 15 micrograms ethinyl estradiol for 24 days; (ii) 5 to 15 micrograms ethinyl estradiol for two days; and (iii) a placebo optionally containing an iron supplement. The court found the patent not invalid, and nonobvious, based on the amount of the combined ingredients and the method of administration. While the prior art disclosed using norethindrone in combination with ethinyl estradiol, it failed to disclose the amounts, and taught away from combining norethindrone with less than 20 micrograms of ethinyl estradiol. In addition, the court found that unexpected results, FDA approval, and commercial success served as secondary considerations to support a finding that the patent was not obvious.

Why Warner Chilcott Prevailed:  Warner Chilcott prevailed because defendants’ expert analysis was driven by hindsight and failed to demonstrate the three principles he identified that a person of ordinary skill in the art (“POSA”) would apply in developing an oral contraceptive regimen. Defendants’ expert identified three principles that a person of ordinary skill would apply: (i) a POSA would start and modify a commercially successful regimen; (ii) a POSA would start with a regimen that was scientifically proven to provide safe and effective cycle control; and (iii) a POSA would proceed one step at a time. The court found defendants’ expert did not follow those principles in reaching his conclusion. He did not identify any commercially successful product that resulted from the primary reference—a prior-art patent.

Secondly, the primary reference did not include any data regarding the efficacy or cycle control of the disclosed regimens. The court also found that a POSA would have to make five changes to the primary reference to create the patented invention. The court determined that these deviations, such as the amount of the ethinyl estradiol and the order of administration, were too many steps. In addition, the court found that the prior art taught away from the patented invention. Norethindrone is not a potent progesterone and the prior art taught that to be effective and achieve cycle control the contraceptive would require more than 20 micrograms of ethinyl estradiol. Moreover, the prior art taught generally that there were efficacy and cycle-control problems with contraceptives containing less than 20 micrograms of ethinyl estradiol.

The court also determined that the patented order of administration was not obvious. The patent requires the progestin and the estradiol be administered for the first 24 days, followed by two days of ethinyl estradiol, followed by two days of placebo. In contrast, the prior art taught that the estrogen-only tablets ought to be administered prior to the combinations because the estrogen allows the subsequently administered progesterone to become more effective and result in a better bleeding pattern. Defendants identified the clinical trials of Loestrin 24 Fe, which was in Phase III clinical trials, as disclosing the patented regimen. The court was not persuaded by defendants’ argument. While the informed-consent form provided an option for notifying the participant’s primary care physician, no evidence was presented that the regimen was disseminated or that any primary-care physician was ever informed of her or his patient’s participation.

Finally, the court found that secondary considerations favoring non-obviousness existed, based upon the FDA’s approval and the commercial success of the product.

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