Janssen Pharm., Inc. v. Watson Labs., Inc.

Patent claiming 25 micrograms ethinyl estradiol not invalid based on genus/species anticipation arguments and obviousness despite the fact that the prior art disclosed a range of 20-50 micrograms of ethinyl estradiol.

October 16, 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name:  Janssen Pharm., Inc. v. Watson Labs., Inc., Civ. No. 08-5103 (SRC), 2012 U.S. Dist. LEXIS 129099 (D.N.J. September 11, 2012) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Ortho Tri-Cyclen® LO (estrogen ethinyl estradiol and progestin norgestimate); U.S. Pat. No. 6,214,815 (“the ’815 patent”).

Nature of the Case and Issue(s) Presented: Watson and Lupin (collectively “Lupin”) each filed an ANDA concerning generic Ortho Tri-Cyclen LO. The parties stipulated that (i) each of the ANDA filings constituted an act of infringement of claims 1 and 4 of the ’815 patent; (ii) summary judgment of infringement should be granted as to claims 1 and 4; and (iii) the patent-in-suit met the requirements under 35 U.S.C. §101 and 112. Three distinct issues were set for trial: patent invalidity on the basis of anticipation; obviousness; and non-statutory double patenting. The court found that the difference between the prior art and the patent claims is the prior art’s disclosure of an ethinyl estradiol dosage range of 0.02-0.05 mg compared with the patent-in-suit’s disclosure of a dosage of 0.025 mg. Lupin argued that the prior art range constituted a genus and within the regimen at issue is one species. Thus, the genus anticipated the species. The court rejected this argument stating that the prior art does not spell out a definite and limited class of contraceptive regimens within the genus.

With respect to the second issue, obviousness, and relying on Eurand, Inc. v. Mylan Pharms., Inc. 676 F.3d 1063 (Fed. Cir. 2012), the court found that even though the claimed invention falls within a range disclosed in the prior art, that fact has no special significance to an obviousness inquiry, but rather, is only one factor to be weighed. While the court conceded that it was undisputed that skilled artisans wanted to create contraceptive regimens with a lower estrogen dosage, the court determined that 25 micrograms was not an obvious choice because the art suggested that lowering the ethinyl estradiol dose decreased cycle control and increased risk of bleeding problems. Lupin also argued that plaintiffs failed to demonstrate unexpected results. The court determined that plaintiffs, at a minimum, demonstrated that Ortho Tri-Cyclen LO produced comparable cycle control to that of Ortho Tri-Cyclen, the higher dose product. Finally, though the court recognized the important differences between obviousness under § 103 and obviousness-type double patenting, which the Federal Circuit explained in Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1297 (Fed. Cir. 2012), the court held that the patents were not obvious under obviousness-type double-patenting by applying the same analysis as it did with obviousness.

Why Janssen Prevailed:  Janssen prevailed against Lupin’s anticipation defense because the court was unwilling to apply the genus/species rule to the numerical range known in the art.  But the Court found that that the prior art genus did not expressly spell out a definite and limited class of contraceptive regimens, and defendants had no legal precedent supporting their position. Lupin argued that one of ordinary skill would know to break the dosage range of 20 to 50 micrograms into dosages evenly divisible by 5.  The court found that there was no teaching in the prior art nor foundation in the Federal Circuit law to transform the infinite range into a discrete set of seven possible dosages.

In determining that the patent claim was not obvious, the court stated that “[d]efendants’ principal obviousness argument could serve as a textbook example of an argument founded on hindsight.” To reach the nonobvious finding, the court relied on prior art studies that compared two progestin dosing regimens that tested dosage levels of 30 micrograms vs. 20 micrograms. The studies demonstrated that lower dosing resulted in inferior cycle control. Thus, the court determined that as of the critical date, a skilled artisan believed that decreasing estrogen dosage results in decreased cycle control. The court further found that Lupin failed to lay adequate legal foundation for the argument that the failure to provide scientifically valid evidence that Ortho Tri-Cyclen® LO exhibits unexpected results should render the patent invalid as obvious. For support, Lupin cited four cases.  Two of those cases were in the legal framework of patent prosecution and not litigation. Therefore, the court found them unpersuasive.  The remaining two cases were directed to the weight of the evidence rather than a legal requirement as to how unexpected results must be demonstrated. Furthermore, the court viewed Lupin’s argument as an attempt to shift the burden of proof, requiring the patentee to demonstrate validity by conclusively proving unexpected results with scientifically valid studies. In the obviousness analysis, the court also analyzed whether one of ordinary skill would have a reasonable expectation of success by inquiring into whether skilled artisans would have believed changing the regimen by reducing the ethinyl estradiol dosage from 35 to 25 micrograms would have resulted in deterioration of cycle control. Lupin challenged the notion that cycle control could be used to determine a reasonable expectation of success since it was not a claim term. The court rejected this argument finding that the patent as a whole expresses that cycle control is a part of what was inventive.  The court weighed secondary considerations against the entire evidence of record and determined that the patent was not obvious. In determining that the patent was not invalid under the doctrine of obviousness-type double-patenting, the court applied its analysis regarding obviousness, including evidence of secondary considerations.

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