In Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court and held that Bayer’s patent covering its Yaz® birth control pill product is invalid as obvious. The court found a strong prima facie case of obviousness, and rejected each of Bayer’s arguments relating to secondary indicia of non-obviousness.

The Patent At Issue

The patent at issue was Bayer’s RE37,564, which was a reissue of U.S. Patent 5,824,667, and covers Bayer’s Yaz® product.

As summarized by the Federal Circuit, Yaz® was different from available combined oral contraceptive (COC) products in that it included a lower dose of ethinylestradiol (EE) and the synthetic progestin drospirenone (DRSP), and a shorter pill-free interval of 24 days, which reduced the risk of “escape ovulation” and unintended pregnancy associated with the lower dose of EE. As described in the Federal Circuit opinion, Bayer’s YAZ® birth control bill product “includes four placebo pills and twenty-four active pills each containing 20 μg EE and 3 mg DRSP.”

The district court found that claims 13 and 15 were not obvious.

13. A combination product for oral contraception, comprising
(a) 23 or 24 daily dosage units, each containing 0.020 mg of ethinylestradiol, and 2.5 to 3.0 mg of drospirenone, and
(b) 5 or 4, respectively, active ingredient-free placebo pills or other indications to show that the daily administration of the 23 or 24 dosage units, respectively, is to be followed by 5 or 4, respectively, pill-free or placebo pill days, wherein each of the dosage units containing drospirenone contains the same amount of drospirenone.

15. A combination preparation of claim 13, which comprises 24 dosage units and 4 placebo pills or other indications to show that no dosage unit or placebo pill is administered during the last 4 days of the menstrual cycle.

The District Court ANDA Litigation

The defendants (Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., Sandoz, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc.) filed Abbreviated New Drug Applications (ANDAs), seeking approval to market generic versions of YAZ®, and making Paragraph IV certifications against the ’564 patent, under 21 USC § 355(j)(2)(A)(vii)(IV). Bayer brought suit under the ANDA litigation framework, asserting patent infringement under 35 USC § 271(e)(2).

All parties moved for summary judgment on the issue of obviousness, and the district court granted summary judgment in favor of Bayer. The defendants appealed.

The Federal Circuit Decision

The defendants had cited six prior art references alleged to render the claims obvious:

  • Australian Patent Application 55094/90 (November 22, 1990)
  • European Patent Application Publication 0 253 607 (April 29, 1992)
  • B.G. Molloy et al., “Missed Pill” conception: fact or fiction?, 290 Brit. Med. J. 1474 (1985)
  • John Guillebaud, The forgotten pill—and the paramount importance of the pill-free week, 12 Brit. J. Fam. Plan. 35 (1987)
  • B-M. Landgren & E. Diczfalusy, Hormonal Consequences of Missing the Pill During the First Two Days of Three Consecutive Artificial Cycles, 29 Contraception 437 (1984) (“Landgren”)
  • N.D. Goldstuck et al., Use and misuse of oral contraceptives by adolescents attending a free-standing clinic, 3 Advances in Contraception 335 (1987)

The Federal Circuit summarized the obviousness arguments as follows:

[T]he Defendants argue that AU’094 discloses a COC combining 20–40 μg EE and 1–10 mg DRSP per active pill—dosage ranges that encompass those recited in claims 13 and 15 of the ’564 patent. The Defendants further contend that EP’607, Molloy, Guillebaud, Landgren, and Goldstuck each disclose 23/5 and/or 24/4 dosing regimens and that those references provided motivation to combine such regimens with the low-dose COCs disclosed in AU’094 by identifying the problem of missed-pill conceptions and suggesting a shortened pill-free interval as a solution.

The Federal Circuit discussed Bayer’s three main arguments:

  • Bayer argues that AU’094 and EP’607 were directed to narrow subpopulations of patients primarily in need of hormone-replacement therapy, so those references would not have been combined by a person of ordinary skill seeking to develop a COC in 1993.
  • [T]he prior art as a whole taught away from the claimed COC preparations at that time in view of the entrenched use of traditional 21/7 dosing and the perceived risks from increasing total synthetic hormone administration by shortening the pill free interval.
  • The district court correctly relied on evidence of unexpected results, expert skepticism, industry praise, and copying as secondary indicia of nonobviousness.

The Federal Circuit agreed with the defendants:

In this case, the cited prior art references set forth every limitation required by the asserted claims and provide express motivation to combine those teachings to derive the claimed COC products. Accordingly, the asserted claims are invalid under § 103.

In particular, the Federal Circuit found, “AU’094 discloses COC preparations that encompass the claimed doses of EE and DRSP, and EP’607 discloses similar COCs, also comprising the claimed dose of EE, administered via the claimed 24/4 and 23/5 regimens.” Further, the court found that the secondary references both recognized the problem of missed-pill conception and proposed the claimed solution (the 24/4 dosing regimen).

The Federal Circuit considered and rejected Bayer’s arguments:

  • With regard to the subject matter of AU’094 and EP’607, the Federal Circuit stated, “those references plainly disclose preparations with hormone replacement and contraceptive applications,” and also noted that “the product claims at issue do not distinguish between target patient populations, whether by age or otherwise.”
  • With regard to the alleged “teaching away,” the Federal Circuit found that the cited passage regarding “conventional wisdom” favoring a 21/7 dosing regimen did not overcome other express teachings of the cited references.
  • The Federal Circuit also determined that “Bayer’s evidence of secondary indicia of nonobviousness … is legally insufficient:”
    • With regard to Bayer’s data “showing that 23/5 administration results in reduced follicular activity compared to 21/7 dosing of the same COC formulation,” the court found that those results “merely confirm that administering additional active pills results in additional follicular suppression,” which was not unexpected, but rather “would have been a matter of ‘common sense.”
    • With regard to expert skepticism, the court found that the fact that the FDA had asked for “clinical safety data and data demonstrating efficacy benefits sufficient to justify the added synthetic hormone exposure required for the proposed 24/4 dosing regimen …  in no way indicates that FDA experts would have been surprised to receive such data.” Instead, the court found that the FDA request was in line with its “normal duties.”
    • With regard to Bayer’s evidence that the invention “was widely praised by experts in the COC field,” the court found that many cited journal articles simply referred to Bayer’s findings, and others were authored by one of the inventors. As summarized by the court, “Such bare journal citations and self referential commendation fall well short of demonstrating true industry praise.” Moreover, the Federal Circuit stated that “industry praise of what was clearly rendered obvious by published references is not a persuasive secondary consideration.”
    • The Federal Circuit seemed to reject  Bayer’s evidence of copying as a matter of law:

Such evidence of copying [by generic manufacturers] in the ANDA context is not probative of nonobviousness because a showing of bioequivalence is required for FDA approval.

The Federal Circuit therefore determined that claims 13 and 15 “are invalid for obviousness,” and thus reversed the judgment of the district court.

Did Bayer’s Patent Serve Its Purpose?

While Bayer no doubt would have preferred that the Federal Circuit had upheld its patent, the patent did keep generic competitors off the market for more than 5 years. The FDA approved YAZ® for marketing on March 16, 2006. From the Federal Circuit decision, it appears that Watson was the first ANDA filer in 2007. Further, the twenty-year term of the patent was set to expire June 30, 2014. Thus, Bayer benefited from all but the last 14 months of the original patent term.