Beware of an Interpretation of a Reference that is Based Upon a Hypothetical Embodiment
| October 27, 2017
Merck Sharp & Dohme B.V. v. Warner Chlilcott Company, LLC
October 19, 2017
Before Dyk, Linn, and Hughes. Opinion by Hughes.
Summary:
The CAFC reversed the finding by the District Court of Delaware that U.S. Patent
No. 5,989,581 was invalid as being obvious in view of International Patent Application
WO 97/02015 (hereinafter PCT ‘015). In reviewing the findings by the District Court, the CAFC highlighted the breadth of the disclosure of PCT ‘015, the teaching away by PCT ‘015 of a one compartment ring system and noted that the finding was based upon impermissible hindsight.
Details:
Merck appeals the District Court of Delaware’s determination that claims 4 and 11 of U.S. Patent No. 5,989,581 (hereinafter ‘581) are invalid as obvious in view of International Patent Application WO 97/02015 (hereinafter PCT ‘015). The commercial embodiment of ‘581 is the NuvaRing®, which is a ring shaped drug-delivery device. Warner argues that ‘581 is invalid but concedes that its generic product would infringe ‘581 if the claims were valid. Id. at 2.
The ‘581 patent achieves a stable release of both progestin, etonogestrel (ETO), and estrogen, ethinyl estradiol (EE), in a single compartment ring system. The ‘581 patent overcomes the problems in the prior art by providing a ring made of a polymer that is supersaturated with ETO. Claims 4 and 11 of ‘581 require a single compartment ring system comprising both progestin and estrogen.
1. A drug delivery system comprising at least one compartment which comprises
a thermoplastic polymer core . . . said core comprising a mixture of a steroidal progestogenic compound and a steroidal estrogenic compound in a ratio by weight that allows a direct release of both said progestogenic compound and said estrogenic compound in physiologically required amounts,
said progestogenic compound being initially dissolved in said polymer core material in a degree of supersaturation of 1 to about 6 times of the amount by weight necessary for obtaining saturation concentration of said progestogenic compound in said polymer core material at 25° C,
said estrogenic compound being dissolved in said polymer core material in a concentration lower than that of said progestogenic compound . . . .
4. A drug delivery system according to claim 1, wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.
5. A drug delivery system in a substantially ring-shaped form and suitable for vaginal administration comprising at least one compartment which comprises
a thermoplastic polymer core . . . said core comprising a mixture of a progestogenic steroidal compound and an estrogenic steroidal compound in a ratio by weight of 10 parts of the progestogenic compound to 1.5–5 parts of the estrogenic compound. . . .
11. A drug delivery system according to claim 5, wherein the core material comprises 0.55 to 0.8% by weight of etonogestrel and 0.12 to 0.18% by weight of ethinyl estradiol.
Warner argued that claims 4 and 11 of ‘581 are anticipated by or rendered obvious by PCT ‘015, which discloses a ring shaped drug delivery device releasing progestin, etonogestrel (ETO), and estrogen, ethinyl estradiol (EE). However, the device of PCT ‘015 is a two compartment ring system. PCT ‘015 explicitly criticizes one compartment ring systems, stating that such systems “show suboptimum release patterns for the difference substances…” Id. at 5.
The District Court found that the ‘581 patent is obvious in view of PCT ‘015. The judgment of the District Court was based upon the finding that PCT ‘015 discloses:
- A two-compartment ring;
- The second compartment is loaded with both ETO and EE;
- The concentration of ETO is higher than EE ; and
- The second compartment comprises 97% of the ring.
The District Court held that it would have been obvious to a skilled artisan at the time of invention “to modify the two-compartment ring so that pharmaceutically required amounts of both ETO and EE are delivered from one compartment.” Id. at 7.
Law regarding Obviousness
- “[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
- Even if all elements of the claim were known, we still must resolve whether a person of ordinary skill in the art would have found it obvious to combine these elements or modify them in a way that meets the claim.
- It is improper to combine references “like separate pieces of a simple jigsaw puzzle” without “explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place these pieces together.” InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349 (Fed. Cir. 2014).
Id. at 6.
The CAFC noted that “PCT ‘015 does not actually disclose a ring with a second compartment that comprises 97% of the ring, and includes a higher concentration of ETO than EE in the second compartment.” Id. at 7. Rather, PCT ‘015 discloses a “broad range of values for the relative size of each compartment as well as concentrations of each compound.” Id. at 7. The CAFC highlighted the breadth of the disclosure of PCT ‘015 by illustrating that “the second compartment can occupy anywhere from 3% to 97% of the ring. Elsewhere, PCT ’015 explains that ‘the second compartment is loaded with 0.05-3% w/w” of ETO and “0.05-5% w/w’ of EE.” Id. at 7.
To arrive at the hypothetical ring that the district court relied on for obviousness, the person of ordinary skill must make the second compartment 97% of the total ring, which is outside of the usual or preferred range disclosed in
PCT ’015. And the person of ordinary skill must also pick a concentration of ETO from the high end of the disclosed range, but conversely select a concentration of EE from the low end of the range. Nothing in PCT ’015 suggests picking these values out of the innumerable possible combinations of ETO concentrations, EE concentrations, and compartment length ratios. Instead, the only way to arrive at the hypothetical ring is by using the ’581 patent as a roadmap to piece together various elements of PCT ’015. That represents an improper reliance on hindsight.
(emphasis added) Id. at 7 and 8. Further, it was noted that the PCT ‘015 was critical of an one compartment ring system, which the CAFC stated establishes that the District Court’s judgment was based upon impermissible hindsight. A “person of ordinary skill in the art would pursue ‘identified, predictable solutions,’ not designs that were seemingly inoperable.” Id. at 8.
Claim 11 recites a one compartment ring system having specific concentrations of each ETO and EE. Warner had argued that “it would have been obvious to calculate the relative concentrations for each compound based on those release rates.” Id. at 9. The CAFC held that this argument is unpersuasive because the disclosure of dosage rate in PCT ‘015 is based upon a two compartment ring system. Warner’s argument and the District Court judgment would require a skilled artisan to calculate the relative concentrations for a two compartment ring, and apply those concentrations to a single compartment, despite PCT ‘015 stating that a single compartment system is difficult to control while a two compartment system achieves consistent release rates. Id. at 9.
The CAFC reverses the District Court’s judgment of invalidity and remanded the case.
Take away:
- One should review an obviousness rejection to determine if it is based upon a hypothetical embodiment of the cited reference.
- One should review the breadth of the disclosure of a cited reference. The breadth of the disclosure of a cited reference may provide arguments of non-obviousness.
