By Donald Zuhn --
The Federal Circuit today vacated-in-part and affirmed-in-part an order by the District Court for the District of New Jersey granting summary judgment of invalidity of U.S. Reissued Patent No. 39,221 based on anticipation and obviousness.
Plaintiff-Appellant Ortho-McNeil Pharmaceutical, Inc. owns the '221 patent, which relates to a tramadol and acetaminophen composition for use in prescription pain relief. Ortho first claimed this composition in U.S. Patent No. 5,336,691, and after receiving FDA approval, began marketing a tramadol/acetaminophen tablet under the brand name Ultracet®.
Seeking approval to market a generic version of Ortho's tramadol/acetaminophen tablet, a number of generic companies filed Abbreviated New Drug Applications (ANDAs) with the FDA. In response to these ANDA filings, Ortho filed multiple lawsuits for infringement of the '691 patent. The generic companies argued that the '691 patent was invalid for anticipation and obviousness in view of U.S. Patent No. 3,652,589, which relates to tramadol, and which discloses a tramadol, p-acetamino-phenol, pentobarbital sodium, and ethoxy benzamide composition. During the course of this litigation, Ortho learned that p-acetamino-phenol was an archaic name for acetaminophen. Because the '589 patent discloses a 1:10 ratio of tramadol to p-acetamino-phenol (i.e., acetaminophen) in its four-compound composition, and this ratio falls within the scope of several claims in the '691 patent, Ortho sought to reissue the '691 patent.
During reissue proceedings, Ortho redrafted all but one of the asserted claims of the '691 patent to narrow them, and amended the lone remaining claim to independent form. The redrafted claims and amended claim (claim 6 of the '221 patent) were allowed to reissue. Following reissue, Ortho amended its complaints against the generic companies to assert the reissue claims. Ortho's cases against Defendants-Appellees Teva Pharmaceuticals Industries, Ltd., Teva Pharmaceuticals USA, Inc., Watson Laboratories, Inc. ("Teva"), and Caraco Pharmaceutical Laboratories, Ltd. ("Caraco") were then consolidated.
Teva and Caraco filed summary judgment motions of invalidity, asserting that the '221 patent was anticipated and rendered obvious by the '589 patent and a series of German publications that were cited during the reissue proceedings (and which disclose a method of managing cancer pain by customizing a co-administration of pain relievers and dosing regimens for particular patients). Ortho disputed Teva's and Caraco's interpretations of the references and submitted expert testimony explaining why the references did not anticipate or render obvious the asserted claims. The District Court, however, granted summary judgment invalidating claim 6 as anticipated and obvious over the prior art, and invalidating the other asserted claims as obvious over the prior art.
In vacating the District Court's summary judgment invalidating the asserted claims other than claim 6, the Federal Circuit determined that these claims recite a pharmaceutical composition of tramadol and acetaminophen in a ratio of about 1:5 to about 1:19, and that "[a] single tablet containing only tramadol and acetaminophen in a fixed dose ratio within the claimed range is not disclosed in the cited prior art." The majority also determined that the '589 patent discloses a four-compound composition and "does not suggest that the pentobarbital sodium and ethoxy benzamide are merely optional for the combination to work as desired." The Court also took note of Ortho's expert testimony that "one of ordinary skill in the art would not find it obvious to try to remove two of the four active ingredients disclosed in [the four-compound composition of the '589 patent] to arrive at the claimed composition." As for the series of German references, the majority noted that Ortho's expert explained that these references "actually teach away from the claimed composition because they emphasize the importance of flexibility in choosing combinations and doses of medications based on individual needs," and also disparage the claimed fixed-dosage combination tablet. The majority concluded that Ortho's reading of the prior art, and expert testimony regarding the understanding of one skilled in the art, raised material questions of fact as to whether a skilled artisan would have found the claimed tramadol/acetaminophen composition obvious, and therefore vacated the District Court's grant of summary judgment as to the asserted claims other than claim 6.
Claim 6 of the '221 patent recites a pharmaceutical composition comprising a tramadol material and acetaminophen, wherein the ratio of the tramadol material to acetaminophen is a weight ratio of about 1:5. With respect to this claim, the Federal Circuit first determined that while the '589 patent discloses a composition comprising tramadol and acetaminophen, the parties were at odds as to whether the '589 patent discloses the recited weight ratio. Stating that "[t]he district court improperly resolved disputed questions of fact" in agreeing with Teva's and Caraco's interpretation of the '589 patent, the majority vacated the District Court's summary judgment that claim 6 is invalid for anticipation.
The majority, however, affirmed as to the District Court's summary judgment that claim 6 is invalid as obvious. The Federal Circuit stated that the ratio of tramadol and acetaminophen disclosed for the four-compound composition of the '589 patent (i.e., 1:10) is so close to the Court's prior construction of "about 1:5" (see Patent Docs report on the prior appeal) that the '589 patent "creates a prima facie case of obviousness with regard to claim 6." The majority concluded that Ortho failed to rebut the prima facie case by "show[ing] that the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results over the prior art range."
Judge Mayer, in his dissent, begins by declaring that:
The claimed invention does nothing more than combine two well-known pain relievers -- acetaminophen and tramadol -- in a single tablet. Since the prior art clearly and unequivocally taught that these two analgesics could be combined for effective pain relief, the claimed invention is the epitome of obviousness.
With respect to the disclosure of a four-compound composition in the '589 patent, Judge Mayer states that:
The only alleged difference between the tablet disclosed in the asserted claims of the RE221 patent and the tablet disclosed in [the '589 patent] is that the latter also contains two additional ingredients, pentobarbital sodium and ethoxy benzamide. Given that ethoxy benzamide was a known carcinogen and pentobarbital sodium was known to have antagonistic interactions with analgesics, it would have been obvious to remove these two drugs from [the '589 patent's] formulation.
Observing that "[n]owhere does [the '589 patent] state that pentobarbital sodium and ethoxy benzamide are required components in a tramadol/acetaminophen tablet," Judge Mayer concludes that the removal of these two compounds would have been "a predictable and simple variation" on the formulation disclosed in the '589 patent. Moreover, in Judge Mayer's view, when the German publications (which disclose combining tramadol with acetominophen to provide pain relief) are read in the light of the '589 patent (which discloses a fixed-dose tablet), "they clearly suggest combining tramadol and acetaminophen in a single fixed-dose tablet." Thus, in Judge Mayer's eyes "there is nothing even arguably new about what Ortho claims to have invented."
Ortho-McNeil Pharmaceutical, Inc. v. Teva Pharmaceuticals Industries, Ltd. (Fed. Cir. 2009)
Panel: Circuit Judges Mayer, Prost, and Moore
Opinion by Circuit Judge Prost; dissenting opinion by Circuit Judge Mayer