Patent Law

Compound

By Gary Odom and Jordan Kuhn

Ortho-McNeil sued Teva over RE39,221, claiming a combination of acetaminophen and tramadol, branded as Tylenol®. The district court granted summary judgment of obviousness to all asserted claims, as well as finding one claim, 6, anticipated. Ortho-McNeil appealed.

Ortho-McNeil Pharmaceutical v. Teva Pharmaceuticals (CAFC 2008-1549) non-precedential

The rules of this scrimmage.

This court reviews a grant of summary judgment de novo. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1302 (Fed. Cir. 2005). Obviousness is ultimately a determination of law, though it is based on questions of fact. Id. at 1302. Anticipation is a question of fact. Id. Because issued patents enjoy a presumption of validity, obviousness and anticipation must be proven by clear and convincing evidence. Impax Labs., Inc. v. Aventis Pharma., Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008). When the patent examiner has considered the asserted prior art and basis for the validity challenge during prosecution, the burden of proving invalidity is especially heavy. Id.; Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990). Summary judgment is only appropriate where there are no material questions of fact and the movant is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); Fed. R. Civ. P. 56(c).

Inventions in most instances rely upon building blocks long since uncovered, and combine elements that are in some sense already known. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 418-19 (2007). The combination of familiar elements according to known methods is likely to be obvious, however, when it does no more than yield predictable results. Id. at 1739. Each case must be decided in its particular context, including the characteristics of the science or technology, the nature of the choices available to one skilled in the art, the specificity of the prior art, and the predictability of results in the area of interest. Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008).

The majority (Judges Prost & Moore) vacated summary judgment over claim 6 being anticipated by the prior art, but found claim 6 obvious, as the difference between the prior art (Flick, example 23) and the claim was a matter of ingredient proportions.

Because the difference between 1:7.1 and 1:10 is so slight, Flick creates a prima facie case of obviousness with regard to claim 6. See Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 782-83 (Fed. Cir. 1985) ("The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."); Haynes Int'l, Inc. v. Jessop Steel Co., 8 F.3d 1573, 1577 n.3 (Fed. Cir. 1993) ("[W]hen the difference between the claimed invention and the prior art is the range or value of a particular variable, then a prima facie rejection is properly established when the difference in range or value is minor.").

Ortho-McNeil has failed to create a material dispute of fact regarding whether "the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (emphasis added); cf. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006) ("Evidence of commercial success, or other secondary considerations, is only significant if there is a nexus between the claimed invention and the commercial success.").

Ortho-McNeil did manage to scare up a question of fact over the other claims to the panel majority's satisfaction, rendering summary judgment premature. So, other than claim 6 obviousness, vacated and remanded.

Judge Mayer took a powder.

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. I therefore respectfully dissent.

The only alleged difference between the tablet disclosed in the asserted claims of the RE221 patent and the tablet disclosed in example 23 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 Flick's formulation.

Flick also teaches that ingredients can be varied as desired... Nowhere does Flick state that pentobarbital sodium and ethoxy benzamide are required components in a tramadol/acetaminophen tablet. "If a person of ordinary skill can implement a predictable variation [of the prior art], § 103 likely bars its patentability." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Here, the removal of pentobarbital sodium and ethoxy benzamide was a predictable and simple variation on the Flick formulation. See id. at 421 ("A person of ordinary skill is . . . a person of ordinary creativity, not an automaton."); Bayer Schering Pharma AG v. Barr Labs., Inc., No. 2008-1282, 2009 U.S. App. LEXIS 17372 (Fed. Cir. Aug. 5, 2009) (affirming an obviousness determination where the patentee was confronted with a limited number of options for modifying a prior art pharmaceutical composition).

In addition to the Flick patent, several other prior art references (the "German references") explicitly teach that tramadol can be combined with acetaminophen to provide effective pain relief.

The situation presented here parallels that presented in Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1480 (Fed. Cir. 1997). There we held that it would have been obvious to combine two drugs, the analgesic ibuprofen and the decongestant pseudoephedrine, in a single tablet since the drugs had been co-administered in the past. There, as here, it was manifestly obvious to combine two well-known drugs--which had previously been administered together--in a single tablet. See In re Diamond, 360 F.2d 214, 217-18 (C.C.P.A. 1966) (concluding that a combination of two therapeutic agents for inflammatory disease was obvious).

Simply put, there is nothing even arguably new about what Ortho claims to have invented. I would affirm.

Full post as published by The Patent Prospector on August 26, 2009 (boomark / email).