Thursday, August 04, 2011

Barr loses argatroban case at CAFC; Japanese translation issue

Although Mitsubishi v. Barr, concerning argatroban (a zwitterion), is nonprecedential, there is a lot to be learned from the case. Barr tried to invalidate claims of Mitsubishi based upon a Japanese article published in 1986 by a Mitsubishi employee, Toshihiro Yamamoto. There was a dispute over the translation.

Thus, as a first point, the CAFC decision addresses "what happens" in a dispute over a translation from a foreign language (here, Japanese) into English. Of legal issues, the CAFC noted:

The fact-finder’s selection of a particular translation as the best translation of a foreign language reference raises pure questions of fact. See Hodosh v. Block Drug Co., Inc., 786 F.2d 1136, 1142-43 (Fed. Cir. 1986); see also Gray v. Noholoa, 214 U.S. 108, 112 (1909). The district court’s selection of the appropriate translation in this case was based in large part on a credibility determination, and such determinations are “virtually never” overturned for clear error. Honeywell Int’l, Inc. v. Hamilton Sund- strand Corp., 523 F.3d 1304, 1314 (Fed. Cir. 2008), quot- ing Anderson v. City of Bessemer City, 470 U.S. 564, 575 (1985). Although Barr contends that Mr. Cross’s translation should be disregarded because it was prepared for purposes of litigation, that is not a sufficient reason to conclude that the district court’s choice of the Cross translation was clearly erroneous. Barr’s remaining arguments relate to inferences drawn from the competing testimony of expert witnesses. The district court is in the best position to draw those inferences, and we find substantial evidentiary support for the court’s acceptance of Mr. Cross’s translation and its rejection of the other translations.

If you don't win the translation issue at trial, you will have a hard time overturning on appeal.

Winning on anticipation is not easy when there is a lack of clarity of the cited reference(s).

In the case, there was separately an issue over the meaning of the word "dissolving." -->

The court found that claim 1 is limited to compositions in which argatroban is completely dissolved in a solvent that contains ethanol, water, and a saccharide, i.e., no further dissolution of argatroban takes place once those three co-solvents are present in the composition. Barr contends that claim 1 covers any system in which some argatroban is dissolved in a solvent containing ethanol, water, and a saccharide, even if most of the argatroban in the solution has been dissolved previously in another solvent system.

Scientific "impossibility" arose:

However, the district court discredited the competing method of preparation proffered by Dr. Needham because his first proposed method was scientifically impossible, his second method involved a nine-step sequence that would be expected to have been disclosed by the reference, and he admitted in a deposition that he did not know how a person of skill in the art would have interpreted Mr. Cross’s translation of Yamamoto. Even if the method of preparation disclosed in Yamamoto, as translated by Mr. Cross, is subject to multiple interpretations, Barr has not shown that Dr. Byrn’s interpretation is implausible. Moreover, the district court took note of the fact that Yamamoto’s description of the argatroban solution was quite cryptic because, as both experts agreed, Yamamoto was focused on the pharmacological activity of the argatroban molecule, rather than on “argatroban’s solubility or on treating the rats.” In order to anticipate, the teaching of a reference must be clear and unambiguous. In re Turlay, 304 F.2d 893, 899 (CCPA 1962). Because Yamamoto does not clearly teach the methods set forth in claims 1 and 2 of the ’052 patent, Barr has not shown that claims 1 and 2 are anticipated by Yamamoto.

Novartis v. Eon came up:

In support of its construction, Barr cites to our decision in Novartis Pharmaceuticals Corp. v. Eon Labs Manufacturing, Inc., 363 F.3d 1306 (Fed. Cir. 2004). In that case, this court determined that a composition claim to a “hydrosol . . .” was limited to “a medicinal preparation . . . prepared outside the body.” Id. at 1311. The court found support for that narrow construction in the patent specification, which referred to the claimed hydrosol as a “pharmaceutical composition” prepared as an “injectable solution.” Id. at 1310.

AND note

Each of the constituent parts of the composition must be pharmaceutically acceptable, although only the composition as a whole needs to be medicinal in nature. See Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1382 (Fed. Cir. 2003) (a “pharmaceutical composition” includes a drug along with a “pharmaceutically acceptable carrier”); In re Gardner, 427 F.2d 786, 787 (CCPA 1970) (a “pharmaceutical composition” is an active compound “in a suitable pharmaceutical carrier”).


See In re ’318 Patent Infringement Litig., 583 F.3d 1317, 1324 (Fed. Cir. 2009) (“human trials are not required for a therapeutic invention to be patentable”). Instead, the court imposed a “minimal requirement that a composition meeting claim 3 must have some medicinal aspect or must pertain to treatment of a clinical indication.”

Barr was a day late, and a dollar short, in making two arguments. This shows up in the two footnotes in the case.

A preamble issue arose, but was dismissed in footnote 1:

Barr briefly argues that the term “pharmaceutical composition” should not be read to limit claim 3 at all because it appears in the preamble to the claims. See Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1358-59 (Fed. Cir. 2010). Barr did not make that argument before the district court, however, and therefore cannot raise it for the first time on appeal. See Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1358-59 (Fed. Cir. 2006).

An enablement argument was disposed of quickly:

Under the proper construction of “pharmaceutical composition,” as set forth above, the claims are clearly enabled. The specification of the ’052 patent discloses methods of preparing three sample solutions containing argatroban, ethanol, water, and a saccharide to be administered by injection.

A more general argument about obviousness was rejected:

Finally, Barr points out that several prior art references disclose solvent systems that include ethanol, water, and a saccharide. However, Barr does not challenge the district court’s finding that those references are not specific to argatroban or, more generally, to zwitterions. The district court did not credit Dr. Needham’s testimony that a person of ordinary skill in the art would have been directed to the specific co-solvent system disclosed in the ’052 patent, because there were a very large number of such systems disclosed in the prior art.

An argument introduced in a reply brief was dismissed in footnote 2:

In its reply brief, Barr challenges Dr. Byrn’s testimony that ethanol was known to reduce the solubility of zwitterions such as argatroban. Barr did not raise that argument in its opening brief, and we therefore decline to consider it. See SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1319 (Fed. Cir. 2006).


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