Friday, August 10, 2012

Concerning Alcon v. Apotex

On August 10, 2012:

Page 1, change “Bruce R. Genderson, argued for plaintiff- appellee” to “Kannon Kumar Shanmugam”.

from Alcon v. Apotex

August 8, 2012:

BRUCE R. GENDERSON, Williams & Connolly, LLP, of Washington, DC, argued for plaintiffs-appellees. With him on the brief were ADAM L. PERLMAN, KANNON K. SHANMUGAM, THOMAS H. L. SELBY and SHELLEY J. WEBB.

from Alcon v. Apotex

The case itself concerned validity of claims of Alcon's U.S. Patent No. 5,641,805. The outcome was that the CAFC reversed the lower court holding that claims 1-3 and 5-7 would not have been obvious over the prior art but affirmed the court’s holding that claims 4 and 8 are not invalid.

Alcon had relied on a motivation argument to overcome obviousness, but stumbled over claim scope:

Alcon contends that the court correctly found that a skilled artisan would not be motivated to formulate an olopatadine eye drop solely based on its antihistaminic activity because the prior art does not supply a reason to focus on olopatadine instead of many other promising antihistamines. (...)

On appeal, however, we must determine what olo- patadine concentrations constitute a “therapeutically effective amount.” The dependent claims are a starting point for ascertaining the concentration of olopatadine covered by claim 1. Claim 2, for example, is directed to the method of claim 1 wherein “the amount of [olo- patadine] is from about 0.0001 w/v. % to about 5% (w/v).” Claim 3 further narrows the range to “about 0.001 to about 0.2% (w/v).” Claim 4 further narrows the range to “about 0.1% (w/v).” As far as the concentrations of olo- patadine, claims 5-8 mirror the ranges disclosed in 1-4, respectively.
It is axiomatic that a dependent claim cannot be broader than the claim from which it depends. See 35 U.S.C. § 112 ¶4 (“[A] claim in dependent form shall con- tain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed.”); see also Intamin Ltd. v. Magnetar Techs., Corp., 483 F.3d 1328, 1335 (Fed. Cir. 2007) (“An inde- pendent claim impliedly embraces more subject matter than its narrower dependent claim.”); AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003) (“Under the doctrine of claim differentiation, dependent claims are presumed to be of narrower scope than the independent claims from which they depend.”). Therefore if claim 2 covers the range from 0.0001% w/v-5% w/v, claim 1 must cover at least that range. Furthermore, because a dependent claim narrows the claim from which it depends, it must “incorporate . . . all the limitations of the claim to which it refers.” 35 U.S.C. § 112 ¶4. As a result, the concentrations recited in the ’805 patent’s dependent claims must necessarily meet claim 1’s limita- tions of being therapeutically effective for treating allergic eye disease by stabilizing conjunctival mast cells. This is clear from the express claim language.

Alcon had problems with claim scope:

Alcon’s counsel argued that, “to the extent that the dependent claims cover a broader range than the range that would be operative to stabilize mast cells,” the inoperative portion of the range “wouldn’t be covered by the claim by virtue of the limitation in claim 1” that mast cell stabilization must occur to a clinically relevant extent. Argument at 14:56-15:22, Alcon Research v. Apotex, No. 2011-1455, available at 11-1455.mp3. Alcon’s counsel thus contended that the claims “would be operative, just at a narrower concentra- tion” than the claimed range. Id. at 15:24-15:27. This is not how patent law works. When you claim a concentra- tion range of 0.0001-5% w/v (as claim 2), you can’t simply disavow the invalid portion and keep the valid portion of the claim. If everything up to 0.001% w/v is admittedly not enabled, then the entire claim is invalid. Similarly, if prior art discloses a portion of the claimed range, the entire claim is invalid. Courts do not rewrite the claims to narrow them for the patentee to cover only the valid portion. Alcon cannot have it both ways. Because claim 2 sets forth a concentration range, that range at a mini- mum must be included in claim 1, whatever its limitations. When analyzing the validity of claim 1 or claim 2, by the express claim language, the clinically relevant therapeutic amount must include 0.0001-5% w/v olo- patadine. That is the claimed concentration range which should be compared to the disclosure of the prior art.

As to motivation:

The only remaining dispute is whether there was a motivation to adapt the formulation disclosed in Kamei, which was tested in guinea pigs, for use in treating aller- gic eye disease in humans. The district court found, as a factual matter, that animal tests, including guinea pig models, are predictive of a compound’s antihistaminic activity and its topical ocular availability in humans. Alcon v. Apotex, 790 F. Supp. 2d at 881. Given this fact finding, the district court clearly erred when it concluded that a person of skill in the art would not have been motivated to use the olopatadine concentration disclosed in Kamei in human eyes. The district court’s error stemmed from its refusal to look at any motivation beyond that articulated by the patent. We have repeatedly held that the motivation to modify a prior art reference to arrive at the claimed invention need not be the same motivation that the patentee had. See KSR, 550 U.S. at 420 (stating that it is error to look “only to the problem the patentee was trying to solve”); see also In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006) (“[T]he skilled artisan need not be motivated to combine [the prior art] for the same reason contemplated by [the inventor].” (citing In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“[T]he law does not require that the references be combined for the reasons contemplated by the inventor.”))); DyStar Textil- farben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1361 (Fed. Cir. 2006) (stating that the motivation to modify the prior art to arrive at the claimed invention “may be found in any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself.”). Here, the motivation to adapt Kamei’s formula- tion for human use is that it is an effective antihistamine in guinea pigs and that animals models are (as the dis- trict court expressly found) predictive of antihistaminic efficacy in humans.

Of inherency:

The parties dispute whether stabilizing conjunctival mast cells is an inherent property of olopatadine and whether inherency may be used in an obviousness analy- sis. We addressed a similar situation in In re Kubin, where we explained that, “[e]ven if no prior art of record explicitly discusses the [limitation], the [patent appli- cant’s] application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed invention], but rather a property necessarily present in the [claimed invention].” 561 F.3d 1351, 1357 (Fed. Cir. 2009). The same is true here. The district court’s construction of “stabilizing conjunctival mast cells” restricts the claims to certain olopatadine concentrations. As in In re Kubin, this claim language does not impose any additional requirement because the ’805 patent itself defines mast cell stabilization as a property that is neces- sarily present at those concentrations.


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