Opinion ID: 806206
Heading Depth: 2
Heading Rank: 1

Heading: Claims 1-3 and 5-7

Text: Apotex argues that the district court erred by finding that the ’805 patent claims would not have been obvious over the prior art. Apotex asserts that claims 1-3 and 5-7 would have been obvious over Kamei, which discloses eye drops with olopatadine concentrations that overlap with the claimed concentration ranges. Apotex argues that even though Kamei tested olopatadine formulations only ALCON RESEARCH v. APOTEX 8 in guinea pig eyes, a person of ordinary skill in the art could use routine methods to adapt these formulations for human use with a reasonable expectation of success. Apotex also argues that the district court erred by focusing on Kamei’s lack of disclosure that olopatadine is safe for human use because the ’805 claims do not recite a “safety” limitation. Apotex contends that the district court erred by requiring that the prior art provide a motivation to use olopatadine specifically as a mast cell stabilizer. Apotex argues that the prior art’s disclosure that olopatadine is an effective antihistamine that can be formulated for ophthalmic use provides sufficient motivation to develop an olopatadine eye drop for humans. Apotex also argues that claiming olopatadine’s mechanism of action (stabilizing conjunctival mast cells) cannot impart patentability to the ’805 patent claims because it is an inherent property of olopatadine. Apotex also asserts that even if this limitation restricts the claims to certain concentrations of olopatadine, the claims nonetheless would have been obvious because the prior art teaches using olopatadine at those concentrations. Apotex also argues that the district court erred by finding that objective evidence supported its holding of nonobviousness. Specifically, Apotex contends that olopatadine’s superior clinical efficacy is due at least in part to its antihistaminic activity, which is not a novel aspect of the ’805 patent. Apotex thus argues that the district court’s findings regarding commercial success, industry praise, and unexpected results lack sufficient nexus to the ’805 patent claims. 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 9 ALCON RESEARCH v. APOTEX activity because the prior art does not supply a reason to focus on olopatadine instead of many other promising antihistamines. Alcon also argues that the court correctly found that there would not have been a reasonable expectation of success in formulating an olopatadine eye drop because, at the time of invention, there were barriers to adapting an oral antihistamine for ophthalmic use. Alcon does not dispute that Kamei teaches using olopatadine eye drops at concentrations that overlap with those in claims 1-3 and 5-7 of the ’805 patent. Instead, Alcon argues that Kamei does not teach that olopatadine would be a mast cell stabilizer at those concentrations or that it would be safe for use in the human eye. Alcon argues that the district court correctly found that the prior art as a whole teaches away from using olopatadine as a mast cell stabilizer. Alcon also asserts that the district court correctly found that mast cell stabilization is not an inherent property of olopatadine because only some concentrations stabilize mast cells to a clinically relevant extent, as required by the court’s claim construction. Finally, Alcon argues that the district court correctly found that objective evidence supports a finding of nonobviousness. As an initial matter, we believe the district court erred in its comparison of the ’805 patent claims and the disclosure of the prior art. Claim 1 recites a method of treating allergic eye disease comprising using a “therapeutically effective amount” of olopatadine to stabilize conjunctival mast cells. The court construed the term “stabilizing conjunctival mast cells” to limit the claims only to concentrations of olopatadine that stabilize conjunctival mast cells “to an extent clinically relevant in the treatment of allergic eye disease.” J.A. 176. This construction is not appealed. Because it is not appealed, we do not decide whether this construction is correct. ALCON RESEARCH v. APOTEX 10 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 olopatadine, 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 contain 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 independent 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 limitations of being therapeutically effective for treating allergic eye disease by stabilizing conjunctival mast cells. This is clear from the express claim language. It is also sup11 ALCON RESEARCH v. APOTEX ported by the specification: “The concentration of Compound A is 0.0001 to 5 w/v %, preferably 0.001 to 0.2 w/v %, and most preferably about 0.1 w/v % . . . .” ’805 patent col.6 ll.43-46. Despite the clear language of the ’805 patent claims, Alcon argues that some olopatadine concentrations covered by claims 1-3 and 5-7 do not stabilize human conjunctival mast cells to a clinically relevant extent and should therefore be excluded from the claims’ scope. The district court found that “[n]ot every concentration of olopatadine applied to the human eye will stabilize the mast cells in the human eye.” Alcon v. Apotex, 790 F. Supp. 2d at 909. The court cited testimony by Alcon’s expert, Dr. Kaliner, that olopatadine at 0.001% w/v (which is covered by claims 1-3 and 5-7) would not stabilize human conjunctival mast cells to a clinically relevant extent. Id. at 909, 935. 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 http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20 11-1455.mp3. Alcon’s counsel thus contended that the claims “would be operative, just at a narrower concentration” than the claimed range. Id. at 15:24-15:27. This is not how patent law works. When you claim a concentration 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 ALCON RESEARCH v. APOTEX 12 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 minimum 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 olopatadine. That is the claimed concentration range which should be compared to the disclosure of the prior art. The Kamei reference discloses treating eye allergies in guinea pigs using eye drops with olopatadine concentrations ranging from 0.0001% w/v to 0.01% w/v. J.A. 10160-63. This range overlaps with the concentrations covered by claims 1-3 and 5-7. Claims 4 and 8 are directed only to a 0.1% olopatadine formulation, and Kamei does not disclose a concentration of olopatadine greater than 0.01%. Kamei expressly discloses eye drops with olopatadine concentrations covered by claims 1-3 and 5-7 and thus overlaps with the ranges disclosed in the ’805 patent. 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 allergic 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 13 ALCON RESEARCH v. APOTEX 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 Textilfarben 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 formulation for human use is that it is an effective antihistamine in guinea pigs and that animals models are (as the district court expressly found) predictive of antihistaminic efficacy in humans. The district court’s fact finding that the prior art did not teach that olopatadine would stabilize human conjunctival mast cells, and indeed taught away from using olopatadine for this purpose, is not clearly erroneous. It is, however, not the only motivation to arrive at the claimed invention. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy. Given that the patent defines, and expressly claims, olopatadine concentrations that are “therapeutically effective” to stabilize conjunctival mast cells, Kamei’s disclosure of overlapping concentrations, even if for a different purpose, meets these claim limitations. ALCON RESEARCH v. APOTEX 14 Although Alcon argues that Kamei would not give a skilled artisan an expectation of success because it does not teach that olopatadine is safe for the human eye, we find this contention to be without merit. Id. While it is true that Kamei does not expressly disclose that olopatadine would be safe for use in human eyes, neither does the ’805 patent. The patent is not based on testing in humans; instead it reports only in vitro tests of olopatadine in human conjunctival mast cells. ’805 patent col.3 l.43 - col.4 l.24. We conclude that, just as a skilled artisan would be able to practice the invention claimed in the ’805 patent despite its lack of explicit instruction that olopatadine is safe for human ophthalmic use, the artisan would have a reasonable expectation of success for adapting Kamei’s formulation for the same use in a human eye. The parties dispute whether stabilizing conjunctival mast cells is an inherent property of olopatadine and whether inherency may be used in an obviousness analysis. 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 applicant’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 necessarily present at those concentrations. Kamei expressly discloses using olopatadine eye drops to treat eye allergies at concentrations that overlap with those in claims 1-3 and 5-7 of the ’805 patent and thus 15 ALCON RESEARCH v. APOTEX meets the “stabilizing conjunctival mast cells” limitation. Moreover, Kamei would give a person of ordinary skill in the art an expectation of success for using olopatadine to treat human eye allergies. We therefore conclude that the district court erred in its determination that there was no prima facie case of obviousness based on Kamei. On appeal, Alcon argues that objective considerations support the district court’s conclusion of nonobviousness. We weigh these objective considerations along with the other parts of the obviousness analysis to determine de novo whether the claims would have been obvious to one of skill in the art. We see no clear error in the district court’s fact findings, but conclude after balancing the objective evidence against the strong evidence of obviousness discussed above, that Apotex has established by clear and convincing evidence that claims 1-3 and 5-7 would have been obvious to one of ordinary skill in the art over Kamei, which discloses every limitation of these claims except that the formulation can be used to treat eye allergies in humans. We have considered all of Alcon’s arguments regarding these claims and find them to be without merit.