Opinion ID: 2620291
Heading Depth: 2
Heading Rank: 2

Heading: ’834 Patent Claim Construction

Text: The district court construed “micronized powder composition” to mean “heat sterilized finely divided dry particles.” After reviewing the patent’s specification and prosecution history, expert testimony, and inventor testimony, the district court further explained that “heat sterilized” refers to “particles that have been sterilized through a process, consistent with heat sterilization, that allows them to essentially maintain the same pharmaco- 8 ASTRAZENECA LP v. BREATH LIMITED logical activity, physico-chemical properties, chemical purity, and physical form as the starting material.” Opinion at –36. AstraZeneca argues that the district court erred by importing limitations into the claims because the plain meaning of “micronized powder composition” has nothing to do with heat sterilization. For further support, AstraZeneca points to the claim’s other language as well as language in the patent’s other claims. The Appellees’ disagree, contending that the district court’s construction is correct and that the plain language and claim differentiation cannot control because the ’834 Patent so limited the invention throughout the specification and prosecution history. The words of a claim are generally given their or- dinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history. There are only two exceptions to this general rule: 1) when a patentee sets out a defini- tion and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution. Thorner, 669 F.3d at 1365 (citation omitted). “The standard for disavowal of claim scope is . . . exacting.” Id. at 1366. “The patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” Id. at 1366 (internal quotation marks omitted). “To constitute disclaimer, there must be a clear and unmistakable disclaimer.” Id. at 1366–67. “Mere criticism of a particular embodiment encompassed in the plain meaning of a claim term is not sufficient to ASTRAZENECA LP v. BREATH LIMITED 9 rise to the level of clear disavowal.” Id. at 1366. “It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation.” Id. With respect to the ordinary, plain meaning of the term “micronized powder composition,” none of the three words imposes, or even implies, any form of sterilization. Indeed, Appellees do not argue to the contrary, arguing instead that the court must look to other evidence to understand that the term is limited to dry heat sterilization. Def.-Appellees’ Br. at 36; Apotex Br. at 42. Appellees also argue that AstraZeneca waived argument based on the term’s plain meaning because it was not argued to the district court, id., but the issue of whether the term “imputes” a sterilization process into the claim clearly was raised to the district court. See Opinion at  (“the Court notes that the parties have disputed whether the term ‘heat sterilized’ imputes a process limitation into the claims.”). Appellees argue that the term’s otherwise plain meaning is limited to heat sterilization because of the patent specification’s disavowal of any other type of sterilized micronized powder compositions. Appellees point to statements within the patent that refer to “the invention” as associated with the particular form of dry heat sterilization described in the patent. They also note that the only acceptable form of sterilization described in the ’834 Patent is heat sterilization. Lastly, they note that the patent disparages several forms of prior art sterilization. The flaw in this argument, however, is that the ’834 Patent’s specification discloses three separate concepts: a process (“a process for sterilization of a powerdered [sic] form of a glucocortico-steriod”), products (“sterile glucocorticosteroids” and “sterile formulations containing glucocorticosteroids”), and methods of use (“use [of the products] thereof in the treatment of an allergic and/or 10 ASTRAZENECA LP v. BREATH LIMITED inflammatory condition on the nose or lungs”). ’834 Patent col. 1 ll. 17–21. There is no dispute that the patent refers only to dry heat sterilization as the preferred method of achieving the claimed “micronized powder composition” and criticizes, often sharply, other forms of sterilization. Nonetheless, “[m]ere criticism of a particular embodiment encompassed in the plain meaning of a claim term is not sufficient to rise to the level of clear disavowal.” Thorner, 669 F.3d at 1366. “It is likewise not enough that the only embodiments, or all of the embodiments, contain a particular limitation.” Id. Moreover, statements with respect to “the invention” are ambiguous at best, given the three distinct types of inventions (processes, products, and methods of use) described in the specification. “To constitute disclaimer, there must be a clear and unmistakable disclaimer.” Id. at 1366–67. At most, the specification is confusing with respect to whether it limits only the disclosed process to a specific form of sterilization or both the process and the disclosed product to a specific form of sterilization. However, that confusion leaves available an interpretation of the patent that the products, as opposed to the processes, are not limited to any particular form of sterilization. Accordingly, we cannot conclude that AstraZeneca disclaimed non-heat sterilized micronized powder compositions based on the specification. Appellees’ argument with respect to the prosecution history similarly is flawed. Critically, much of the prosecution history relied on by Appellees concerns two different categories of claims: product claims (then-pending claims 65–83) and product-by-process claims (thenpending claims 84–157). For example, claim 65 recites a “sterile” powder, while claim 84 recites a “sterilized” powder. AstraZeneca explained that a powder can be “sterile” without ever having been “sterilized,” but that a “sterilized” powder must have undergone a sterilization ASTRAZENECA LP v. BREATH LIMITED 11 process. AstraZeneca further explained that claims directed to “sterilized” powders were product-by-process claims, rather than product claims. The asserted claims at issue here do not recite a “sterilized” powder. Rather, the claims recite a “micronized powder composition” that “meets the criteria of sterility” according to the US Pharmacopeia. See, e.g., ’834 Patent at Claim 1. Rather than invoking the “sterilized” product-by-process limitations, the asserted claims refer merely to a powder that is sterile, irrespective of how that sterility was achieved. Nothing in the prosecution history expresses an unmistakable disavowal of that scope. “Courts must generally take care to avoid reading process limitations into an apparatus claim . . . because the process by which a product is made is irrelevant to the question of whether that product infringes a pure apparatus claim . . . .” Baldwin Graphic Systems, Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008) (internal quotations omitted). In general, “[t]he method of manufacture, even when cited as advantageous, does not of itself convert product claims into claims limited to a particular process. . . . A novel product that meets the criteria of patentability is not limited to the process by which it was made.” Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000). AstraZeneca, during prosecution, was careful to specify which claims were product-by-process claims, implicating the method by which the product is made, and which claims were not so limited. The prosecution history is replete with examples of AstraZeneca noting that prior art sterilization methods resulted in compounds with a different structure than that claimed in the then-pending product-by-process claims 84–157, but these arguments never were made with respect to then-pending claims 65–83. It is true that a patent applicant may disclaim products created by other 12 ASTRAZENECA LP v. BREATH LIMITED processes during the prosecution history when the patent applicant overcomes a rejection against product and process claims by indicating that the process is necessary to produce the claimed product and the patent applicant does not limit the disclaimers to the process claims. See Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384–85 (Fed. Cir. 2005). Here, however, we cannot conclude that this is the case where arguments were directed specifically only to the then-pending product-by-process claims 84–157. With respect to then-pending claims 65–83, AstraZeneca’s arguments were limited to statements that it would not have been obvious to achieve the claimed powder (at the time of the invention) because of certain flaws in the prior art sterilization techniques. This is conceptually distinct from disavowing sterile powders that could be produced by the prior art techniques. Appellees further direct the court to aspects of the prosecution history discussing then-pending claims 3, 8, 10, 11, and 39, which specifically recite elements for sterilization by heat treatment or require that a dry powder be sterilized. Neither concept is present in the asserted claims, which in contrast do not specifically recite heat treatment and, though sterile, could either 1) never have been sterilized (if synthesized as sterile in the first instance, for example) or 2) have been sterilized and then dried. With these distinctions between the thenpending claims and the asserted claims, we cannot conclude that comments directed to the then-pending claims disavow scope regarding the asserted claims. Concluding that the claim term’s plain meaning does not impart sterilization to the composition and that nothing contained in the specification or the prosecution history limit the term to a specific type of sterilization or disavow other types of sterilization, we need not reach ASTRAZENECA LP v. BREATH LIMITED 13 AstraZeneca’s arguments concerning claim differentiation and the other language in the claims. For the foregoing reasons, we hold that the district court erred by adding the “heat sterilized” limitation into the claims at issue. The term “micronized powder composition” is construed more accurately as “finely divided dry particles.” Remand is necessary for all Appellees under the new claim construction. Though Sandoz and Apotex contend that remand is unnecessary under a new construction, the court disagrees. While AtraZeneca does not appear to dispute that the “micronized powder composition” must be “dry,” remand still is necessary because asserted claim 50 does not claim, as Apotex contends, a sterile powder, but rather claims a sterile suspension consisting of that powder composition and an aqueous solution.