Categories: Claim Construction Date: Jun 15, 2014 Title: Takeda v. Zydus: No Margin of Error for a Precisely Claimed Size and Theoretical Arguments Insufficient to Invalidate Claim
|Title||Takeda Pharma. Co. v. Zydus Pharma USA, Inc., No. 2013-1406 (Fed. Cir. Feb. 20, 2014).|
| Claim construction and Infringement||[Whether the district court erred in finding that claim 1 was infringed because it] construed the claim term “fine granules having an average particle diameter of 400 μm or less” . . . to mean “fine granules up to and including the enteric coating layer having an average particle diameter of 400 μm (±10%) or less.”|
Takeda at *3 (emphasis added) (text added).
| Indefiniteness||[Whether] the '995 patent is indefinite because it does not specify the method of measurement that should be used to determine average particle diameter.|
Id. at *10-11 (text added).
| Written Description||[Whether claim 1 is invalid for lack of written description because it] addresses average particle size in the finished tablet, while the specification only teaches how to measure particle size pre-tableting with no discussion of how to ensure particle size is not altered by that process.|
Id. at *14 (text added).
| Enablement||[Whether] the patent is invalid for lack of enablement because a skilled artisan would not be able to determine the average particle diameter using the coulter counter method of measurement without undue experimentation.|
Id. at *17 (text added).
 Claim construction and Infringement
|[T]he district court erred in reading a margin of error into the disputed claim term . . . when the phrase "400 μm or less" is not qualified by the word "about" or any other indicator of imprecision.|
Takeda at *6.
|[Without the added breadth of the margin of error,] there can be no dispute that Zydus’s ANDA product does not literally infringe claim 1 of the ’994 patent.|
Id. at *9-10 (text added).
| Indefiniteness||That there is more than one way of determining the average particle diameter of a particular sample does not render that clear claim language indefinite.|
Id. at *13.
| Written Description||[A] hypothetical possibility that tableting could affect particle size in a relevant way [does not warrant finding] that the district court committed clear error by finding that such evidence was not clear and convincing proof of invalidity.|
Id. at *15 (text added).
| Enablement||[B]ecause the patent identifies laser diffraction as a viable measurement technique, and there is no dispute that a skilled artisan would know how to use laser diffraction to measure particle diameter, Zydus has not established that the patent is invalid for lack of enablement on this basis.|
Id. at *16.
|Procedural History||Zydus Pharmaceuticals USA, Inc. [et al.] (“appellants” or “Zydus”) appeal from a final judgment of the U.S. District Court for the District of New Jersey finding that appellants had infringed claim 1 of U.S. Patent No. 6,328,994 (“’994 patent”) [owned by Takeda] and had failed to establish that it was invalid.|
Takeda at *2 (text added).
|Legal Reasoning (Prost, Plager, Chen)|
|Prevacid® SoluTab™||Takeda Pharmaceutical Company Limited [et al.] (“appellees” or “Takeda”) own patents that claim the formulation for the brand-name drug Prevacid® SoluTab™ . . . a proton pump inhibitor used to treat . . . acid reflux . . . as an orally disintegrable tablet. A patient taking Prevacid® SoluTab™ simply allows the tablet to disintegrate in his or her mouth, leaving behind thousands of granules which the patient then swallows.|
Takeda at *2.
|Claim 1 of the ’994 patent||An orally disintegrable tablet which comprises (i) fine granules having an average particle diameter of 400 μm or less, which fine granules comprise a composition coated by an enteric coating layer comprising a first component which is an enteric coating agent and a second component which is a sustained-release agent, said composition having 10 weight % or more of an acid-labile physiologically active substrate that is lansoprazole and (ii) an additive wherein said tablet having a hardness strength of about 1 to about 20 kg, is orally disintegrable.|
Id. at *3 (emphasis added).
|Dispute||In 2010, Zydus filed an abbreviated new drug application (“ANDA”) with the Food and Drug Administration, seeking to manufacture a generic version of Prevacid® SoluTab™. Takeda then filed suit, alleging that Zydus’s ANDA product infringed multiple claims of several patents. Only claim 1 of the [U.S. Patent No. 6,328,994 (“’994 patent”)] remains at issue. Zydus counterclaimed, alleging that claim 1 was invalid for failure to comply with the requirements of 35 U.S.C. § 112.|
Id. at *2-3 (text added).
| Claim construction and Infringement|
|Legal Standard||Our starting point in construing a claim term must be the words of the claim itself[; h]owever, it is axiomatic that the claims “must be read in view of the specification, of which they are a part.” |
Takeda at *5 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d 517 U.S. 370 (1996)) (text added).
|No Indication of Imprecision in Claim||Beginning with the claim language itself—as we must—there is no indication in the claim that 400 μm was intended to mean anything other than exactly 400 μm. To the contrary, the phrase “400 μm or less” is not qualified by the word “about” or any other indicator of imprecision.|
Id. at *6.
|Specification Supports No Margin of Error||[T]he specification contrasts the “fine granules” of the claimed invention with larger “conventional” granules, which it defines as “400 μm or more of average particle diameter” [and] explains that conventional granules of that size “produce a feeling of roughness in the mouth”—one of the very problems the claimed invention purports to solve. Id. col. 2 ll. 16-17. That clear dividing line between the “fine” granules of 400 μm or less (which avoid a feeling of roughness in the mouth) and “conventional” granules of 400 μm or more (which do not) disappears if the “fine granules” are construed as incorporating a 10% deviation. . . . Nowhere does the specification suggest that an average particle size greater than 400 μm (even within 10% of that figure) could achieve the inventive result of avoiding a feeling of roughness in the mouth.|
Id. at *6-8.
|Prosecution History Supports No Margin of Error||[T]he inventors distinguished the claimed invention over a potentially invalidating prior art reference because the reference failed to disclose an average particle diameter of 400 μm or less. J.A. 7228. The inventors explained that “[b]y having the average particle diameter of the granules within 400 μm, the feeling of roughness in a mouth can be prevented.” . . . [T]he inventors have consistently relied on 400 μm as the dividing line between granules that would avoid roughness in the mouth and those that would not—meaning those that were within the scope of the invention, and those that were not.|
Id. at *8-9.
|Claim Construction Reversal Warrants Infringement Reversal||We therefore reverse the district court’s claim construction and conclude that the proper construction of the disputed claim term is “fine granules having an average particle diameter of precisely 400 μm or less.” . . . Even using virtual dissection, however, Takeda measured Zydus’s ANDA product as having an average particle diameter of 412.28 μm—well outside the claimed range as we have now construed it. Appellants’ Br. 31; J.A. 8338. Thus, there can be no dispute that Zydus’s ANDA product does not literally infringe claim 1 of the ’994 patent.|
Id. at *9-10.
|Legal Standard||“Whether a claim is invalid for indefiniteness requires a determination whether those skilled in the art would understand what is claimed when the claim is read in light of the specification.” |
Takeda at *10 (quoting Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)).
|Theoretical Minor Differences Insufficient to Render Indefinite||It is true that there was evidence from both parties’ experts that there are several possible ways to measure average particle diameter. . . . Because the two methods use different means of approximating average particle diameter, they can produce different results even for the same sample. However, we do not believe that the mere possibility of different results from different measurement techniques renders claim 1 indefinite. . . . Moreover, there is no evidence that the differences between these techniques are in fact significant; there was evidence before the trial court that although the results may be different, there is a “high degree of correlation for the results” between the two techniques. . . . That there is more than one way of determining the average particle diameter of a particular sample does not render that clear claim language indefinite.|
Id. at *11-13 (footnotes omitted).
| Written Description|
|Legal Standard||The test for written description is “whether the disclosure of the application . . . reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” |
Takeda at *14 (quoting Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)).
|Theoretical Arguments Do Not Warrant Clear Error||Zydus argues that claim 1 addresses average particle size in the finished tablet, while the specification only teaches how to measure particle size pre-tableting with no discussion of how to ensure particle size is not altered by that process. . . . However, Zydus’s argument depends on there actually being an impact on particle size from the tableting process, and the evidence showed the opposite. . . . [H]ere, the evidence established only a hypothetical possibility that tableting could affect particle size in a relevant way. We simply cannot say that the district court committed clear error by finding that such evidence was not clear and convincing proof of invalidity.|
Id. at *14-15 (footnotes omitted).
|Legal Standard||Under the enablement requirement of 35 U.S.C. § 112, “the specification must enable one of ordinary skill in the art to practice the claimed invention without undue experimentation.” |
Takeda at *16 (quoting Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999)).
|Disclosure of Any Measurement Method Sufficient for Enablement||Zydus argues that the patent is invalid for lack of enablement because a skilled artisan would not be able to determine the average particle diameter using the coulter counter method of measurement without undue experimentation. [But i]t is well established that the “enablement requirement is met if the description enables any mode of making and using the invention.” Thus, because the patent identifies laser diffraction as a viable measurement technique, and there is no dispute that a skilled artisan would know how to use laser diffraction to measure particle diameter, Zydus has not established that the patent is invalid for lack of enablement on this basis.|
Id. at *16 (internal citations omitted).
No Requirement of Deagglo-meration Prior to Measurement
|[W]e note for the record that if the district court had been correct that the patent requires deagglomeration prior to particle size measurement . . . it could not be said that the written description informed a skilled artisan how to make and use the claimed invention. However, . . . we believe that the district court clearly erred in making that finding and will not invalidate the patent on that basis. . . . The only method of measurement discussed in the specification is laser diffraction, which cannot account for hard agglomerates. We cannot conclude that the patent affirmatively requires a step that was entirely absent from (and even precluded by) the procedure described in the specification.|
Id. at *17.
|[W]e reverse the district court’s claim construction ruling and resulting finding of literal infringement, affirm the court’s judgment of no invalidity, and remand for further proceedings consistent with this opinion.|
Takeda at *18.