Pfizer Inc. et al v. Apotex Inc. et al

Filing 58

MEMORANDUM ORDER: Memorializing decisions made at the Markman Hearing. Signed by Judge Richard G. Andrews on 6/28/2019. (nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

PFIZER INC., PF PRISM C.V., PFIZER PFE
IRELAND PHARMACEUTICALS
HOLDING 1 B.V., and PFIZER
MANUFACTURING HOLDINGS LLC,
Plaintiffs,

Civil Action No. 1: 18-cv-00795-RGA

V.

APOTEX, INC. and APOTEX CORP.,
Defendants.

MEMORANDUM ORDER

This memorandum order reflects and memorializes the decisions I made during the
Markman hearing in this case. I have considered the Parties' Joint Claim Construction Brief.
(D.I. 51). I heard oral argument, and resolved the Parties' disputes, on June 24, 2019.
The Parties sought construction of three terms in U.S. Patent No. 8,791,140 ("'140
Patent"). Specifically, the Parties disputed terms that appear in exemplary claims 1 and 5:
l. A crystalline form of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2yl)ethenyl]indazole, wherein said crystalline form has a powder X-ray diffraction
pattern comprising a peak at diffraction angle (20) of 6.0±0.1 and further
comprising at least one peak at diffraction angle (20) selected from 11.5±0.1,
21.0±0.1 and 26.9±0.1.
5. A crystalline form of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2yl)ethenyl]indazole, wherein said crystalline form has a solid state NMR spectrum
comprising 13 C chemical shifts at 150.1±0.2, 136.6±0.2, 135±0.2, 116.9±0.2 and
27.5±0.2 ppm.
(' 140 Patent, claims 1,5 (disputed terms italicized)).

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On the "crystalline form" term, I ruled that the Applicant disclaimed forms of 6-[2(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyl]indazole ("axitinib") other than
Form XLI. When faced with a restriction requirement, the applicant chose to pursue Form XLI.
(D.I. 35, Exh. 4 at 4). Later, when the examiner required the applicant to claim Form XLI more
specifically, the applicant selected the claimed peaks and chemical shifts as the identifying
characteristics of the Form. (D.1. 35; Exh. 6 at 8; see also D.I. 35, Ex. 5 at 10 (examiner's
rejection and suggestion that the applicant claim Form XLI with reference to the compound's
chemical nature)). That is, the applicant represented to the examiner, and the public, that an
axitinib crystal that produces the claimed peaks is Form XLI.
The Parties agreed at oral argument that Form XLI is the claimed invention. They didn't
even seriously dispute that only Form XLI, and not some other Form of axitinib, produces the
claimed peaks and chemical shifts. Thus, it is reasonable to say that Form XLI is defined by the
claimed peaks. In order to prove infringement, Plaintiffs need only prove that the accused
substance produces the claimed peaks or chemical shifts. Plaintiffs are not, however, required to
separately prove, presumably by some other technique, that the substance is Form XLI. Thus, I
ruled that "crystalline form" has its plain and ordinary meaning.
On the "peak" and " 13 C chemical shift" terms, I ruled that, on the record presented.to me,
Defendants have not proven indefiniteness by clear and convincing evidence. Accordingly, I
construed "peak" and " 13 C chemical shift" as having their plain and ordinary meanings.
Although Defendants argued that the plain and ordinary meaning does not clarify the terms in the
context of the patent, they did not disagree that the terms, outside the patent, generally have the
plain meanings proposed by Plaintiffs. (D.I. 51 at 47, 68). Thus, I found that the plain and
ordinary meaning of "peak" is "a signal that is discernible from the noise" and the plain and
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ordinary meaning of " 13 C chemical shift" is "signal in the solid-state NMR spectrum that is
discernible from the noise."

IT IS SO ORDERED this

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of June 2019.

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