throbber
Filed on behalf of: Mallinckrodt Hosp. Prods. IP Ltd.
`
`
`
`
`
`
`Entered: February 10, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`_______________________
`
`Case IPR2015-00529
`U.S. Patent No. 8,846,112 B2
`_______________________
`
`Before LORA M. GREEN, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`PATENT OWNER’S SUR-REPLY TO PRAXAIR DISTRIBUTION, INC.’S
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,846,112
`
`
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`The Construction of “Pharmaceutically Acceptable Nitric Oxide
`Gas” Is Undisputed .......................................................................................... 1
`
`III. The “Providing . . . Information” Elements Of Claims 1-11 Are
`Entitled To Patentable Weight ......................................................................... 2
`
`A.
`
`B.
`
`AstraZeneca Is Inapposite ..................................................................... 3
`
`King Is Also Inapposite ......................................................................... 5
`
`IV. Claims 1-11 Of The ’112 Patent Are Not Directed To An
`Inherent Property Of Nitric Oxide ................................................................... 9
`
`V.
`
`The Objective Indicia Of Non-Obviousness Are Compelling ...................... 10
`
`VI. Conclusion ..................................................................................................... 10
`
`i
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`I.
`INTRODUCTION1
`Petitioner’s arguments assume that claims 1-11 of the ’112 Patent are
`
`directed only to the provision of prior art nitric oxide gas. They are not; the
`
`claimed methods require providing pharmaceutically acceptable nitric oxide gas,
`
`along with critical information to effectuate new methods of using the drug—a
`
`safer treatment that helps avoid serious adverse events in at-risk patient
`
`populations. As set forth in the specification, these new methods would not exist
`
`without the claimed information. The providing information claim element is
`
`entitled to patentable weight because it is inextricably intertwined with the
`
`implementation—and function—of the claimed methods. The Board should affirm
`
`the claims’ validity.
`
`II. THE CONSTRUCTION OF “PHARMACEUTICALLY
`ACCEPTABLE NITRIC OXIDE GAS” IS UNDISPUTED
`
`Petitioner neither disputes Patent Owner’s construction of “pharmaceutically
`
`acceptable nitric oxide gas” nor proposes an alternative. The only expert testimony
`
`comes from Patent Owner’s expert. (See Ex. 2020 at 30-31; Ex. 1057 at 64:4-21.)
`
`The Board should adopt Patent Owner’s uncontested construction: “suitably safe
`
`
`1 Patent Owner sought, and was granted, leave to file a 10 page sur-reply to
`
`respond to arguments first raised in Petitioner’s Reply.
`
`
`
`1
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`for pharmaceutical use.” (See Resp. at 21-23.)2,3
`
`III. THE “PROVIDING . . . INFORMATION” ELEMENTS OF CLAIMS
`1-11 ARE ENTITLED TO PATENTABLE WEIGHT
`
`Petitioner contends that the “providing . . . information” elements cannot be
`
`functionally related to the claimed methods for two reasons: (1) per AstraZeneca
`
`LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010), “instructions for use do not
`
`create a new or unobvious drug or change the drug’s ability to treat [a disease]”;
`
`and (2) per King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267 (Fed. Cir. 2010),
`
`“[i]nformation regarding how to administer [a pharmaceutically acceptable drug]
`
`does not change the method of obtaining and supplying that [drug].” (Reply at 8,
`
`
`2 Petitioner’s suggestion that the “preamble is not limiting,” (Reply at 6 n.3), is
`
`wrong; Patent Owner relied on the preamble to overcome prior art and it is
`
`therefore limiting as a matter of law. (See Resp. at 19-20.)
`
`3 Petitioner’s suggestion that this construction may be impermissible because it
`
`could “var[y] over time” (Reply at 6-7 n.4) is incorrect. See Mass. Inst. of Tech. &
`
`Elecs. for Imaging, Inc. v. Abacus Software, 462 F.3d 1344, 1353 (Fed. Cir. 2006)
`
`(meaning of claim terms set at time of filing). Such terms are common. See, e.g.,
`
`Apotex Inc. v. Alcon Pharm., Ltd., No. IPR2013-00012, 2013 WL 5970130, at *4
`
`(P.T.A.B. Mar. 19, 2013) (defining “pharmaceutically acceptable vehicle” to
`
`include composition that can be “safely” used).
`
`
`
`2
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`10.)4 Neither point has merit.
`
`A. AstraZeneca Is Inapposite
`Petitioner’s reliance on AstraZeneca is misplaced. There, the Federal
`
`Circuit found instructions contained in an FDA-required label to be functionally
`
`unrelated to a claimed drug product, 633 F.3d at 1048, 1063, reasoning that “[t]he
`
`instructions in no way function with the drug to create a new, unobvious product,”
`
`because “[r]emoving the instructions from the claimed kit does not change the
`
`ability of the drug to treat respiratory diseases.” Id. at 1065. Petitioner’s argument
`
`parrots this language, but ignores the claims at issue here: “Patent Owner’s revised
`
`instructions for use do not create a new or unobvious drug or change the drug’s
`
`ability to treat hypoxic respiratory failure.” (Reply at 8.)5
`
`4 All emphases are added unless indicated otherwise.
`
`5 AstraZeneca did not hold printed instruction for a drug to be per se unpatentable;
`
`it merely found that the required functional relationship was absent. All limitations
`
`of a claim, including printed matter, must be considered—“the board cannot
`
`dissect a claim, excise the printed matter from it, and declare the remaining portion
`
`of the mutilated claim to be unpatentable.” In re Gulack, 703 F.2d 1381, 1385 &
`
`n.8 (Fed. Cir. 1983) (explaining that its predecessor court grew “notably weary of
`
`reiterating th[e] point . . . that printed matter may well constitute structural
`
`limitations upon which patentability can be predicated.”).
`
`
`
`3
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`The challenged claims, however, are not product claims as in AstraZeneca.
`
`They claim new, non-obvious methods for providing a drug product to be used in a
`
`safer manner. That is not a distinction without difference. While information does
`
`not transform a drug product into a new product, it can transform a method into a
`
`new, unobvious method.
`
`Petitioner also relies on AstraZeneca’s statement that “FDA regulations
`
`require a label containing information needed for the safe and effective use of any
`
`drug,” which “is a requirement for FDA approval, not patentability.” 633 F.3d at
`
`1065. But the claims in AstraZeneca did not contain a claim element—like the
`
`“pharmaceutically acceptable” term in the claims at issue—that functionally links
`
`the required safety of the drug to the claimed invention. (See Resp. at 31-33
`
`(discussing relevant expert testimony).)6
`
` Put simply, the information in
`
`
`6 Contrary to Petitioner’s contentions (Reply at 13-14), expert testimony is relevant
`
`to this determination. See, e.g., In re Distefano, 808 F.3d 845, 848 (Fed. Cir. 2015)
`
`(printed matter analysis includes “factual findings” reviewed for “substantial
`
`evidence”). Dr. Rosenthal answered the relevant factual question here. (See Ex.
`
`1057 at 60:1-61:3 (“I understand that pharmaceutically acceptable nitric oxide gas
`
`requires the provision of information that’s described in the ’112 patent.”); see also
`
`Resp. at 31-33.)
`
`
`
`4
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`AstraZeneca was, at best, functionally tied to FDA approval, but here it is
`
`inextricably and functionally intertwined with the recited “pharmaceutically
`
`acceptable” claim limitation (in addition to otherwise directly effectuating a new
`
`method of using nitric oxide as described above).7 (See Resp. at 23-27.)
`
`B. King Is Also Inapposite
`Petitioner’s reliance on King is similarly misplaced. Petitioner relies on
`
`King to argue a lack of functional relationship because providing “[i]nformation
`
`regarding how to administer [pharmaceutically acceptable nitric oxide] does not
`
`change the method of obtaining and supplying that gas.” (Reply at 10.) That
`
`suggestion is without merit. The drug at issue in King was normally consumed
`
`with food. 616 F.3d at 1277-79. The Federal Circuit reasoned that claim language
`
`informing patients of the additional benefits of doing so was not functionally
`
`related to the methods, and could not impart patentability. Id. The Court
`
`explained that “[i]rrespective of whether the patient is informed about the benefits,
`
`the actual method, taking [the drug] with food, is the same.” 616 F.3d at 1279.
`
`7 This language is absent from claims 12-22, for which Patent Owner has not
`
`asserted the “providing . . . information” elements to be functionally related to the
`
`methods. That difference should not be ignored. See Schumer v. Lab. Comput.
`
`Sys., Inc., 308 F.3d 1304, 1316 (Fed. Cir. 2002) (“When determining the validity
`
`of the claims of a patent, each claim must be separately considered.”).
`
`
`
`5
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`That is not the case here. Unlike in King, the information the claims require
`
`transforms the ordinary methods: the information is “sufficient” to cause
`
`physicians to alter the methods of using nitric oxide to avoid potentially life-
`
`threatening adverse events. (See Ex. 1001 at cls. 1-11.) The written description
`
`discusses the required functional effect of altering nitric oxide treatment methods
`
`to exclude at-risk patients and provides an example of how such information
`
`empirically transformed treatment. (See, e.g., id. at 12:48-58.) The prosecution
`
`history further confirms that a number of adverse events occurred without the
`
`information and that the frequency of such events dropped significantly after the
`
`information changed the exclusion criteria. (See, e.g., Ex. 1056 at 667.)
`
`Claim 1 expressly requires that the information provided be “sufficient to
`
`cause a medical provider considering inhaled nitric oxide treatment [for certain
`
`contraindicated patients] . . . to elect to avoid treating one or more of [those]
`
`patients” to avoid the risk of a serious side effect. (Ex. 1001 at cl. 1.) The claims
`
`ensure a changed method—the information must be of the sort that is “sufficient”
`
`to cause physicians to not treat at-risk patients (or, at a minimum, alter the
`
`treatment plan to carefully weigh the risks of doing so, see, e.g., cls. 3-4). Several
`
`dependent claims expressly require administration of nitric oxide altered by the
`
`provided information: (i) Claim 3 requires receiving information and one patient
`
`(not-at-risk) receiving nitric oxide treatment while another at-risk patient may not;
`
`
`
`6
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`(ii) Claim 4 requires that at least one patient who has LVD is nevertheless
`
`administered pharmaceutically acceptable nitric oxide gas; and (iii) Claim 9
`
`requires discontinuing nitric oxide
`
`treatment “in accordance with
`
`the
`
`recommendation” provided. (Id. at cls. 3, 4, 9.)
`
`Petitioner has no substantive response. Its invocation of King relies on
`
`mischaracterizing the claims as being limited to simply supplying nitric oxide—
`
`which ignores the novel functional (and essential) effect of the provided
`
`information on the administration of nitric oxide. (See Reply at 10.) Petitioner
`
`never addresses the “sufficient to cause” requirement in claim 1. (Id.) For claims
`
`3 and 4, Petitioner admits there are administration steps, but oddly states that they
`
`are irrelevant because “[a] doctor may choose to treat or not treat a patient based
`
`on her own skill and experience” (whether or not a doctor—or anyone for that
`
`matter—chooses to practice a claimed method is entirely irrelevant to invalidity).
`
`(Reply at 10 n.5.) And Petitioner fails to address claim 9 at all, waiving any right
`
`to dispute the patentability of that claim.
`
` At bottom, Petitioner ignores the critical fact that the “providing . . .
`
`information” limitation is functionally intertwined with the claimed methods and
`
`transforms the ordinary, prior art methods of supplying and using nitric oxide into
`
`new, unobvious ones that better ensures patient safety. Because of that functional
`
`relationship, the limitation should be afforded patentable weight under King.
`
`
`
`7
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`That conclusion is confirmed by In re Huai-Hung Kao, 639 F.3d 1057,
`
`1072-73 (Fed. Cir. 2011). The claimed method there required (i) administering a
`
`painkiller and (ii) “providing information” about a correlation between renal
`
`impairment and bioavailability of that painkiller. Id. at 1064. The Court held that
`
`the “providing information” step was due no patentable weight because it had no
`
`functional relationship to administering the painkiller. Id. at 1073. “Just as in
`
`King,” the informing step did not “‘transform[ ] the process of taking the drug.’”
`
`Id. at 1072-73 (quoting King, 616 F.3d at 1279). The converse is true here. As
`
`discussed, the “providing . . . information” steps in the subject claims transform the
`
`process of administering nitric oxide. (See, e.g., Ex. 1001 at cls. 1, 3, 4, 9.) The
`
`specification confirms that the information is of the sort that empirically resulted in
`
`such a change. (Ex. 1001 at 12:48-58.) Thus, the “providing . . . information”
`
`limitations are therefore functionally related to the underlying method and deserve
`
`patentable weight.
`
`Indeed, the functional importance of the provided information to the claimed
`
`invention here is no different from the inseparable nature of the printed digits to
`
`the endless band in Gulack, 703 F.2d at 1383-87, or the essential nature of the
`
`deliberately false volumetric measurements to the measuring devices in In re
`
`Miller, 418 F.2d 1392, 1396 (C.C.P.A. 1969). Eliminating the printed digits in
`
`Gulack or the volumetric indicia in Miller would have fundamentally altered the
`
`
`
`8
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`function of the inventions in those cases. The same is true here—withholding the
`
`provided information would eliminate the novel safer method of using nitric oxide
`
`otherwise effectuated by that information.
`
`IV. CLAIMS 1-11 OF THE ’112 PATENT ARE NOT DIRECTED TO AN
`INHERENT PROPERTY OF NITRIC OXIDE
`
`Petitioner suggests that the challenged claims are invalid because they
`
`merely “acknowledge[] an inherent property of nitric oxide.” (Reply at 11-12.)
`
`The Board’s refusal to institute IPRs on the four related patents, which recognized
`
`the novelty of the disclosed inventions, precludes this argument. See Nos.
`
`IPR2015-00522, -00524, -00525, -00526 Paper 12. And none of Petitioner’s cases
`
`involve method claims directed to the provision of information or administration
`
`based on information that was previously unknown, and are thus inapposite.
`
`Indeed, Petitioner only asserts that “recognizing previously unknown qualities of a
`
`product is not inventive.” (Reply at 12.) But new methods can be patented. See,
`
`e.g., In re Ngai, 367 F.3d 1336, 1338-39 (Fed. Cir. 2004); Prometheus Labs., Inc.
`
`v. Roxane Labs., Inc., 805 F.3d 1092, 1098 (Fed. Cir. 2015) (“[A] particular
`
`treatment may be effective with respect to one subset of patients and ineffective
`
`(and even harmful) to another subset of patients. Singling out a particular subset of
`
`patients for treatment . . . may reflect a new and useful invention that is patent
`
`eligible despite the existence of prior art or a prior art patent disclosing the
`
`
`
`9
`
`

`
`Case IPR2015-00529
`U.S. Patent No. 8,849,112
`
`treatment method to patients generally.”) (internal citation omitted).
`
`V. THE OBJECTIVE INDICIA OF NON-OBVIOUSNESS ARE
`COMPELLING
`
`Petitioner asserts that the INOT22 study—which the PTAB found to be
`
`“compelling” with respect to the related patents—should be disregarded.
`
`Petitioner supports this conclusion with only attorney argument that “[t]he
`
`INOT22 study does not even relate to the challenged claims.” (Reply at 21.) The
`
`record proves otherwise; Dr. Rosenthal having provided unrebutted testimony that
`
`based on the results of the INOT22 study, the prescribing information for
`
`INOmax® (which is approved for the treatment of neonates) was amended to
`
`include the requisite warnings regarding patients with LVD. (Ex. 2020 ¶ 65; see
`
`also Ex. 1001 at 9:51-56.)8 Dr. Rosenthal thus established the nexus between the
`
`INOT22 study and neonatal patients, such as those in claims 1-11.
`
`VI. CONCLUSION
`For the reasons set forth above, Patent Owner respectfully submits that the
`
`Board should confirm the validity of the subject claims.
`
`Dated: February 10, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Robert Steinberg/ (Reg. No. 33,144)
`
`
`8 Dr. Rosenthal disagreed that information from a certain patient population is per
`
`se irrelevant to another patient population. (Ex. 1057 at 136:23-140:21.)
`
`
`
`10
`
`

`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 10th day of
`
`February, 2016, true and correct copies of the foregoing PATENT OWNER’S
`
`SUR-REPLY TO PRAXAIR DISTRIBUTION, INC.’S PETITION FOR
`
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,846,112 were served by
`
`electronic mail on Petitioner’s lead and backup counsel at the following email
`
`addresses:
`
`sanjay.murthy@klgates.com
`
`benjamin.weed@klgates.com
`
`sara.kerrane@klgates.com
`
`michael.abernathy@klgates.com
`
`margaux.nair@klgates.com
`
`maria.doukas@klgates.com
`
`Praxair-Ikaria@klgates.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By: /Robert Steinberg/
`
`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket