Trials@uspto.gov
`571-272-7822
`
`Paper No. 52
`Entered: March 5, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS INC., AND APOTEX HOLDINGS, INC.,
`Petitioner,
`
`v.
`
`OSI PHARMACEUTICALS LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01284
`Patent 6,900,221 B1
`____________
`
`
`Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU YANG,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`571-272-7822
`
`Paper No. 52
`Entered: March 5, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC., APOTEX CORP., APOTEX PHARMACEUTICALS
`HOLDINGS INC., AND APOTEX HOLDINGS, INC.,
`Petitioner,
`
`v.
`
`OSI PHARMACEUTICALS LLC,
`Patent Owner.
`____________
`
`Case IPR2016-01284
`Patent 6,900,221 B1
`____________
`
`
`Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU YANG,
`Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`IPR2016-01284
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`INTRODUCTION
`
`OSI Pharmaceuticals LLC (“Patent Owner”) filed a Request for
`Rehearing (Paper 51, “Reh’g Req.”) of the Final Written Decision (Paper 49,
`“FWD”) in which we concluded that Petitioner had shown by a
`preponderance of the evidence that claims 44‒46 and 53 of U.S. Patent No.
`6,900,221 B1 (Ex. 1001, “the ’221 patent”) are unpatentable under 35
`U.S.C. § 103(a) over the combination of Schnur1 and OSI’s 10-K2 or Gibbs.3
`We grant Patent Owner’s Request for Rehearing to the extent we
`reconsider the argument made by counsel at the oral hearing as to the level
`of ordinary skill in the art. For the reasons that follow, however, we deny
`Patent Owner’s request to the extent that we decline to alter our
`determination that Petitioner has demonstrated by a preponderance of the
`evidence that claims 44‒46 and 53 are unpatentable over the combination of
`Schnur and OSI’s 10-K or Gibbs.
` STANDARD OF REVIEW
`When reconsidering a final written decision the Board reviews the
`
`decision to determine whether we misapprehended or overlooked a matter.
`See 37 C.F.R. § 42.71(d). Fed. Cir. 2004); In re Gartside, 203 F.3d 1305,
`1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be
`modified lies with the party challenging the decision.” Office Patent Trial
`
`
`1 Schnur et al., U.S. Patent No. 5,747,498, issued May 5, 1998 (Ex. 1009)
`(“Schnur”).
`2 Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange
`Act of 1934 for the Fiscal Year Ended September 30, 1998, Commission
`File Number 0-15190, OSI Pharmaceuticals, Inc. (Ex. 1011) (“OSI’s 10-K”).
`3 J.B. Gibbs, “Anticancer Drug Targets: Growth Factors and Growth
`Factor Signaling,” 105 J. CLIN. INV. 9‒13 (2000) (Ex. 1010) (“Gibbs”).
`2
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`Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request
`for rehearing, the dissatisfied party must, in relevant part, “specifically
`identify all matters the party believes the Board misapprehended or
`overlooked, and the place where each matter was previously addressed in a
`motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial
`Practice Guide, 77 Fed. Reg. at 48,768. We address Patent Owner’s
`arguments with these principles in mind.
` ANALYSIS
`On rehearing, Patent Owner argues that we improperly relied on the
`expert opinions of Petitioner’s expert, Dr. Giuseppe Giaccone, whose
`testimony, Patent Owner contends, “was not offered from the perspective of
`a person having ordinary skill in the art of the challenged claims of [the ’221
`patent].” Reh’g Req. 1. According to Patent Owner, because Dr. Giaccone
`did not testify as an ordinary artisan, the “expert testimony on which the
`Petition is grounded is irrelevant, [we] should reconsider [our] determination
`that claims 44-46 and 53 of the ’221 patent (Ex. 1001) would have been
`obvious over” the combination of Schnur and OSI’s 10-K or Gibbs. Id.
`Specifically, Patent Owner contends that “Petitioners’ invalidity theory was
`. . . tied to Dr. Giaccone’s heightened level of skill in the art requiring
`specialized training in thoracic oncology.” Id. at 4.
`
`Patent Owner notes that in our Final Written Decision, we declined to
`adopt Petitioner’s definition of the ordinary artisan, averring that we
`“rejected Petitioners’ suggestion that the ordinary artisan ‘would have the
`ability to infer facts from disclosures in the prior art directed to the
`development of drugs to treat lung cancer, and specifically [non-small cell
`lung cancer], and would not require every fact to be explicitly laid out in the
`
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`prior art.’” Id. at 5. Rather, we adopted Patent Owner’s definition that the
`ordinary artisan would be “a medical oncologist who would hold an M.D.
`degree and would have completed several years of practice in the field of
`oncology.” Id. at 5 (citing FWD 8‒9).
`Patent Owner asserts that even though we rejected Petitioner’s
`definition of the ordinary artisan, we “did not consider whether doing so
`impacted how [we] should weigh Dr. Giaccone’s other testimony.” Reh’g
`Req. 5‒6. Specifically, Patent Owner asserts that we erred in stating that
`both counsel had agreed at oral argument that the level of skill of the
`ordinary artisan should not affect the outcome of the proceeding. Id. at 6.
`Patent Owner contends that its counsel disputed that point, stating that
`although Patent Owner’s expert had offered alternative opinions
`“under both definitions”
`(Tr., 37:10
`(Paper 48)),
`the
`determination of the level of skill in the art could be outcome
`dispositive for Petitioners if Dr. Giaccone’s definition of the
`level of skill in the art was not adopted because his opinions were
`offered exclusively from the perspective of someone with more
`than ordinary skill . . . .
`Id. (citing Paper 48 (“Tr.”), 37:12‒18).
`
`Patent Owner contends that our misapprehension of its counsel at oral
`argument affected our obviousness analysis, warranting rehearing. Reh’g
`Req. 7. That is, Patent Owner asserts, because Dr. Giaccone testified “from
`the perspective of someone with more than ordinary skill in the art,”
`Dr. Giaccone more easily concluded that the claims of the ’221 patent were
`rendered obvious over the combination of Schnur and OSI’s 10-K or Gibbs.
`Id. at 9.
`
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`At trial, Petitioner advocated for the following definition of the level
`
`of skill of the ordinary artisan, relying on the testimony of its expert,
`Dr. Giaccone:
`A person of ordinary skill in the art relevant to the
`challenged claims of the ’221 patent would have a medical
`degree and at least some specialized training in oncology, and
`more particularly, specialized training in thoracic oncology. (See
`Ex. 1002 at ¶ 52.) A person of ordinary skill in the art would
`also have several years of clinical experience, and a substantive
`understanding and experience using the medications and
`therapies effective for treating various lung cancers at the
`relevant time. (See 1002 at ¶ 52.) A person of ordinary skill in
`the art may have collaborated with others having expertise in
`pharmaceutical formulation development and pharmaceutical
`drug development. (Ex. 1002 at ¶ 51.)
`Paper 3 (“Pet.”) 13.
`
`Patent Owner, however, relying on its expert, Dr. Bunn, argued that
`that the ordinary artisan “would be a medical oncologist who would hold an
`M.D. degree and would have completed several years of practice in the field
`of oncology.” Paper 20 (“PO Resp.”) 26 (citing Ex. 2021 ¶¶ 22‒23).
`
`In declining to adopt Petitioner’s definition of skill of the ordinary
`artisan, we noted that the claims encompassed cancers other than non-small
`cell lung cancer, and, thus, found that “the ordinary artisan would be a
`medical oncologist who would hold an M.D. degree and would have
`completed several years of practice in the field of oncology.” FWD 9. We
`did not just rely on Dr. Bunn’s testimony as to the level of skill on the
`ordinary artisan, however, but noted that “the level of ordinary skill in the art
`in this proceeding is reflected by the prior art of record.” Id. (citing Okajima
`v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc.,
`57 F.3d 1573, 1579 (Fed. Cir. 1995)).
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`In defining the level of ordinary skill, we also stated:
`[D]uring oral hearing, counsel for both parties opined that the
`outcome of the obviousness analysis would be the same under
`either parties’ definition of the ordinary artisan. Tr. 22:3‒8,
`37:9‒11. Thus, our analysis would be the same under either
`Petitioner’s or Patent Owner’s definition of the ordinary artisan.
`FWD 9.
`
`We acknowledge that during oral hearing, as to the level of ordinary
`skill, counsel for Patent Owner argued:
`In terms of the definition of a person of skill, since we
`touched on that, our expert used the same definition that had been
`applied previously by a District Court. We disagree that one
`would narrow the definition for each claim. The claims
`themselves address multiple cancers. So we don’t believe the
`higher requirement of specialty in thoracic oncology is
`necessary.
`But even so, our expert, Dr. Bunn, has that expertise and
`he’s opined under both definitions. So from our standpoint, the
`outcome should be the same, whichever definition is applied.
`But we’ll note that their expert, Dr. Giaccone, only applied his
`definition, which is a higher standard. He did not offer an
`opinion under the more general definition that a court has
`previously adopted and that is consistent with the scope of the
`claim. So this, again, is another deficiency with their petition
`that we think could be dispositive if Dr. Giaccone's opinions
`were rejected as not applying the right standard.
`Tr. 37:3‒18.
`
`We disagree with Patent Owner, however, that there is such a
`substantive difference between its definition of the ordinary artisan and
`Petitioner’s that would cause us to make any different findings or come to
`any different conclusions in the case. Thus, to the extent we may have
`misapprehended the argument of Patent Owner’s counsel at the oral hearing,
`we determine any such misunderstanding did not impact our fact finding or
`
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`analysis. And as noted above, we did not consider Dr. Giaccone’s testimony
`in a vacuum, but in the context of the level of ordinary skill as evidenced by
`the prior art of record, as well as the other evidence made of record by the
`parties in this proceeding. In that regard, we note that Patent Owner in its
`Request for Rehearing does not point us to any argument it made in its
`papers that the definition of the ordinary skill is determinative of the
`outcome of any of the issues in this case.
`
`Patent Owner contends also that our Final Written Decision
`“repeatedly referred to, cited, and credited the irrelevant testimony of
`Dr. Giaccone,” and lists several places in our Final Written Decision where
`we relied on Dr. Giaccone testimony, as well as our reasons for that reliance.
`Reh’g Req. 8‒9. Importantly, however, as discussed above, Patent Owner
`does explain how the difference between Petitioner’s definition of the
`ordinary artisan and its definition would modify our fact-finding and
`analysis. For that reason alone, we decline to discount Dr. Giaccone’s
`testimony or change our determination that the combination of Schnur and
`OSI’s 10-K or Gibbs renders the challenged claims obvious. In the interest
`of completeness, however, we address each of those portions of the Final
`Written Decision identified by Patent Owner below.
`[I]nterpret and evaluate the Gibbs reference and the testimony
`of Dr. Gibbs (FWD at 37-39 (Paper 49) (citing and quoting
`Giaccone Dep., 115:12-20 (Ex. 2020) (“We credit the testimony
`of Dr. Giaccone, who testified that the statement in Gibbs ‘is a
`pretty strong and precise statement saying, there is activity in
`non-small cell lung cancer patients.’”))
`We acknowledge that we relied on the testimony of Dr. Giaccone
`
`relating to the Gibbs reference. See FWD 37‒40. Specifically, in our Final
`Written Decision, in response to Patent Owner’s argument (PO Resp. 53)
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`that the ordinary artisan would understand that when Gibbs referred to an
`“acceptable therapeutic index,” the reference was only referring to ZD-1839,
`and not erlotinib (i.e. CP-358,774), we acknowledged that Dr. Gibbs, the
`author of the Gibbs reference, declared:
`Based on references 12 and 13, the abstracts from the 1999
`ASCO and AACR Conferences, and my own personal
`recollection, my research at the time of my article did not identify
`any information suggesting that CP-358,774 exhibited anti-
`tumor activity in NSCLC. I was (and still am) not aware of any
`published abstracts or articles describing the clinical or
`preclinical response of a NSCLC tumor to CP-358,774 that were
`available as of the time my article was published, and I reviewed
`no such abstracts or articles in drafting my article.
`FWD 38‒39 (quoting Ex. 2022 ¶ 14).
`
`In finding that the above testimony of Dr. Gibbs was entitled to little
`weight in determining whether the Gibbs reference was referring to CP-
`358,774 when referring to “good anti-cancer activity” and “an acceptable
`therapeutic index,” we cited the Gibbs reference itself, which explicitly
`discloses:
`
`The EGF receptor is also the target for the development of
`inhibitors of the intracellular tyrosine kinase domain. ZD-1839
`and CP-358,774, competitive inhibitors of ATP binding to the
`receptor’s active site, are currently in clinical trials (12, 13).
`Their mechanism of action has led to some concern about safety,
`given the variety and physiological significance of protein
`kinases and other enzymes that bind ATP. However, these
`compounds appear to have good anti-cancer activity in
`preclinical models, with an acceptable therapeutic index,
`particularly in patients with non-small cell lung cancer.
`Id. at 39 (quoting Ex. 1010, 10). That is, Gibbs refers to two compounds,
`ZD-1839 and CP-358,774, and refers to compounds in the plural in stating
`that the compounds have anticancer activity. See id. Thus, we found that
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`“the clear inference [of the Gibbs reference] is that erlotinib has anti-cancer
`activity against non-small cell lung cancer.” Id.
`
`In that regard, we credited the testimony of Dr. Giaccone, noting that
`Dr. Giaccone
`testified that the statement in Gibbs “is a pretty strong and precise
`statement saying, there is activity in non-small cell lung cancer
`patients.” Ex. 2020, 115:12‒20. In addition, Dr. Giaccone
`testified further that statement by Dr. Gibbs would have been
`based on the information he had at the time, and that as Dr. Gibbs
`was a reputable pharmacologist, and as the statement was made
`in “a peer-reviewed journal of high impact,” he would have
`trusted that Dr. Gibbs “was saying something very important.”
`Ex. 2020, 115:12‒20.
`
`Id.
`
`The testimony of Dr. Giaccone, therefore, was consistent with the
`express statements made in the Gibbs reference, in contrast to the testimony
`of Dr. Gibbs, who testified that he was an experienced editor, and that he
`never attempted to correct or retract that statement made in the Gibbs
`reference. Id. at 39‒40 (quoting Ex. 1049, 29:18‒30:16).
`
`We determine, therefore, that any misapprehension of Patent Owner’s
`argument as to the level of skill of the ordinary artisan at the oral hearing
`does not change our determination that the ordinary artisan would not read
`the above discussed statements of the Gibbs reference as only applying to
`ZD-1839.
`[S]uggest that erlotinib was a preferred compound and that
`Gibbs or OSI 10-K would have pointed to the use of erlotinib,
`from the compounds of Schnur, for the treatment of NSCLC
`(FWD at 16-18 (Paper 49) (citing Giaccone Decl. ¶¶ 93, 102-
`107 (Ex. 1002)))
`
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`The portion of our Final Written Decision to which Patent Owner is
`referring is an overview of Petitioner’s challenge on which we instituted
`trial, and not our analysis of that challenge. In presenting that overview, we
`merely noted the evidence that Petitioner relied on in support of its
`challenge, which evidence included the Declaration of Dr. Giaccone.
`As we note above, however, Patent Owner’s Request for Rehearing
`does not point out how Dr. Giaccone’s statement of the level of skill in the
`art impacts our fact-finding and the analysis of the challenge. In addition, as
`also noted above, we relied on additional evidence as the level of ordinary
`skill, that is, the prior art of record as well as other evidence made of record
`by the parties. Finally, we note that we do not discern such a difference as
`the level of skill in the art defined by Petitioner, which we declined to adopt,
`and that as defined by Patent Owner, that it would change our fact-finding
`and analysis of the challenge.
`[S]uggest that individuals working at pharmaceutical
`companies would have reviewed documents similar to the OSI
`10-K (FWD at 20-21 (Paper 49) (citing Giaccone Dep., 75:18-
`76:16, 78:9-80:5 (Ex. 2020)))
`We acknowledge that we relied on the testimony of Dr. Giaccone in
`
`finding that “an ordinary artisan would have looked to OSI’s 10-K to
`determine what drugs and treatments pharmaceutical companies were
`working on at the time of invention.” FWD 21. Specifically, we noted, as
`argued by Petitioner (Paper 33 (“Reply”) 10), “Dr. Giaccone testified that
`his peers working at pharmaceutical companies routinely reviewed
`documents similar to OSI’s 10-K to learn of the development status of
`potentially competing products, and Dr. Giaccone even gave an example of
`[an ordinary artisan], who at the relevant time would likely have reviewed
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`OSI’s 10-K.” FWD 20‒21 (citing Ex. 2020, 75:18‒76:16, 78:9‒80:5). We
`noted further, however, that the testimony of Dr. Giaccone was corroborated
`by the testimony of Patent Owner’s fact witness, Dr. Gibbs. Dr. Gibbs,
`“who at the time of the Gibbs reference relied upon by Petitioner, worked as
`a senior director of cancer research at Merck Research Laboratories,”
`testified “‘competitor data could be made available,’ and that is something
`he would review as ‘it related to [his] project.’” Id. at 21 (citing Ex. 1049,
`19:3‒12, 20:19‒21:1).
`
`Moreover, we note that Patent Owner also relied on the testimony of
`Dr. Giaccone in arguing that the ordinary artisan would not have looked to
`OSI’s 10-K. See P.O. Resp. 33. In particular, Patent Owner contended that
`“Petitioner’s expert, Dr. Giaccone, admitted that before this proceeding, he
`had never relied on or heard of a 10-K, testifying that it is not a scientific
`publication, and that it does not contain scientific data.” FWD 20 (citing
`Ex. 2020, 77:21‒78:8, 81:17‒20, 75:15‒17, 86:11‒14, 81:17‒20).
`
`We determine, therefore, that our determination that the ordinary
`artisan would have looked to OSI’s 10-K is consistent with the evidence of
`record, including the testimony of Dr. Giaccone and Dr. Gibbs.
`[I]dentify the structure of erlotinib (FWD at 18-19 (Paper 49)
`(citing Giaccone Decl. ¶¶ 28-29 (Ex. 1002)))
`We cited our Decision on Institution in determining that that the
`
`Petition had sufficiently established that CP-358,774 and erlotinib are the
`same compound. FWD 18. In particular, we noted that the Petition had
`pointed us to paragraph 28 of Dr. Giaccone’s Declaration, and in paragraph
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`29 of that Declaration, Dr. Giaccone cited Moyer,4 which specifically
`defines “CP-358,774” as “[6,7-Bis(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-
`ethynylphenyl) amine.” Id. at 19 (citing Decision on Institution 16). We
`also cited Ariosa Diagnostics v. Verinata Health, Inc., 805 F. 3d 1359, 1365
`(Fed. Cir. 2015) for the proposition that “[a]rt can legitimately serve to
`document the knowledge that skilled artisans would bring to bear in reading
`the prior art identified as producing obviousness.” Thus, our reliance on
`Dr. Giaccone’s Declaration to support our finding that CP-358,774 and
`erlotinib are the same compound is supported by prior art of record,
`specifically Moyer.
`[S]uggest that erlotinib did not satisfy a long-felt need for
`improved treatments for non-small cell lung cancer (“NSCLC”)
`patients (FWD at 42 (Paper 49) (citing Giaccone Reply
`Decl. ¶¶ 8-10 (Ex. 1053)))
`In responding to Patent Owner’s argument that long-felt need
`
`supported the patentability of the challenged claims, we acknowledged that
`Petitioner cited paragraphs 8 to 10 of Dr. Giaccone’s Reply Declaration
`(Ex. 1053) in support of its contention that “erlotinib did not satisfy a long-
`felt need as it does not treat nearly 90% of patients with non-small cell lung
`cancer.” FWD 42 (citing Reply 19).
`In finding that Patent Owner’s evidence of long-felt need was weak,
`however, we noted that “[a]ll types of objective evidence of nonobviousness
`must be shown to have a nexus to the claimed invention.” Id. at 42‒43
`(citing In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995) (nexus
`
`
`4 Moyer et al., Induction of Apoptosis and Cell Cycle Arrest by CP-358,774,
`an Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinase. 57
`CANCER RESEARCH 4838‒4848 (1997) (Ex. 1016) (“Moyer”).
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`generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial
`success); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-
`felt need)). In particular, we stated that the challenged claims were not
`limited to the treatment of patients with non-small cell lung cancer, but
`included treatment of mammals, and that the challenged claims did not
`require a clinical effect. Id. at 43. In addition, we noted that Patent Owner
`acknowledged in its Response that “the FDA required it to change its label
`as it is only effective in treating approximately 10% of patients with non-
`small cell lung cancer.” Id.
`
`Therefore, our finding that the evidence of long-felt need is weak
`relied primarily on a lack of nexus. Id. at 42. To the extent we relied on the
`testimony of Dr. Giaccone that erlotinib was only approved for treatment of
`subset of non-small cell lung cancer, that testimony is supported by Patent
`Owner’s admission that “Tarceva is currently approved for the treatment of a
`subset of NSCLC patients,” as well as the evidence that Patent Owner relied
`upon to support that statement. PO Response 12 (citing Ex. 2030, 1;
`Ex. 2021 ¶¶ 41, 102‒107; Ex. 2023 ¶ 7).
`
`We determine, therefore, that any misapprehension of Patent Owner’s
`argument as to the level of skill of the ordinary artisan at the oral hearing
`does not change our determination that Patent Owner’s evidence of long-felt
`need is weak.
`[D]iminish OSI’s evidence of the failure of others in developing
`treatments for NSCLC (FWD at 44 (Paper 49) (citing Giaccone
`Reply Decl. ¶ 11 (Ex. 1053)))
`In our Final Written Decision, we merely noted that Petitioner relied
`
`on paragraph 11 of Dr. Giaccone’s Reply Declaration (Ex. 1053) in
`addressing Patent Owner’s argument that the failure of others supported the
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`patentability of the claims. FWD 44 (quoting Reply 20). Rather, in our
`analysis, similarly to long-felt need, we noted that “the claims do not require
`treatment of humans, much less regulatory approval, Patent Owner has
`failed to establish that the long felt need for FDA approved drugs to treat
`non-small cell lung cancer has the required nexus to the challenged claims.”
`Id. at 44‒45.
`
`We determine, therefore, that any misapprehension of Patent Owner’s
`argument as to the level of skill of the ordinary artisan at the oral hearing
`does not change our determination that Patent Owner’s evidence as to the
`failure of others is weak.
`[S]uggest that Tarceva’s commercial success is not probative
`(FWD at 47-48 (Paper 49) (citing Giaccone Reply Decl. ¶ 10
`(Ex. 1053)))
`In our Final Written Decision, we noted that Petitioner was arguing
`that the sales of Tarceva “were not driven by its actual treatment
`of cancer, but instead an overly broad approval by FDA that was
`subsequently revoked.” Id. That is, Petitioner argues, “on
`October 18, 2016[,] FDA eliminated the original label and
`limited the patient population to those who tested positive for
`epidermal growth factor receptor (EGFR) exon 19 deletions or
`exon 21 (L858R) mutations, which only accounts for about 10%
`of the NSCLC patient population. “ Id. at 23 (citing Ex. 1048,
`23:9‒26:6, 99:22‒101:13; Ex. 1053 ¶ 10; Ex. 1051, 3‒4).
`FWD 47‒48. Dr. Giaccone’s Reply Declaration (Exhibit 1053) was only
`cited as evidence on which Petitioner was relying to support its argument
`that FDA limited the patient population that could be treated using Tarceva.
`In our analysis as to commercial success, however, we did not rely on the
`fact that the FDA had had limited the patient population in declining to find
`that the purported commercial success supported the patentability of the
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`claims, rather, we relied on the presence of a blocking patent to Tarceva. Id.
`at 49.
`Specifically, in determining that the purported commercial success did
`
`not support the patentability of the claims, we noted that “erlotinib was
`previously known and patented.” Id. (citing Exhibit 1009 (Schnur)). That
`is, we were persuaded by Petitioner’s argument that “the blocking patent
`would have deterred others from exploring the commercial potential of
`Tarceva, and thus, that blocking patent to Tarceva limits the applicability of
`other evidence of commercial success.” Id.
`
`We determine, therefore, that any misapprehension of Patent Owner’s
`argument as to the level of skill of the ordinary artisan at the oral hearing
`does not change our determination that that Patent Owner’s evidence of the
`purported commercial success of Tarceva is also weak.
` ORDER
`
`Accordingly, it is hereby:
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`
`15
`
`
`
`
`
`
`
`
`
`IPR2016-01284
`Patent 6,900,221 B1
`
`For PETITIONER:
`
`Blake Coblentz
`Aaron Lukas
`COZEN O’CONNOR PC
`Wcoblentz@cozen.com
`ALukas@cozen.com
`
`
`
`For PATENT OWNER:
`
`Emily Whelan
`Jonathan Roses
`Kevin Yurkerwich
`WILMER CUTLER PICKERING HALE AND DORR LLP
`emily.whelan@wilmerhale.com
`jonathan.roses@wilmerhale.com
`kevin.yurkerwich@wilmerhale.com
`
`
`
`16
`
`
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