«
`
`CONTROL NOS. 90/007,542 AND 90/007,859
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`DOCKET NOS. 22338-10230 AND -1 0231
`
`REEXAMINATION CONTROL NOS. 90/007,542 AND 90:'007,859
`
`Attomey‘s Docket No. 22338-10230, 40231
`
`Patent
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Group Art Unit:
`
`3991
`
`Examiner:
`
`B'M' C6133
`
`I
`
`Control Nos:
`
`Confirmation Nos.:
`
`90l00‘7,542
`90i'007,859
`
`".7585 (’542)
`6447 ('859)
`
`Filed:
`
`C542)
`13 May 2005
`23 December 2005 C859)
`
`Patent Owner:
`
`Genentech, Inc. and
`City of Hope
`
`For:
`
`Merged Reexaminations ofU.S. Patent No. 6,331,415 (Cabilly et al.)
`
`DECLARATION OF DR. E. FINTAN WALTON UNDER 37 C.F.R.
`
`1.132
`
`1, E. Fintan Walton, do hereby declare and state
`
`1.
`
`2.
`
`3.
`
`I am a citizen ofand reside in the United Kingdom.
`
`I hold bachelor’s and doctoral degrees, both from Trinity College, University of Dublin,
`Ireland.
`I also conducted research at the University of Michigan. My research
`experience, in which I reached the level of departmental head at Celltech Ltd. (1984-
`l992), covered gene expression, metailoproteinases and HIV research.
`I gained broad
`commercial experience in biotechnology in my management positions at Celltech Ltd.
`(1984-I992), and before that at Bass Brewing Ltd. (1982-1983).
`
`I am presently Chairman and CEO of PharmaVentures Ltd., a company that assists
`healthcare company clients in forming alliances, conducting acquisitions and executing
`other transactions of strategic importance, including patent license agreements.
`ln
`addition to its consulting services, PharrnaVentures publishes reports on deal making to
`the phannaccutical and related industries and produces a proprietary comprehensive
`database, PharmaDeals, which contains details of over 28,000 transactions that have
`taken place in the pharmaceutical industry. Those details include, where available,
`information on total deal value, upfront payments, equity investments, milestone
`payments, royalty rates and other financial parameters.
`
`4.
`
`Through my experience at PharmaVentures and elsewhere, I have built up substantial
`expertise in the analysis ofhealthcare markets and of phannaceutical and biotechnology
`
`WALTON § L132 DECLARATION
`
`PAGE 1
`
`EVIDENCE APPENDIX
`
`PAGE B1233
`
`Sanofi/Regeneron Ex. 1046, pg 1105
`
`Mylan Ex. 1046, pg 1105
`
`

`
`CONTROL NOS. 90/007,542 AND 90/007,859
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`DOCKET NOS. 22338-10230 AND -1023’!
`
`REEXAMINATION CONTROL NOS. 90/007.542 AND 90/007,859
`
`5.
`
`6.
`
`7.
`
`companies, their technologies, and their intellectual property, Deal structuring, valuation
`and negotiation fonn a major part of my business.
`
`My company has been retained for this reexamination to evaluate certain conclusions
`made by the Patent and Trademark Office about the licensing of U.S. Patent 4,399,216
`(the “Axel patent”) as reported in an article published in the Harvard Journal ofLaw &
`Technology Vol. 17, No. 2, Spring 2004, at pp. 583-618 (the “Harvard Journal article").
`We were also asked to evaluate the licensing ofU.S. Patent No. 6,331,415 (“the ‘4l5
`patent”) to determine if the ‘4l 5 patent is recognised within the industry and enjoys
`commercial success that would be relevant to the patentability ofthe ‘415 patent.
`
`My company has been previously retained to act as an expert witness in Medlrnmune,
`Inc. v. Genentech, Inc. and City of Hope, Case No. CV03-2567', which was filed in the
`Central District of California.
`
`1 note that 1 have been, and am being. compensated for my time at a rate o1'$65(}.00 per
`hour. Attached as Exhibit A is a list enumerating the materials that I reviewed in
`preparing my declaration.
`
`Introductory Remarks
`
`8.
`
`9.
`
`1 have extensive experience in reviewing patent licensing practices in the healthcare
`sector.
`1 have reviewed many patent license agreements and evaluated the circumstances
`under which these licenses were taken.
`
`Based on my experience, I have learned that in executing a patent license, a company
`usually will not agree to pay substantial fees, or provide other significant economic
`concessions, to a patent owner unless that company has reached a conclusion that the
`patentee could successfully enforce the patent being licensed against the company. If the
`prospective licensee reaches a conclusion that either the patent is invalid, or that its
`conduct would not result in a finding of infringement of the patent, that prospective
`licensee generally will not take the license, or will not otherwise provide any significant
`economic concessions to the patent owner.
`
`Observations On Overlap of Axel Licensees and ‘415 Patent Licensees
`
`10.
`
`I 1.
`
`I have read the comments at page 46 ofthe Final Action concerning the licensing ofthe
`Axel patent, based on what was reported in the Harvard Journal article. In particular, I
`observe that the Final Action concludes from what is reported in the article that the
`licensing of the Axel patent provides evidence that “one of ordinary skill in the art
`interpreted the Axel patent claims as being directed to functional proteins, including
`antibodies." 1 do not draw the same conclusion from this article.
`
`Initially, lobserve that the Harvard Journal article describes the technological advance
`made by Dr. Axel and his collaborators as being the simultaneous transformation ofa
`eukaryotic cell with a selectable marker and another foreign gene that coded for desired
`proteinaceous material, where the presence of the selectable marker allowed for isolation
`of successful transformants from non-transformants (see generally pp. 584-586).
`
`WAl.'l'ON § 1.132 D1:'CLARA'1'1UN
`
`PAGE 2
`
`EVIDENCE APPENDIX
`
`PAGE B1234
`
`Sanofi/Regeneron Ex. 1046, pg 1106
`
`Mylan Ex. 1046, pg 1106
`
`

`
`4
`
`CONTROL NOS. 90/007,542 AND 90/007,859
`
`DOCKET NOS. 22338-10230 AND -10231
`
`REEXAMJNATION CONTROL NOS. 90/007,542 AND 90/007,859
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`17.
`
`The Harvard Journal article does not explain why the reported Axel patent licensees took
`a license under one or more ofthe Axel patents.
`It does provide, at pages 592-593, a list
`of observations based on the reported Axel patent licenses.
`
`According to the Harvard Journal article, six ofthe products reported as subject to a
`license under the Axel patent do not fall within any of the categories specifically claimed
`in that patent.' See Harvard Journal article at pp. 592-593. These products include:
`Ovidrel®, a recombinant human chorionic gonadotropin; Epogen® and Proerit®,
`recombinant human erythropoietin; Aranesp®, a modified recombinant human
`erythropoietin; Gonal—i®_. a human follicle stimulating hormone‘, and Thyrogen®, a
`recombinant human thyroid stimulating hormone. See Harvard Journal article at pp. 615,
`616 and 618.
`
`The Harvard Journal article also indicates that the majority of the reported licensed
`products, including certain Genentech products, are not antibodies. See Harvard Journal
`article at pp. 592-593, 614-618.
`
`The Harvard Journal article reports that 28 of 29 of the products reported as subject to a
`license under the Axel patent are produced in CHO cells (a particular type of mammalian
`host cell), and that “. . .it is almost certain that all {of the manufacturing processes] use
`some selective agents in culturing their transformed cells in accordance with the Axel
`patent." Harvard Journal article at p. 593.
`
`In view of these observations, 1 do not believe one can reasonably conclude that
`companies took licenses under the Axel patent based on an understanding that the
`licensed product was specifically claimed in the Axel patent. Indeed, at least six ofthe
`products are not specifically claimed in the Axel patent. This demonstrates to me that
`whether the protein made by these licensees was specifically claimed in the Axel patent
`could not have been a significant reason why they took their respective licenses.
`
`To the extent that one can infer anything from what is reported in the Harvard Journal
`article about why the Axel patent licensees took their respective licenses, it would be that
`these licensees believed the Axel patent to be broadly claiming the technique of using a
`selectable marker in mammalian host cells that allowed for isolation ofsuccessful
`
`transformants from non-transformants. This seems to be the only common factor
`reported in the licensing data for the licensed products.
`It is also the advance in the field
`of recombinant DNA technology that the Harvard Journal article attributes to Dr. Axel
`and his collaborators.
`
`,
`;
`‘
`
`18.
`
`Accordingly, I do not believe the licensing information provided in the Harvard Journal
`anicle is evidence that a person of ordinary skill in the art interpreted the Axel patent
`claims as being directed to production of functional proteins, including antibodies.
`
`'
`
`The Axel patent claims indicate that the foreign DNA employed could code for interferon, insulin,
`growth hormone, clotting factor, viral antigen, antibody or enzyme. See Harvard Journal article at
`page 588 and Axel patent claims 3-8.
`
`WALTON § 1.132 DECLARATION
`
`PAGE 3
`
`EVIDENCEAPPENDIX
`
`PAGE B1235
`
`Sanofi/Regeneron Ex. 1046, pg 1107
`
`Mylan Ex. 1046, pg 1107
`
`

`
`4
`
`-v
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`CONTROL NOS. 90/007,542 AND 90/007,859
`
`DOCKET NOS. 22338-10230 AND -1 0231
`
`REEXAMINATION CONTROL NOS. 90f007,542 AND 901007.859
`
`19.
`
`20.
`
`An additional observation can be made about the licensing experiences ofthe Axel
`patent. Specifically. I observe that two antibody products were identified in the Harvard
`Journal article as having been licensed under the Axel patent (i.e., Humira® by Abbott,
`and Zevalin® by Biogen Idec). See Harvard Journal article at pp. 614, 617. These two
`antibody products are also licensed under the ‘4l5 patent.2
`
`I believe Abbott and Biogen ldec are companies with extensive experience in licensing
`patents concerning biological products. Based on my experience, the decision of each
`company to license both the ‘415 and Axel patents suggests two things. First. each
`company must have concluded that both patents covered in some manner the way their
`products are made. Second, each company must have concluded that the ‘4l5 patent was
`independently patentable over the Axel patent. Otherwise, neither company would have
`taken a license under both patents, or paid royalties under both patents to different patent
`OWIICTS.
`
`
`Overview of the ‘4l5 Patent and Its Place in the Industry and Market
`
`21.
`
`22.
`
`23.
`
`I have been informed that evidence of substantial licensing of an invention by market
`participants supports a Conclusion that the invention is not obvious, in part because it
`indicates that the industry has recognised that the patent represents a non-obvious
`advance over the prior art.
`I also have been told that evidence ofcommereial success of
`an invention supports a conclusion that an invention is not obvious over the prior art.
`
`l understand that evidence oflicensing and commercial success of the ‘-415 patent is
`appropriate to consider ifit can be linked to the merits ofthe invention (c.g., as opposed
`to being attributable to the prior art).
`In this case, this means that licensing and
`commercial success evidence is relevant if it can be shown to be attributable to the merits
`
`of the ‘415 patent, rather than being due to the merits ot'U.S. Patent 4,816,567 (“the ‘567
`patent") and other prior art, or being due to other factors unrelated to the merits of the
`‘4l5 patent.
`
`Accordingly, I have evaluated whether the licensing by others ofthe ‘4lS patent, and the
`royalties Genentech has been paid on U.S. sales of products licensed under the ‘4l5
`patent, are properly attributable to the metits of the ‘415 patent, independent of the merits
`of the ‘567 patent and other prior art.
`
`Licensing Activitv ofthe ‘415 Patent
`
`24.
`
`I have reviewed each of the licenses Genenteeh has entered into under the ‘4l5 patent.’
`In general. confidentiality considerations between Genenteeh and the licensees preclude
`
`2
`
`I know this based on my review of each otthe licenses Genentecb has entered into under the ‘4l5
`patent.
`
`Because ofconfidentiality considerations regarding these licenses. I have not provided a detailed
`table ofthe companies, products. and terms ofthe licenses. Nevertheless, my opinions are grounded
`on the terms ofthese licenses.
`
`WALTON § L132 DECLARATION
`
`PAGE 4
`
`EVIDENCE APPENDIX
`
`PAGE B1236
`
`Sanofi/Regeneron Ex. 1046, pg 1108
`
`Mylan Ex. 1046, pg 1108
`
`

`
`4
`
`CONTROL NOS. 90/007,542 AND 90/007,859
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`DOCKET NOS. 22338-10230 AND -10231
`
`RE EXAMINATION CONTROL NOS. 90/007,542 AND 90/007,859
`
`25.
`
`26.
`
`27.
`
`23.
`
`29.
`
`30.
`
`public disclosure ofmany terms and conditions ofthe licenses. Because of this, I present
`my findings in a manner that limits disclosure oflicense terms.
`
`Genentech has licensed the ‘415 patent, either in conjunction with the ‘S67 patent or
`without the ‘S6? patent, to at least 35 companies.
`
`Of the companies that have licensed the ‘4l5 patent, many have elected to take licenses
`under both the ‘567 and the ‘4-15 patents, while others have taken licenses only under the
`‘#115 patent‘ and not under the ‘567 patent.
`
`A number of licenses granting rights under both the ‘S67 and ‘4l5 patents require the
`licensee to pay one royalty on net sales ofproducts covered by the ‘567 patent and a
`separate and additional royalty on net sales of products covered by the ‘-41 5 patent, even
`if the product was also covered by the ‘567 patent. In other words, in certain of these
`“dual” licenses, the royalty obligations under each patent are independent. 5
`
`I also observe from my review of the licenses that after the ‘4l 5 patent issued, but before
`the ‘567 patent expired, several licenses were entered into that granted rights only under
`the ‘4l5 patent (i.e., without also granting rights under the ‘567 patent).
`
`A number of the companies that have taken a license under the ‘4l5 patent are currently
`marketing an antibody product under that license within the United States. '3
`
`The companies that have taken licenses under the ‘4l 5 patent include some of the largest
`biotechnology and pharmaceutical companies in the world in terms of product revenue,
`as identified by Med Ad News in 2005 and 2007.7
`
`Revenue Generated From Licensing Activity
`
`31.
`
`I have reviewed reports of royalty payments made by licensees under the ‘S67 and the
`‘415 patents for therapeutic antibody products sold in the U.S., including a compilation of
`
`These licenses did grant rights to continuations, continualions-in-part, divisionals of the ‘4l 5 patent,
`and foreign counterparts of those patents. No such U.S. patents have issued to date.
`
`5 Medlmmune has licensed both the '4l5 and the ‘567 patent for Synagis®, but has paid royalties to
`Gencntcch only under the ‘4l 5 patent. See Joint Appendix Volume 1 tiled with the United States
`Supreme Court in Medlmmzme. lrzc. v Genentech. No. 05-608 at pp. 414-416.
`
`6
`
`Some products publicly known to be licensed under the ‘£115 patent are l-lumira®, Remicade®,
`Synagis®, Tysabri® and Erhitux®. See Genentech Presentation by David Ebersman, [nvcstmcnt
`Community Meeting, Financial Overview, 14 March 2008, at slide 8. available at,
`www.genecom/gene/iri'webcasts/"pd!"/finance.pdf.
`
`7 Med Ad News, July 2005, “Top 100 biotechnology companies," Med Ad News, September 2007.
`“Top 50 pharmaceutical companies.“
`
`WALTON § l.l32 DECLARATION
`
`PAGE 5
`
`EVIDENCE APPENDIX
`
`PAGE B1237
`
`Sanofi/Regeneron Ex. 1046, pg 1109
`
`Mylan Ex. 1046, pg 1109
`
`

`
`OONTROL NOS. 90/007,542 AND 90/007,859
`
`DOCKET NOS. 22338-10230 AND -1 0231
`
`RFEXAMINATION CONTROL NOS. 90/007,542 AND 90/007,859
`
`this data prepared by employees of Genentech in the finance gr0up.E That compilation
`provides data showing royalty payments made on U.S. sales ofantibody products
`licensed under the ‘4l5 patent that Genentech has received on an annual basis since its
`issuance.
`
`32.
`
`I have discussed the information that I received from Genentech and the manner in which
`
`the information was generated with the employees in the finance group who compiled
`this information.
`In particular, I have been informed that the information was compiled
`from royally statements that licensees ofthe ‘4l 5 patent provided to Genentech for sales
`made during the quarter covered by the licensee’s royalty statement.
`I have also been
`informed that those statements differentiated sales made in the US. from sales made
`outside ofthe U.S.
`
`33.
`
`35.
`
`36.
`
`Because I understand how the information was collected and have reviewed the licensing
`provisions that correspond to these royalty payments, I believe the data I reviewed
`accurately reflect the royalties that Genentech has been paid pursuant to licenses under
`the ‘415 patent, whether or not in conjunction with the ‘567 patent.
`
`I believe it is possible to readily identify a portion of the total licensing revenue, paid to
`Genentech by all licensees of either or both of the ‘4-15 and ‘567 patents, that is
`exclusively attributable to the ‘41S patent. Specifically, this would be amounts of
`licensing revenue paid by: (at) companies that have licensed only the ‘4l5 patent, and not
`the ‘567 patent; and (b) Medlmmune for license obligations arising from sales of
`Synagis®, which Medlmmune asserts it pays only because of its obligation under the
`‘41S patent.” As of December 31, 2007, these amounts totaled approximately $346
`million.
`
`I note that this estimate is conservative because I have not included any amounts of
`royalty payments made by dual licensees, other than Medlmmune, under the ‘4 1 5 and
`‘567 patents.
`I note that a portion of such royalties would certainly be exclusively
`attributable to ‘4l5 patent license obligations because many of the license provisions
`impose independent obligations on the licensee to pay royalties on each of the ‘-415 and
`‘567 patents.
`
`In 2007, there were 21 therapeutic antibodies or therapeutic products containing an
`antibody fragment (collectively “therapeutic antibody products") marketed within the
`U.S. These products are identified in Table l of Piggee, Christine, “Therapeutic
`Antibodies Corning Through the Pipeline," Analytical Chemistry, Vol. 80 Issue 7, pp.
`2305-2310 (April 2008), along with other antibody related drugs, including in vivo
`diagnostic agents. These products are used in treating cancer, inflammation, allergy,
`organ transplant rejection, macular degeneration as well as cardiovascular, autoimmune
`and infectious diseases. Based on my review ofthe ‘4l5 licenses that Genentech has
`
`Because ofconfidentiality considerations concerning these licenses, I cannot provide this compilation
`as an appendix to this declaration. However, I can and do report information from this compilation in
`a way that reasonably respects these confidentiality considerations.
`See footnote 5.
`
`WALTON ti L132 DECLARATION
`
`PAGE 6
`
`EVIDENCE APPENDIX
`
`PAGE B1238
`
`Sanofi/Regenfleroiri Ex. 1046, pg 1110
`
`Mylan Ex. 1046, pg 1110
`
`

`
`4
`
`4
`
`CONTROL NOS. 90/007,542 AND 90/007,859
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`DOCKET NOS. 22338-10230 AND -10231
`
`REEXAMINATION CONTROL NOS. 90/007,542 AND 90/007,859
`
`entered into, almost all of the 21 therapeutic antibodies identified in the Piggee article are
`licensed under the "4! 5 patent, both alone and in conjunction with the ‘S67 patent. As
`illustrated in the figure below, the yearly US. sales ofall of the 21 therapeutic antibody
`products have been significant and show a strong positive trend. Based on the licenses
`that I have reviewed and the information reviewed to generate this figure, I am aware that
`billions of dollars ofthe U.S. sales of non-Genenteoh products are attributable to products
`licensed under the ‘4lS patent.
`
`US Therapeutic Antibody Sales
`
`D Other Products
`
`I Genentech Products
`
`16 -i
`
`14 *.
`
`i
`
`'2
`
`Tn‘
`l
`c
`-__8_ 10 4
`ii
`
`3 8 1‘
`
`W2 ,
`
`6
`
`3
`an
`1 D 4
`
`1995
`
`1997
`
`‘I998
`
`1999
`
`2000
`
`Y
`
`2002
`2001
`Year
`
`2003
`
`200:4
`
`2005
`
`2006
`
`2007
`
`2 0
`
`Source: Evaluate.l;h_anna
`
`Wm
`
` _Q£.Qthcrs
`
`37.
`
`Dozens ofpharmaceutical companies, including some oftho largest in the world in terms
`of product revenues, have licensed the ‘4l5 patent. A subset ofthese companies markets
`many of the 2] therapeutic antibodies that are presently available on the U.S. market and
`have paid substantial sums for the right to practice the ‘4 l 5 patent technology. '0
`
`'” As noted above, in addition to the $346 million that is readily attributable exclusively to the ‘4l5
`patent, there is a portion of royalties paid by dual licensees that would certainly be exclusively
`attributable to ‘M5 patent license obligations because many of the license provisions impose
`independent obligations on the licensee to pay royalties on each ofthe "415 and ‘S67 patents.
`
`WALTON {:3 1.132 DECLARATION
`
`PAGE 7
`
`EVIDENCE APPENDIX
`
`PAGE B1239
`
`Sanofi/Regeneron Ex. 1046, pg 1111
`
`Mylan Ex. 1046, pg 1111
`
`

`
`4
`
`' CONTROL NOS. 90/007,542 AND 90/007,859
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`DOCKET NOS. 22338-10230 AND -10231
`
`REEXAMINATION CONTROL NOS. 90/007,542 AND 90/007,859
`
`38.
`
`39.
`
`40.
`
`41.
`
`42.
`
`43.
`
`Based on my experience, it is reasonable to conclude that licensees ofthe ‘4l5 patent
`took a license under that patent after assessing its validity and whether their conduct
`could be found to infringe the patent.
`In my opinion, one part of the validity assessment
`would have been whether the ‘4l5 patent defined a patentable invention over the ‘S6?
`patent claims, considered with any other information in the public record prior to the
`filing date of the two patents.
`
`For any licensee agreeing to pay separate royalties on both the ‘-415 and the ‘S67 patents
`in the event the licensed product was believed to implicate both patents, the licensee
`would have had an additional motivation to focus on whether the ‘41 S patent defined
`inventions that were separately patentable over the ‘567 patent claims.
`
`The fact that so many companies have licensed the ‘415 patent, and that a subset of those
`companies have paid substantial sums to Genentech attributable solely to the licensing of
`the ‘4l5 patented technology, indicates to me that there is widespread industry
`recognition that the ‘4l5 patent claims are independently patentable over the ‘567 patent
`claims and the prior knowledge concerning antibody technology.
`
`I also believe that the evidence showing that commercially marketed therapeutic
`antibodies have been licensed under only the ‘4l5 patent indicates that the companies
`that took these ‘415-only licenses believed that the ‘4l5 patent defined a distinct and
`separately patentable invention relative to the ‘S67 patent claims when they took those
`licenses.
`
`Based on my experience, the "43 S patent is one ofa relatively small number ofpatents
`that have been broadly licensed to many companies in the biotechnology industry.
`
`As lunderstand the role licensing of the patent plays in obviousncss evaluations, I
`believe the foregoing strongly supports a conclusion that the ‘£115 patent claims define
`inventions that are not obvious over, and therefore independently patentable in view of,
`the ‘567 patent claims, when they are considered alone or in conjunction with the prior
`art known before the common filing date ofthese patents.
`
`Conclusions Regarding Commercial Success
`
`44.
`
`45.
`
`46.
`
`As explained in paragraph 36 above, the therapeutic antibody products that are licensed
`under the ‘M5 patent have generated billions of dollars in drug sales. These monoclonal
`antibodies are Sold for use in numerous therapeutic fields.
`
`Genentech has received several hundred million dollars in royalties from these companies
`that are attributable solely to licenses granted under the ‘4l5 patent.
`lbelieve, based on
`my experience, that these companies paid these substantial royalties because they have
`each concluded that the way they make their products would likely be found by a court to
`be covered by the ‘4l5 patent claims.
`In my opinion, this is strong evidence ofa
`substantial degree ofcommereial success that is attributable solely to the ‘4l5 patent.
`
`As l understand the role that this evidence plays in obviousncss evaluations, i believe
`these significant amounts of compensation that companies have paid Genentech pursuant
`
`WALTON 5 l,l32 DECLARATION
`
`PAGE 8
`
`EVIDENCE APPENDIX
`
`PAGE B1240
`
`Sanofi/Regeneron Ex. 1046, pg 1112
`
`Mylan Ex. 1046, pg 1112
`
`

`
`0
`
`- CONTROL NOS. 90/007,542 AND 90/007,859
`REEXAMINATION CONTROL Nos. 90/007,542 AND 901001859
`
`DOCKET NOS. 22338-10230 AND -10231
`
`to their license obligations is evidence of commercial success of the ‘4l5 patent, and
`supports a conclusion that the ‘4l 5 patent claims are not obvious over the ‘567 patent
`claims, when they are considered alone or in conjunction with the other prior art known
`prior to the common filing date of the ‘567 patent.
`
`**1I$*$****=|=
`
`I declare that all statements made herein of my own knowledge are true and that all statements
`made on information and belief are believed to be true; and further that these statements were
`made with the knowledge that willful false statements and the like so made are punishable by
`fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that
`such willful false statements may jeopardise the validity of the patent subject to this
`reexamination proceeding.
`
`,
`l
`tj
`'
`I
`:
`..
`E. Fintan Walton
`
`__
`
`/
`
`'1
`Lt’
`.'}(v\_G
`Date
`
`-"7
`
`-r , "'-
`
`UJAI TON 81 IT} HFFI ADATll'\'i\l
`
`IJAGF‘ C!
`
`EVIDENCE APPENDIX
`
`PAGE B1241
`
`Sanofi/Regeneron Ex. 1046, pg 111.3“.-
`
`Mylan Ex. 1046, pg 1113
`
`

`
`,5
`
`I
`
`‘ CONTROL NOS. 90/007,542 AND 90/007,859
`
`DOCKET NOS. 22338-10230 AND -10231
`
`Control Nos. 90/007.542 and 90J'007,S59
`
`Attorney Docket No. 223 38-10230
`
`List of Materials Reviewed In Preparing this Declaration:
`
`EXHIBIT A
`
`U.S. Patent and Trademark Office's communication dated February 25, 2008
`Recent Developments “Columbia, Co-transformation, Commercialization & Controversy: The
`Axel Patent Litigation," Harvard Journal of Law & Technology, Vol. 17, No. 2, Spring
`2004 pp. 583-618
`U.S. Patent No. 4,399,216
`U.S. Patent No. 6,331,415
`U.S. Patent No. 4,816,567
`Genentech-Cabilly License agreements produced under the protective order in Medlmmune, Inc.
`v. Genentech, Inc. and City ot'Hope, Case No. CV03—2567'
`Gencntech Royalty Statements regarding ‘4 1 5 and ‘567 patents produced under the protective
`order in Medlmmune, Inc. v. Genentech, Inc. and City of Hope, Case No. CV/03-2567
`Joint Appendix Volume I filed with the United States Supreme Court in Medlmmune, Inc. v
`Genenlech, No. 05-608
`Genentech Presentation by David Ebersman, Investment Community Meeting, Financial
`Overview, 14 March 2008, at slide 8, available at,
`www.gene.com/genet’ir:’webcasts/pdfffinancepdf
`Summary Report of Royalties Paid to Genentech by licensees of the ‘4l5 patent, prepared by
`Genenlech based on information sent by licensees of the ‘4 15 patent to Genenteeh
`Med Ad News, July 2005, “Top 100 biotechnology companies"
`Med Ad News, September 2007, “Top 50 pharmaceutical companies”
`Piggee, Christine “Therapeutic Antibodies Coming Through the Pipeline,” Analytical Chemistry,
`Vol. 30, Issue 7, pp. 2305-10. (April 2003)
`EvaluatePharma, (analysis and intelligence service for the pharma and biotech sector), London,
`UK
`
`WALTON § l.l32 DECLARATION
`
`EVIDENCE APPENDIX
`
`PAGE B1242
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`Sanofi/Regeneron Ex. 1046, pg 1114
`
`Mylan Ex. 1046, pg 1114