Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 1 of 91 PageID #: 1044
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 18-1363-CFC
`
`)))))))))
`
`GENENTECH, INC., AND CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD.,
`
`Defendant.
`
`DEFENDANT SAMSUNG BIOEPIS CO., LTD.’S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`
`Samsung Bioepis Co., Ltd. (“Bioepis” or “Defendant”), by and through its attorneys,
`
`hereby submits this Answer, Defenses, and Counterclaims to the Complaint filed by Plaintiffs
`
`Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Plaintiffs”) on September 4, 2018
`
`(the “Complaint”).
`
`ANSWER TO COMPLAINT
`
`Each of the paragraphs below corresponds to the same-numbered paragraphs (each a
`
`“Paragraph”) in the Complaint. Bioepis denies all allegations in the Complaint, whether express
`
`or implied, that are not specifically admitted below. Any factual allegation below is admitted only
`
`as to the specific admitted facts, not as to any purported conclusions, characterizations,
`
`implications, or speculations that arguably follow from the admitted facts. Moreover, to the extent
`
`that any of Plaintiffs’ allegations are vague or ambiguous, Bioepis denies said allegations. To the
`
`extent that any of the Complaint’s headings or footnotes constitute allegations, Bioepis specifically
`
`denies each and every one of them. Bioepis reserves the right to amend this Answer or to assert
`
`other defenses as this action proceeds. Bioepis denies that Plaintiffs are entitled to the relief
`
`requested or any other relief. Bioepis responds to the Complaint as follows:
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 2 of 91 PageID #: 1045
`
`NATURE OF THE CASE
`
`1.
`
`Bioepis admits that breast cancer is a serious disease affecting women in the United
`
`States. Bioepis lacks knowledge or information sufficient to form a belief about the truth of the
`
`remaining allegations in Paragraph 1 and, therefore, denies the same.
`
`2.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth
`
`of the allegations in Paragraph 2 and, therefore, denies the same.
`
`3.
`
`Bioepis admits that Herceptin® contains an antibody called trastuzumab. Bioepis
`
`lacks knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations in Paragraph 3 and, therefore, denies the same.
`
`4.
`
`To the extent the allegations in Paragraph 4 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth of the remaining
`
`allegations in Paragraph 4 and, therefore, denies the same.
`
`5.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth
`
`of the allegations in Paragraph 5 and, therefore, denies the same.
`
`6.
`
`Bioepis admits that the United States Patent and Trademark Office has granted
`
`patents assigned to Genentech. To the extent that the allegations in Paragraph 6 purport to describe
`
`or characterize publicly available documents, Bioepis objects to such characterization or
`
`description of those documents and notes that those documents speak for themselves and no
`
`response is required. Bioepis lacks knowledge or information sufficient to form a belief about the
`
`truth of the remaining allegations in Paragraph 6 and, therefore, denies the same.
`
`2
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 3 of 91 PageID #: 1046
`
`7.
`
`Bioepis admits that it submitted an abbreviated Biologic License Application
`
`(“aBLA”) to the United States Food and Drug Administration (“FDA”) seeking licensure of its
`
`trastuzumab product (“SB3”). Paragraph 7 otherwise contains Plaintiffs’ characterization of their
`
`claims, applicable law and regulations, and/or legal conclusions, to which no response is required.
`
`To the extent a response is required, Bioepis denies such allegations.
`
`8.
`
`Bioepis admits that the Biologics Price Competition and Innovation Act (“BPCIA”)
`
`was enacted in 2010. Bioepis further admits that it exchanged information with Genentech
`
`pursuant to the BPCIA to narrow the scope of the patent disputes involving SB3. Paragraph 8
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent a response is required,
`
`Bioepis denies such allegations.
`
`9.
`
`Bioepis admits that the Complaint purports to bring a civil action for patent
`
`infringement pursuant to 35 U.S.C. § 271(e)(2). Bioepis further admits that the Complaint purports
`
`to seek declaratory judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C. § 2201; a preliminary
`
`or permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B), 35 U.S.C. § 271(a), (b), or 35 U.S.C.
`
`§ 283; and monetary damages. Bioepis admits that in the Complaint, Plaintiffs purport to assert
`
`21 patents against Bioepis. Paragraph 9 otherwise contains Plaintiffs’ characterization of their
`
`claims, applicable law and regulations, and/or legal conclusions, to which no response is required.
`
`To the extent a response is required, Bioepis denies the allegations.
`
`PARTIES
`
`10.
`
`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 10 and, therefore, denies the same.
`
`3
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 4 of 91 PageID #: 1047
`
`11.
`
`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 11 and, therefore, denies the same.
`
`12.
`
`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 12 and, therefore, denies the same.
`
`13.
`
`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 13 and, therefore, denies the same.
`
`14.
`
`15.
`
`Admitted.
`
`Bioepis admits that it develops biologic drugs. Bioepis further admits that it filed
`
`an aBLA seeking licensure for SB3, and that Merck & Co., Inc. is Bioepis’s commercialization
`
`partner for SB3 in the United States. Bioepis otherwise denies the allegations in Paragraph 15.
`
`JURISDICTION AND VENUE
`
`16.
`
`Bioepis admits the Complaint purports to bring an action under the BPCIA, 42
`
`U.S.C. § 262(l) and the Patent Laws of the United States, Title 35, United States Code, and the
`
`Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202. Paragraph 16 otherwise contains conclusions
`
`of law to which no response is required. Bioepis admits that the Court has subject matter
`
`jurisdiction over this case.
`
`17.
`
`Bioepis admits that it is a company organized and existing under the laws of the
`
`Republic of Korea. Paragraph 17 otherwise contains conclusions of law to which no response is
`
`required. Bioepis does not contest venue for the purposes of this action only.
`
`18.
`
`Bioepis admits that it filed an aBLA with the FDA for SB3. Paragraph 18 otherwise
`
`contains conclusions of law to which no response is required. Bioepis does not contest personal
`
`jurisdiction for purposes of this action only.
`
`4
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 5 of 91 PageID #: 1048
`
`THE PARTIES’ PRE-SUIT EXCHANGES
`
`19.
`
`Bioepis admits that it submitted a press release on December 20, 2017, announcing
`
`the FDA had accepted for review Bioepis’s aBLA for SB3. To the extent the allegations in
`
`Paragraph 19 purport to describe or characterize publicly available documents, Bioepis objects to
`
`such characterization or description of those documents and notes that such documents speak for
`
`themselves and no response is required.
`
`20.
`
`Paragraph 20 contains Plaintiffs’ characterization of their claims, applicable law
`
`and regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`21.
`
`Bioepis admits that Genentech sent a letter on December 27, 2017, requesting a
`
`copy of the aBLA for SB3. Bioepis otherwise denies the remaining allegations in Paragraph 21.
`
`22.
`
`Bioepis admits that on January 8, 2018, it provided Genentech with access to
`
`documents and information concerning SB3 pursuant to 42 U.S.C. § 262(l)(2)(A). Paragraph 22
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`23.
`
`Bioepis admits that Genentech sent a letter to counsel for Bioepis on January 12,
`
`2018. Bioepis otherwise denies the allegations in Paragraph 23.
`
`24.
`
`Bioepis admits that Genentech and Bioepis engaged in further correspondence in
`
`January and February 2018. Bioepis otherwise denies the allegations in Paragraph 24.
`
`25.
`
`Bioepis admits that it provided Genentech with additional documents and
`
`information requested by Genentech on February 15, 2018 and February 20, 2018. Bioepis
`
`otherwise denies the remaining allegations in Paragraph 25.
`
`5
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 6 of 91 PageID #: 1049
`
`26.
`
`Bioepis admits that Genentech wrote to Bioepis on March 1, 2018, agreeing to
`
`provide Bioepis with a list of patents within 60 days from Bioepis’s production of additional
`
`documents on February 20, 2018. Bioepis otherwise denies the remaining allegations in Paragraph
`
`26.
`
`27.
`
`Bioepis admits that Genentech sent a letter to Bioepis on March 30, 2018, regarding
`
`Bioepis’s production of documents and information concerning SB3. Bioepis further admits that
`
`it responded to Genentech’s letter on April 16, 2018. Bioepis denies the remaining allegations in
`
`Paragraph 27.
`
`28.
`
`Bioepis admits that Genentech provided a list of patents to Bioepis on April 23,
`
`2018 and informed Bioepis it was not prepared to license any of the listed patents to Bioepis.
`
`Paragraph 28 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`29.
`
`30.
`
`Bioepis denies the allegations in Paragraph 29.
`
`Bioepis admits that it provided a statement to Genentech on June 22, 2018, in
`
`accordance with 42 U.S.C. § 262(l)(3)(B). Bioepis denies the remaining allegations in Paragraph
`
`30.
`
`31.
`
`Bioepis admits that on August 17, 2018, Genentech provided a statement to Bioepis
`
`purporting to be in response to Bioepis’s June 22, 2018 statement. Bioepis admits that Genentech
`
`proposed that 21 patents be included in a patent infringement action. Bioepis further admits that
`
`it responded in writing to Genentech on August 23, 2018, and that the parties engaged in further
`
`discussions thereafter. Bioepis denies the remaining allegations in Paragraph 31.
`
`6
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 7 of 91 PageID #: 1050
`
`32.
`
`Bioepis admits that on September 3, 2018, it sent a letter to Genentech regarding
`
`the patents to be included in an infringement action pursuant to 42 U.S.C. § 262(l)(6). Bioepis
`
`otherwise denies the allegations in Paragraph 32.
`
`BIOEPIS’S aBLA PRODUCT
`
`33.
`
`Bioepis admits that it has issued press releases concerning SB3. Bioepis further
`
`admits that SB3 is a biosimilar drug and that the reference product for SB3 is Herceptin®. To the
`
`extent the allegations in Paragraph 33 purport to describe or characterize publicly available
`
`documents, Bioepis objects to such characterization or description of those documents and notes
`
`that such documents speak for themselves and no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`34.
`
`Bioepis admits that it submitted an aBLA for SB3 seeking approval for the same
`
`indications for which Herceptin® was approved in the United States. To the extent the allegations
`
`in Paragraph 34 purport to describe or characterize publicly available documents, Bioepis objects
`
`to such characterization or description of those documents and notes that such documents speak
`
`for themselves and no response is required. Paragraph 34 otherwise contains Plaintiffs’
`
`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
`
`no response is required. To the extent that a response is required, Bioepis denies the allegations.
`
`35.
`
`Bioepis admits that it submitted an aBLA for SB3 to the FDA. Paragraph 35
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`7
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 8 of 91 PageID #: 1051
`
`GENENTECH’S ASSERTED PATENTS
`
`36.
`
`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
`
`the allegations in Paragraph 36 and, therefore, denies the same.
`
`37.
`
`Bioepis admits that Genentech has asserted U.S. Patent No. 6,331,415, U.S. Patent
`
`No. 7,923,221, U.S. Patent No. 6,407,213, U.S. Patent No. 7,846,441, U.S. Patent No. 7,892,549,
`
`U.S. Patent No. 6,627,196, U.S. Patent No. 7,371,379, U.S. Patent No. 6,339,142, U.S. Patent No.
`
`6,417,335, U.S. Patent No. 9,249,218, U.S. Patent No. 8,574,869, U.S. Patent No. 7,993,834, U.S.
`
`Patent No. 8,076,066, U.S. Patent No. 8,425,908, U.S. Patent No. 8,440,402, U.S. Patent No.
`
`6,610,516, U.S. Patent No. 7,390,660, U.S. Patent No. 7,485,704, U.S. Patent No. 7,807,799, U.S.
`
`Patent No. 8,512,983, and U.S. Patent No. 9,714,293. Bioepis denies the remaining allegations in
`
`Paragraph 37.
`
`The Cabilly Patents
`
`38.
`
`To the extent the allegations in Paragraph 38 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 38 contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent a response is required,
`
`Bioepis denies the allegations.
`
`39.
`
`Bioepis admits
`
`that
`
`the ’415 patent
`
`is
`
`titled “Methods of Producing
`
`Immunoglobulins, Vectors and Transformed Host Cells for Use Therein,” that the United States
`
`Patent and Trademark Office issued the ’415 patent on December 18, 2001, and that what purports
`
`to be a copy of the ’415 patent is attached to the Complaint as Exhibit A. Bioepis lacks knowledge
`
`or information sufficient to form a belief about the truth of the allegations in the last sentence of
`
`8
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 9 of 91 PageID #: 1052
`
`Paragraph 39 and, therefore, denies the same. Paragraph 39 otherwise contains Plaintiffs’
`
`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
`
`no response is required. To the extent that a response is required, Bioepis denies the allegations.
`
`40.
`
`Bioepis admits that the ’221 patent is titled “Methods of Making Antibody Heavy
`
`and Light Chains Having Specificity for a Desired Antigen,” that the United States Patent and
`
`Trademark Office issued the ’221 patent on April 12, 2011, and that what purports to be a copy of
`
`the ’221 patent is attached to the Complaint as Exhibit B. Bioepis lacks knowledge or information
`
`sufficient to form a belief about the truth of the allegations in the last sentence of Paragraph 40
`
`and, therefore, denies the same. Paragraph 40 otherwise contains Plaintiffs’ characterization of
`
`their claims, applicable law and regulations, and/or legal conclusions, to which no response is
`
`required. To the extent that a response is required, Bioepis denies the allegations.
`
`The ’213 Patent
`
`41.
`
`To the extent the allegations in Paragraph 41 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 41 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`42.
`
`Bioepis admits that the ’213 patent is titled “Method for Making Humanized
`
`Antibodies,” that the United States Patent and Trademark Office issued the ’213 patent on June
`
`18, 2002, and that what purports to be a copy of the ’213 patent is attached to the Complaint as
`
`Exhibit C. Bioepis lacks knowledge or information sufficient to form a belief about the truth of
`
`the allegations in the last sentence of Paragraph 42 and, therefore, denies the same. Paragraph 42
`
`9
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 10 of 91 PageID #: 1053
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`The Combination Chemotherapy Patents
`
`43.
`
`To the extent the allegations in Paragraph 43 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 43 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`44.
`
`Bioepis admits that the ’441 patent is titled “Treatment with Anti-ErbB2
`
`Antibodies,” that the United States Patent and Trademark Office issued the ’441 patent on
`
`December 7, 2010, and that what purports to be a copy of the ’441 patent is attached to the
`
`Complaint as Exhibit D. Bioepis lacks knowledge or information sufficient to form a belief about
`
`the truth of the allegations in the last sentence of Paragraph 44 and, therefore, denies the same.
`
`Paragraph 44 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`45.
`
`To the extent the allegations in Paragraph 45 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 45 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`10
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 11 of 91 PageID #: 1054
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`46.
`
`Bioepis admits that the ’549 patent is titled “Treatment with Anti-ErbB2
`
`Antibodies,” that the United States Patent and Trademark Office issued the ’549 patent on
`
`February 22, 2011, and that what purports to be a copy of the ’549 patent is attached to the
`
`Complaint as Exhibit E. Bioepis lacks knowledge or information sufficient to form a belief about
`
`the truth of the allegations in the last sentence of Paragraph 46 and, therefore, denies the same.
`
`Paragraph 46 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`47.
`
`To the extent the allegations in Paragraph 47 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 47 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`48.
`
`Bioepis admits that the ’908 patent is titled “Treatment with Anti-ErB2
`
`Antibodies,” that the United States Patent and Trademark Office issued the ’908 patent on April
`
`23, 2013, and that what purports to be a copy of the ’908 patent is attached to the Complaint as
`
`Exhibit F. Bioepis lacks knowledge or information sufficient to form a belief about the truth of
`
`the allegations in the last sentence of Paragraph 48 and, therefore, denies the same. Paragraph 48
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`11
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 12 of 91 PageID #: 1055
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`The Method of Administration Patents
`
`49.
`
`To the extent the allegations in Paragraph 49 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 49 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`50.
`
`Bioepis admits that the ’196 patent is titled “Dosages for Treatment with Anti-
`
`ErbB2 Antibodies,” that the United States Patent and Trademark Office issued the ’196 patent on
`
`September 30, 2003, and that what purports to be a copy of the ’196 patent is attached to the
`
`Complaint as Exhibit G. Bioepis lacks knowledge or information sufficient to form a belief about
`
`the truth of the allegations in the last sentence of Paragraph 50 and, therefore, denies the same.
`
`Paragraph 50 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`51.
`
`Bioepis admits that the ’379 patent is titled “Dosages for Treatment with Anti-
`
`ErbB2 Antibodies,” that the United States Patent and Trademark Office issued the ’379 patent on
`
`May 13, 2008, and that what purports to be a copy of the ’379 patent is attached to the Complaint
`
`as Exhibit H. Bioepis lacks knowledge or information sufficient to form a belief about the truth
`
`of the allegations in the last sentence of Paragraph 51 and, therefore, denies the same. Paragraph
`
`51 otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`12
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 13 of 91 PageID #: 1056
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`The Acidic Variants Patents
`
`52.
`
`To the extent the allegations in Paragraph 52 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 52 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`53.
`
`Bioepis admits that the ’142 patent is titled “Protein Purification,” that the United
`
`States Patent and Trademark Office issued the ’142 patent on January 15, 2002, and that what
`
`purports to be a copy of the ’142 patent is attached to the Complaint as Exhibit I. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 53 and, therefore, denies the same. Paragraph 53 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`54.
`
`Bioepis admits that the ’335 patent is titled “Protein Purification,” that the United
`
`States Patent and Trademark Office issued the ’335 patent on July 9, 2002, and that what purports
`
`to be a copy of the ’335 patent is attached to the Complaint as Exhibit J. Bioepis lacks knowledge
`
`or information sufficient to form a belief about the truth of the allegations in the last sentence of
`
`Paragraph 54 and, therefore, denies the same. Paragraph 54 otherwise contains Plaintiffs’
`
`13
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 14 of 91 PageID #: 1057
`
`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
`
`no response is required. To the extent that a response is required, Bioepis denies the allegations.
`
`55.
`
`Bioepis admits that the ’218 patent is titled “Protein Purification,” that the United
`
`States Patent and Trademark Office issued the ’218 patent on February 2, 2016, and that what
`
`purports to be a copy of the ’218 patent is attached to the Complaint as Exhibit K. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 55 and, therefore, denies the same. Paragraph 55 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`HER2 Diagnostic Patents
`
`56.
`
`To the extent the allegations in Paragraph 56 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 56 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`57.
`
`Bioepis admits that the ’834 patent is titled “Detection of ErbB2 Gene
`
`Amplification to Increase the Likelihood of the Effectiveness of the ErbB2 Antibody Breast
`
`Cancer Therapy,” that the United States Patent and Trademark Office issued the ’834 patent on
`
`August 9, 2011, and that what purports to be a copy of the ’834 patent is attached to the Complaint
`
`as Exhibit L. Bioepis lacks knowledge or information sufficient to form a belief about the truth of
`
`the allegations in the last sentence of Paragraph 57 and, therefore, denies the same. Paragraph 57
`
`14
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 15 of 91 PageID #: 1058
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`58.
`
`Bioepis admits that the ’066 patent is titled “Gene Detection Assay for Improving
`
`the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” that the United
`
`States Patent and Trademark Office issued the ’066 patent on December 13, 2011, and that what
`
`purports to be a copy of the ’066 patent is attached to the Complaint as Exhibit M. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 58 and, therefore, denies the same. Paragraph 58 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`59.
`
`Bioepis admits that the ’402 patent is titled “Gene Detection Assay for Improving
`
`the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” that the United
`
`States Patent and Trademark Office issued the ’402 patent on May 14, 2013, and that what purports
`
`to be a copy of the ’402 patent is attached to the Complaint as Exhibit N. Bioepis lacks knowledge
`
`or information sufficient to form a belief about the truth of the allegations in the last sentence of
`
`Paragraph 59 and, therefore, denies the same. Paragraph 59 otherwise contains Plaintiffs’
`
`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
`
`no response is required. To the extent that a response is required, Bioepis denies the allegations.
`
`Cell Culture, Purification, and Antibody Manufacturing Patents
`
`60.
`
`To the extent the allegations in Paragraph 60 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`15
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 16 of 91 PageID #: 1059
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 60 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`61.
`
`Bioepis admits that the ’516 patent is titled “Cell Culture Process,” that the United
`
`States Patent and Trademark Office issued the ’516 patent on August 26, 2003, and that what
`
`purports to be a copy of the ’516 patent is attached to the Complaint as Exhibit O. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 61 and, therefore, denies the same. Paragraph 61 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`62.
`
`Bioepis admits that the ’660 patent is titled “Methods for Growing Mammalian
`
`Cells In Vitro,” that the United States Patent and Trademark Office issued the ’660 patent on June
`
`24, 2008, and that what purports to be a copy of the ’660 patent is attached to the Complaint as
`
`Exhibit P. Bioepis lacks knowledge or information sufficient to form a belief about the truth of
`
`the allegations in the last sentence of Paragraph 62 and, therefore, denies the same. Paragraph 62
`
`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
`
`and/or legal conclusions, to which no response is required. To the extent that a response is
`
`required, Bioepis denies the allegations.
`
`63.
`
`Bioepis admits that the ’704 patent is titled “Reducing Protein A Leaching During
`
`Protein A Affinity Chromatography,” that the United States Patent and Trademark Office issued
`
`the ’704 patent on February 3, 2009, and that what purports to be a copy of the ’704 patent is
`
`16
`
`

`

`Case 1:18-cv-01363-CFC Document 33 Filed 11/19/18 Page 17 of 91 PageID #: 1060
`
`attached to the Complaint as Exhibit Q. Bioepis lacks knowledge or information sufficient to form
`
`a belief about the truth of the allegations in the last sentence of Paragraph 63 and, therefore, denies
`
`the same. Paragraph 63 otherwise contains Plaintiffs’ characterization of their claims, applicable
`
`law and regulations, and/or legal conclusions, to which no response is required. To the extent that
`
`a response is required, Bioepis denies the allegations.
`
`64.
`
`Bioepis admits that the ’799 patent is titled “Reducing Protein A Leaching During
`
`Protein A Affinity Chromatography,” that the United States Patent and Trademark Office issued
`
`the ’799 patent on October