ATTORNEY DOCKET NO. 23278.2.US.9
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`)
`)
`) Group Art Unit: 1629
`)
`) Examiner: Not Yet Assigned
`)
`) Examiner in Parent: Shirley V. GEMBEH
`)
`) Confirmation No.: 3806
`)
`)
`
`In reApplication of:
`
`Giorgio CALDERARI et al.
`
`Application No.: 13/901,830
`
`Filed: May 24, 2013
`
`For:
`
`LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`SUBSTANCE OF THE INTERVIEW
`
`Pursuant to 37 C.F.R. § 1.133 and MPEP § 713.04, Applicants herein provide a
`
`written statement as
`
`to
`
`the substance of the
`
`in-person
`
`interview conducted
`
`on June 13, 2013, between Applicants' representatives, Clark Sullivan, Mariagrazia
`
`Zotti, Amanda Murphy, and Tom Irving, and Examiner Gembeh and her supervisor
`
`Brandon Fetterolf.
`
`MPEP § 713.04 provides the following guidelines:
`
`(A) a brief description of the nature of any exhibit shown or any
`
`demonstration conducted:
`
`Applicants' representatives showed slides that were attached to the
`
`Examiner's Interview Summary, and are attached again.
`
`In addition, Applicants'
`
`representatives provided a binder to each of the Examiners containing the
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1008
`
`Exh. 1008, Page 1 of 19
`
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`)
`)
`) Group Art Unit: 1629
`)
`) Examiner: Not Yet Assigned
`)
`) Examiner in Parent: Shirley V. GEMBEH
`)
`) Confirmation No.: 3806
`)
`)
`
`In reApplication of:
`
`Giorgio CALDERARI et al.
`
`Application No.: 13/901,830
`
`Filed: May 24, 2013
`
`For:
`
`LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`SUBSTANCE OF THE INTERVIEW
`
`Pursuant to 37 C.F.R. § 1.133 and MPEP § 713.04, Applicants herein provide a
`
`written statement as
`
`to
`
`the substance of the
`
`in-person
`
`interview conducted
`
`on June 13, 2013, between Applicants' representatives, Clark Sullivan, Mariagrazia
`
`Zotti, Amanda Murphy, and Tom Irving, and Examiner Gembeh and her supervisor
`
`Brandon Fetterolf.
`
`MPEP § 713.04 provides the following guidelines:
`
`(A) a brief description of the nature of any exhibit shown or any
`
`demonstration conducted:
`
`Applicants' representatives showed slides that were attached to the
`
`Examiner's Interview Summary, and are attached again.
`
`In addition, Applicants'
`
`representatives provided a binder to each of the Examiners containing the
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1008
`
`Exh. 1008, Page 1 of 19
`
`
`
`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 2 of 4
`
`evidence and allegations of the alleged on-sale bar from the pending related
`
`litigation, which were also previously
`
`filed
`
`in an
`
`Information Disclosure
`
`Statement;
`
`(B) identification of the claims discussed:
`
`all claims were discussed;
`
`(C) identification of specific prior art discussed:
`
`the alleged on-sale bar allegations and evidence from the pending related
`
`litigation were discussed;
`
`(D) identification of the principal proposed amendments of a substantive
`
`nature discussed, unless these are already described on the Interview Summary
`
`form completed by the examiner:
`
`no amendments were proposed;
`
`(E) the general thrust of the principal arguments of the applicant and the
`
`examiner should also be identified, even where the interview is initiated by the
`
`examiner. The identification of arguments need not be lengthy or elaborate. A
`
`verbatim or highly detailed description of the arguments is not required. The
`
`identification of the arguments is sufficient if the general nature or thrust of the
`
`principal arguments can be understood in the context of the application file. Of
`
`course, the applicant may desire to emphasize and fully describe those
`
`arguments which he or she feels were or might be persuasive to the examiner:
`
`Applicants' representatives explained why the allegations of on-sale bar
`
`are erroneous, as set forth in the slides;
`
`Exh. 1008, Page 2 of 19
`
`
`
`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 3 of 4
`
`(F) a general indication of any other pertinent matters discussed:
`
`Applicants' representatives explained the previously filed
`
`Information
`
`Disclosure Statement. The Examiners also requested appropriate Terminal
`
`Disclaimers, and such disclaimers have been filed.
`
`In addition, there was a
`
`general discussion of other co-pending related applications;
`
`(G) if appropriate, the general results or outcome of the interview:
`
`As reflected in the Examiner's Interview Summary, the Examiners agreed
`
`that the on-sale allegations do not apply to this JMM ("Jedi Master Mixer")
`
`application. See also "Examination Guidelines for Implementing the First
`
`Inventor to File Provisions of the Leahy-Smith America Invents Act," Federal
`
`Register/Val. 78, No. 31/Thursday, February 14, 2013/Rules and Regulations
`
`11059, at 11062, 11084, n. 8. The Examiners also agreed to consider the
`
`Terminal Disclaimers;
`
`(H) in the case of an interview via electronic mail, a paper copy of the
`
`Internet e-mail contents MUST be made and placed in the patent application file
`
`as required by the Federal Records Act in the same manner as an Examiner
`
`Interview Summary Form, PTOL 413, is entered:
`
`Because the interview was conducted in person, this element is not
`
`applicable.
`
`Exh. 1008, Page 3 of 19
`
`
`
`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 4 of 4
`
`Applicants believe the claims are in condition for allowance. If there are any fees
`
`due in connection with the filing of this Substance of the Interview, please charge the
`
`fees to Deposit Account 504667.
`
`Respectfully submitted,
`
`ARNALL GOLDEN GREGORY LLP
`
`Clark G. Sullivan
`Reg. No. 36,942
`
`ARNALL GOLDEN GREGORY LLP
`( 404) 873-8500
`(404) 873-8501 (fax)
`Customer No.: 53449
`
`Attorney Docket No.: 23278.2.US.9
`
`Exh. 1008, Page 4 of 19
`
`
`
`ATTACHMENT
`ATTACHMENT
`
`Exh. 1008, Page 5 of 19
`
`
`
`Aloxi®
`Helsinn Healthcare
`
`Patent Application Overview
`June 13, 2013
`Application No. 13/087,012
`
`Exh. 1008, Page 6 of 19
`
`
`
`• Fourth 5-HT3 Antagonist to Market
`• FDA approval 7/25/2003
`• About $600 million in worldwide sales
`annually
`• Unexpected ability to treat nausea and
`vomiting resulting from chemotherapy for five
`consecutive days
`
`Exh. 1008, Page 7 of 19
`
`
`
`• At least four patent challengers, including:
`-Teva
`-Sandoz
`- Dr. Reddy's
`
`• Those three defendants have erroneously raised
`on sale bar defenses against the patents covering
`Aloxi®, which Examiner Gembeh properly issued:
`- us 7,947,725
`- us 7,960,424
`- us 7,947,724
`
`Exh. 1008, Page 8 of 19
`
`
`
`RCE of 13/087,012
`
`• "Terminal Sterilization Application"
`• Allowed February 27, 2013
`• Motions to amend invalidity contentions
`served by the defendants shortly before
`allowance
`• Duty of disclosure required us to file an RCE
`• Critical date: 1/30/02
`
`Exh. 1008, Page 9 of 19
`
`
`
`Other New Applications
`
`• An application to reissue '725 patent
`{13/900,174)
`-Added limitations for the dose (0.25 mg)
`• One new TRACK 1 CON
`• Four new TRACK 1 CIPs (pre- and post-AlA
`claims)
`-Cover a new formulation for Japanese market
`-Choice of Law: governed by AlA 102(a)(1), (a)(2),
`and 103, and by pre-AlA 102(g)
`
`Exh. 1008, Page 10 of 19
`
`
`
`Defendants' On Sale Bar Arguments
`
`• Litigation challengers raised three on sale bar
`defenses
`-Two Development and Manufacturing agreements:
`• Oread Toll Manufacturing Agreement1 (7 /98)
`• SP/Osobio Toll Manufacturing Agreement (6/02) preceded by
`letter of intent (10/00)
`- One Distribution Agreement
`• MGI/Eisai Supply and Purchase Agreement (4/01)
`
`1 A toll manufacturing agreement is an arrangement in which a firm, which has a specialized
`equipment, processes raw materials or semi-finished goods for another firm.
`
`Exh. 1008, Page 11 of 19
`
`
`
`SP Pharmaceuticals: No On-Sale Bar
`
`• SP Pharmaceuticals (toll manufacturer)
`allegedly "sold" the finished clinical trial drug
`product materials to Helsinn
`• But title at all times remained with Helsinn:
`Section 2.08 Ownership of Materials. Title to all API, work in process and
`finished Products shall at all times remain with Helsinn. SP and Helsinn
`shall maintain insurance with respect to such property as provided in Article
`XIII hereof.
`• SP merely had a license:
`Section 10.01 Limited License. Helsinn grants a non-exclusive, royalty-free
`license to SP to use Helsinn patents and other intellectual property supplied
`by Helsinn solely for the purpose of manufacturing the Product for Helsinn
`under this Agreement.
`
`Exh. 1008, Page 12 of 19
`
`
`
`SP Pharmaceuticals: No On-Sale Bar
`
`• MPEP 2133.03(b):
`-"A sale is a contract between parties wherein the
`seller agrees 'to give and to pass rights of
`property' in return for the buyer's payment or
`promise 'to pay the seller for the things bought or
`sold.'"
`• Because title remained with Helsinn at all
`times, there was no on-sale bar.
`
`Exh. 1008, Page 13 of 19
`
`
`
`Oread: No On-Sale Bar
`• Oread Labs (toll manufacturer) allegedly
`"sold" the finished clinical trial drug product
`materials to Helsinn
`• But title at all times remained proprietary with Helsinn
`("the Client"):
`Article 7- Use of Materials, Confidential Information and Intellectual Property
`7.1 The parties hereto acknowledge that all samples, development materials,
`and confidential information are proprietary to Client and are part of the
`confidential information of Client. Oread agrees (i) to account for all materials
`provided by Client; (ii) not to provide samples of any Client supplied materials to
`any third party without the express written consent of Client; (iii) not to attempt
`to analyze or characterize Client supplied materials, except as necessary for the
`Projects; (iv) to return (or destroy if Client so directs) all unused quantities of
`materials to Client upon completion of the subject studies, or sooner if Client so
`directs, and (v) not to use any Client confidential or proprietary information
`except as provided herein or in the Confidentiality Agreement.
`• Therefore, no sale (see MPEP 2133.03(b))
`
`Exh. 1008, Page 14 of 19
`
`
`
`MGI: No On-Sale Bar
`• Helsinn entered into two agreements with MGI:
`"License Agreement" and "Supply and Purchase
`Agreement"
`
`License Agreement Section 4.1
`MGI hereby acknowledges and agrees that
`4.1.1 at the Effective Date of this Agreement the Products are under
`development by HHC for the purpose of submitting the relevant Registration
`application to the Regulatory Authorities of the Territory,
`4.1.4 HHC makes no warranty and nothing in this Agreement may or shall be
`construed as a warranty by HHC that the Products will obtain the Registration or
`that a Product can be developed and registered from the Know-how and MGI
`shall have no claim against HHC arising out of any delay or refusal by the
`Regulatory Authorities to issue the Registration in any way whatsoever.
`
`Exh. 1008, Page 15 of 19
`
`
`
`MGI: No On-Sale Bar
`
`• Helsinn allegedly "offered to sell" drug substance
`to MGI (licensee I distributor)
`• But, in fact, agreement contemplated MGI would only make
`offers to buy
`• Helsinn (HBP) had full discretion to accept or reject MGI's
`offers, and only in writing
`
`Supply and Purchase Agreement Section 4.2
`The Products will be supplied to MGI only against MGI's written order and all orders
`shall be subject to written acceptance and confirmation by HBP before becoming
`binding. Such acceptance and confirmation may be by facsimile or otherwise. Each
`order by MGI shall be for a minimum quantity corresponding to the size of one
`production batch of Products, as shall be indicated in due time by HBP, or multiples
`thereof.
`
`Exh. 1008, Page 16 of 19
`
`
`
`MGt: No On-Sale Bar
`
`• MGI did not place any orders before the critical
`date
`
`• And, even if an order had been placed, those
`orders were not binding until "written
`acceptance and confirmation" by Helsinn.
`
`Exh. 1008, Page 17 of 19
`
`
`
`MGI: No On-Sale Bar
`
`-
`
`• MPEP 2133.03{b) addresses this situation
`exactly, citing Linear Technology Corp. v. Micrel/
`Inc., 275 F.3d 1040 (Fed. Cir. 2001):
`11(Court held there was no sale within the meaning
`of 35 U.S.C. 102{b) where prospective purchaser
`submitted an order for goods at issue, but received
`an order acknowledgement reading 'will advise-not
`booked.' Prospective purchaser would understand
`that order was not accepted.)."
`
`Exh. 1008, Page 18 of 19
`
`
`
`MGI: No On-Sale Bar
`
`• MPEP 2133.03(b):
`11A contract for the sale of goods requires a concrete
`offer and acceptance of that offer."
`
`-
`
`• Because Helsinn never accepted an order before
`the critical date, there was no on-sale bar.
`
`Exh. 1008, Page 19 of 19
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