`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`)
`)
`) Group Art Unit: 1629
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`) Examiner: Not Yet Assigned
`)
`) Examiner in Parent: Shirley V. GEMBEH
`)
`) Confirmation No.: 3806
`)
`)
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`In reApplication of:
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`Giorgio CALDERARI et al.
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`Application No.: 13/901,830
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`Filed: May 24, 2013
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`For:
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`LIQUID PHARMACEUTICAL
`FORMULATIONS OF
`PALONOSETRON
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Commissioner:
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`SUBSTANCE OF THE INTERVIEW
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`Pursuant to 37 C.F.R. § 1.133 and MPEP § 713.04, Applicants herein provide a
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`written statement as
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`to
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`the substance of the
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`in-person
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`interview conducted
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`on June 13, 2013, between Applicants' representatives, Clark Sullivan, Mariagrazia
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`Zotti, Amanda Murphy, and Tom Irving, and Examiner Gembeh and her supervisor
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`Brandon Fetterolf.
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`MPEP § 713.04 provides the following guidelines:
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`(A) a brief description of the nature of any exhibit shown or any
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`demonstration conducted:
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`Applicants' representatives showed slides that were attached to the
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`Examiner's Interview Summary, and are attached again.
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`In addition, Applicants'
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`representatives provided a binder to each of the Examiners containing the
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`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
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`Exh. 1008, Page 1 of 19
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`
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`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 2 of 4
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`evidence and allegations of the alleged on-sale bar from the pending related
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`litigation, which were also previously
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`filed
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`in an
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`Information Disclosure
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`Statement;
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`(B) identification of the claims discussed:
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`all claims were discussed;
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`(C) identification of specific prior art discussed:
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`the alleged on-sale bar allegations and evidence from the pending related
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`litigation were discussed;
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`(D) identification of the principal proposed amendments of a substantive
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`nature discussed, unless these are already described on the Interview Summary
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`form completed by the examiner:
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`no amendments were proposed;
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`(E) the general thrust of the principal arguments of the applicant and the
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`examiner should also be identified, even where the interview is initiated by the
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`examiner. The identification of arguments need not be lengthy or elaborate. A
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`verbatim or highly detailed description of the arguments is not required. The
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`identification of the arguments is sufficient if the general nature or thrust of the
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`principal arguments can be understood in the context of the application file. Of
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`course, the applicant may desire to emphasize and fully describe those
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`arguments which he or she feels were or might be persuasive to the examiner:
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`Applicants' representatives explained why the allegations of on-sale bar
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`are erroneous, as set forth in the slides;
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`Exh. 1008, Page 2 of 19
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`
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`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 3 of 4
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`(F) a general indication of any other pertinent matters discussed:
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`Applicants' representatives explained the previously filed
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`Information
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`Disclosure Statement. The Examiners also requested appropriate Terminal
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`Disclaimers, and such disclaimers have been filed.
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`In addition, there was a
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`general discussion of other co-pending related applications;
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`(G) if appropriate, the general results or outcome of the interview:
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`As reflected in the Examiner's Interview Summary, the Examiners agreed
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`that the on-sale allegations do not apply to this JMM ("Jedi Master Mixer")
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`application. See also "Examination Guidelines for Implementing the First
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`Inventor to File Provisions of the Leahy-Smith America Invents Act," Federal
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`Register/Val. 78, No. 31/Thursday, February 14, 2013/Rules and Regulations
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`11059, at 11062, 11084, n. 8. The Examiners also agreed to consider the
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`Terminal Disclaimers;
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`(H) in the case of an interview via electronic mail, a paper copy of the
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`Internet e-mail contents MUST be made and placed in the patent application file
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`as required by the Federal Records Act in the same manner as an Examiner
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`Interview Summary Form, PTOL 413, is entered:
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`Because the interview was conducted in person, this element is not
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`applicable.
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`Exh. 1008, Page 3 of 19
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`
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`U.S. Application No.: 13/901,830
`Substance of Interview
`June 17, 2013
`Page 4 of 4
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`Applicants believe the claims are in condition for allowance. If there are any fees
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`due in connection with the filing of this Substance of the Interview, please charge the
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`fees to Deposit Account 504667.
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`Respectfully submitted,
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`ARNALL GOLDEN GREGORY LLP
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`Clark G. Sullivan
`Reg. No. 36,942
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`ARNALL GOLDEN GREGORY LLP
`( 404) 873-8500
`(404) 873-8501 (fax)
`Customer No.: 53449
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`Attorney Docket No.: 23278.2.US.9
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`Exh. 1008, Page 4 of 19
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`
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`ATTACHMENT
`ATTACHMENT
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`Exh. 1008, Page 5 of 19
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`
`
`Aloxi®
`Helsinn Healthcare
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`Patent Application Overview
`June 13, 2013
`Application No. 13/087,012
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`Exh. 1008, Page 6 of 19
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`
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`• 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
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`Exh. 1008, Page 7 of 19
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`
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`• At least four patent challengers, including:
`-Teva
`-Sandoz
`- Dr. Reddy's
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`• 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
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`Exh. 1008, Page 8 of 19
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`
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`RCE of 13/087,012
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`• "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
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`Exh. 1008, Page 9 of 19
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`
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`Other New Applications
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`• 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)
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`Exh. 1008, Page 10 of 19
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`
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`Defendants' On Sale Bar Arguments
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`• 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)
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`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.
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`Exh. 1008, Page 11 of 19
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`
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`SP Pharmaceuticals: No On-Sale Bar
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`• 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.
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`Exh. 1008, Page 12 of 19
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`
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`SP Pharmaceuticals: No On-Sale Bar
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`• 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.
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`Exh. 1008, Page 13 of 19
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`
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`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))
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`Exh. 1008, Page 14 of 19
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`
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`MGI: No On-Sale Bar
`• Helsinn entered into two agreements with MGI:
`"License Agreement" and "Supply and Purchase
`Agreement"
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`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.
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`Exh. 1008, Page 15 of 19
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`
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`MGI: No On-Sale Bar
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`• 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
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`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.
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`Exh. 1008, Page 16 of 19
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`
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`MGt: No On-Sale Bar
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`• MGI did not place any orders before the critical
`date
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`• And, even if an order had been placed, those
`orders were not binding until "written
`acceptance and confirmation" by Helsinn.
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`Exh. 1008, Page 17 of 19
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`
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`MGI: No On-Sale Bar
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`-
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`• 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.)."
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`Exh. 1008, Page 18 of 19
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`MGI: No On-Sale Bar
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`• MPEP 2133.03(b):
`11A contract for the sale of goods requires a concrete
`offer and acceptance of that offer."
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`-
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`• Because Helsinn never accepted an order before
`the critical date, there was no on-sale bar.
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`Exh. 1008, Page 19 of 19