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IP Issues in the Therapeutic Antibody Industry

  • Protocol
Antibody Engineering

Part of the book series: Springer Protocols Handbooks ((SPH))

Abstract

The following section is related to IP issues in the therapeutic Antibody industry. A rough overview over protected enabling techniques and compounds is provided, in order to facilitate the entry into freedom to operate studies. Furthermore, some general information about specific issues is provided, and the stories of some historic lawsuits fought between Antibody companies in the past are being told.

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Notes

  1. 1.

    The present article does not represent, or replace, legal counsel. Although all information has been assembled with utmost care, the authors exclude any liability for damages caused by actions or opinions relying on this information.

  2. 2.

    Clarke, M., Keynote at 7th “Recombinant Antibodies,” June 24–26, 2008, Dublin

  3. 3.

    German Center for Cancer Research.

  4. 4.

    CHO cells are, for example, being used for the production of Avastin, Humira, Herceptin, Rituxan, Vectibix, Raptiva, Campath, and Xolair.

  5. 5.

    Data as of October 2008.

  6. 6.

    EPO decision T542/95.

  7. 7.

    EPO decisions T355/92; T510/94.

  8. 8.

    Merck vs. Olin Mathieson, 253 F.2d 156, 160 (4th Cir. 1958).

  9. 9.

    Three step approach, as applied in the BGH decisions “Kunststoffrohrteil,” “Schneidmesser I,” “Schneidmesser II,” “Custodiol I,” “Custodiol II,” GRUR 2002, 511–531.

  10. 10.

    “Catnic test” as applied in Kirin-Amgen, Inc. v Hoechst Marion Roussel Ltd. [2004] UKHL 46 (2004-10-21).

  11. 11.

    Art. 2 of the Protocol on the Interpretation of Art. 69 EPC.

  12. 12.

    BGH decision “Imidazoline,” BGH GRUR 1972, 541.

  13. 13.

    EU Directive 98/44/EC, see rule Rule 29 of the EPC.

  14. 14.

    35 U.S.C. § 112/6.

  15. 15.

    Graver Tank vs. Linde, 339 U.S. 605 (1950), and Warner-Jenkinson vs. Hilton Davis 520 US 17 (1997).

  16. 16.

    Festo Corp. vs. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed. Cir. 2000).

  17. 17.

    see Noelle v. Lederman (Fed. Cir. April 2004).

  18. 18.

    Data retrieved from the FamPat database as of November 2008.

  19. 19.

    Art. 54(5) EPC.

  20. 20.

    35 U.S.C. 101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a Patent therefore.”

  21. 21.

    The EMEA defines Biosimilars as follows: “The active substance of a similar biological medicinal product must be similar, in molecular and biological terms, to the active substance of the reference medicinal product”. The FDA states that “Follow-on protein products (are) proteins and peptides that are intended to be sufficiently similar to a product already approved.”

  22. 22.

    see, among others, guideline EMEA/CHMP/42832/2005.

  23. 23.

    Data as of Sept. 2009.

  24. 24.

    An application under § 505(b)(2) is currently the only feasible way for approval of Biosimilars in the US, but, according to the FDA, only applicable for small, non-glycosylated proteins, like Somatropin (22kD). Before this background, generic drug manufacturer Teva has decided not to wait for the enactment of an accelerated Biosimilar approval regime in the US, but will go for a full approval for its GCSF Biosimilar (which is approved in the EU already), despite higher costs.

  25. 25.

    Data as of Sept. 2009.

  26. 26.

    The EMEA organized a workshop on Biosimilar antibodies in July 2009, to which about 160 people from academic and regulatory institutions and from 40 biopharmaceutical companies located worldwide had been invited.

  27. 27.

    EMEA/CHMP/BMWP/632613/2009 guideline (Concept paper on the development of a guideline on similar biological medicinical products containing monoclonal antibodies exists as a concept paper only.

  28. 28.

    IgG are n-glycosylated in CH2 (Asn 297) and have about 150 kD. scFV are unglycosylated and have about 26 kD.

  29. 29.

    GTC press release of August 9, 2007.

  30. 30.

    Introduced to the German Patent Act in the course of the implemention of EC Directive 2004/27/EC.

  31. 31.

    Also known as Hatch-Waxman Act, or Bolar exemption.

  32. 32.

    Telectronics Pacing Systems vs. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992).

  33. 33.

    BGH “Clinical trials II,” Mitt. 1997, 253.

  34. 34.

    Merck vs. Integra, 545 U.S. 193 (U.S. Supreme Court 2005).

  35. 35.

    BGH GRUR 1971, 243 “Gewindeschneidvorrichtungen.”

  36. 36.

    Example “Use/Practice of the [Kit] is covered by Patent No X assigned to X. Purchase of the [Kit] does not imply or convey a license to practice. Commercial entities must obtain a license from X. Non-profit institutions may obtain a complimentary license for research not sponsored by industry. Please contact X.”

  37. 37.

    A respective amendment was set in force January 1, 1995, following the GATT implementing legislation.

  38. 38.

    See WIPO (World Intellectual Property Organization) survey of January 2002.

  39. 39.

    According to information provided by IMS Health Incorporated.

  40. 40.

    Regulation EEC/1768/92.

  41. 41.

    Compliant with TRIPS agreement, Article 39 (3), which all members of the WTO have agreed upon.

  42. 42.

    Regulation (EC) 726/2004.

  43. 43.

    Hatch-Waxman Act, Section 505(j) 21 U.S.C. 355(j) of Federal Food, Drug, and Cosmetic Act.

  44. 44.

    Food and Drug Administration Modernization Act.

  45. 45.

    Data as of September 2009.

  46. 46.

    EU: Regulation 141/2000; U.S.: Orphan Drug Act.

  47. 47.

    Japan, Europe, South Korea, Cuba, Ukraine, India, China, Colombia, Peru, Brazil, Pakistan, Argentina Singapore, Indonesia and Mexico (according to YM Biosciences).

  48. 48.

    According to EPO information.

  49. 49.

    London Agreement, which came into force in May 2008.

  50. 50.

    Data as of November 2008.

  51. 51.

    As under some circumstances possible under Arts 28, 30 of the EC Treaty, see decision of the EuGH (European Court of Justice) GRUR Int. 1974, 454 “Centrafarm,” also BGH GRUR 2000, 299 “Karate”

  52. 52.

    EPO decision T669/04.

  53. 53.

    University of Rochester vs. G.D. Searle & Co, 358 F.3d 916, Court of Appeals for the Federal Circuit.

  54. 54.

    Bayer vs. Housey, 2003 U.S. App. Lexis 17453 (Fed. Cir. Aug. 22, 2003).

  55. 55.

    LLC, No. M830,. 2007 U.S. App. LEXIS 19768 (Fed. Cir. Aug. 20, 2007).

  56. 56.

    US Patent Reform Act of 2009, which is pending before the Senate and the House of Representatives, suggests a first-to-file system in case Europe and Japan introduce a one year grace period (the latter being quite unlikely).

  57. 57.

    Note that in Canada small entity status is applicable to universities and businesses having less than 50 employees.

  58. 58.

    Bayh-Dole Act (35 U.S.C. § 200–212).

  59. 59.

    § 611 ff of the German Civil Code (“BGB”).

  60. 60.

    Upjohn Co. vs. US, 449 U.S. 383, 389 (1981).

  61. 61.

    Smith vs. Alyeska Pipeline Service, 538 F.Supp. 977 (D.Del. 1982).

  62. 62.

    Convolve vs. Compaq, 224 F.R.D. 98, 104 (S.D.N.Y. 2004).

  63. 63.

    § 1 (2) Nr. 5 of the Utility Model Act.

  64. 64.

    BGH “Demonstrationsschrank,” GRUR 2006, 842.

  65. 65.

    According to a study provided by the EPO in February 2006, 1st instance litigation costs in the UK are between 4–6 times higher than in Germany.

  66. 66.

    Only 7% of 1st instance decisions of the Dusseldorf court are revoked in the 2nd instance (pers. comm. of Judge Kühnen,head of patent litigation chamber of the Düsseldorf appellate court).

  67. 67.

    Wirtschaftswoche Nr. 29/2004.

  68. 68.

    Often disrespectfully termed “italian torpedo.”

  69. 69.

    EU enforcement directive 2004/48/EC.

  70. 70.

    This chapter has been written by Alan J. Morrison of Cohen Pontani Lieberman & Pavane LLP, New York. It reflects the views and considerations of the co-author, which should not be attributed to Cohen Pontani Lieberman & Pavane LLP or to any of its clients.

  71. 71.

    363 F.3d 1247 (Fed. Cir., 2004).

  72. 72.

    Dusseldorf Appelate Court, 2 U 80/02.

  73. 73.

    Rechtbank’S-Gravenhage, File Numbers 04/2384 and 04/3065.

  74. 74.

    Marketed in Germany by Novartis under license of Genentech.

  75. 75.

    Statement of the American Academy of Ophthalmology (AAO) in October 2007.

  76. 76.

    Der Spiegel, September 29, 2008, p. 140.

  77. 77.

    Record number S 2 KA 181/07 of July 2, 2008.

  78. 78.

    03 Civ. 8484.

  79. 79.

    EPO annual report, 2007.

  80. 80.

    EPO fees for an opposition are 635 €, while fees for a nullity suit before the Federal Patent Court (BPatG) depend on the amount in dispute calculated by the value of the patent (e.g., value = 1.000.000 €, court fees = 20.052,- €). The comparison does not include attorney fees. Note that in the latter, the losing party bears all costs. However, nullity suits have effect on a national patent derived from the respective European Patent only, i.e., it might be that several parallel nullity suits are necessary. However, a centralized European Nullity procedure is now under discussion.

  81. 81.

    US Patent Reform Act of 2007, which has passed the House of Representatives in 2007 and has been prepared for the Senate in 2008, suggests the introduction of a post grant opposition procedure.

  82. 82.

    EPO appeal cases T 1212/97 and T 0400/97.

  83. 83.

    For details of the settlement see Morphosys’ press release of Dec. 23, 2002.

  84. 84.

    Full text available from the US Patent Full Text and Image Database.

  85. 85.

    According to Genentech’s Annual report (Form 10K) filed with the SEC February 26, 2008.

  86. 86.

    CV 03-2567 (C.D. Cal. Jan. 14, 2004; February 18, 2004; Mar. 15, 2004; April 29, 2004).

  87. 87.

    Gen-Probe vs. Vysis (359 F. 3d 1376 (2004).

  88. 88.

    U.S. Supreme Court, Case No. 05-608 1/9/07.

  89. 89.

    BGH “Gewindeschneidvorrichtungen,” GRUR 1971, 243.

  90. 90.

    Genentech press release of June 11, 2008.

  91. 91.

    Genentech press release of Feb 24, 2009.

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Author information

Authors and Affiliations

  1. Michalski Hüttermann & Partner Patent Attorneys, Düsseldorf, Germany

    Ulrich Storz

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  1. Ulrich Storz
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Correspondence to Ulrich Storz .

Editor information

Editors and Affiliations

  1. (Biomedical Engineering) Institut für Zellbiologie und Immunologie, Universität Stuttgart, Allmandring 31, 70569, Stuttgart, Germany

    Roland Kontermann

  2. Technische Universität Braunschweig, Institut für Biochemie und Biotechnologie, Spielmannstraße 7, 38106, Braunschweig, Germany

    Stefan Dübel

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Storz, U. (2010). IP Issues in the Therapeutic Antibody Industry. In: Kontermann, R., Dübel, S. (eds) Antibody Engineering. Springer Protocols Handbooks. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-01147-4_39

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  • DOI: https://doi.org/10.1007/978-3-642-01147-4_39

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-01146-7

  • Online ISBN: 978-3-642-01147-4

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