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The Selection of Patents – The Choice Between Regulatory Reforms and Market Reliance to Weed Out Suspect Patents

Abstract

Sir Nicholas Pumfrey J., in an attempt to guide the judicial mind to segregate obvious patents from nonobvious inventions, noted that: “Both the Scylla of considering nothing obvious except that to which the skilled man is driven and the Charybdis of considering every invention obvious that can be decomposed into a sequence of obvious steps must be avoided.” The task of creating a standard that would serve as a guidepost to avoid the obvious in the quest to glean the invention from the improvement has been tedious and remains ongoing. In this regard, one of the oldest debates for which a solution has eluded policy makers relates to the choice between market reliance versus regulatory reforms. The choice of either option as a tool to address policy concerns presents credible advantages as well as disadvantages. The United States has embraced both of these options to address concerns relating to various aspects of the legal system. This paper contrasts the preference for market forces in the United States to streamline the doctrine of nonobviousness with the preference for regulatory reforms to achieve the same objective in India. In this regard, grant opinions from the Indian patent office – a relatively difficult research tool – have been examined to illustrate the standard and demonstrate the results of regulatory reforms on the quality of patents in India. In doing so, the paper also analyzes the conformity of the standard with the TRIPS Agreement, compares it with the standard in the United States and discusses how regulatory reforms have affected the development of the law on nonobviousness in India.

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Notes

  1. 1.

    The Environmental Protection Agency is an agency of the United States Federal Government with rule-making authority. The United States Patent and Trademark Office is an agency established under the Department of Commerce with authority to establish its own rules and regulations. The Code of Federal Regulations codifies the rules and regulations and publishes them in the Federal Register by the departments and agencies of the Federal Government. For example, Titles 37 and 40 of the CFR outline the regulations of the USPTO and the EPA respectively. See generally http://www.ecfr.gov.

  2. 2.

    For example, in the United States, a “new form of a known substance” such as metabolites, salts, polymorphs, or esters of existing compounds remain protectable independently of and separately from the original active ingredient. Such a practice has resulted in a greater number of patents, forming a patent family or portfolio. See generally Polk Wagner and Parchmovsky (2005). Studies have identified the relatively minor nonobvious distinctions of these patents from the parent ingredients, the possibility for an increased term of exclusivity owing to the later filing/priority dates of these patents and the consequential ill effects of such patents. See, e.g., Kapczynski et al. (2012), available at: http://www.plosone.org/article/info:doi/10.1371/journal.pone.0049470. See also European Commission, “Pharmaceutical Sector Inquiry: Final Report” (2009). But the assertion is that such patents can be readily challenged and can be scrutinized by the courts where they may be invalidated should they embody limited nonobviousness, thus allowing the market to act as a gate-keeper to weed out such patents. See C. Scott Hemphill and Bhaven Sampath, “Drug Patents at the Supreme Court,” 339 SCIENCE 1386 (22 March 2013), available at: http://www.sciencemag.org (asserting that secondary patents are thought to be less likely to meet the legal standards of patent validity). See also Hemphill and Sampath (2012); See generally Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1366 (Fed. Cir. 2007); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1338 (Fed. Cir. 2005); Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382–83 (Fed.Cir. 2003) (where such patents were challenged and invalidated); see also Stan Bernard, “Why Product Lifecycle Management Fails Pharma: Time for a Rethink?”, available at: http://bernardassociatesllc.com/wp-content/uploads/2013/08/PE_Drug-Life-Optimization_StanBernard2.pdf (discussing Drug Life Optimization Management strategies).

  3. 3.

    See generally Hemphill and Sampath (2012).

  4. 4.

    See generally 35 USC § 2 and 37 CFR § 1001 (detailing the power of the USPTO to issue regulations to streamline patent and trademark examination and prosecution).

  5. 5.

    Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments – Results of the Uruguay Round, 33 I.L.M 181 (1994) (hereinafter WTO). The WTO consists of countries that are party to the Uruguay Round Agreements of the General Agreement on Tariffs and Trade (GATT). See 4 Pat. L. Fundamentals § 21:18 (2d ed.).

  6. 6.

    Trade-Related Aspects of Intellectual Property Rights, 1994, Annex IC to the General Agreement on Tariffs and Trade, Uruguay Round, World Trade Organization, done at Marrakesh, 15 April 1994, 33 I.L.M. 1981 (1994), reprinted in World Trade Organization, “The Results of the Uruguay Round of Multilateral Trade Negotiations” 365 (1995) (hereinafter TRIPS).

  7. 7.

    Adelman et al. (1998).

  8. 8.

    Harries v. Air King Products Co., 183 F.2d 158, 162 (2d Cir. 1950).

  9. 9.

    Great Atl. and Pac. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 151; 71 S. Ct. 127, 129; 95 L. Ed. 162 (1950).

  10. 10.

    See Cipla Ltd., and Ors v. Glaxo Group Ltd., [2004] R.P.C. 43 (CA).

  11. 11.

    Id.

  12. 12.

    Cuno Eng’g Corp. v. Automatic Devices Corp., 314 U.S. 84, 91; 62 S. Ct. 37, 41; 86 L. Ed. 58 (1941).

  13. 13.

    Crennan (2007).

  14. 14.

    Harries v. Air King Prods. Co., 183 F.2d 158, 162 (2d Cir. 1950).

  15. 15.

    Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248, 265–67 (1850).

  16. 16.

    Id.

  17. 17.

    Id.

  18. 18.

    Hughes (1988).

  19. 19.

    Id.

  20. 20.

    35 USC § 103.

  21. 21.

    See generally Khader and Ragavan (2014).

  22. 22.

    383 U.S. 1 (1966).

  23. 23.

    Id., at 15.

  24. 24.

    Additionally, secondary considerations, such as the commercial success of the patented invention, may be relevant to determining nonobviousness. Id.

  25. 25.

    Lee (2010).

  26. 26.

    732 F.2d 1572, 1577 (Fed. Cir. 1984); see also Duffy and Merges (2007).

  27. 27.

    Id., at 1577.

  28. 28.

    J. Duffy and R. Merges, supra note 26, at 664; see also Ashland Oil v. Delta Resins and Refractories, 776 F.2d 281, 297 (Fed. Cir. 1985).

  29. 29.

    See also P. Lee, supra note 25, at 1719.

  30. 30.

    See U.S. Department of Commerce (1998).

  31. 31.

    See Feroz Ali Khader and A. Ragavan, supra note 21, at 581–85.

  32. 32.

    Id.

  33. 33.

    Id.

  34. 34.

    Brown (1995).

  35. 35.

    KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007); 127 S.Ct. 1727; 167 L. Ed.2d 705 (2007).

  36. 36.

    After the KSR decision of the Supreme Court, the U.S. patent office issued new examination guidelines outlining several bases for rejections under 35 U.S.C. § 103, one of which was the TSM test. See U.S. Patent and Trademark Office (2008) (hereinafter MPEP), available at: http://www.uspto.gov/web/offices/pac/mpep/mpep.htm.

  37. 37.

    Elliott (2009).

  38. 38.

    Id., at 1094; see also Irving et al. (2009).

  39. 39.

    Lim and Wang (2008).

  40. 40.

    Id.

  41. 41.

    Id.; see also T. Irving et al., supra note 38, at 181. See generally 37 C.F.R. § 132 (2008) (detailing the requirements for submission of expert testimony).

  42. 42.

    35 U.S.C. § 282.

  43. 43.

    See generally Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1456; 46 U.S.P.Q.2d 1169, 1174 (Fed. Cir. 1998) (en banc); see also Paul R. Michel, “Appellate Advocacy: One Judge’s View”, 1 Fed. Cir. B.J. 1, 4–5 (1991).

  44. 44.

    See generally Chatlynne (2009).

  45. 45.

    United States Patent and Trademark Office, “Accountability Report 2012” 73; see also United States Patent Office, “Annual Report 2007–2011”, available at: http://www.uspto.gov/about/stratplan/ar/index.jsp.

  46. 46.

    Id. See also Crouch (2012); see generally Dreyfus (2006).

  47. 47.

    See Leahy Smith America Invents Act, Pub. L. 112–29 (H.R. 1249).

  48. 48.

    Innovation Bill, H.R. 3309 (2013).

  49. 49.

    See Indian Patents Act, No. 39 of 1970, as amended by Patents (Amendment) Act, No. 38 of 2002, Sec. 2(1)(ja).

  50. 50.

    Id.; Khader (2007) (for a detailed account on the inventive step standard in Indian law).

  51. 51.

    Id., see also Indian Patents Act, No. 39 of 1970, Sec. 2(1)(j).

  52. 52.

    Id.

  53. 53.

    See Indian Patents Act, No. 39 of 1970, as amended by Patents (Amendment) Act, No. 15 of 2005, India Code (2005), Sec. 2.

  54. 54.

    Khader (2007).

  55. 55.

    F. Hoffmann-La Roche Ltd v. Cipla Ltd., 37 P.T.C. (Del.) 71 (2008).

  56. 56.

    See Hallen Co. v. Brabantia (U.K.) Ltd., (1989) R.P.C. 307, 327.

  57. 57.

    The definition of inventive step in Sec. 2(1)(ja) of the Patents Act, 1970, prior to the Patents (Amendment) Act, 2005, defined inventive step as “a feature that makes the invention not obvious to a person skilled in the art”.

  58. 58.

    Feroz Khader and S. Ragavan, supra note 21, at 583–4.

  59. 59.

    Id.

  60. 60.

    Id., at 585.

  61. 61.

    Id.

  62. 62.

    See Richardson-Vicks Inc’s Patent, (1997) R.P.C. 888 (CA) 897; Windsurfing Int’l Inc. v. Tabur Marine (Great Britain) Ltd., (1985) R.P.C. 59, 72; Johns-Manville Corpn’s Patent, [1967] F.S.R. 327; (1967) R.P.C. 479.

  63. 63.

    See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367; 231 U.S.P.Q. 81 (Fed. Cir. 1986).

  64. 64.

    Id.

  65. 65.

    See Mölnlycke AB v. Procter and Gamble Ltd., (1994) R.P.C. 49, 113.

  66. 66.

    See Haberman v. Jackel Int’l Ltd., [1999] F.S.R. 683, 699.

  67. 67.

    J.T. Eaton and Co. v. Atlantic Paste and Glue Co., 106 F.3d 1563 (Fed. Cir. 1997); see also Richdel Inc. v. Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983); Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299 (Fed. Cir. 2006).

  68. 68.

    35 USC 103.

  69. 69.

    The phrase “technical advancement of considerable economic significance” was used in the context of the grant of a compulsory licence. The expression was used in relation to another patent specifically to compare two patents held by the same patentee, one of which would be subject to compulsory licensing. For instance, the current Sec. 88(3) of the Patents Act as amended in 2002 reads as follows:

  70. 70.

    See The Office of Controller General for Patents, Designs and Trademarks, “Manual for Patent Procedures and Practice (India)” (Draft version 01.11), available at: http://www.ipindia.nic.in [hereinafter MPPP (2008)]. This version contained certain guidelines on determining nonobviousness that did not figure in the 2011 version. See The Office of Controller General for Patents, Designs and Trademarks “Manual for Patent Procedures and Practice (India)” (Draft version 01.11), available at: http://www.ipindia.nic.in [hereinafter MPPP (2011)].

  71. 71.

    See MPPP (2008), supra note 70; see also MPPP (2011), supra note 70. Since its first issuance in the year 2005, the MPPP continues to remain in draft form. For the purposes of analysis, we have relied on two versions of the MPPP, i.e. the manuals of 2008 and 2011.

  72. 72.

    See MPPP (2008), supra note 70, at § 3.10.5–7.

  73. 73.

    Id., at § 3.10.6.

  74. 74.

    Id., at § 3.10.7.

  75. 75.

    See Benmax v. Austin Motor Co. Ltd., 70 R.P.C. 284 (CA) 288 (U.K.) (1953).

  76. 76.

    See Brugger v. Medic-Aid Ltd., (1996) R.P.C. 635, 653 (U.K.).

  77. 77.

    See Ganendro Nath Banerji v. Dhanpal Das Gupta, 1945 A.I.R. 32 (Oudh) 6, at 9.

  78. 78.

    24 Halsbury’s Laws of England 586 (2d ed.).

  79. 79.

    See Ganendro Nath Banerji v. Dhanpal Das Gupta, 1945 A.I.R. 32 (Oudh) 6, at 9.

  80. 80.

    1982 A.I.R. 1444 (S.C.) (India).

  81. 81.

    Id.

  82. 82.

    See, e.g., Canadian Gen. Electric Co. Ltd. v. Fada Radio Ltd., 1930 A.I.R. 1 (P.C.) (India), (holding that a small inventive step is nevertheless, an inventive step); see also Gillette Indus., Ltd. v. Yeshwant Bros., 1938 A.I.R. 347 (Bom.) (India), (holding that the simplicity of an invention does not dilute the inventiveness).

  83. 83.

    383 U.S. 1, 12, 19 (1966), which is an important decision of the U.S. Supreme Court that conceptualized the test for nonobviousness (in a trilogy of cases) enunciating a test for nonobviousness based on the scope and content of prior art, the differences between prior art and the claims at issue and the level of “ordinary skill” in the art at the time the invention was made; see also Calmar Inc. v. Cook Chem. Co., 383 U.S. 1, 26 (1966); United States v. Adams, 383 U.S. 39 (1966).

  84. 84.

    2008 P.T.C. 37 (Del.) 71.

  85. 85.

    Id.

  86. 86.

    Id.

  87. 87.

    [1985] R.P.C. 59 (stating that obviousness is proved by: (1) identifying the inventive concept embodied in the patent; (2) imputing to a normally skilled but unimaginative addressee what was common general knowledge in the art at the priority date; (3) identifying the differences if any between the matter cited and the alleged invention; and (4) deciding whether those differences, viewed without any knowledge of the alleged invention, constituted steps that would have been obvious to the skilled man or whether they required any degree of invention).

  88. 88.

    383 U.S. 1 (1966).

  89. 89.

    Id.

  90. 90.

    2008 P.T.C. 37 (Del.) 71. This case raised the question of whether the single distinguishing feature identified by the presence of an ethynyl group particularly substituted at meta position of the phenyl ring would amount to fulfilling the inventive step requirement (the product itself was directed to 4-(substituted phenylamino) quinazoline derivative with an alleged inventive step being the methyl substitute in the third position).

  91. 91.

    See Patent Act, 2005, Secs. 14–16.

  92. 92.

    Id., at Sec. 12.

  93. 93.

    Id. Under Sec. 12(1)(b), the examiner is empowered to make a report on whether there are lawful grounds for objection to the grant of the patent under the Act in pursuance of the application.

  94. 94.

    See Patent Act, 2005, Sec. 14.

  95. 95.

    Id., at Secs. 14–15; see also Indian Patent Rules (Gazette of India, section II(3)(ii)) (20 April 1972), as amended by Indian Patent Rules (Gazette of India, section II(3)(ii)) (20 May 2003), available at: http://www.ipindia.nic.in/ipr/patent/patent_re_03.pdf (accessed 8 August 2011), at Rules 28(3), 129 (hereinafter Indian Patent Rules (2003)).

  96. 96.

    See MPPP (2008), supra note 70, at § 3.12.1 (“The examiner (or any other person) considering the question of whether or not an invention is obvious has to bear in mind that it is an ex-post facto analysis. He can be very easily misled by a line of reasoning involving taking the solution and working backwards to the problem by a succession of easy steps. In considering a prior publication, the examiner has to avoid looking at the document under the influence of the application he is examining, and should attempt to place himself in the shoes of the skilled person faced with the problem at hand.”). The MPPP (2011), supra note 70, is surprisingly silent on the question of ex-post facto analysis.

  97. 97.

    See Patent Act, 2005, Sec. 107.

  98. 98.

    See Patent Act, 2005, Sec. 25(1)(e), 25(2)(e).

  99. 99.

    Id., at Sec. 25(1)(a).

  100. 100.

    Id., at Sec. 25(1)(b).

  101. 101.

    Id., at Sec. 25(1)(d).

  102. 102.

    Id., at Sec. 25(1)(e).

  103. 103.

    Id., at Sec. 25(1)(g).

  104. 104.

    Id., at Sec. 25(1)(h). Both pre- and post-grant opposition can be made on the grounds that the invention is anticipated by knowledge or practices of a local or indigenous community in India, or improper mention of biological material used for the invention. See Patent Act, 2005, Sec. 25(k); see also Indian Patent Rules, (2003), supra note 95, at Rule 55.

  105. 105.

    See Indian Patent Rules, supra note 95, at Rules 28(3), 129.

  106. 106.

    See Indian Patents Act, No. 39 of 1970, as amended by Patents (Amendment) Act, No. 15 of 2005, India Code (2005), Sec. 25(1) (hereinafter Patents Act, 2005).

  107. 107.

    See also Indian Patents Rules, (2003), supra note 95, at Rule 56 (post-publication of the patent application, the pre-grant opposition procedure begins when the third party sends a statement along with evidence, which prompts the patent office to notify the applicant. If the applicant submits his statement along with evidence within 3 months, a hearing is constituted), id., at Rules 55(4), 55(6).

  108. 108.

    See Patent Act, 2005, supra note 106, at Sec. 2(1)(t). “Person interested” includes a person engaged in or promoting research in the same field as that to which the invention relates. Any person including an organization that has a manufacturing or trading interest in the goods connected with the patented article or who has a financial interest in manufacturing such goods or who possesses patents relating to the same subject, is considered as a person interested.

  109. 109.

    Press Release, Ministry of Commerce and Industry, Press Information Bureau, “Important Changes Incorporated in the Patents (Amendment) Bill, 2005, as Compared to the Patents (Amendment) Bill, 2003” (23 March 2005), available at: http://pib.nic.in/release/release.asp?relid=8096 (accessed 9 August 2011).

  110. 110.

    See Patent Act, 2005, supra note 106, at Sec. 25(1) read with MPPP (2011), supra note 70, at §7.1.2 (v).

  111. 111.

    See 35 U.S.C. §§ 301-03.

  112. 112.

    See generally Khader (2008).

  113. 113.

    Id.

  114. 114.

    See, e.g., Krishnan (2003).

  115. 115.

    Indian Patent Application No. 959/MAS/1995 (filed 27 July 1995).

  116. 116.

    Roche’s Application (Opposition by Tamil Nadu Networking People with AIDS), 17 March 2009, Patent Office, Chennai; see also IN 207232. No hearing was conducted before the pre-grant order was issued. When the opponents raised the issue of a hearing, the patent office replied that the grounds for objections raised in the statements were considered and dismissed. See Deepak (2009).

  117. 117.

    Id., highlighting that when opponents raised the issue of a hearing, the patent office responded by asserting that the grounds for objections raised in the statements were considered and dismissed.

  118. 118.

    Indian Network of People Living with AIDS v. Union of India, Writ Petition No. 24904 of 2008 (C.H.C.) filed under Art. 226, Indian Constitution (1950).

  119. 119.

    Id., at 2.

  120. 120.

    Id., at 51.

  121. 121.

    See “Roche’s Plea: SC asks patent office to decide by January 31”, Bus. Standard (19 December 2008), available at: http://www.business-standard.com/india/news/roches-plea-sc-asks-patent-office-to-decide-by-january-31/343715/.

  122. 122.

    See Roche v. Indian Network for People living with HIV/AIDS and Tamil Nadu Networking People with HIV/AIDS, 17 March 2009, Patent Office, Chennai.

  123. 123.

    See Hoffman La Roche (Post-grant opinion) (30 April 2010). Opponents include Ranbaxy, Cipla, Matrix and Bakul Laboratories, along with Delhi Network of Positive People, Indian Network of People living with HIV/AIDS and the Tamil Nadu Network of People with HIV/AIDS. Id. (on file with authors) (hereinafter Hoffman La Roche (Post-grant opinion), (30 April 2010)).

  124. 124.

    The opponents asserted that the patent was for the ester form of a known drug – ganciclovir, which was first disclosed in a 1980s U.S. patent bearing No. 4,355,032 (filed 21 May 1981). Another U.S. patent bearing No. 5,043,339 (filed 18 December 1989), it was alleged, disclosed the l-valine ester of ganciclovir hydrochloride while the specifications and the examples in EP0375329 disclosed the method of making the subject matter of the application. Moreover, the owner of the European patent enjoyed the benefit of a supplementary protection certificate claiming valganciclovir hydrochloride. See also Hoffman La Roche, Post-grant opinion (30 April, 2010).

  125. 125.

    See Intellectual Prop. Office, U.K., “Supplementary Protection Certificates: Guide for Applicants”, available at: http://www.ipo.gov.uk/spctext.pdf. A supplementary protection certificate (SPC), obtainable individually for different countries of the European Union, is an extension of a patent given to compensate for regulatory delays that the product suffered. An SPC comes into effect after the patent expires. While an SPC can extend up to a maximum of 5.5 years, the total market exclusivity of the product cannot extend beyond a total of 15.5 years.

  126. 126.

    See Hoffman La Roche (Post-grant opinion) (30 April 2010). Opponents include Ranbaxy, Cipla, Matrix and Bakul Laboratories along with Delhi Network of Positive People, Indian Network of People living with HIV/AIDS and the Tamil Nadu Network of People with HIV/AIDS.

  127. 127.

    Id.

  128. 128.

    Id.

  129. 129.

    Id.

  130. 130.

    Id., at para. 34. Valacyclovir was then combined with hydrochloric acid to result in valacyclovir hydrochloride (sold as Valtrex, an anti-herpes drug by GSK). Valgancyclovir when combined with hydrochloric acid results in valgancyclovir hydrochloride (sold as Valcyte by Roche).

  131. 131.

    Id., at para. 41.

  132. 132.

    Id., at para. 42. The patent office added that there was no comparison between the hydrochloride salts of other forms of esters and the hydrochloride salt of mono-valine ester of ganciclovir.

  133. 133.

    Id., at para. 45.

  134. 134.

    IN 1225/MUM/2005 (filed 30 Sept. 2005).

  135. 135.

    Mumbai Patent Office, In the Matter of an application for Patent by IPCA Labs Limited, Patent Application No. 1225/MUM/2005 (24 February 2011) (on file with authors). During prosecution, the applicant amended the claims as follows: “A pharmaceutical tablet comprising β-arteether core coated by an enteric coat to delay the release; wherein, the enteric coat comprises hypromellose phthalate 12–14 %; dibutyl phthalate 1–2 %; titanium dioxide 0.3–0.7 % and talc 0.3–0.7 % by weight of the formulation.”

  136. 136.

    Id.

  137. 137.

    Id.

  138. 138.

    Id. See also World Intellectual Property Office, “Methods and Compositions for the Treatment of Helicobacter Pylori-Associated Diseases Using Endoperoxide Bridge-Containing Compounds”, WIPO Doc. WO 2005/048912 (2 June 2005); see generally WO 2005/048912 (titled D1, this invention relates to methods and compositions for the treatment of pathological conditions associated with ferrous-dependent bacteria, such as Helicobacter pylori).

  139. 139.

    Id. WO 02/078714 (titled D2, this invention relates to gastric juice resistant formulations consisting of anti-infective compounds which inhibit the 2-C-methylerythrose-4 metabolic pathway and its salts and esters; U.S. Patent No. 5,578,637 (filed 3 May 1995) (titled D3, this application discloses methods for inhibiting cancer cells from compounds having an endoperoxide moiety by enhancing intracellular iron concentrations.

  140. 140.

    Id. WO 92/02217 (D4 disclosed a synergistic antimalarial combination of benflumetol with a antimalarial agent from the artemisinine group such as artemether); U.S. Patent No. 6,284,772 (filed 28 Sept. 1999) (D5 describes Indolo [2, 1-b]quinazoline-6,12-dione, and substituted derivatives, which exhibit potent in vitro antimalarial activity against Plasmodium falciparum); U.S. Patent No. 6,486,199 (filed 21 June 2001) (D6 describes a method for treatment of malaria using a spiro or dispiro 1, 2, 4-trioxolane).

  141. 141.

    Mumbai Patent Office, In the Matter of an application for Patent by IPCA Labs Limited, Patent Application No. 1225/MUM/2005, 9 (24 February 2011) (on file with authors).

  142. 142.

    IN 1049/CHE/2004 (filed 11 October 2004).

  143. 143.

    Id., at para. 10.

  144. 144.

    Id., at para. 13.

  145. 145.

    Id.

  146. 146.

    No. 2860/Delnp/2004 (filed 23 September 2004).

  147. 147.

    Tissuegene Inc’s Application, (2010) P.F.R. 4 (P.O.) (New Delhi) (19 January 2010), (hereinafter TissueGene).

  148. 148.

    Id., at 1.

  149. 149.

    Id., at 4.

  150. 150.

    See also 68 Calcified Tissue Int’l 87–94 (2001).

  151. 151.

    TissueGene, supra note 147, at para. 5.

  152. 152.

    U.S. Patent No. 6,315,992 (filed 30 June 1999).

  153. 153.

    TissueGene, supra note 147, at para. 5.

  154. 154.

    Id., at para. 8.

  155. 155.

    Novartis v. Cipla, Pre-grant opposition (on file with authors).

  156. 156.

    593/CHENP/2005 (filed 11 April 2005).

  157. 157.

    Novartis v. Cipla, Pre-grant opposition, supra note 155, at para 20.

  158. 158.

    Indian Patent Application No. 959/MAS/1995 (filed 27 July 1995); Roche’s Application (Opposition by Tamil Nadu Networking People with AIDS), (2009) P.F.R. 4 (P.O.); see also IN 207232.

  159. 159.

    Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124, 127; 126 S. Ct. 2921 (2006) (Breyer J., with whom Stevens J. and Souter J. joined, dissenting).

  160. 160.

    Id.

  161. 161.

    Id.

  162. 162.

    See 35 U.S.C. §102(b).

  163. 163.

    Novartis v. Union of India, 2013 MIPR (1) 313 (SC).

  164. 164.

    Id., at 378.

  165. 165.

    Id., at 377.

  166. 166.

    Id., at 353.

  167. 167.

    See Patent Act, 1970 (India), Sec. 25.

  168. 168.

    See Patent Act, 2005, supra note 106, at Sec. 3.

  169. 169.

    F. Hoffmann La Roche v. Cipla Ltd., 2008 MIPR (2) 35.

  170. 170.

    F. Hoffmann La Roche v. Cipla Ltd., (2009) MIPR (2) 1. The Supreme Court reflected the same sentiment in Bajaj Auto Ltd v. TVS Motor Company Ltd., by holding that patent infringement suits should be decided expeditiously by the trial court where possible to prevent the overuse of interlocutory relief. See 41 P.T.C. 398 (S.C.) (2009).

  171. 171.

    See Bilcare Ltd. v. Supreme Indus., 2007 MIPR (2) 13 (H.C. of Delhi) (“No presumption of validity attaches to a patent granted by the Controller under the Act notwithstanding examination and investigation made under Sections 12 and 13.”). The Patent Act, 2005, supra note 106, at Sec. 113, discusses obtaining a certificate of validity of the specification to determine costs in a suit – which indicates that not all granted patents are automatically presumed valid.

  172. 172.

    Schering Corp. v. Geneva Pharmaceuticals, 339 F.3d 1373, 1381 (Fed.Cir. 2003) (The court suggested that a metabolite could be protected if drafted to claim “its pure and isolated form… or as a pharmaceutical composition. The patent drafter could also claim a method of administering the metabolite or the corresponding pharmaceutical composition.”).

  173. 173.

    See generally Hemphill and Sampath (2012).

  174. 174.

    Bernard (2013).

  175. 175.

    Pfizer v. Apotex, 488 F.3d 1377 (Fed. Cir. 2007), 488 F.3d 1348 (Fed. Cir. 2007).

  176. 176.

    U.S. Patent No. 4,572,909 (filed 3 February 1984).

  177. 177.

    U.S. Patent Nos. 3,816,612 (the ’612 patent) and 4,032,637 (filed 31 October 1974) (the ’637 patent).

  178. 178.

    37 C.F.R. § 1.132.

  179. 179.

    Pfizer v. Apotex, 480 F.3d 1348, 1362 (2007).

  180. 180.

    127 S. Ct. 1727 (2007).

  181. 181.

    Conversations with Feroz Ali Kharder, Patent Practitioner, Chennai India and MHDR Chair, IIT Chennai, India (June 2014).

  182. 182.

    Id.

  183. 183.

    Id.

  184. 184.

    Apart from pre- and post-grant oppositions, the multilevel challenge mechanism under the Indian Patents Act includes revocation proceedings under Sec. 64(1) either before the Intellectual Property Appellate Board (IPAB) or by way of a counter-claim in a patent infringement suit before a court. But in Dr. Aloys Wobben v. Yogesh Mehra, MANU/SC/0519/2014, the Supreme Court restricted the multilevel challenge mechanism by holding, among other things, that initiation of post-grant opposition by a party will eclipse the right of that party to later file revocation proceedings. This decision goes against the policy of allowing for a multilevel mechanism for challenging patents.

  185. 185.

    See generally Indian Constitution, at preamble.

  186. 186.

    Agreement on Trade-Related Aspects of Intellectual Property Rights, Art. 27, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299; 33 L.L.M. 1197 (1994) (“Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”).

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Acknowledgments

Special thanks to Professor Arti Rai for her comments on the earlier draft of this paper.

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Correspondence to Srividhya Ragavan.

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This paper draws from a piece that appeared as a book chapter in Ruth L. Okediji, William L. Prosser and Margo A. Bagley (eds.), “Patent Law in Global Perspective” (Oxford University Press, 2014).

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Ragavan, S., Khader, F. The Selection of Patents – The Choice Between Regulatory Reforms and Market Reliance to Weed Out Suspect Patents. IIC 46, 38–65 (2015). https://doi.org/10.1007/s40319-014-0293-9

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Keywords

  • Patent
  • Regulatory reforms
  • Nonobviousness
  • India – inventive step
  • Developing countries
  • Market mechanism