Patentability of Biotechnology: A Comparative Study with Regard to the USA, European Union, Canada and India

Kshitij Kumar Singh²

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Abstract

Modern biotechnological advances have posed new challenges before the existing patent laws of countries as biotechnological inventions differ markedly from chemical and mechanical inventions that have been the traditional subject matter of patents. With the development of human genomics and success of the Human Genome Project, the gene becomes more important because of its informational content rather than its material qualities (physical attributes). Patent is a subject primarily concerned with questions inside a jurisdiction. Although the adoption and ratification of trade-related aspects of intellectual property rights (TRIPS) has brought a unified character to patent laws of member countries of the World Trade Organization (WTO) to a certain extent, these countries have adopted different approaches regarding biotechnology patents in tune with their national policies. As a result, the scope and coverage of biotechnology patents vary from country to country. Even in countries having similar patent laws such as the USA and Canada, interpretations of such laws by courts vary significantly. These variations among countries are important for the proper understanding of the trends in biotech patents. Therefore, the present chapter makes a comparative study of patent laws and practices relating to biotechnology patents in the USA, Canada, European Union and India in order to collate the common issues and the differences among and between them. The USA being a pioneer in biotechnology research exerts great influence upon other countries; the European Union reflects the unified approach of different member states in a politically diversified system; Canada makes a distinction between patenting of higher life forms and lower life forms and India represents the concerns of developing countries.

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Notes

1.
Organisation for Economic Co-operation and Development (1999).
2.
Bud (1991).
3.
Ibid.
4.
Id at 444.
5.
Id at 444–45.
6.
Ibid.
7.
Yelpaala (2000).
8.
Ibid.
9.
Ibid.
10.
Ibid.
11.
Boyd (1997).
12.
Ibid.
13.
Ibid.
14.
Ibid.
15.
Burk (1991).
16.
Ibid.
17.
Dutfield (2009).
18.
Pila (2003).
19.
Dutfield, supra note 17, at 192.
20.
Ibid.
21.
Cain (2003a).
22.
Id., at 121.
23.
Ibid.
24.
Ibid.
25.
Nuffield Council of Bioethics (2002).
26.
Merrill and Mazza (2006a).
27.
Gold (2009a).
28.
Ibid.
29.
Sec. 53(a) European Patent Convention, 1973.
30.
Gold and Knoppers, supra note 27, at 22.
31.
Ibid.
32.
Sec. 3(b), Patents Act, 1970.
33.
Gold and Knoppers, supra note 27, at 22.
34.
Ibid.
35.
Id., at 25.
36.
Dutfield, supra note 17, at 194–95.
37.
U.S. Constitution, Art. 1, Sec. 8, Cl. 8.
38.
35 U.S.C. Sec . 101.
39.
Dutfield, supra note 17, at 195.
40.
Id., at 195–96.
41.
Id., at 196.
42.
Rimmer (2008).
43.
Dutfield, supra note 17, at 196.
44.
Philip Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology, 224–25 (Oxford: Oxford University Press, 4th edn., 2004), cited in Rimmer, supra note 42, at 24.
45.
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
46.
Dutfield, supra note 17, at 196.
47.
Id., at 195.
48.
Klein (2007).
49.
Boettiger and Bennet (2006).
50.
Dutfield, supra note 17, at 200.
51.
Pila, supra note 18.
52.
Ibid.
53.
Dutfield, supra note 17, at 195.
54.
Id., at 196.
55.
Kevles (2011)
56.
Ibid.
57.
Ibid.
58.
A. Chakrabarty, ‘Microorganisms having multiple compatible degradative energy-generating plasmids and preparation thereof’, (1972) U S Patent No: 4,259,444.
59.
Ibid.
60.
447 US 306 (Chakrabarty).
61.
Id, at 306–307.
62.
447 US 307 (Chakrabarty).
63.
Ibid.
64.
Application of Chakrabarty 571 F.2d 40 Cust. & Pat. App. (1978) cited in Rimmer, supra note 42, at 28.
65.
Ibid.
66.
Application of Bergy 563 F.2d 1031 Cust. & Pat. App. (1977).
67.
M. Bergy, J. Coats and V. Malik, ‘Process for preparing lincomycin’, (1974) US Patent Application No: 477, 766 cited in Rimmer, supra note 42 at 29.
68.
Application of Bergy 563 F.2d 1031 at 1038 Cust. & Pat. App. (1977) cited in Rimmer, supra note 42, at 29.
69.
Application of Bergy 596 F.2d 952 Cust. & Pat. App. (1979) cited in Rimmer, supra note 42, at 29.
70.
Rimmer, supra note 42, at 30.
71.
447 U.S. 308–318. (Chakrabarty).
72.
444 U.S. 37(1979).
73.
Id., at 42.
74.
289 U.S. 178(1933).
75.
Id., at 199.
76.
447 U. S. 308 (Chakrabarty).
77.
Ibid
78.
Id., at 308–309, quoting 5 Writings of Thomas Jefferson 75–76 (Washington ed. 1871).
79.
Act of Feb. 21, 1793, Sec. 1, 1 Stat. 319.
80.
447 U.S. 309 (Chakrabarty).
81.
Ibid, referring S Rep. No 1979, 82d Cong., 2d Sess., 5 (1952); H.R.Rep. No. 1979, 82d Cong., 2d Sess., 6 (1952).
82.
447 U.S. 309 (Chakrabarty), referring Parker v. Flook,437 U.S. 584(1978); Gottschalk v. Benson, 409 U. S. 63 , 409 U. S. 67 (1972); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127, 333 U. S. 130(1948); O’Reilly v. Morse,15 How. 62,56 U. S. 112-121 (1854); Le Roy v. Tatham,14 How. 156,55 U. S. 175(1853) Le Roy v. Tatham,14 How. 156, 55 U.S. 175 (1853).
83.
447 U.S. 309 (Chakrabarty), quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 130 (1948).
84.
447 U. S. 309–10, quoting Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887).
85.
333 U. S. 127, 333 U. S. 130(1948).
86.
333 U. S. 127, 333 U.S. 130 (1948).
87.
333 U.S. 131 (1948).
88.
447 U.S. 310 (Chakrabarty).
89.
Id., at 311.
90.
Id., at 312.
91.
Id., at 314.
92.
Id., at 304, 314–18.
93.
Rimmer, supra note 42, at 42.
94.
447 U.S. 319 (Chakrabarty).
95.
Ibid.
96.
Ibid.
97.
Ibid.
98.
Fowler (1994), 150 quoted in Dutfield, supra note 17, at 198.
99.
Dutfield, supra note 17, at 198.
100.
Demaine and Fellmeth (2002).
101.
Eisenberg (2006) quoted in Rimmer, supra note 42, at 44–45.
102.
Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. & Interferences 1985).
103.
Dutfield, supra note 17, at 198.
104.
Ibid.
105.
Rimmer, supra note 42, at 84.
106.
Demaine and Fellmeth, supra note 100, at 318.
107.
Ibid.
108.
Rimmer, supra note 42, at 85, quoting Ex Parte Allen 2 USPQ 2d. P. 1425, 2) (1987).
109.
Ibid.
110.
Rimmer, supra note 42, at 85.
111.
Demaine and Fellmeth, supra note 100, at 319, quoting Ex parte Allen, 2 U.S.P.Q.2d (BNA) 1425 (Bd. Pat. Appeals & Interferences (1987).
112.
Ex Parte Allen 2 U.S.P.Q.2d,.1425, 2 (1987).
113.
Ibid.
114.
Rimmer, supra note 42, at 85.
115.
Id., at 85–86.
116.
Demaine and Fellmeth, supra note 100, at 319.
117.
United States Patent and Trademark Office (1987), ‘Notice: animals-patentability’, Official Gazette, United States Patent and trademark Office, 1077, 8, 21 April.
118.
Ibid.
119.
Ibid.
120.
Animal legal Defense Fund v. Quigg 710 F.Supp. 728, 9 U.S.P.Q.2d 1816 (N.D.Cal. 1889); Animal Legal Defense Fund v. Quigg 932 F.2d 920 C.A. Fed. (Cal.), 1991.
121.
Animal legal Defense Fund v. Quigg 710 F.Supp. 728, 9 U.S.P.Q.2d 1816 (N.D.Cal. 1889).
122.
Rimmer, supra note 42, at 87.
123.
Id., at 90.
124.
Demaine and Fellmeth, supra note 100, at 318, citing U. S. Patent No. 4736,866 (issued Apr. 12, 1988).
125.
Dutfield, supra note 17, at 199, quoting Kelves (2006), 79.
126.
Rimmer, supra note 42, at 89.
127.
Rimmer, supra note 42, at 98–99.
128.
Demaine and Fellmeth, supra note 100, at 320.
129.
Ibid.
130.
Ibid.
131.
Rimmer, supra note 42, at 99.
132.
United states Patent and Trademark Office ‘Media advisory: facts on patenting life forms having a relationship to humans’, (1998) http://www.uspto.gov/web/offices/com/speeches/98-06.htm, quoted in Rimmer, supra note 42, at 99–100.
133.
Demaine and Fellmeth, supra note 100, at 320.
134.
Rimmer, supra note 42, at 100.
135.
Demaine and Fellmeth, supra note 100, at 320, quoting Donald J. Quigg, Statement by Assistant Sec’y of Comm. & Comm’r of Pat. & Trademarks, 1077 Off. Gazette U.S. Pat. &Trademark OFF. 24 (Apr.7, 1987) at 24.
136.
Rimmer, supra note 42, at 100.
137.
Ibid.
138.
Ibid.
139.
Id., at 101–102.
140.
Id., at 102, quoting Editorial, ‘Hybrid too human patent: case highlights lack of criterion for genetically modified organisms’, Nature Review Drug Discovery, (2005), http://www.nature.com/news/2005/050328/full/nrd1710.html, 31 March.
141.
Id., at 102 quoting Editorial, ‘Patenting pieces of people’, 21 Nature Biotechnology, 341, (1 April, 2003).
142.
Sec. 33(a), Leahy-Smith America Invents Act (AIA) 2011, available at http://www.gpo.gov/fdsys/pkg/BILLS-112hr1249enr/pdf/BILLS-112hr1249enr.pdf (Visited on Sept. 27, 2011).
143.
Sec. 33(b), Leahy-Smith America Invents Act (AIA) 2011, available at http://www.gpo.gov/fdsys/pkg/BILLS-112hr1249enr/pdf/BILLS-112hr1249enr.pdf (Visited on Sept. 27, 2011).
144.
Diamond v. Diehr, 450 U.S. 175, 185 (1981).
145.
Goldstein and Gold (2002).
146.
196 F.496 (2nd Cir. 1912).
147.
Id. 497.
148.
Id., at 498.
149.
427 F.2d 1394 (C.C.P.A. 1970).
150.
Id., at 1401–02.
151.
563 F.2d 1031 (C.C.P.A. 1977).
152.
Id, at 1032.
153.
Id., at 1035.
154.
447 U.S. 303 (1980).
155.
Goldstein and Gold, supra note 145.
156.
Id., at 1316–17; Genentech Inc. received a patent for a DNA isolate consisting essentially of a DNA encoding human tissue plasminogen activator (1988) (U.S. Patent No. 4,766,075); Kiren Amgen obtained a patent (1987) for “purified and isolated” DNA sequences encoding erythropoietin” (U.S. Patent No. 4,703,008).
157.
Id, at 1317; OncorMed has obtained a patent (1988) for an isolated coding sequence of the BRCA1 gene (U.S. Patent No. 5,750,400), which can be used for screening individuals with an increased genetic susceptibility to breast or ovarian cancer because of the inherited mutation of the BRCA1 gene.
158.
Ibid; Human Genome Sciences, Inc., has obtained a patent (2001) for polynucleotides encoding human tr10 receptor, a member of the tumor necrosis factor (TNF) receptor superfamily and the TRAIL receptor subfamily. (U.S. Patent No. 6,214,580).
159.
Ibid.
160.
Ibid., quoting Utility Examination Guidelines, 6 Fed. Reg. 1092, 1093 (Jan. 5, 2001).
161.
Ibid., citing Biotechnology: Patents, Licensing & FDA Practice at I-48, Patent Resources Group, Inc. (2000).
162.
Ibid., citing Biotechnology: Patents, Licensing & FDA Practice at I-49, I-50. Patent Resources Group, Inc. (2000).
163.
Amgen Inc. v Chugai Pharma. Co. 927 F.2d 1200 (Fed. Cir. 1991).
164.
Id., at 1206.
165.
Conley (2009).
166.
Amgen, supra note 163, at 1204, quoting U.S. Patent No. 4, 703,008 (Filed Nov. 30, 1984).
167.
Conley, supra note 165, at 115–16.
168.
Id., at 116.
169.
Amgen Inc. v. Chugai Pharma. Co., 13 U.S.P.Q.2d 1737, 1759 (D. Mass. 1989), quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
170.
Conley, supra note 165, at 116.
171.
Nese (2009).
172.
Eisenberg (2003).
173.
Ibid.
174.
Eisenberg (2002).
175.
Merrill and Mazza (2006b).
176.
Ibid.
177.
Ibid.
178.
Davis et al. (2005).
179.
Ibid.
180.
Eisenberg, supra note 174, at 1383.
181.
Ibid.
182.
Ibid.
183.
USPTO Utility Examination Guidelines, 66 Fed. Reg. 1092, 5 Jan 2001.
184.
Nese, supra note 171, at 153, quoting John Merz and Mildred Cho, “What Are Gene Patents and Why are People Worried About Them?” 8 Community Genetics 203 (2005).
185.
In re Fisher, 421 F.3d 1365 (C.A., Fed., 2005).
186.
Supra note 183.
187.
Merrill and Mazza, supra note 175, at 73.
188.
Id., at 73, citing Leroy v. Tatham, 55 U.S. 156, 175 (1853); Mackay Co. v. Radio Corp., 306 U.S. 86, 94 (1939); Gottschalk v. Benson, 409 U.S. 63 (1972); Diamond v. Chakrabarty 447 U.S. 303 (1980) and Dickey-John Corp. v. Tapetronics Corp., 710 F.2d 329 (7th Cir. 1983).
189.
Merrill and Mazza, supra note 175, at 77.
190.
Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998).
191.
Merrill and Mazza, supra note 175, at 77.
192.
Gottschalk v. Bensen, 409 U.S. 63 (1972); Parker v. Flook, 437 U.S. 584 (1978).
193.
Hotel Security Checking Co., v. Lorraine Co., 160 F.467 (2d Cir. 1908).
194.
Merrill and Mazza, supra note 175, at 77.
195.
Street Bank, supra note 190, at 1373.
196.
Id., at 1375–76, quoted in Merrill and Mazza, supra note 175, at 77–78.
197.
Id., at 1373.
198.
AT & T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (Fed. Cir. 1999).
199.
Merrill and Mazza, supra note 175, at 79.
200.
Ibid., quoting supra note 198, at 1358.
201.
Conley, supra note 165, at 120.
202.
Laboratory Corp. Of America Holdings v. Metabolite Laboratories, Inc., 126 S. Ct. 2921 (2006).
203.
Holman (2007).
204.
Ibid.
205.
Lab. Corp., supra note 202 (Breyer J. dissenting).
206.
Ibid.
207.
Id., at 2925 (LabCorp did not refer in the lower courts to Sec. 101 which sets forth the subject matter that is patentable, and within the bounds of which the ‘law of nature’ principle most comfortably fits.) cited in Conley, supra note 165, at 121.
208.
Ibid. (emphasis added; citation omitted) in Conley, supra note 165, at 121.
209.
Holman, supra note 203.
210.
Ibid.
211.
Ibid.
212.
In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc).
213.
Ibid.
214.
Id., at 954.
215.
Id., at 963.
216.
Ibid.
217.
Id., at 962.
218.
Ibid.
219.
Ibid.
220.
Id, at 965 (quoting In re Comisky, 499 F.3d 1365, 1377–79 (Fed. Cir. 2007)).
221.
Id., at 965.
222.
Nese, supra note 171, at 171.
223.
Bilski et al. V. Kappos, No. 08–964 (2010).
224.
Diamond v. Diehr, 450 U. S. 175, 182 quoted in Bilski, supra note 223, at 2.
225.
Ibid.
226.
Bilski, supra note 223, slip op. at 9.
227.
Association for Molecular Pathology et al. v United States Patent and Trademark Office et al., No. 09-CV 4515, (S.D.N.Y. March 29, 2010).
228.
Id., at 2.
229.
Id., at 3–4.
230.
Ibid.
231.
AMP v USPTO, supra note 227, at 99–102.
232.
Id., at 92.
233.
Id., at 121.
234.
Id., at 3–4.
235.
Id., at 125.
236.
Amgen, supra note 163, at 1206.
237.
In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970).
238.
Id., at 1401–02.
239.
Bilski, supra note 212, at 954.
240.
AMP v USPTO, supra note 227, at 4.
241.
Id., at 147.
242.
Association of Molecular Pathology et al. v. United States Patent and Trademark Office et al., available at http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf,2011) (Visited on August 30, 2011).
243.
Conley and Vorhaus (2011a).
244.
Prometheus Labs, Inc. v. Mayo Collaborative Servs, 581 F.3d 1336 (Fed. Cir. 2009).
245.
Id., at 1339.
246.
Id., at 1339–40.
247.
Id., at 1340.
248.
Ibid.
249.
Ibid.
250.
Prometheus Labs, Inc. v. Mayo Collaborative Servs; No. 04-CV-1200 JAH (RBB), 2008 WL 878910, at 6 (S.D. Cal. Mar. 28, 2008), at 14.
251.
Prometheus, supra note 244, at 1350.
252.
Conley and Vorhaus (2011b).
253.
Bilski, supra note 223.
254.
Ibid.
255.
Conley and Vorhaus, supra note 252.
256.
Mayo Collaborative Services v. Prometheus Labs., Inc. 130 S. Ct. 3543 (2010).
257.
Prometheus Labs. Inc. v. Mayo Collaborative Services 628 F.3d 1347 (Fed. Cir. 2010).
258.
566 U.S. _(2012) (Slip opinion at 8–11).
259.
Id., at 16.
260.
Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. 569 U. S. ____ (2013) (Docket no. 12–398)
261.
Id., at 10–18.
262.
Id., at 16–17.
263.
Id., at 17–18.
264.
Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. 569 U. S. ____ (2013) (SCALIA, J., concurring at 1).
265.
Arti K. Rai & Robert Cook Deegan, “Moving beyond “Isolated” Gene Patents” 341 Science 137–138, available at http://www.sciencemag.org/content/341/6142/137 (lat visited on June 26,2014).
266.
Ibid.
267.
Ibid.
268.
Anand Mohan Chakrabarty, “Patenting human genes and mutations: A personal perspective” 19 Journal of Commercial Biotechnology” 2–5 (2013), available at http://commercialbiotechnology.com/index.php/jcb/article/view/626/576 (last visited June 26, 2014).
269.
Rai and Deegan, supra note 265.
270.
Ibid.
271.
35 U.S.C. Sec. 101 prescribes, “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, subject to the conditions and requirements of this title.”
272.
Kankanala (2007).
273.
35 U.S.C. Sec.102.
274.
35 U.S.C. Sec. 102(g).
275.
Sec. 3 of the Leahy-Smith America Invents Act 2011 (enacted on September 16, 2011).
276.
35 U.S.C. Sec. 102(g).
277.
Ibid.
278.
Kankanala, supra note 272, at 43.
279.
Coleman v. Dines, 754 F.2d 353, 359, 224 USPQ 857, 862 (Fed.Cir. 1985).
280.
Great Northern Corp. V. Davis Core & Pad Co., 782 F.2d 159, 165, 228 USPQ 356, 358 (Fed.Cir. 1986).
281.
Weil v. Fritz, 572 F.2d 856, 865 n. 16, 196 USPQ600, 608 n. 16 (CCPA 1978).
282.
Hybritech v. Monoclonal Antibodies Inc., 802 F.2d 159,165,228 USPQ356, 358 (Fed.Cir.1986).
283.
Amgen, supra note 163.
284.
Id., at 1206, 1207.
285.
Fiers v. Revel, 948 F.2d 1164 (C.A.Fed., 1993).
286.
Id., at 1169, 1170.
287.
Kridl v. McCormick, 05 F.3d 1446 (C.A. Fed. 1997).
288.
Kankanala, supra note 272, at 49.
289.
Brown v. Barbacid, 276 F.3d 1327 (C.A.Fed., 2002).
290.
Kankanala, supra note 272, at 50.
291.
Singh v. Brake, 48 Fed.Appx.766 (C.A. Fed., 2002).
292.
Kankanala, supra note 272, at 51.
293.
Invitrogen Corp. Clontech Laboratories, Inc., 429 F.3d 1052, 1068, 1069 (C.A. Fed. (Md.) 2005)
294.
Kankanala, supra note 272, at 53.
295.
35 U.S.C. Sec. 102(a).
296.
35 U.S.C. Sec. 102(b).
297.
Kankanala, supra note 272, at 54.
298.
Ibid.
299.
In re Crish, 393 F.3d 1253 (C.A. Fed., 2004).
300.
Kankanala, supra note 272, at 55.
301.
In re Ngai, 91 Fed.Appx. 153 (C.A.Fed., 2004).
302.
Kankanala, supra note 272, at 57.
303.
35 U.S.C. Sec. 102(b).
304.
Kankanala, supra note 272, at 58.
305.
35 U.S.C. Sec. 102(b).
306.
Kankanala, supra note 272, at 58, citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998).
307.
35 U.S.C. Sec. 102 (Conditions for Patentability; Novelty) as amended by Sec. 3 of the Leahy-Smith America Invents Act, 2011.
308.
35 U.S.C. Sec. 100 as amended by Sec. 3 of the Leahy-Smith America Invents Act, 2011.
309.
Lemley (2011)
310.
Ibid.
311.
Ibid.
312.
Ibid.
313.
35 U.S.C. Sec. 101.
314.
Brenner v Manson, 383 U.S. 519 (1966).
315.
Id., at 533.
316.
Ibid.
317.
Id., at 533.
318.
Id., at 534.
319.
Kankanala, supra note 272, at 30.
320.
Brenner, supra note 314, at 536.
321.
Merrill and Mazza, supra note 17, at 81.
322.
In re Brana, 51 F.3d 1560 (1995).
323.
Lakshmikumaran (2007).
324.
Brana, supra note 314, at 1562.
325.
Id., at 1565.
326.
Id., at 1566.
327.
Id., at 1568.
328.
Merrill and Mazza, supra note 17, at 81.
329.
U.S. Utility Examination Guidelines, 60 Fed. Reg. 36,263 (July 14, 1995).
330.
Merrill and Mazza, supra note 17, at 82.
331.
USPTO, Utility Examination Guidelines, 66 Fed. Reg. 1092 (January 5, 2001).
332.
Id., at 1098, quoted in Merrill and Mazza, supra note 17, at 82.
333.
Lakshmikumaran, supra note 323, at 51.
334.
Merrill & Mazza, supra note 17, at 82.
335.
In re Fisher, 421 F.3d 1365 (C.A. Fed., 2005).
336.
Merrill and Mazza, supra note 17, at 83.
337.
Ibid.
338.
Ibid.
339.
35 U.S.C. Sec. 103.
340.
Lakshmikumaran, supra note 323, at 48.
341.
Ibid.
342.
Graham v. John Deere Co., 383 U.S. 1, 17–18, 86 S.Ct. 684, 693–94 (1966).
343.
Lakshmikumaran, supra note 323, at 48.
344.
Hybritech Inc. v. Monoclonal Inc., 802 F.2d 1367 (C.A. Fed. (Cal.), 1986).
345.
Id., at 1380.
346.
In re. O’ Farrell, 853 F.2d 894 (C.A. Fed., 1988).
347.
In re Vaeck, 947 F.2d 488 (C.A.Fed., 1991).
348.
Kankanala, supra note 272, at 76.
349.
In re Dillon, 919 F.2d 688 (Fed. Cir. 1990 (en banc).
350.
Merrill and Mazza, supra note 17, at 86.
351.
Amgen, supra note 163.
352.
Ibid.
353.
Id., 1208.
354.
Ibid.
355.
Id., 1208.
356.
Merrill and Mazza, supra note 17, at 85.
357.
Nese, supra note 171, at 165.
358.
Merrill and Mazza, supra note 17, at 84.
359.
Ex parte Deuel, 33 U.S.P.Q. 2d 1445, 1447 (Bd. Pat. App. & Int’f. 1993) (citing the view of PTO examiners).
360.
In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995).
361.
In re Bell, 991 F.2d 781 (Fed. Cir. 1993).
362.
Rai (1999).
363.
Ibid.
364.
Id., at 833–34.
365.
Id., at 834.
366.
Merrill and Mazza, supra note 17, at 86.
367.
Sec. 103. Conditions for patentability; non-obvious subject matter as amended by Sec. 3 of the Leahy-Smith America Invents Act, 2011 (Applies to applications with effective filing dates after March 16, 2013).
368.
Lemley, supra note 309.
369.
35 U.S.C. Sec. 112.
370.
Ibid.
371.
Gulliford (2004).
372.
Id., at 721 (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991).
373.
35 U.S.C. Sec. 112.
374.
Gulliford, supra note 371, at 721.
375.
Ibid.
376.
Ibid.
377.
35 U.S.C. Sec. 112.
378.
Gulliford, supra note 371, at 721.
379.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed.Cir. 1991).
380.
Merrill and Mazza, supra note 17, at 88 [citing Amgen Inc. v. Hoechst Marion Roussel Inc. 314 F.3d 1313, 1330 (2003), Regents of University of California v. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997); Fiers v Revel, 984 F.2d 1164, 1170–71 (Fed. Cir. 1993)].
381.
Id., at 89.
382.
Id., at 88 [citing Regents of the University of California v. Eli Lilly 119 F.3d 1559 at 1568 (Fed. Cir. 1997); Fiers v. Revel., 984 F.2d 1164, 1171 (Fed. Cir. 1993).]
383.
Kankanala, supra note 272, at 100 [citing Fiers v. Revel., 984 F.2d 1164, 1170 (Fed. Cir. 1993)].
384.
Id., at 102 [citing Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559, 1569 (Fed. Cir. 1997)].
385.
Enzo Biochem Inc. v. Gen-Probe Inc., 323 F.3d 956 (C.A. Fed. (N.Y.) 2002).
386.
Kankanala, supra note 272, at 108.
387.
Capon v. Eshar (Capon), 418 F.3d 1349 (C.A.Fed., 2005).
388.
Falko-Gunter Falkner v Inglis, 448 F.3d. 1357 (C.A.Fed., 2006).
389.
Kankanala, supra note 272, at 106.
390.
Id., at 107.
391.
Id., at 108.
392.
USPTO Guidelines and Training Materials on Written Description, Federal Register/Vol. 66, No. 4/Friday, 5 January, 2001.
393.
Kankanala, supra note 272, at 107.
394.
Nese, supra note 171, at 162.
395.
Amgen, supra note 163.
396.
Nese, supra note 171, at 162.
397.
Ibid.
398.
Ibid, quoting Amgen, supra note 163, at 1212.
399.
Vaeck, supra note 347.
400.
Id., at 494.
401.
Enzo biochem Inc. v. Calgene Inc., 188 F.3d 1362 (C.A. Fed. (Del.), 1999).
402.
Id., at 1373.
403.
Id., at 1374.
404.
Falko, supra note 388.
405.
Kankanala, supra note 272, at 114.
406.
Ibid.
407.
Nese, supra note 171, at 163.
408.
Amgen, supra note 163, at 1214.
409.
Nese, supra note 171, at 163.
410.
Lemley, supra note 309.
411.
Dutfield, supra note 17, at 202.
412.
Id., at 202–203.
413.
Bryan (2009).
414.
The Boards of Appeal at EPO consist of Enlarged Board of Appeal, a Legal Board of Appeal and 26 technical boards of appeal. Among these, technical boards of appeal and the Legal Board of Appeal deal with appeals filed in relation to decisions reached by the first instance in the patent grant procedure, i.e. the Receiving Section and the Examining, Legal and Opposition Division. On the other hand, the Enlarged Board of Appeal deals with cases referred to it either by one of the technical boards of appeal or by the Legal Board of Appeal or by the President of the European Patent Office for a decision on an important point of law in order to secure uniform application of the law. Further, with the entry of the revised European Patent Convention in December 2007, the Enlarged Board of Appeal also reviews the decisions of the boards of appeal upon the petition of a party; available at http://www.epo.org/about-us/boards-of-appeal/faq-boards-of-appeal.html (Visited on July 20, 2011).
415.
Dutfield, supra note 17, at 204–205.
416.
Id., at 202.
417.
Id., at 206.
418.
Jameson (2009) cited in Bryan, supra note 413, at 57.
419.
Dutfield, supra note 17, at 206–207.
420.
Id., at 207.
421.
Zekos (2006).
422.
Ibid.
423.
Article 52, European Patent Convention.
424.
Zekos, supra note 421.
425.
Supra note 423.
426.
Rule 23 of the Implementing Regulations to the Convention on the Grant’ of European Patents on 5 October, 1973 as last amended by decision of the Administrative Council of the European Patent Organisation of 9 December, 2004.
427.
Ibid.
428.
Art. 53(b), European Patent Convention.
429.
Rule 23b(6) and Rule 23c(c) of the Implementing Regulations, supra note 413.
430.
Kankanala, supra note 272, at 21.
431.
Art. 53(b), European Patent Convention.
432.
23 c of the Implementing Regulations, supra note 413.
433.
Kankanala, supra note 272, at 22 (citing Recital 30 of the Biotech Directve).
434.
NOVARTIS/Transgenic Plant, Technical Board of Appeal 3.3.4 [1999] E.P.O.R. 123.
435.
Kankanala, supra note 272, at 22.
436.
Harvard/Onco-Mouse, 1989 O.J. EPO 451.
437.
Harvard/Onco-Mouse, 1990 O.J. EPO 476.
438.
Rimmer, supra note 42, at 90.
439.
Ibid.
440.
Harvard/Oncomouse [2003] OJEPO 473.
441.
Rimmer, supra note 42, at 90.
442.
Id., at 91.
443.
Harvard/Oncomouse [2004] T 0315/03–3.3.8.
444.
Rimmer, supra note 42, at 91.
445.
Kankanala, supra note 272, at 23.
446.
Rule 23 c (a) of the Implementing Regulations, supra note 413.
447.
Rule 23 b (3) of the Implementing Regulations, supra note 413.
448.
Kankanala, supra note 272, at 23.
449.
Rule 23 e (2) of the Implementing Regulations, supra note 413.
450.
Kankanala, supra note 272, at 23.
451.
Howard Florey/Relaxin (Opposition by Franktion der Grunen Im, Europaischen Parliament; Lannoye), Opposition Division [1995] E.P.O.R. 541.
452.
Rule 23 (d) of Implementing Regulations supra note 413.
453.
Rule 23e (1) of Implementing Regulations supra note 413.
454.
Rule 23e (2) of Implementing Regulations supra note 413.
455.
Art. 52(1), European Patent Convention.
456.
Art. 54, European Patent Convention.
457.
Brian Cain, Legal Aspects of Genetic Technology 127 (Sweet & Maxwell Ltd, London, 2003).
458.
G2/88 [1990] O.J. EPO 93.
459.
Cain, supra note 457, at 128.
460.
Ibid.
461.
Howard Florey Relaxin (Oppositions by Franktion der Grunen Im Europaischen Parliament; Lannoye), Opposition Division, 8 December 1994, (1995) E.P.O.R. 541.
462.
Kankanala, supra note 272, at 61–62.
463.
Kiren Amgen/Erythropoietin v. (Oppositions by Genzyme; Elanex Pharmaceuticals; Merckle; Boehringer Mannheim; Behringwerke; AKZO Pharma, Technical Board of Appeal 3.3.4, 21 November 1994, (1995)E.P.O.R. 629.
464.
Kankanala, supra note 272, at 63.
465.
R. v. Genentech/HIF-Gamma, T 223/92, Technical Board of Appeal 3.3.2, 20 July, 1993, (2003) E.P.O.R. 12, 106, 107.
466.
Biogen/Human Beta-interferon (Opposition by Schering, Technical Board of Appleal 3.3.4, 8 April, 1997 T 207/94 (1999) E.P.O.R. 451, 453, 461, 462.
467.
BIOGEN/Hepatitis B Virus (Opposition by Abbott;Takeda; Warcoin;Smithkline Beecham;Institute Pasteur; Intervention by Medeva) TechnicalBoard of Appeal 3.3.2, 16 June, 1994,(1999) E.P.O.R. 361, 377, 378.
468.
Unilever/Chymosin (Opposition by Celltech; Hansens Laboratorium), T/386/94,Technical Board of Appeal 3.3.4, 11 January, 1996, (1996), (1997) E.P.O.R. 184. 193, 194.
469.
Art. 54, European Patent Convention.
470.
Art. 56, European Patent Convention.
471.
Cain, supra note 457, at 130.
472.
Ibid.
473.
Triazole case, T939/92, OJ EPO 1996, 309.
474.
Guidelines for Examination in the European Patent Office, 71 Part C Chapter IV.
475.
T0455/91 (Genentech) [1995], O.J. EPO684.
476.
Cain, supra note 457, at 131.
477.
Ibid.
478.
T60/89 (Harvard) [1995] O.J. EPO 268.
479.
Biogen Inc v Medeva plc [1997] R.P.C.1.
480.
Ibid.
481.
[1989] R.P.C. 147.
482.
Cain, supra note 457, at 131.
483.
T2/83, OJ EPO 1984, 265.
484.
Biogen case, T296/93, OJ EPO 1995, 627
485.
Unilever case, T386/94, OJ EPO 1996, 658.
486.
Trilateral Project 24.1 at 2.1., cases E and D].
487.
Zekos, supra note 421.
488.
Art. 52(1), European Patent Convention.
489.
Art. 57 European Patent Convention.
490.
Cain, supra note 457, at 134.
491.
Art. 52(4), European Patent Convention.
492.
Guidelines for Examination in the European Patent Office, 57 Part C Chapter IV
493.
Id., at 54d.
494.
Cain, supra note 457, at 134.
495.
Du Pont/Appetite Suppressant [1987] E.P.O.R. 6 (1986).
496.
Kankanala, supra note 272, at 41.
497.
Harvard/Transgenic animal, Technical Board of Appeal 3.3.8 [2005] E.P.O.R. 31 (2006).
498.
Id. at 342.
499.
Ibid.
500.
Cain, supra note 457, at 137.
501.
Rule 27 (a) of Implementing Regulations supra note 428.
502.
Cain, supra note 457, at 137.
503.
Pioneer/Oilseed Brassica, Technical Board of Appeal 3.3.4, 5th March, 2004 [2004] E.P.O.R. 41.
504.
Id, at 421, 422.
505.
R. v. Massachusetts Institute of Technology/Biopolymers, Technical Board of Appeal 3.3.4, 21st January, 1998 [2003] E.P.O.R. 16.
506.
Id., at 142.
507.
Mycogen/Modifying Plant Cells (Opposition by Unilever, Centerns, Sandoz, Monsanto, and Max Planc Institute), Technical Board of Appeal 3.3.4, 8th May, 1996 [1998] E.P.O.R. 114.
508.
Kankanala, supra note 272, at 118.
509.
R. v. Genentech/HIF-Gamma, Technical Board of Appeal 3.3.2, 20th July, 1993 [2003] E.P.O.R. 12.
510.
Kankanala, supra note 272, at 119.
511.
Biogen/Recombinant DNA (Oppositions by Hoffman la Roche; Upjohn; Boehringer Ingelheim Zentrale; Bender; Cetus; Hoechst; Boehringer Mannheim, Technical Board of Appeal 3.3.2, 16th March, 1989 [1990] E.P.O.R. 190.
512.
Kankanala, supra note 272, at 122.
513.
GenetechI/Polypeptide Expression, Technical Board of Appeal 3.3.2, 27th January, 1988 [1989] E.P.O.R. 1.
514.
Ibid.
515.
Kankanala, supra note 272, at 124.
516.
Id., at 126.
517.
Art. 53, European Patent Convention.
518.
Art. 6.1 of Biotech Directive.
519.
Art. 6.2 of Biotech Directive.
520.
Recital 38 of Biotech Directive.
521.
Recital 39 of Biotech Directive.
522.
Cain, supra note 457, at 151.
523.
Harvard/Oncomouse, Examining Division, 14th July, 1989 [1990] E.P.O.R. 10.
524.
Id., at 11.
525.
Harvard/Oncomouse, T19/90, Technical Board of Appeal 3.3.2, 3rd October, 1990 [1990] E.P.O.R. 501.
526.
Ibid.
527.
Horward Florey/Relaxin (Oppositions by Franklin der Grunen In Europaischen Parliament; Lannoye) Opposition Division, 8th December, 1994 [1995] E.P.O.R. 541.
528.
Id., at 549.
529.
Id., at 550.
530.
Ibid.
531.
Id., at 551.
532.
Ibid.
533.
Id., at 551
534.
Ibid.
535.
Plant Genetic System/Glutamine Synthetase Inhibitors (Opposition by Greenpeace), Technical Board of Appeal 3.3.4, 21st February 1995, T/356/93, {1995] E.P.O.R. 357.
536.
Id., at 372.
537.
Kankanala, supra note 272, at 137.
538.
Id., at 138.
539.
Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, [2002] 4 S.C.R. 45.
540.
Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902.
541.
Zahl (2004).
542.
Anita Nador, “The Patenting of Biotechnology in Canada”, available at http://www.samedanltd.com/magazine/12/issue/44/article/1245.(visited on 29/07/2012).
543.
Ibid.
544.
35 U.S.C. Sec. 101 enunciates patentable subject matter as “[w]hoever 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, subject to the conditions and requirements of this title.”
545.
R.S.C. 1985, c. P-4, s. 2.
546.
Id. s. 28.3.
547.
Id. s. 27.8
548.
Tennessee Eastman Co. et al. v. Commissioner of Patents (1972), 8 C.P.R. (2d) 202.
549.
Manual of Patent Office Practice [MPOP] Chapter 12.04.02 “Medical treatment”
550.
Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, [2002] 4 S.C.R. 45; Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902.
551.
Pioneer Hi-Bred Ltd. V. Canada (Commissioner of Patents) [1989] S.C.R. 1623 [(1989), 25 C.P.R. (3rd), 257 (S.C.C.)] at pp. 263–265.
552.
Schlumberger Canada Ltd. v. Commissioner of Patents (1981) 56 C.P.R. (2d) 204 (FCA).
553.
MPOP Chapter 16.03.02 “Patentability and Programming”.
554.
Ibid.
555.
Art. 53(a) of the European Patent Convention stipulates that European patent shall not be granted in respect of “inventions the commercial exploitation of which would be contrary to “ordre public” or morality;..”
556.
Harvard College v. Canada (Commissioner of Patents), [2002 SCC 76, 116–121 per Bastarache J., and 89–102 per Binnie J.].
557.
Re Application of Abitibi Co., (1982), 62 C.P.R. (2d) 81 (P.A.B).
558.
Perry (2008).
559.
Id., at 72–73.
560.
(1982), 62 C.P.R. (2d) 81 (P.A.B) [Re Abitibi] cited in Perry, supra note 559, at 73.
561.
Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents) (1989), 25 C.P.R. (3d) 257 (S.C.C.).
562.
Pioneer, [25 C.P.R. (3d) p. 259].
563.
Ibid.
564.
Ibid.
565.
Sec. 12.03.01(a) of the Patent Office Manual cited in supra note 41.
566.
Supra note 562.
567.
Ibid.
568.
Pioneer, [25 C.P.R. (3d) p. 260].
569.
Ibid.
570.
Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents) [1987] 3 F.C. 14 cited in supra note 550, at 260.
571.
Pioneer, supra note 556.
572.
Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents) [1987] 3 F.C. 9, cited in supra note 562, at 260.
573.
Re Application of Abitibi Co., (1982), 62 C.P.R. (2d) 81 (PAB).
574.
Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents) [1987] 3 F.C. 9–10, cited in supra note 562, at 261.
575.
Zahl, supra note 542.
576.
Pioneer, supra note 562, at 263–264.
577.
Id., at 264.
578.
Pioneer, supra note 562, at 264–265.
579.
Id., at 265.
580.
Manual of Patent Office Practice [MPOP] Chapter 17.02.02 “Processes to Produce Life Forms”.
581.
Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, [2002] 4 S.C.R. 45.
582.
Garland and Smordin (2003).
583.
Ibid.
584.
Leder, P. and T. Stewart, ‘Transgenic animals’ (1985) Canadian Patent No: CA 1341442 cited in Rimmer, supra note 42 at 91.
585.
Garland and Smordin, supra note 583, at 162–163.
586.
Garland and Smordin, supra note 583, at 163.
587.
Abitibi, supra note 558.
588.
Garland and Smordin, supra note 583, at 163.
589.
Pioneer, [1987] 3 F.C. 8, 14 C.P.R. (3d) 491 (C.A.).
590.
Garland and Smordin, supra note 583, at 163–164.
591.
Id., at 164.
592.
Id., at 165.
593.
Rimmer, at 91.
594.
Ibid
595.
Garland and Smordin, supra note 583, at 167.
596.
Rimmer, at 91.
597.
Ibid.
598.
Harvard College v. Canada (Commissioner of Patents), [2002] SCC 76.
599.
Rimmer, at 91–92
600.
Garland and Smordin, supra note 583, at 168–169.
601.
Id., at 169.
602.
Harvard College, supra note 599 at para. 158.
603.
Id., at para. 159.
604.
Id., at para. 160.
605.
Id., at para. 166.
606.
Garland and Smordin, supra note 583, at 170.
607.
Harvard College, supra note 599 at para. 188.
608.
Id., at para. 196.
609.
Id., at para. 199.
610.
Garland and Smordin, supra note 583, at 171.
611.
Ibid.
612.
Canadian Biotechnology Advisory Committee (2002).
613.
Garland and Smordin, supra note 583, at 171–172
614.
Harvard college, supra note 599, at 57.
615.
Id., at para. 52.
616.
Id., at paras. 46–56.
617.
Id., at paras. 2, 3 and 33–38.
618.
Id., at paras. 12 and 13.
619.
Canadian Biotechnology Advisory Committee, Biotechnology and Intellectual Property: Patenting of Higher Life Forms and Related Issues: Interim Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (CBAC, Otawa, 2001) at 6, cited in Garland and Smordin, supra note 583, at 173.
620.
Harvard College, supra note 599, at para. 114.
621.
Id., at 60.
622.
Id., at 63.
623.
Canadian Biotechnology Advisory Committee (2003).
624.
Id., at 5.
625.
Garland and Smordin, supra note 583, at 174.
626.
Manual of Patent Office Practice [MPOP] Chapter 17.02.01a “Higher and Lower Life Forms”.
627.
Monsanto, supra note 541.
628.
Crane (2009).
629.
Ibid.
630.
Law and Marles (2004).
631.
Monsanto, supra note 541, at para. 11.
632.
Id., at para. 12.
633.
Law and Marles, supra note 631.
634.
Monsanto, supra note 541, at para. 6.
635.
Monsanto Canada Inc. v. Schmeiser, (2001), 202 F.T.R. 78, 12 C.P.R. (4th) 204, [2001] F.C.J. No. 436 (QL), 2001 FCT 256.
636.
Monsanto Canada Inc. v. Schmeiser, ([2003] 2 F.C. 165, at para. 40).
637.
Monsanto, supra note 541.
638.
Id., at para. 17.
639.
Id., at para. 20.
640.
Id., at para. 21, quoting Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 2002 SCC 76 (“Harvard Mouse”).
641.
Id., at paras. 22 and 23.
642.
Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77, at paras. 42–44.
643.
Monsanto, supra note 541, at para. 24.
644.
R.S.C. 1985, c. P-4, s. 42.
645.
Monsanto, supra note 541, at para. 28.
646.
Id., at 34, quoting H. G. Fox, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th ed. 1969).
647.
Law and Marles, supra note 631, at 45.
648.
Ibid.
649.
Ibid.
650.
Ibid.
651.
Ibid.
652.
Monsanto, supra note 541, at para. 111.
653.
Id., at para. 130.
654.
Id., at paras. 138 and 139.
655.
Law and Marles, supra note 631.
656.
Monsanto, supra note 541, at para. 160.
657.
Law and Marles, supra note 631, at 47.
658.
Manual of Patent Office Practice (MPOP), supra note 627.
659.
Patent Act, R.S.C. 1985, c. P-4, ss. 2, 28.2(1)(a).
660.
Id., s. 28.2 (1)(a)-(d).
661.
Id., s. 2.
662.
Gold (2009b).
663.
Apotex Inc. v. Wellcome Foundation Ltd., [2002]4 S.C.R. 153(S.C.C.).
664.
Gold and Knoppers, supra note 663, at 21.
665.
Nador, supra note 543.
666.
Patent Act, R.S.C. 1985, c. P-4, s. 28.3.
667.
Supra note 664.
668.
Patent Act, R.S.C. 1985, c. P-4, s. 27.3.
669.
Id., s. 28.1.
670.
Patent Rules, s. 111.
671.
Dimminaco A.G. v. Controller of Patents, Designs & Trade Marks, (2002) I.P.L.R. July 255, 269 (Calcutta H.C.).
672.
Mueller (2008).
673.
Ibid.
674.
The Patents (Amendment) Act, 1999 (17 of 1999).
675.
Jauhar and Narnaulia (2010).
676.
The Patents (Amendment) Act, 2002 (38 of 2002).
677.
Mueller, supra note 673.
678.
The Patents (Amendment) Act, 2005 (15 of 2005).
679.
Mueller, supra note 673.
680.
447 U.S. 303 (1980).
681.
Mueller, supra note 673.
682.
Diminaco, (2002) I.P.L.R. July 255 (Culcutta H.C.), at 259.
683.
Mueller, supra note 673.
684.
Diminaco, (2002) I.P.L.R. July 255 (Calcutta), at 258, 270.
685.
Id., at 258, 259, 261.
686.
Mueller, supra note 673.
687.
Diminico, (2002) I.P.L.R. July 255 (Calcutta), at 261, 262.
688.
Id., at 268.
689.
Ibid.
690.
Ibid.
691.
Id., at 269.
692.
Ibid.
693.
Id., at 266–268.
694.
Id., at 270.
695.
M/s. Bishwanath Prasad Radhey Shyam v. M/s. Hindustan Metal Indus., A.I.R. 1982S.C. 1444.
696.
Dimminaco, I.P.L.R. July 255 (Calcutta), at 269.
697.
Id., at 269–70.
698.
Jauher and Narnaulia, supra note 676, at 60.
699.
Ibid.
700.
Id., at 61.
701.
Sec. 2(1)(j) of The Patent Act, 1970 (Substituted by the Patent (Amendment) Act 38 of 2002, Sec. 3, for clause (j) (w.e.f. 20-5-2003).
702.
Rep. by the Patents (Amendment) Act 15 of 2005, Sec. 4 (w.r.e.f. 1-1-2005).
703.
Jauher and Narnaulia, supra note 676, at 61.
704.
Sec. 3 of the Patents Act, 1970 (as amended in 1999, 2002 and 2005).
705.
Sec. 3(c) of the Patents Act, 1970 [Ins. by Patent (Amendment) Act 38 of 2002, Sec. 4 (w.e.f. 20-5-2003)].
706.
Sec. 3(j) of the Patents Act, 1970 [Ins. by Patent (Amendment) Act 38 of 2002, Sec. 4 (w.e.f. 20-5-2003)].
707.
Kankanala, supra note 272.
708.
Supra note 693.
709.
Annexure 1, Examination Guidelines for Patent Applications relating to inventions in the Field of Chemicals, Pharmaceuticals and Biotechnology, Manual Patent Practice and Procedure, 2005.
710.
Ibid.
711.
Id., citing Sec. 3(c), Indian Patent Act, 1970, as amended in 2002.
712.
Sec. 3 of the Patents Act 1970, as amended by the Patents (Amendment) Act 38 of 2002.
713.
Kankanala, supra note 272, at 27.
714.
Supra note 702.
715.
Sec. 2(l) Sec. 2(1)(l) of the Patents Act, 1970, substituted by the Patent (Amendment) Act 15 of 2005, Sec. 2(g), for clauses (l) and (m) (w.r.e.f. 1-1-2005).
716.
MPPP, 2011, Chapter 08.03.02.
717.
Ibid.
718.
Sec. 2(1)(j)(a) of the Patents Act, 1970, substituted by the Patent Amendment Act 38 of 2002s. 3, for clause (j) (w.e.f. 20-5-2003) and Patent (Amendment) Act 15 0f 2005, Sec. 2 (f), for clause (ja) (w.r.e.f. 1-1-2005).
719.
Kankanala, supra note 272, at 96.
720.
Ibid.
721.
Supra note 702..
722.
Sec. 2(1)(ac) of the Patents Act 1970, substituted by the Patents (Amendment) Act 38 of 2002, Sec. 3, for clause (a) (w.e.f. 20-5-2003).
723.
MPPP, 2005, Chapter II, Page 13, Para. 2.4.
724.
Kankanala, supra note 272, at 40.
725.
7.0 Biotechnology Inventions, Annexure I, Manual of Patent Practice and Procedure, 2005.
726.
Kankanala, supra note 272, at 41.
727.
Sec. 3(d) of the Patents Act 1970 as amended in 2005.
728.
Supra note 725.
729.
MPPP, 2011, Chapter 08.03.04.
730.
Sec. 10(4)(a) of the Patents Act, 1970.
731.
Sec. 10(4)(b) of the Patents Act, 1970.
732.
MPPP, 2005, 7.0, at 142 (examination guidelines pertaining to biotechnological inventions).
733.
1970 Patents Act, No. 39, Sec. 10(4)(d)(ii). The Act was amended in 2005 to reflect India’s accession to the Budapest Treaty; the prior version of the Act required deposit of biological material ‘to an authorized depository institution as may be notified by the Central Government in the Official Gazette.’
734.
2005 Patents (Amendment) Act, No. 15, Sec. 8(b)(i) (amending 1970 Patents Act, § 10(4)(d)(ii)).
735.
1970 Patents Act, Sec. 10(4)(d)(ii)(A)-(D).
736.
Sec. 10(4)(d)(ii)(D) of the Patents Act 1970, substituted by the Patents (Amendment) Act 15 of 2005, Sec. 5(b)(ii), for sub-clause (A) (w.r.e.f. 1-1-2005).
737.
Mueller, supra note 673.
738.
Sec. 3(b) of the Patents Act, 1970, substituted by the Patent Amendment Act 38 of 2002, Sec. 4, for clause (b) (w.e.f. 20-5-2003).
739.
Para. 7.0 Annexure I, Examination guidelines for patent applications relating to inventions in the field of chemicals, pharmaceuticals and biotechnology, Manual Patent Practice and Procedures.
740.
Ibid.
741.
Kankanala, supra note 272, at 138.
742.
Ibid.
743.
MPPP, 2011, Chapter 8 Para. 03.05.02 page 80–81.
744.
Jauher and Narnaulia, supra note 676, at 61.
745.
Indian Patent Office, Annual Report 2007–08, available at http://ipindia.gov.in/cgpdtm/AnnualReport_English_2007-2008.pdf (last visited on September 20, 2011).
746.
Ibid.
747.
Ibid.
748.
WT/GC/W/302.
749.
Jauher and Narnaulia, supra note 676, at 61.
750.
Ibid.

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Kshitij Kumar Singh

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Singh, K. (2015). Patentability of Biotechnology: A Comparative Study with Regard to the USA, European Union, Canada and India. In: Biotechnology and Intellectual Property Rights. Springer, New Delhi. https://doi.org/10.1007/978-81-322-2059-6_2

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