Abstract
The generic pharmaceutical sector in India transformed over the last few decades. However, certain recent judicial developments may impact the flexibility that generic companies have for development of future generics. This article looks at some of these developments. The developments covered are: a) interpretation and application of the Bolar flexibilities and b) hurdles in claiming use under S.107 A.
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References
1.
‘Rights of Patentees’ are covered in India under S.48 of the Patents Act, 1970. It states: “48. Rights of Patentees Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted under this Act shall confer upon the patentee— (a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India; (b) where the subject matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India. ”
2.
Copy of the 1911 Act, www.indiaip.com/product_image/1399278119.pdf (accessed 30 July 2021).
3.
For a detailed history of Compulsory Licenses in India, refer “Compulsory licences on pharmaceutical patents in India: A short article ” (Journal of Generic Medicines (2017) 13(3) DOI: 10.1177/1741134317691804).
4.
Copy of the 1970 statute, https://indiankanoon.org/doc/1937976/ (accessed 30 July 2021).
5.
Please refer Paragraphs 100-101 of the 1959 ‘REPORT on the revision of the patents law by Justice N. Rajagopala Ayyangar’, https://spicyip.com/wp-content/uploads/2013/10/ayyangar_committee_report.pdf (accessed 30 July 2021).
6.
The provision read: “S.5: Inventions where only methods or processes of manufacture patentable.- (1) In the case of inventions- (a) claiming substances intended for use, or capable of being used, as food or as medicine or drugs, or, (b) relating to substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds,) no patent shall be granted in respect of claims for the substances themselves, but claims for the methods or processes of manufacture shall be patentable… ”
7.
8.
S.5 was repealed by the Patents (Amendment) Act, 2005 that came into effect from 01/Jan/2005.
9.
For a deeper look into evergreening strategies and types of such patents, please refer “Ever-greening: A status check in selected countries ” (Journal of Generic Medicines (2010) 7, 227–242. DOI: 10.1057/jgm.2010.14).
10.
Article 30. Trade-Related Aspects of Intellectual Property Rights, https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm (1995, accessed 30 July 2021).
11.
Now enshrined in the US Patents legislation – 35 U.S. Code § 271(e)(1): “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
12.
This legislative change was the result of Roche Products v. Bolar Pharmaceutical 733 F.2d 858 (Fed. Cir. 1984). For background, refer ‘The curious case of India’s Bolar provision ’ (Journal of Generic Medicines . 2018;14 (1 ):16 –21 . DOI:10.1177/1741134317745351).
13.
Inserted by Act 38 of 2002 with effect from 20 May, 2003.
14.
District Courts are vested with the jurisdiction to try infringement suits and thus are courts of first instance. However, there are five High Courts in India that can also act as the court of first instance in patent infringement by virtue of them having “original jurisdiction” and thus can directly be courts of first instance. It is apposite to mention that an order of the District Court can be appealed before a single judge of High Court. An appeal from the order of a single judge of the High Court can be challenged before a two-judge bench of the High Court (Division Bench). An appeal from the order of the Division Bench lies before the Supreme Court.
15.
CS(COMM) No.1592/2016 at the High Court of Delhi.
16.
Bayer had originally initiated a patent infringement suit against Natco (CS (OS) 1090/2011 at the High Court of Delhi) in 2011 for infringement of its patent (before the issuance of the historic ‘Nexavar’ compulsory license in 2012). For more information, refer ‘Compulsory licences on pharmaceutical patents in India – A short article ’ (Journal of Generic Medicines . 2017;13 (3 ):108 –113 . DOI:10.1177/1741134317691804).
17.Bayer Corporation v. Union of India & Ors. , W.P. (C) 1971/2014 before the High Court of Delhi.
18.
As noted earlier, section 48(a) covers the Rights of Patentees in the context of product patents.
19.
Order of High Court of Delhi dated 08.03.2017 in W.P.(C) No.1971/2014 & CS(COMM) No.1592/2016, https://indiankanoon.org/doc/56241748 (accessed 30 July 2021).
20.
Para 47, ibid.
21.
Para 25, ibid.
22.
Para 26, ibid.
23.
Para 46 of Order of High Court of Delhi dated 08.03.2017 in W.P.(C) No.1971/2014 & CS(COMM) No.1592/2016.
24.
Para 60, ibid.
25.
RFA(OS)(COMM)6/2017.
26.
LPA 359/2017.
27.
The Bayer/Union of India, Natco appeal came for hearing in front of the division bench comprising the Hon'ble Acting Chief Justice Ms. Gita Mittal and Hon'ble Ms. Justice Anu Malhotra. The Natco order dated 12/May/2017, http://delhihighcourt.nic.in/dhcqrydisp_O.asp?pn=98391&yr=2017 (accessed 30 July 2021).
28.
Order dated 06/Dec/2017 of the High Court of Delhi in RFA (OS) (Comm) 6/2017.
29.
Bayer Corporation v. Union of India & Ors, https://indiankanoon.org/doc/85364944/ (accessed 30 July 2021).
30.
Para 94, ibid.
31.
Para 28, judgement of the High Court of Delhi dated 22.04.2019 in LPA 359/2017 and RFA (OS) (COMM) 6/2017.
32.
Para 29, ibid .
33.
Para 84, ibid .
34.Ibid.
35.
Para 91, ibid.
36.
Para 105, ibid .
37.
Para 107, ibid .
38.
Para 110, ibid .
39.
Para 111, ibid .
40.
CS COMM 154 of 2020 and I.A. 4200 of 2020 – order dated 03/June/2020, http://delhihighcourt.nic.in/dhcqrydisp_o.asp?pn=81996&yr=2020 (accessed 30 July 2021).
41.
Order of the High Court of Delhi dated 19/June/2020 in CS(COMM) 183/2020, http://delhihighcourt.nic.in/dhcqrydisp_o.asp?pn=84204&yr=2020 (accessed 30 July 2021).
42.
CS(Comm) 547/2020 at the Delhi High Court, Order dated 11/Dec/2020, http://delhihighcourt.nic.in/dhcqrydisp_o.asp?pn=248809&yr=2020 (accessed 30 July 2021).
43.
Order of the High Court of Delhi dated 23 December 2020 in CS(Comm) 565/2020.
44.
Order dated 10.03.2021 of High Court of Delhi in H. Lundbeck A/S & Anr. v. Hetero Drugs Limited & Anr.
45.Merck Sharp and Dohme Corp. & Anr. versus SMS Pharmaceuticals Limited [CS (COMM) 463/2020, Delhi High Court- order dated 21/Oct /2020], http://delhihighcourt.nic.in/dhcqrydisp_o.asp?pn=195021&yr=2020 (accessed 30 July 2021).
46.Ex-parte orders are orders that are issued without hearing the opposite party. These are normally temporary in nature till the next hearing where the opposite party would also be heard. However, at times, these orders tend to get extended causing hardships for the opposite party.
47.
Copy of the Order, https://indiankanoon.org/doc/177825690/ (accessed 30 July 2021).
48.
The April 2019 Order, https://indiankanoon.org/doc/85364944/ (accessed 30 July 2021).
49.
Order of the High Court of Delhi dated 19.03.2008 in F-Hoffmann La Roche Ltd. v. Cipla Ltd , https://indiankanoon.org/doc/64813/ (accessed 30 July 2021).
50.
Refer news article, www.telegraphindia.com/india/alert-on-affordable-medicines/cid/1691499 (accessed 30 July 2021).