Author: Nishant Shastri
College: ILS Law college, pune
Abstract
Indian patent practice is traditionally seen as a balance between innovation and access.
The problem with this is that while it is very convenient analytically, it is quite unhelpful in practice. Firms are faced with a series of trade-offs where any benefit gained through one trade-off results in costs at another. For example, drafting a claim that will cover commercial variations makes the claim vulnerable to challenges under Section 10 on grounds of insufficiency. An amendment to secure grant of the patent under Sections 57 to 59 limits the scope available for equivalents. The assertion of exclusivity in an aggressive manner under Section 48 creates vulnerability under both Sections 84 and 106. In this paper, I would like to demonstrate that the Patents Act, 1970 presents not individual doctrinal puzzles but a systematic network of trade-offs and that the uncertainties that matter here arise from the interactions of rules rather than any single provision. Through the jurisprudence of the Intellectual Property Divisions since 2021 and the amended Patents (Amendment) Rules, 2024, this paper will try to identify eight such interactions and argue that the only logical way forward would be managing the patent life cycle as an asset.
I. Introduction
The predominant academic perspective on Indian patent law is one of balance: private incentives versus public access, TRIPS obligations versus development sovereignty, innovation versus cost.1 These are genuine questions. These are also questions of a wrong abstraction of the firm, which needs to make a decision every Tuesday whether to narrow its claims to secure grant, or respond to a cease-and-desist letter with a request for non-infringement, or manufacture locally before the third anniversary of the grant.These are conflicts, not philosophy, of the Patents Act, 1970 for that firm.2 In each case, the issue constitutes a real dilemma in its true sense: an either/or choice,
1 See, e.g., Parliamentary Standing Comm. on Commerce, 161st Report, Review of the Intellectual Property Rights Regime in India (July 23, 2021) (Rajya Sabha Secretariat, India) [hereinafter 161st Report].
2 The Patents Act, No. 39 of 1970, India Code (1970) [hereinafter Patents Act], as amended by the Patents (Amendment) Act, No. 15 of 2005, India Code (2005)
with the benefit of the one being the price of the other, with the statute applying the pressure on both sides without solving it. The primary thesis of this paper is that these problems do not arise by accident but constitute the inevitable outcome of a statute that governs a patent through five separate phases in its life cycle— application, grant, working, enforcement, and revocation—through clauses that have been framed at different times and for different purposes.3
There are three reasons why it is timely to revisit this analysis. First, the Tribunals Reforms Act, 2021 has scrapped the Intellectual Property Appellate Board and transferred revocation proceedings from the Controller to the High Courts.4 The Delhi High Court, which received nearly three thousand transferred matters, constituted a dedicated Intellectual Property Division in July 2021 and notified specialised rules, including rules governing patent suits, in February 2022.5 This leads to a consolidation of technologically literate judgment which, in four years, has produced more useful precedent than what was produced in ten years prior.Second, the Patents (Amendment) Rules, 2024 fundamentally changed the compliance regime, shrinking the period for seeking examination, revising the requirements of disclosure under Section 8, and, importantly from the perspective of enforcement discussed later, reducing the number of statements of working from yearly to three-yearly.6 Finally, the empirical landscape has turned out to be a volatile one which actually serves to illustrate the thesis itself. The number of grants went up from zero in the financial year 2022-23 to 1,03,057 in the financial year 2023-24, before dropping down to 33,504 in 2024-25.7 According to the Controller General, this is the number of filings went the other way, touching 1,10,375 in 2024–25, with domestic applicants going past sixty-one per cent of the total.8
3 The 1970 Act, the 2002 amendments implementing Article 27 of TRIPS, and the 2005 amendments introducing product patents and Section 3(d) reflect materially different legislative purposes. See Agreement on Trade-Related Aspects of Intellectual Property Rights arts. 27, 31, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299.
4 The Tribunals Reforms Act, No. 33 of 2021, India Code (2021).
5 Delhi High Court Intellectual Property Rights Division Rules, 2022, and High Court of Delhi Rules Governing Patent Suits, 2022, notified Feb. 24, 2022.
6 The Patents (Amendment) Rules, 2024, G.S.R. 169(E) (Mar. 15, 2024) (India).
7 Office of the Controller Gen. of Patents, Designs & Trade Marks, Annual Report 2024–25 (India). The 2023–24 figure is reported at Press Information Bureau, Gov’t of India, Indian Patent Office Grants 1,03,057 Patents in FY 2023-24 (2024).
8 Id. Domestic filings stood at 68,201 of 1,10,375, or 61.79%, against 51,574 of 90,300 (55.96%) in the preceding year.
An increasing number of domestic filers is now up against a validity screen set during a time when theprimary applicants were foreign multinationals. This friction is what is being examined in the pages that follow.Part II considers the conflict between claim scope and Indian patentability and disclosure requirements. Part III considers the conflict between exclusivity and working and public interest considerations. Part IV deals with the problem of infringement defence, where the accused company is forced to decide between redesign, licensing, opposition, revocation, and litigation under conditions of compounded uncertainty. Part V identifies the eight statutory fissures which cause these problems, and Part VI provides the integrated solution.
II. Prosecution: Claim Breadth Against Patentability and Disclosure
A. The Efficacy Filter and the Cost of Incremental Innovation
Under Section 3(d), the discovery of any new form of a known substance, which is not resulting in an increase in the known efficacy of the said substance shall be deemed to be non-invention.9 where the new formulation does not lead to an improvement in the therapeutic efficacy of the known substance does not qualify as an invention.9 In the case of Novartis AG v. Union of India, the Supreme Court ruled that the beta-crystalline form of imatinib mesylate did not meet this criterion because it merely enhanced efficacy in terms of solubility, stability, flow properties, and bioavailability but not therapeutic efficacy.10 The Court also rejected the argument that a patentee may claim broad coverage in one patent while reserving disclosure for a later one, observing that coverage and disclosure must be coextensive.11
The practical upshot is that Indian prosecution will need proof of utility derived from a use that no other important jurisdiction requires at the very same point. An improvement in formulation that is commercially and technically valid – increased shelf-life, decreased administration, an effective polymorph – is patentable in the US and Europe but not India unless the claimant can show a therapeutic difference. Such proof is usually comparative, is made early, and is not undone by the claimant’s regulatory disclosures. The Standing Committee on Commerce, in its 2021 report, upheld Section 3(d) as compliant with the TRIPS Agreement and as a bulwark against evergreening, which implies that the test is a permanent one and not just a temporary one.12
9 Patents Act § 3(d).
10 Novartis AG v. Union of India, (2013) 6 S.C.C. 1 (India).
11 Id.
12 161st Report, supra note 1.
B. The Asymmetry Within Section 3(k)
Clause 3(k) does not include “mathematical or business method or a computer programme per se or algorithms.”13 The Indian courts have evolved this clause into two totally different rules. So far as software is concerned, in the case of Ferid Allani v. Union of India, the Delhi High Court ruled that the phrase “per se” should be read. In case an invention using computers shows any technical effect or technical contribution, it will not fall within the scope of the exclusion clause.14
This position has been consistently re-iterated, for instance, in Blackberry Ltd. v. Assistant Controller of Patents, wherein the court has stated that the patent examiners cannot make novelty of hardware a pre-requisite since technical contribution is the key criterion.15
In terms of business methods, however, the rule is the complete reverse. In OpenTV Inc. v. Controller of Patents and Designs, it was decided that the exclusion in respect of business methods was “absolute and not qualified,” and without a “per se” or “as such” modifier to the exclusion clause – although at the same time noting the need for legislative review in light of the large investment in the field.16
The result is that this is an issue of drafting that is highly delicate. Invention of a payment system, an insurance system, a logistics system, or a platform will generally have two descriptions, one describing it as a technical solution and another as a way of conducting business. One specification, when described from a different perspective, can fall on either side of an absolute barrier. The contradiction is not between the applicant and the examiner, but between two internally valid descriptions of the same thing.
C. Sufficiency and the Coverage–Disclosure Gap
Section 10(4) demands that the full description of the invention includes a disclosure of the best way of carrying out the invention, and shall include claims defining the scope of protection; Section 10(5) demands that such claims shall be clear, concise, and reasonably drawn from the subject-matter disclosed.17 The conflict is a simple and universal one: The wider the claim made, the greater the amount of disclosure required for its proof.
13 Patents Act § 3(k).
14 Ferid Allani v. Union of India, W.P.(C) 7/2014 (Delhi H.C. Dec. 12, 2019) (India).
15 Blackberry Ltd. v. Assistant Controller of Patents & Designs, C.A.(COMM.IPD-PAT) 318/2022 (Delhi H.C. Aug. 30, 2024) (India); see also Microsoft Tech. Licensing LLC v. Assistant Controller of Patents & Designs (Delhi H.C. 2023) (India).
16 OpenTV Inc. v. Controller of Patents & Designs, 2023:DHC:3305 (Delhi H.C. May 11, 2023) (India).
What makes India different is the point at which the conflict arises. In AstraZeneca AB v. Intas Pharmaceuticals Ltd., the applicant was seeking interim injunction on dapagliflozin, despite having taken out a species patent after the expiry of a genus patent for the same product.18 However, the Delhi High Court dismissed the claim for an injunction because the defendants had raised a prima facie challenge based on the discrepancy between the claims made by the patentee and the disclosure,and stressed the quid pro quo nature of the deal: the specification should enable the skilled person to work the invention once the patent expires.19 The Division Bench affirmed.20 What follows from this for the prosecutor is that the sufficiency issue is not finally decided upon at grant, but rather it is reopened on the basis of the scope assertions made by the patentee at the very point when the patentee needs it most. In litigation, a genus-species filing strategy that is efficient during prosecution becomes a concession by the patentee.
This situation occurs most frequently in biotechnology, chemistry, and pharmaceuticals, where a claim will generally refer to a category based on structure or function, whereas the specification provides examples for a limited number of embodiments. If the subject matter includes living material that cannot be sufficiently described in writing, the specification will have to comply with the deposit requirement of Section 10(4)(d)(ii).21 Neither does the statute nor the current case law provide any numerical criteria with respect to the number of instances required to demonstrate the class at issue. What the applicant has to deal with is thus a probability rather than a threshold which has to be estimated years ahead of testing the claim.
D. Amendments, Divisionals, and the Prosecution Record
Section 57 to 59 allow only disclaimers, corrections and explanations, and do not allow any amended claim which is not wholly confined within the ambit of a claim prior to the amendment and which does not disclose any matter substantially previously disclosed.22 The narrowing which guarantees grant is thus rendered an irreversible part of the patent specification.
17 Patents Act § 10(4)–(5).
18 AstraZeneca AB v. Intas Pharms. Ltd., 2020 S.C.C. OnLine Del 1446 (India).
19 Id.
20 AstraZeneca AB v. Intas Pharms. Ltd. (Delhi H.C. Div. Bench 2021) (India).
21 Patents Act § 10(4)(d)(ii) (requiring deposit of biological material with an international depositary authority under the Budapest Treaty where the material cannot be described adequately and is not available to the public).
22 Patents Act §§ 57–59.
Two implications arise therefrom. One deals with equivalents. In Communication Components Antenna Inc. v. Ace Technologies Corp., for instance, the Delhi High Court addressed itself to the prosecution history of the equivalent foreign application while interpreting the claim in India.23 For applicants pursuing a family of applications through jurisdictions, it turns this administrative practice of leaving the national phase opposing procedures in the hands of local counsel who work towards getting grants for the same in their offices into a potential litigation problem.
The second issue relates to divisionals. In the case of Syngenta Ltd. vs. Controller of Patents and Designs, a Division Bench settled a referred dispute and ruled that a divisional application would only be maintainable if a multiple number of inventions have been claimed in the parent provisional or complete specification, and not just in its claims.24 This overtook the narrower position in Boehringer Ingelheim.25 The Rules of 2024 ultimately enshrined.26 The key here is that the parent specification, formulated in previous years amidst business uncertainties, now decides everything about the company’s future options in filing.
III. Enforcement: Exclusivity Against Working and Public Interest
A. Section 48 as a Conditional Right
While section 48 grants the exclusive right of excluding others from manufacturing, using, offering for sale, selling, or importing the patent product, the provision is specifically provided under “subject to the other provisions contained in this Act.”27
They are not marginal provisions. Provision 47 requires that all patents be subject to conditions allowing the government and experimentation/research use.28 Under Section 83, the rule regarding how patented inventions work is given thus: “Patents are granted with a view to encouraging inventions, and for securing that the inventions are worked commercially in India, and not merely for the purpose of giving to patentees a monopoly of importation.”29 Indian exclusivity is thus contingent in a way that has no direct counterpart in the jurisdictions where most Indian patent holders’ patent holdings have been generated. The rightconferred is conditional, and those conditions are enforceable by others.
23 Commc’n Components Antenna Inc. v. Ace Techs. Corp. (Delhi H.C. July 12, 2019) (India), aff’d, 2023:DHC:2479-DB (Delhi H.C. Div. Bench Apr. 10, 2023) (India).
24 Syngenta Ltd. v. Controller of Patents & Designs, 2023:DHC:7473-DB (Delhi H.C. Div. Bench Oct. 13, 2023) (India).
25 Boehringer Ingelheim Int’l GmbH v. Controller of Patents, 2022:DHC:2682 (Delhi H.C. 2022) (India).
26 The Patents (Amendment) Rules, 2024, supra note 6, r. 13(2A).
27 Patents Act § 48
B. The Compulsory Licence: Credible Threat, Rare Instrument
Under Section 84, an application can be made by any person interested after three years from the grant of the patent on any one of the following three grounds:
(i) Reasonable requirements of the public have not been satisfied.
(ii) The invention is not available to the public at a reasonable cost.
(iii) The invention is not being worked in the territory of India.30
The one-time use of this is highly significant. In the case of Bayer Corporation v.
Natco Pharma, the Controller issued India’s first-ever compulsory license for sorafenib tosylate, where all three conditions were met: only a tiny proportion of patients were supplied to, the cost of about ₹2,80,000 per month was not reasonable enough, and the importer’s reliance on import did not qualify as working in India.31 Licence was granted on a monthly fee of Rs. 8,800 against 6% royalty, raised to 7% on appeal; this decision was confirmed by Bombay High Court and Supreme Court did not interfere in the matter.32
Two more applications thereafter were unsuccessful. The first one was BDR Pharmaceuticals vs.
Bristol-Myers Squibb where the Controller denied the application regarding dasatinib due to the inability to prove the prima facie case and most importantly to show their best efforts to get a voluntary license in accordance with Section 84(6)(iv).33
In Lee Pharma Ltd. v. AstraZeneca AB, The patent application for saxagliptin was unsuccessful on all three statutory criteria.34 What emerges is an unusual situation for the patentee to deal with. In 14 years, the instrument has come up once. But the availability of the instrument shapes negotiations at all times, since the profile that brings about the application –
28 Id. § 47.
29 Id. § 83(a)–(c).
30 Id. § 84(1)(a)–(c).
31 Bayer Corp. v. Natco Pharma Ltd., C.L.A. No. 1 of 2011 (Controller of Patents Mar. 9, 2012) (India).
32 Bayer Corp. v. Union of India, O.A. No. 35 of 2012 (I.P.A.B. Mar. 4, 2013) (India), aff’d, Bayer Corp. v. Union of India (Bombay H.C. July 15, 2014) (India), SLP dismissed (S.C. Dec. 2014) (India).
33 BDR Pharms. Int’l Pvt. Ltd. v. Bristol-Myers Squibb Co., C.L.A. No. 1 of 2013 (Controller of Patents Oct. 29, 2013) (India); Patents Act § 84(6)(iv).
34 Lee Pharma Ltd. v. AstraZeneca AB, C.L.A. No. 1 of 2015 (Controller of Patents Jan. 19, 2016) (India).
a costly import-reliant product catering to a need that is large and unmet – is quite diagnostic and fully within the patentee’s capability of changing. The issue here is of maximizing price and exclusivity on the one side and creating evidence of reasonable availability and local working of the instrument that precludes it from being used.
C. Working Information After the 2024 Rules
146(1) confers the Controller with power to ask for information in regard to the extent to which the patented invention has been carried out commercially in India.35 The regime underwent reforms as a consequence of the public interest litigation filed in Shamnad Basheer v. Union of India.36
However, the Rules for 2024 took a step in the opposite direction. Under the new Rule 131(2), the statement in Form 27 must be made only once every three years, and the duty to disclose the approximate amount accrued in India has been scrapped, and penalty for non-disclosure is provided under Section 122(1)(b) as amended by the Jan Vishwas (Amendment of Provisions) Act, 2023. 37
It is an important shift in strategic advantage. The compliance requirements of patent owners have been lowered considerably. So have the resources of evidence that would support the Section 84 claimant’s argument regarding non-working. The conditions on which exclusivity is based are still present; but the evidence necessary to enforce those conditions has been lowered.37
D. Opposition and Portfolio Risk
Clause 25(1) allows anyone to oppose the grant of a patent following publication and before grant; Clause 25(2) allows a party who is interested to oppose for up to twelve months following grant.38
In Novartis AG v. Natco Pharma Ltd., a Division Bench of the Delhi High Court dealt with the consequent misuse.39 The court observed that the examination process and opposition are two parallel yet distinct processes wherein an opponent has a right to be heard in the matter of representation but does not have any right to participate in the process of examination, even regarding the amendments made by the controller.40
35 Patents Act § 146.
36 Shamnad Basheer v. Union of India, W.P.(C) 5590/2015 (Delhi H.C. 2018) (India).
37 The Patents (Amendment) Rules, 2024, supra note 6, r. 131(2); The Jan Vishwas (Amendment of Provisions) Act, No. 18 of 2023, India Code (2023); Patents Act § 122(1)(b).
38 Patents Act § 25(1)–(2).
39 Novartis AG v. Natco Pharma Ltd., LPA 50/2023 (Delhi H.C. Div. Bench Jan. 9, 2024) (India).
In the case of the patentee, the critical issue is that opposition is not an after litigation defence, but is a core and early element of Indian procedure. While applications, divisionals, and patents of addition leave options open, they increase the opportunities for a validity attack to be made,and the issue in commercial disputes is not whether there is a patent, but whose member of the family is going to count.
IV. Infringement Defence: Litigation, Revocation, and Continuity
A. Jurisdiction, Burden, and the Revocation Menu
According to Section 104, no suit for infringement may be brought in any court below the level of the District Court; and where there is a claim for revocation, such suit and counterclaim are elevated to the High Court.41 Under Section 104A, the burden of proof is placed on the party accused of infringement regarding process-patent cases where a new product is involved.42 Section 107 makes all the grounds available for revocation under Section 64 available as a defence against a charge of infringement.43
Section 64 is wide-ranging, covering lack of novelty, lack of inventive step, insufficiency, lack ofpatentability, and, of especial importance, failure to make disclosures required under Section 8 in relation to foreign applications.44 Section 8 Jurisprudence shows how a procedural duty turns into a substantive peril. In the case of Chemtura Corp. v. Union of India, the Delhi High Court took very seriously the suppression of information regarding foreign prosecutions.45 The court in Koninklijke Philips v. Maj. (Retd.) Sukesh Behl included materiality and willfulness in the power of revocation, stating that since section 64(1) is drafted in permissive language, non-compliance does not mean that the registration is automatically revoked, but that there was a suppression of material information done deliberately.46
This problem for the defendant is one of sequence and expense. Early determination of the issue of validity would be preferable; however, claim construction, evidence of infringement, and interim remedies occur simultaneously, and the legislation deals separately with jurisdiction, burden, defenses, and remedies.
40 Id.; Patents Rules, 2003, r. 55.
41 Patents Act § 104.
42 Id. § 104A.
43 Id. § 107.
44 Id. §§ 8, 64(1)(m).
45 Chemtura Corp. v. Union of India (Delhi H.C. Aug. 28, 2009) (India).
46 Koninklijke Philips Elecs. N.V. v. Maj. (Retd.) Sukesh Behl, FAO(OS) 16/2014 (Delhi H.C. Div. Bench Nov. 7, 2014) (India).
B. Interim Relief and the Credible Challenge
The interim stage is where the issues in Indian patent cases are largely determined due to the fact that the commercial impact of the injunction – costs of redesign, write-off of stock, interference in distribution chain, delay in regulatory approvals – often outweighs the ultimate award of damages.
The law laid down in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. continues to be the governing principle. The single judge did not grant interim relief on erlotinib as the defendant had made a credible challenge to the patent’s validity. Public interest considerations were in Favor of the defendant as well.47 The instructional coda is that Roche triumphed on the merits: infringement was found by the Division Bench in 2015.48 A valid counterclaim will nullify the injunction, but does not immunise the infringer.
This results in an equilibrium that is efficient from one perspective but disturbing from another. Valid invalidity claims on the part of defendants would enable them to remain in the market, and patents that are weak could no longer serve as a basis to secure settlement through injunctions. However, the owner of a valid patent may never receive protection throughout the commercial lifetime of his patent and can only rely on an uncertain damages remedy as explained in Section IV.D. In contrast, Merck Sharp & Dohme v. Glenmark shows the opposite scenario.49
This imbalance has been met by the IP divisions with an interim measure. Instead of being forced into a choice of either total restraint or total freedom of trade, courts increasingly compel the defendant to provide security in the form of an interim deposit, bank guarantee, or promise to account based on a percentage of sales in order to continue trading until judgment. This approach enables the defendant to maintain his commercial operations, while at the same time insulating the patentee from a judgment which could not be enforced. The conflict, moreover, moves forward to an earlier and less well-substantiated point, since the amount of security is determined on the basis of much less evidence than that required for a damages award.
47 F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2008 (37) P.T.C. 71 (Del.) (India), aff’d, 2009 (40) P.T.C. 125 (Del.) (Div. Bench) (India).
48 F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (Delhi H.C. Div. Bench Nov. 27, 2015) (India).
49 Merck Sharp & Dohme Corp. v. Glenmark Pharms. Ltd., FAO(OS) 190/2013 (Delhi H.C. Div. Bench Mar. 20, 2015) (India).
C. Groundless Threats and the Cease-and-Desist Problem
Sections 105 and 106 deal with the right to declare non-infringement and with measures to counter baseless threats of infringement proceedings, which include a declaration of the unjustifiability of such threats, an injunction against further continuation thereof, and compensation.50
The problem here is one of communication, and it tends to be seriously underappreciated. It is in the patentee’s best interest to provide the notification, because such a step removes the defence of innocent infringement under Section 111 and allows for the determination of malice necessary for enhanced damages. However, making the assertion in a broad fashion, without doing a claim-by-claim analysis, and without intending to litigate, transforms the patentee from the position of a plaintiff into that of a defendant. This means that the pre-litigation communication in India should be drafted at a standard that seems unnecessary elsewhere.
D. Damages, Accounts, and the Evidentiary Bottleneck
Injunction along with either damages or account of profits is the right of the winning party under Section 108, while according to Section 111 this right is limited if the defendant can prove it did not know about the existence of the patent.51 The more recent jurisprudence is far more optimistic than the conventional belief. In the case of Lava International Ltd. v. Telefonaktiebolaget LM Ericsson, the Delhi High Court granted around 244 crore plus interest based on the FRAND rate of net selling price ₹by analyzing the behavior of the implementer as an unwilling licensee.52 In the case of Communication Components Antenna Inc. v. Mobi Antenna Technologies (Shenzhen), the Court awarded about 217 crore in lost profits damages.53 In Strix Ltd. vs. Maharaja Appliances Ltd., the total of damages and costs exceeded 81 lakh, calculated on the basis of a notional royalty since specific loss could not be proved.54
The difficulty arises from an evidential problem, not a theoretical one. The claimant needs to show the connection between the infringement and the loss in sales, pricing, substitution, or licensing value,
50 Patents Act §§ 105–106.
51 Id. §§ 108, 111.
52 Lava Int’l Ltd. v. Telefonaktiebolaget LM Ericsson, 2024 S.C.C. OnLine Del 2497 (India).
53 Commc’n Components Antenna Inc. v. Mobi Antenna Techs. (Shenzhen) Co., CS(COMM) 977/2016 (Delhi H.C. May 16, 2024) (India).
54 Strix Ltd. v. Maharaja Appliances Ltd., 2023 S.C.C. OnLine Del 7128 (India).
and most companies do not keep evidence of that kind. The disparity is awkward in that, on the one hand, there can be a solid claim for damages for liability without being able to prove losses, while, on the other, there might be a threat of an injunction without there being much recoverable damage.
E. The Bolar Exemption and Export
Clause 107A(a) excludes from the definition of “infringement” acts that are reasonably related to the development and submission of information relating to any regulation of products.55 In the case of Bayer Corporation vs. Union of India, the Division Bench ruled that “selling” under Section 107A would include exporting, thus allowing a generic producer to export a patented invention abroad for purposes of registration, the determination of which depends on its purpose and conduct and not on any set quantitative criterion.56 This gives the accused company a significant window of legal time before expiration; while for the patent holder, it eliminates volume of exports as a clear sign of infringing intention.
V. The Eight Seams
This suggests that a stronger statement of the thesis can now be made. The sources of operational ambiguity lie at eight distinct intersections between clauses.
First, between Section 3(d) and the general requirement of patentability: the applicant must establish novelty and inventive step, and then establish an independent requirement of efficacy whose determination will be sector and fact specific. Second, between Section 3(k)’s two provisions: exclusion of software as a qualified exception and business method as an absolute exception, for inventions that could be so characterised. Third, between Section 10 disclosure and Section 48 scope: the extent of protection sought by the patentee in the former is limited by what was disclosed by him in the latter. Fourth, between Sections 57 to 59 and the doctrine of equivalents: amendments required for grant limit the construction possible later. Fifth, between the opposition to Section 25 and the revocation under Section 64: the validity challenges will be multiple and sequential, making the date and venue of the real test uncertain. Sixth, between the exclusivity of Section 48 and the obligations of Sections 83-92A: the business strategy that ensures maximum gain is also the one that makes compulsory licensing possible. Seventh, between Sections 105 and 106 and the incentive to notify: enforcing notice liability and unjustified threat liability overlap. Eighth, between Section 108 remedy and Section 111 limitations, with the help of the evidentiary standard that the legislation does not mention.
55 Patents Act § 107A(a).
56 Bayer Corp. v. Union of India (Delhi H.C. Div. Bench Apr. 22, 2019) (India).
This is not an error in drafting. They are all policy decisions that were made at different points of time, and the issue comes up because of the conflict between them.
VI. The Integrated Response
However, if the conflict is structural, then there is no departmental solution. The following four propositions hold.
At the prosecution stage, the specification must be written having in mind the enforcement record that it is going to turn into. Comparative efficacy data regarding novel claims must be collected before prosecution rather than in reaction to the examination report. Computer-related inventions must be claimed with a view to a demonstrated technical effect since re-characterization after a Section 3(k) objection constitutes advocacy. Genera and species patent application must be analysed having regard to the coverage-disclosure gap that would arise at the interim stage, and the Section 8 disclosures must be monitored according to the scheduled basis since the Philips materiality standard is a defence rather than safe harbour.
At the portfolio stage, the divisional patenting strategy must be gauged by Syngenta: optionality that is not supported by the parent specification is illusory. Working and pricing decisions must be modelled having in mind the compulsory license exposure starting from the third year after grant, especially if the invention is import-dependent and falls into the sector where public health is sensitive issue.
When it comes to the freedom-to-operate stage, the defendant company is required to consider the prosecution history – foreign prosecution history included – before making a decision whether to go with redesign, license, opposition, or defense. When there is a good defense on the grounds of invalidity, the approach taken by Roche will generally make defense in conjunction with an accounting obligation more attractive than redesign; when there is no such defense, early licensing will keep the company away from security deposit risks inherent in SEP and technology litigation.At the enforcement stage, the record of damage is supposed to be built right during that process, not post hoc, the letter pre-litigation must be tuned in line with Section 106, and venue choice must be made based on competence of Intellectual Property Divisions.
VII. Conclusion
The first challenge that arises from the Indian patent law context does not involve patents versus litigation. Rather, it involves managing a patent as an asset over its lifecycle by drafting claims that are commercially broad enough yet adequately disclosed, avoiding amendments that would generate estoppel and added-matter issues, ensuring continued monitoring for opposition and revocation risks, preventing enforcement from raising groundless threat and public interest risks, and maintaining evidence of working, licensing, pricing, and loss from the grant date, not the date of suit.
What is clear from the institution-building in the past five years is that the quality of adjudication has been enhanced without cutting down on the seams. The specialist Divisions adjudicate these disputes more efficiently; there is no difference in kind in the way they decide these disputes. What is different is that the doctrine is sufficiently advanced such that the seams can be predicted and priced. That is not a resolution but rather, for the firm, the more useful outcome.
