[This post has been co-authored with SpicyIP intern Sidhi Pramodh Rayudu with research assistance from Aadvika Anandal. Sidhi is a final year B.A. LL.B (Hons) student at Hidayatullah National Law University, Raipur. Aadvika is a second year student B.A. LL.B (Hons) at NALSAR University of Law, Hyderabad.]
Is “plurality of an invention” indispensable for maintaining a Divisional Application? If so, where should this invention be disclosed? After the divergent understanding of the two Single Benches of the Delhi High Court, a Division Bench finally put these questions to rest.
Before getting to the DB order, let’s first understand what a divisional application is. The Patent Act accommodates filing of a patent application with either provisional or complete specifications under Section 9. Section 7(1) states that ordinarily, each application should relate to a single invention only. In the event where an application contains more than one invention a divisional application under Section 16 can be filed for an invention disclosed in the provisional or complete specification of a previously filed parent application. The idea behind Section 16 is to offer flexibility to patent applicants when their initial application encompasses multiple inventions. Controversy around divisional application arose when a Single Judge bench in Syngenta Ltd. v. Controller of Patents (2023), differed with the findings of a coordinate bench in Boehringer Ingelheim v. Controller of Patents (2022) on the necessity of having multiple inventions in the parent application (plurality) in order to file a divisional application, and whether the location of its disclosures in provisional applications is sufficient. The Single Judge referred these questions to the Division Bench (DB). In October 2023, the DB, interpreting Section 16, clarified that a plurality of inventions in the parent application is indeed required for divisional applications, and that these inventions can be disclosed in either the provisional or complete specification of the parent application.
In the present post we shall look at how divisional applications have been assessed previously, the different interpretations of the three orders and the implication of the DB order for the pharmaceutical sector.
Setting the Criteria for Divisional Applications: Boehringer Ingelheim v. Controller of Patents:
Section 16 and the concerned rules on divisional applications have been previously discussed by the Intellectual Property Appellate Board (IPAB) in LG Electronics v. Controller of Patents order that held that voluntary / suo moto divisional applications must pertain to a “distinct invention” clarifying that the claims of the parent application and claims of divisional application should be different under Section 16 (3). Later, in ESCO Corporation v. Controller of Patent and Designs the IPAB specified that divisional application should solely stem from the claims of the parent application, emphasizing the principle of “what is not claimed is disclaimed” i.e. to obtain a patent on something described in the specifications, it must be specified in the claims (see Tony Mon George the Regents of the University of Michigan v. Controller of Patents and Designs (OA/48/2020/PT/DEL).
Later in the Boehringer Ingelheim case, the applicant submitted a PCT national phase application with 18 separate claims. Over the course of prosecution, these claims were amended thrice, from ‘use claims’ involving a specific inhibitor, to broader ‘product claims’ incorporating combinations featuring the same inhibitor. These amendments were rejected by the Controller under Section 59, arguing that the amendments were beyond the scope of the original claims, primarily basing the rejection on the inhibitor’s use rather than its product-related applications.
The applicant sought a divisional application on the rejected amendments. This application was then objected by the Controller on grounds that the claims had already been examined and refused in the parent application. An appeal was filed against thie order. The High Court, building on the ESCO interpretation and the principle of “what is not claimed is disclaimed,” concluded that the absence of ‘product claims’ in the parent application precluded the applicant from pursuing a divisional application with these separate/additional claims. For a detailed discussion on this ruling and its veracity, readers can refer to Amit’s comprehensive two-part post here and here.
Challenging Boehringer Ingelheim: Revisiting Divisional Patent Application Criteria
A coordinate bench of J. Hari Shankar in Syngenta v. Controller disagreed with the Court’s interpretation in the Boehringer Ingelheim order. The case arose when Syngenta’s divisional application, based on a patent application for an “Agrochemical concentrate with adjuvant and hydrotrope,” was rejected by the Indian Patent Office. Though not specifically cited in the Controller’s rejection order, the Court noted during arguments that the rejection was aligned with the Boehringer Ingelheim case’s position. Discussing the Boehringer Ingelheim order, the Court expressed reservations on its finding on the following grounds:
- Highlighting the absence of a comma after “raised by the Controller” in Section 16, the Court understood that the plurality requirement might only apply when the Controller raises objections, and will not apply in case of voluntary divisional applications. To substantiate this, the Court relied on the language of Article 4G of the Paris Convention, stating that it indicated the requirement of the plurality of inventions only with respect to cases where an objection about the same has been raised by the Controller and not when the divisional application is filed suo motu.
- Assuming the premise that a parent patent application must contain multiple inventions for a divisional application, the Court examined whether such plurality must be mentioned explicitly in the claims. On this, the Court relied on the language of Section 16 (1) and the Patent Office Practice and Procedure Manual to suggest that an invention in divisional application can be disclosed in provisional specification and need not be disclosed in the claims of the parent application.
Based on this analysis and his apprehension on the Boehringer case, the single judge referred two questions for consideration to a Division Bench of the Delhi High Court:
- “Does the requirement of a plurality of inventions in the parent application for a Divisional Application to be maintainable may still apply even when the Divisional Application is filed by the applicant voluntarily (suo moto) and is not based on any objection raised by the Controller.
- Assuming that the requirement of a plurality of inventions in the parent application was necessary for a Divisional Application to be maintainable, did the plurality of inventions have to be reflected in the claims in the parent application, or was it sufficient if the plurality of inventions was reflected in the disclosures in the complete specifications accompanying the claims in the parent application?”
Division Bench clarifies Comma Controversy on Divisional Patent Application:
Examining Section 16, the Court focused on the maintainability of a divisional application independent of the outcome of the parent application. The Court held that the placement of comma in the text of Section 16(1) is not as critical as stated in the Single Judge order. Instead, the Court clarified that, the requirement of disclosing the plurality of invention in provisional or complete specification of the parent application, is a must regardless of whether the divisional application is filed voluntarily (suo moto) or in response to an objection by the Controller. Thus, stating that the only restriction here is regarding non-duplication of claims between the parent and divisional application under Section 16(3). Fleshing out the legislative intent of Section 16 through Clause 05.02.02 of the Manual of Patent Office Practice and Procedure, it was observed that Section 16(1) permits plurality of inventions to be disclosed within either the provisional or complete specification. Further aligning this with Article 4G of the Paris Convention, the Court acknowledged the right to file divisional applications both suo-moto and objection-based, as long as the parent application discloses plurality of inventions.
However, the Court’s response to the second question seems controversial. The bench analyzed Boehringer Ingelheim and concluded that the single judge wrongfully relied on the “what’s not claimed is disclaimed” principle to set the limitation on disclosure of the invention in divisional filings and asserted that the principle is relevant only for infringement analysis and not for divisional applications and claim drafting. Doing so, the Court read Section 16(1) literally and held that divisional applications can be filed for inventions which are disclosed not only in the complete specification but also in the provisional specification of the parent application. For its reasoning on the “What’s not claimed, is disclaimed” finding, the DB relied on the House of Lords’ finding in Electric and Musical Industries Ltd. et al vs. Lissen Ltd, a position taken in 1939 when India didn’t have an independent patent regime in place, and effectively overlooked the practice of the Indian Patent Office (see para. 05.03.15) and other notable resources where the importance of this principle in delineating the scope of the invention has been reiterated (for instance see here (pdf) and here at pg. 182).
Examining the Impact: How Flexibility in Divisional Patent Applications Could Shape Access to Medicines:
The DB order has thus expanded the scope for filing divisional application and a probable offshoot of this interpretation is that applicants may strategically file multiple divisional applications for inventions to form a thicket of sorts over the invention. Also, whether the above interpretation will enable the applicant to file divisional application over inventions which have been refused earlier? Asking this question is important because a divisional application can be filed “at any time before the grant of the patent” and not till the parent application has been “disposed of”.
One sector that this order is bound to have a massive impact on is the pharmaceutical sector where strategic filings of divisional application on the basis of overbroad disclosures can eventually impinge the entry of generic and biosimilar medicines in the market. As highlighted by Katarina Foss-Solbrekk in their paper, often divisional applications are not only about getting grants but are also about resetting the deadline clock to come up with answers to objections and also to demotivate generics. They substantiated this argument by citing the Abbvie-Humira EP1406656 divisional applications where after being opposed by 15 companies, Abbvie eventually withdrew its application but in the meantime had filed many second generation divisional applications (divisional applications stemming from an earlier divisional application). One of the reasons one of the cited aggravating factors to make matters worse is the slow opposition procedure at the European Patent Office (EPO). The average time since the first office action and the final decision of the EPO is 24.3 months. In comparison to this, India has an average pendency time to dispose of an application of 51 months.
All in all, with this broad interpretation by the Court, a meticulous assessment of divisional applications is now warranted by the Indian Patent Office. These can be in the form of undertaking rigorous checks against double patenting. However, the abnormally high number of patent grants and celebration thereof, somewhat makes one apprehensive whether this will be seen as a problem by the patent office in the first place.