In IPR Amicus Issue No. 49, dated August 2015, the interplay between the Biological Diversity Act, 2002 (BDA), and intellectual property rights in India, specifically, the Patents Act, 1970 (Act) was broadly explored, with particular reference to biological inventions.
In this article, we further attempt to explore and understand the evolving nexus between the BDA and the Patents Act, particularly during prosecution of applications which disclose the use of biological material(s). In recent Indian Patent Office (IPO) practice, it has been made abundantly clear that inventions which disclose the use of any biological material, not only limited to claims, if obtained from India, would be subject to the provision of Section 6, sub-section (1) [see end note 1] of the BDA. Further, the application will not be granted until compliance is sought and received by the Applicant. However, in this issue, we go beyond, and try to understand the mindset of the Controllers at the IPO when it comes to the BDA.
While there is no provision in the Patents Act directing the Controller to defer grant of a patent for want of BDA compliance, this is one of the few instances of very active and effective collaboration between two different organisations.
In two recent orders passed under Section 15 of the Patents Act by the Kolkata Patent Office, dated 29th January 2016 [see end note 2], and 3rd March 2016 [see end note 3], the applications were refused under Section 83 [see end note 4] of the Patents Act, particularly with reference to sub-section (a) [see end note 5] and (g) [see end note 6]. In both the applications, the Applicant had disclosed the use of certain biological material which were otherwise sourced from outside India.
In the first order, the Controller in his refusal had reasoned that as the imported biological material is also available in India in commercial scale, if the same is instead imported from outside India, it is unclear as to whether the product will be available to the public at a reasonable price or not. As per the Controller, this supposed deficiency defeats the intent of Section 83(a), and (g). The Controller further observed that in light of the provisions of Section 83(a), and (g), necessary permission from the NBA ought to be taken.
In the second order, in a similar fashion, the Controller in his refusal reasoned that the intent of Section 83(a), and (g) is defeated as the biological material is available and commercially produced in India, thus it is unclear as to how the product would be made available to the public at a reasonable price. The Controller also directed obtaining prior NBA approval.
Firstly, the Controller in the twin orders has reasoned that since it is not clear as to how the product will be available to the public at a reasonable price, Section 83(g) of the Patents Act is attracted. The Controller has given no basis for his assessment or how he has arrived at the conclusion. In fact, the language in the order is suggestive that the Controller has in fact, not arrived at any definitive conclusion as to how the invention, if made from imported material, would not be reasonably priced for sale in India. Secondly, there is no clarity as to what is “reasonable” as can be found in Section 83(g). What yardstick did the Controller employ in determination of scope of the said section? The lack of objectivity is suggestive that rejection on this ground alone is arbitrary in nature.
Thirdly, it would suggest that the element linking Section 83(a) to the particular order(s) would be the term “reasonably practicable”. Again, the order does not deal with the interpretation to the term “reasonably”, “practicable” or “reasonably practicable”. In fact, no light has been shed on any reasonable quantification of the terms which may help explain the relevance of Section 83(a) in the particular instance. It perhaps may be hypothesized that the order alludes to the financial aspect of “reasonably practicable” as mentioned in Section 83(g).
Fourthly, the Controller has mentioned the fact that the Applicant is of India origin. Does this have any implication on the invocation of Section 83 in these particular cases? Does this imply that Indian applicants, should only source biological material from India? Would Indian applicants be held different if not higher standard of compliance? Will foreign applicants also fall under the ambit of Section 83? These are some very practical and pertinent questions which remain unanswered at this point of time. Most importantly, in examining a patent application for grant, is there a statutory requirement to take into account section 83?
Fifthly, the Controller in his order has unambiguously stated that in view of the availability of the biological materials (used in the patent applications) in India in commercial scale, and the scope of Section 83(g) of the Patents Act, NBA approval should be taken. Section 6 of the BDA however, clearly states that prior approval is required only if the biological resource is obtained from India, which would imply that the applicant would have no legal obligation to seek prior NBA approval. However, the orders discussed herein begs the question as to whether the Controllers intends to bring under the ambit of the BDA, Indian applicants or for that matter any applicant who uses any biological material, which is also otherwise available in India in a commercial scale? Is this a backdoor for NBA to force applicants to (at the very least) file an application seeking approval to file for intellectual property rights? If the applicant does not use any biological material obtained from India, but is forced to come to NBA in light of the two orders by the Indian Patent Office, what is the relevance of Section 6 of the BDA? Even if one were to consider that an applicant seeks and receives approval from the NBA where the applicant expressly discloses use of foreign biological material as directed by the IPO, does the NBA have the mandate to give such approvals in such matters?
Lastly, it is to be noted that Section 83 of the Patents Act is in Chapter XVI, which is titled “Working of Patents, Compulsory Licences and Revocation”. In fact, the title of Section 83 is “General principles applicable to working of patented inventions”. This suggests the various sections included under the said Chapter relate necessarily to post grant actions. Do the orders represent “overreach” of the powers vested in the Controller? How can the applicant or the patent office reliably determine future compliance with Section 83(g) of the Patents Act, or, for that matter any of Section 83? Is this a reasonable requirement?
It may be in the interest of the nation, and its people that the principles of Section 83 of the Patents Act are complied with by the applicant upon grant of the patent. However, necessitating prior compliance along with NBA approval is not expected by the statute. At least one reason being that such compliance is purely speculative in nature, and highly subjective, both of which lead to more ambiguity in the matter, and do not lay down any clear roadmap for others to follow.
These twin orders raise a lot of questions, which may seriously prejudice the interests of both Indian and foreign applicants applying for patent rights in India, particular those involving to biological materials. If one were to interpret the order that the IPO expects applicants domestic and foreign alike, to use biological material sourced from India (if available commercially), and consequently seek NBA approval, this would put an undue burden on the applicant anywhere in the world, and may in fact detract from filing for intellectual property rights in India.
Lastly, it would be interesting to see if the orders are challenged at the Intellectual Property Appellate Board or the High Court by the applicant and how the metes and bounds of Section 83 are interpreted by the higher bodies. In all probability the orders will be set aside as ultravires the Patents Act and BDA.