I had earlier covered Shamnad Basheer v. Union of India where the petitioner highlighted the failure to enforce statutory provisions relating to the disclosure as to how patentees have worked their inventions. This is a unique provision in the Indian Patents Act, 1970 (section 146(2)), and year after year, patentees are mandated to submit information (through Form 27) on the extent to which they’ve worked their patent i.e converted it to an innovative product and supplied the product to the market in a manner that satisfies the reasonable requirements of the public. The information provided by Form 27 is required to examine whether the patented invention is satisfying the reasonable requirements of the public. This information is pertinent for examining the necessity for invoking compulsory licensing provisions and revocation provisions.
The GoI has now released the Draft Patent (Amendment) Rules, 2015 wherein hardly any of the defects in the extant Form 27 have been addressed. Content wise, the draft Form 27 is different only in the following aspects: a) it asks whether the licensee is exclusive or not; and b) it asks for details of products commercialized by utilizing the patent. [Gopika covered the development here.]
The Draft Patent Rules, 2015, as far as Form 27 is concerned, is a complete disappointment. The Writ Petition highlighted all the defects in Form 27. Evidently, the Writ Petition has been overlooked.
At this juncture, I would like to take a closer look at “professionalism” from the perspective of institutional ethics. Just like “integrity” (which I discussed in an earlier post), “professionalism” is a pregnant term which engrains crystallized principles. In a benign sense, it is an internalized duty to do well. It is a kind of performance ethic, close to a noble calling, by which professionals simply are called to do their best, for anything less would be embarrassing to them. It is an ingrained pride in performance. In other words, professionalism is adherence to a set of normative and behavioural expectations usually embodied in a code of ethics. Well, how professionally made is the draft Indian Patent Rules, 2015? It is for you to decide after reading this post…
As to help you decide, I shall now briefly discuss the defects in the extant Form – 27. I shall be relying on the Writ Petition which had brought this out well. I suggest this Writ Petition to anyone who is interested in knowing more about the whole issue. It is a quality output. You will not be disappointed if you invest your time in reading it.
Defects in Form 27
a) Vague wording
Form 27 requires patentees and licenees to “give whatever details are available” without mandating such disclosure in stronger terms, given that it is a statutory mandate under section 146 (to disclose the full extent of commercial working of the patent). Naturally, as the Writ Petition rightly argues, “the patentees and licensees had taken advantage of this ‘loose’ provision and provided virtually insignificant, incomplete information.”
b) Insufficient information pertaining to working of patent
Form 27 requires the following information: “If worked: quantum and value (in Rupees), of the patented product:
i) manufactured in India.
ii) imported from other countries. (give country wise details)”
Form 27 exudes ignorance of working of pharmaceutical industry. As the Writ Petition rightly notes, “When it comes to patented drugs, for instance, it is necessary to know the required dosage per patient to effectively assess as to how many patients are being served through the supply of the patented product. This aspect was critical factor in the grant of first compulsory licence in relation to Nexavar®. Both the Controller of Patents that decided to grant this licence at the first instance and the appellate authorities (IPAB and Mumbai High Court) that upheld the grant of this licence had to determine the total number of patients requiring the drug as against the total number of patients actually receiving the drug from Bayer’s sales in the market.”
c) Vague requirement on disclosing licensing information
Form 27 requires patentees to disclose “whatever details are available: the licences and sub-licences granted during the year.” Again, as a natural outcome, this vagueness is (intentionally or not) misused. As to examine the working of patent, it is pertinent to know whether the patent has been licensed in the first place, names of licencees, the broad terms of licence etc.
d) Reasonable requirements
The FORM-27 declaration merely requires patentees to state whether or not the reasonable requirement of the invention to the public have been met. The Writ Petition rightly argues that “….this vague and broad question is non-sensical, since it is likely to be met with only one standard response from all patentees, namely that they are satisfying the reasonable requirements of the public. One is hard pressed to think of any patentee that would state otherwise, and our FORM-27 investigations do not disclose a single filing that states so. Rather than merely asking the patentee to self attest whether or not it believes it is satisfying the reasonable requirements of the public, the FORM-27 declaration ought to call for more particular information as would help make this assessment. In particular, the patentee ought to be asked to submit the following:
i) estimated demand of the patented invention or product;
ii) extent to which the demand has been met (i.e., availability);
iii) details of any special schemes or steps undertaken by the patentee to satisfy the demand.”
Further, Form – 27 should mandatorily capture a) the potential manifestations of the patent; and b) related multiple patents covering the same product (which are common in telecom industry). Knowledge of related patents and potential manifestations of the patent is crucial for de-bottlenecking especially when patents go haywire. Ideally, patent should not be a ‘sword’ against innovation. But when it does, it is imperative that the regulator puts its feet down. In the absence of requisite information such as the ones mentioned above, the regulator obviously cannot effectively play its role.
So, how professionally made is the draft Indian Patent Rules, 2015? It is for you to decide…Personally speaking, I hope this post draws the attention of Mr. Amitabh Kant, Secretary, DIPP, who is considered to be one among the most efficient IAS officers in the country.