On February 28, 2014, the office of the Controller General of Patents, Design and Trade Marks (CGPDTM), Department of Industrial Policy and Promotion, Ministry of Commerce & Industry, Government of India had issued a set of draft guidelines for examination of patent applications in the field of pharmaceuticals and had invited comments from the various stakeholders who would be affected by the implementation of these draft guidelines into their finalised version.
Consequently agencies like the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Commission’s Director-General for Trade, the International Federation of Intellectual Property Attorneys (FICPI), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japan Pharmaceutical Manufacturers Association (JPMA), the Lawyers Collective, Mylan Laboratories, the Organisation of Pharmaceutical Producers of India (OPPI), South Centre (Innovation and Access to Knowledge Programme), the US –India Business Council (USIBC) and many other advocacy groups and individuals had commented.
On June 12, 2014 the CGPDTM had customarily published these comments in their website before vetting them. Then a discussion meeting of the various stake holders were held in New Delhi and those proceedings were published online by the CGPDTM on August 1. Subsequently a second set of draft guidelines for Examination of Patent Applications in the Field of Pharmaceuticals was issued by the CGPDTM on the August 12, after vetting the stakeholder’s comments. These findings are a cursory analysis of those comments concluding with their logical implications and the message the Indian pharma majors should heed to.
Silence on ‘working’ of pharma inventions
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Sankar Sundaram
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One salient feature about the stakeholder’s comments in general is their stark silence in respect to the draft guidelines’ connection, to the import and working of pharmaceutical inventions into our country. It is understandable that most of the comments represent interests who along with securing patent protection for their pharmaceutical-related intellectual property in highly regulated markets also-want it protected in our country. While it is a good indication that more the patents filed in a country more is its development in the field of science and technology, this growth should be self-attained and not be thrust or solicited. Naturally, most of these comments don’t mention about the need for accessibility of the pharma inventions by the patients whose interest too, these guidelines are intended to promote.
Bias against pharma sector?
Some comments air the view that these guidelines show a bias against the pharma sector and also that there is no need to warrant a special treatment for the pharma sector. It has been further pointed out by some agencies that the guidelines regarding bad patents are exemplifying only pharmaceutical sector’s applications.
Interestingly, there exists a precedent where an US court (the US district Court for Columbia) had on May 30, 2014 ruled that the US Federal Trade Commission (FTC) has statutory authority to issue pharma industry-specific rules under a certain Hart-Scott-Rodino Antitrust Improvements Act, provided that there is a rational basis for the rules and the FTC observes the procedural requirements of the Administrative Provisional Act of the USA. As a result of this Court’s decision, the US FTC’s all commercially significant rights test could be applied to the transfer of patent rights in the US pharma industry. Could this be construed as a discriminatory and biased treatment against the pharma sector of the US?
Further, if pharma patents are run-of-the-mill stuff with no need for a distinction between other type of patents, then why has the Generating Antibiotic Incentives Now (GAIN) Act enacted by the US Congress in 2012 been providing extended marketing exclusivities to the pharma manufacturers of anti-infective drugs in the US for Qualified Infectious Disease Product-NDA Approved drugs?
Pharma patent claims unduly broad
It has been pointed out that there are no evidences in the draft guidelines to support a statement that pharma patent claims are unduly broad. But, a casual look at any of the patent applications, almost anywhere in the world, would exude the fencing, hedging, or thicketing measures undertaken by a patent-applicant. There are quite a few patentees who would permit a third party to make a commercial advantage out of their patent teachings. The playing fields need to be level, whether in India or elsewhere. Certainly, it would be a welcome scenario to see, in the draft guidelines, the examples of allowed claims in the actual patent applications, which have been issued over the last 20 years and which relate to the discovery of drugs used to treat tropical-afflicting diseases. These examples, for our country would be like a motivational tonic. Only internationally, these patent applications for the antibiotic-related Active Pharmaceutical Ingredients (APIs) are becoming rarer and rarer, over the last 40 years.
Section 3(i) broader than permitted by TRIPS Article 27.3
It has been expressed that Section 3(i) of the India Patents Act which excludes from patentability “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is broader than the narrow exception to patentability permitted by Trade Related Aspects of Intellectual Property Rights (TRIPS) Article 27.3. As any physician would vouch, prophylaxis and cure are the therapies for any patient foreseeing to undergo medicinal treatment and these are the fundamental rights of any life anywhere in the world, period. These are not negotiable and cannot constitute any TRIPS Article 27.3 violation.
Purpose of granting ‘selection’ inventions self defeating
It has been commented that the draft guidelines need to clarify that ‘selection’ inventions could be novel and therefore patentable, including over the prior art that might have disclosed a broader genus. The very purpose of granting selection patents is self defeating and is likely to lead to the abuse of the patent system of a country, especially with respect to APIs. This is because not only is non-obviousness one of the criteria for the grant of a patent protection, but the chemical art is inherently unpredictable. Now, assuming that a genus patent has been granted to a research company and another research company too comes out independently with a better species- API and after applying for a patent gets one on a species subset. Would the former innovator be so magnanimous to accept the later granted species patent or would it appeal against the grant of the patent on obviousness grounds? You cannot have the cake and eat it too. Of course any research team would like to reap the patent protection conferred by a state.
Opposition to obviousness consideration
In the paragraph of the Draft Guidelines regarding a reasonable expectation of success in the obviousness consideration, opposition has been raised for the statement “In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious tests”. To negate this opposition, instead of totally deleting that statement, if it can be amended suitably, as for example – In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious to try alternatives- then it would make the ground of the the CGPDTM even clearer to all the stakeholders.
A relevant example could be a recent rejection of non obviousness in the US of the superiority of the SSSSS isomer of an angiotensin-converting enzyme inhibitor over the RRSSS isomer of the same stereoisomer. This is in fact the result of the dicta in the US Supreme Court’s ruling for a recent obviousness/non-obviousness case wherein it has been ruled that when the effects in the inventions are enhanced, as compared to the prior-art and this enhancement has been got by the application of a finite number of identified predictable solutions within the grasp of the person having ordinary skill in the art, then, the invention is more likely to be obvious.
Prohibition against plants and animals overbroad
Many agencies point out that the draft guideline’s prohibition, under Section 3(j) of the Patents Act, 1970, against plants and animals is overbroad. But then, after the recent cases at the Supreme Court of the US, it could be inferred that natural products are not patentable in the US unless they are significantly different to the product as it occurs in nature. On a different note, the United States Patent and Trademarks Office’s (USPTO) draft guidance excludes from patenting, chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature unless there is a markedly different change in their structures as compared to the naturally occurring substance.
Preventing biopiracy of traditional knowledge
Many agencies express the view that Section 3(p) of the Patent Act, 1970 which excludes from patentability “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” would affect the patentability of a claim in a patent application. Unlike many countries, in India more than 100 languages and dialects are being spoken. Hence, it has not been possible for the exhaustive and complete codification of the concepts, in any one particular language, to this day. This is despite the availability of the Traditional Knowledge Digital Library (TKDL) database, made available by India. If the traditional knowledge is treated as prior art, then it would generate the complexity of diverting the pursuit of novelty/anticipation of an invention into a hunt for a written description, enablement etc in a common language, which in many instances is difficult to unearth, despite the prevalence of the word of mouth. This would divert our country’s resources needed for ascertaining patentability into a witch-hunt for archives in one of the 13 official languages of the World Intellectual Property Organization (WIPO).
There are reservations from certain agencies regarding the requirement in the draft guidelines stating that if biological materials are used in an invention, an identification of the country of source and geographical origin is required to be disclosed in the specification. They call this as an additional requirement which they say introduces ‘significant uncertainty’ as the country of source and/or geographical origin may or may not be discoverable by a patent applicant. There are numerous instances of misuse of traditional knowledge for the purpose of securing patent protection. A cursory Internet-search using the term ‘biopiracy’ would tell a plethora of stories about the use of traditional knowledge in medical therapies being appropriated and then patent-issued unilaterally by one entity, without having served the interests of the total community from whom the knowledge was got in the first place.
So, while these draft guidelines are intended to strengthen the Intellectual Property (IP) protection cover to the actual holders of this knowledge, additional milieu has been covered by the second draft Guidelines of CGPDTM in the August 2014 amendments enhancing the discoverability of the source and geographical origin of the invention.
Markush claim applications
Many agencies object to the first draft guidelines’ requirement to provide in a Markush claim application the disclosure of all the possible embodiments covered under the claimed Markush formula, to provide physical and chemical properties of claimed compounds, and to include a test conducted for each embodiment to overcome the objection on the claims to prevent the Indian Intellectual Property Offices’ action as “lacking unity of invention, as well as for insufficiency of disclosure” as unreasonable.
Now, the amended draft guideline states that test conducted for the representatives of such embodiments be included in the patent application, as opposed to all the possible embodiments. Thus the objection regarding the old draft guideline has been overcome.
If too many (a quantity outnumbering the working realm of the patent applicant) Markush claims are patent-issued and the patentee does not work all of those Markush products and causes these Markush product patents to be amenable for a section 83 action under the Patents Act 1970 by the Indian Patent Office, was it worthwhile in the first place to get a patent issued for those Markush formulae compounds?
Also, an unduly broad Markush claim, could lead to a situation where a subset of the originally claimed invention, suddenly turns out to show “surprising activity”. As can be seen in draft guidelines’ example 1 of section 8.10 and once again in Draft Guidelines’ example 1 of section 12.10 there are pointers in the draft guidelines wherein Markush products have been quoted as being patent-eligible. Further, the Scope part of the second draft guidelines of CGPDTM in the August 2014 amendments includes a disclaimer regarding the non-limiting nature of the proffered examples in the draft guidelines.
In defense of additional patentability criteria
Some comments tend to out howl the patentability criteria expressed in these draft guidelines as imposing additional requirements of patentability for pharmaceuticals. It is well known that oftentimes ‘new’ in the patent law has been interpreted to mean a previously known, but not recited in the claims process for the preparation of an already known compound or to mean a new method of use or to mean a new homologue etc. Similarly non-obvious in the patent law has been interpreted to mean subject matter which could have been arrived at anyway using the knowledge of a person skilled in the art.
Similarly industrial applicability or utility has been interpreted to mean contribution of a certain technique in the academic-enhancement of further knowledge or to point out to an intermediate whose uses is not known now and which could be put into a future use. This is equivalent to requesting that a weed be conferred patent protection because it is a plant out of place and on a fine day there would be a technology, which would find a good use for the weed, though there is no current use for that weed. There is no discrimination against pharmaceuticals in the draft guidelines with respect to TRIPS Article 27. But the draft guidelines imply that the intellectual property rights (IPR) protection should be earned by a deserving applicant in exchange for the subject matter disclosed.
With respect to a clarification requesting better discussions for a product-by-process patent application, concerning the three situations relating to i) a novel product alone or ii) a novel process alone or iii) a novel product which is a result of a novel process, it could be interpreted by the use of the legend ‘alone’ in the dicta of the case law cited, that it is dependent on the combination of considerations quoted in the Research Foundation Of State University Of New York Vs Assistant Controller Of Patents [OA/11/2009/PT/DEL (ORDER No. 200/2012)]; “Accordingly the product by process claim must define a novel and un-obvious product and the patentability in such claim cannot depend on the novelty and un-obviousness of the process limitation alone”.
Excluding patentability for new uses of known substances
It has been commented that India diverges from other jurisdictions by excluding patentability for new uses of known substances. In India the method of treatment is not a patentable invention under sec 3(i) whereas in the US and Australia the use of a compound for the method of treatment of a disease has been conferred patent protection on the grounds of definiteness. All the same, many of the Latin American countries have excluded the patentability for new uses of known drugs and France is currently considering offering permission for the off-label uses of an API. So, to expect other states to follow the same set of rules for intellectual property protection is rather primitive.
For our country which adopts the common law principles, there needs to be ample legal space for the evolution of standards commensurate with the technical advancements in any field. As IPRs are territory-based, a comparison of the different states’ advancement requirements in scientific and technological arena are also different. Again, the scope and breadth and interpretation of IP laws may be different in different jurisdictions, depending on the medical needs of the citizens of the country in question and the need of the country to protect its public health, as per TRIPS Article No 27.2. A situation where the applicant may seek “the second use/indication in the form of a product claim of an already known pharma compound/new form of a known substance or compound” has been dealt with deftly in the second draft Guidelines of CGPDTM in the August 2014 amendments.
Keeping room for evolution of IP laws
What is being understood as ‘big’ or ‘small’ or ‘significant’ today may not be the same in the near future. There needs to be breadth for the evolution of techno-legal glossary. It is a bedrock principle in patent law that the meaning of a word turns on its context. Thus, no Patent Act and Rules of any country anywhere in the world would clarify the numerical value of the terms ‘finite’ and ‘infinite’ in quantifying the solutions for a technical problem. This would have to be decided on a case by case basis. Also the relevant prior art searching is by itself an art. Like any art, it cannot be rigidly bound within the four corners of any guidelines. It would be best left to the imagination and the talent of the Examining Corps, to do the search, a total justice.
A pragmatic approach
The fact that so many comments have been expressed shows the strength of the Indian pharma sector and is a tribute by the national and international agencies to the ‘pharmacy of the world’. But, this strength needs to be sustained by the way of drug discovery in those therapeutic segments where there exists a dearth of treatment. This drug discovery is easier when our country’s manpower and the monetary backup from abroad are pooled together.
Secondly, these draft guidelines when adopted would surely open the flood-gates of litigation in the IPR sector. The concerned departments of our country need to be ready for this and if necessary, a special patent court similar to the Court of Appeals for the Federal Circuit of the US needs to be established.
