Showing posts with label India. Show all posts
Showing posts with label India. Show all posts

Sunday, 9 March 2014

Does India Follow “First to File” or “First to Invent” Rule in Patent Filing?

PatLit is pleased to welcome the following guest post from fellow blogger Sai Deepak (of The Demanding Mistress, here). Here Sai addresses a fundamental issue, that of entitlement to a patent. This is what he has to say:
Does India Follow “First to File” or “First to Invent” Rule in Patent Filing?
It is a common perception that, under the Indian patent regime, whoever files a patent application over an invention first, is the one entitled to a patent on it. But does this perception have a basis in the Patents Act, 1970? Importantly, is this perception correct?

One of the things that a litigator’s training teaches you is that, no matter how pedantic it may seem, interpretation of the law must not be based on what people think or assume, but must be solidly rooted in what the statute says, which is further backed by logic and common sense. In short, the letter of the law must be given its due, and the enquiry must begin with the wording of the provision, as opposed to a pre-conceived notion of what we think the law is, or ought to be.

If one applied this proposition to the issue at hand, the provision to look into is Section 6 of the Patents Act:
6. Persons entitled to apply for patents 
(1) Subject to the provisions contained in section 134, an application for a patent for an invention may be made by any of the following persons, that is to say,—(a) by any person claiming to be the true and first inventor of the invention;(b) by any person being the assignee of the person claiming to be the true and first inventor in respect of the right to make such an application;(c) by the legal representative of any deceased person who immediately before his death was entitled to make such an application. 
(2) An application under sub-section (1) may be made by any of the persons referred to therein either alone or jointly with any other person.
From the above, it is clear that Section 6 governs the entitlement of a person to file an application for a patent. The provision says that “any person claiming to be the true and first inventor of the invention” may file an application for a patent. The provision uses both “true” and “first”, in that order. This means the person must have invented the invention by himself (or by themselves in case there are several inventors) without free-riding on the efforts of another person. The second condition is that the person must also be the “first one to truly invent” the invention. Nowhere does the provision seem to convey a “first to file” rule where entitlement is based on prior filing.

Given this, where do we get the conclusion from that India follows a “first to file rule” when the emphasis is clearly on the first person to truly invent the invention?

Merely because a person files an application for a patent “claiming to be the true and first inventor”, does it follow that his claim is irrebuttable? Since the requirements under Section 6 are conjunctive and hence two-fold i.e. “true and first”, even if the person’s claim of being the true inventor is in fact true, it is possible that he may not be the first inventor. It is only his belief/claim that he is the first inventor because to the best of his knowledge no one seems to have published the invention in public domain or has filed for a patent.

Be that as it may, his belief could be misplaced, and it might be possible for another person to prove that he (the other person) is not only the true inventor, but was also the first one to invent the invention. If so, does the Act provide for a remedy which could be invoked to prove “true and first inventorship”?

To the best my knowledge and understanding, there is no such remedy under the pre and post-grant opposition mechanisms in Section 25(1)(a) or (2)(a) since both refer to an invention which has been “wrongfully obtained”, which is also dealt with under Section 64(1)(c) which deals with revocation of patents. Reproduced below are the relevant provisions:
25. Opposition to the patent
(1) Where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground—
(a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims; 
(2) At any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of a patent, any person interested may give notice of opposition to the Controller in the prescribed manner on any of the following grounds, namely:—
(a) that the patentee or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims;64. Revocation of patents.— 
(1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on any of the following grounds, that is to say—
(c) that the patent was obtained wrongfully in contravention of the rights of the petitioner or any person under or through whom he claims;
“Wrongfully obtained”, as understood from these provisions, refers to a situation where the true inventor has been defrauded by another person who has applied for a patent or who has been granted one. In other words, the patent applicant/patentee is not the “true inventor” since he has obtained the invention “wrongfully”. If the true inventor’s challenge under these provisions is successful, the patent application/patent shall be transferred to his name pursuant to Sections 26 and 52 respectively.

However, an allegation of an invention being “wrongfully obtained” is distinct from the issue under discussion. The distinction is that while Sections Section 25(1)(a) or (2)(a) and 64(1)(c) address a situation where fraud is committed on the true inventor, the issue under discussion refers to a situation where the patent applicant has not committed fraud, but is merely under the factually misplaced belief that he is the “true and first inventor”.

Based on my reading of the Act, the remedy for the second situation lies in Section 64(1)(b) which provides for a ground of revocation based on to “entitlement to apply for a patent”. This, in my opinion, is a reference to Section 6 which says who says who is entitled to apply for a patent. Reproduced below is Section 64(1)(b):
64. Revocation of patents. 
(1) Subject to the provisions contained in this Act, a patent, whether granted before or after the commencement of this Act, may, be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement of the patent by the High Court on any of the following grounds, that is to say—

(b) that the patent was granted on the application of a person not entitled under the provisions of this Act to apply therefor:
To cut a long story short, while Section 64(1)(c) addresses an allegation of the invention being “wrongfully obtained”, Section 64(1)(b) addresses a situation where the “true and first inventor” challenges the grant of a patent by virtue of him being the “true and first inventor”. Therefore, if a person X believes that another person Y ought not to have been granted a patent since X conceived of the invention before Y, and Y is merely the first filer of the patent application, X has a remedy under Section 64(1)(b) after the patent has been granted. Surprisingly, such a remedy has not been provided for under the pre and post-grant oppositions in Section 25(1) or (2). Consequently, X has to wait until a patent is granted in order for him to challenge its grant.

However, what is certainly clear from the above is that the statute adopts a “first to invent” rule, and not “first to file”. Despite the absence of any ambiguity in the statutory framework, it is indeed intriguing that most people assume that India follows the “first to file” rule.

The policy argument that could be used to support the “first to invent” rule is that if the true and first inventor does not wish to file for a patent, and instead wishes to protect his invention as a trade secret, why should another person be granted a patent merely because he is the “first to file”?

Tuesday, 4 February 2014

India's IPAB highlights importance of due process when reviewing patent applications

A friend from Kerala, the state with the highest literacy rate and life expectancy in India, reported news of two recent orders issued by the Intellectual Property Appellate Board (IPAB), which set aside a couple of decisions of the Assistant Controller of Patents & Designs. Interestingly, the IPAB found that, in both cases, the Assistant Controller failed to provide the patent applicant with a fair review of its application, either issuing a cryptic, non-speaking, and vague response, or violating the 'Principle of Natural Justice'.

In the first decision (no. 8/2014), the IPAB reviewed the Assistant Controller's rejection of a patent application filed in 2006 by Schering Co. The application claimed the crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist (Vorapaxar), used for the treatment of acute coronary syndrome chest pain caused by coronary artery disease (for more information, see this post at SpicyIP). The Assistant Controller rejected the application for lack of inventive step, under Section 2(1)(ja) of the Patents Act, adding that the applicant had failed to provide evidence of enhanced therapeutic efficacy, as required by Section 3(d) of the Patents Act (widely discussed after the Novartis judgment, and also commented on a previous PatLit post). Schering appealed the rejection, alleging that the Assistant Controller failed (i) to take into account the arguments raised by the applicant, and (ii) to state the reasons for the contested decision.

The IPAB observed that, under Section 15 of the Patents Act, 'the learned Controller ought not to have mechanically refused the application and on the other hand he could have exercised discretion to give opportunity to the applicant/appellant by making amendments in the application' (and later deciding whether to accept or reject the amended application). According to the board, the Assistant Controller issued a 'cryptic and non-speaking order', which failed to take into account all the arguments raised by the patent applicant. Similarly, when assessing the lack of inventive step, 'the Controller has given a very bald and vague reason without going into the details of the entire document'. Setting aside the contested decision, the IPAB remanded the matter to the Assistant Controller, bound to 'consider the matter afresh by affording sufficient reasonable opportunity to the applicant/appellant to substantiate their claims'.

In the second decision (no. 9/2014), the IPAB examined the Assistant Controller's rejection (see also here) of the application filed by Abraxis BioScience LLC in 2005 (no. 2899/DELNP/2005 - here), which claimed a pharmaceutical composition consisting of (i) a pharmaceutical agent (including, in particular, propofol, paclitaxel, or docetaxel), and (ii) a pharmaceutically acceptable carrier, comprising deferoxamine, to inhibit microbial growth, and a protein such as albumin, to reduce side effects. The applicant challenged the rejection, maintaining that the Assistant Controller unlawfully refused to provide Abraxis with an opportunity to be heard before taking a final decision, violating Section 14 of the Patents Act. Such violation, according to the applicant, determined a violation of the Principle of Natural Justice, as Abraxis was deprived of its right to immediately appeal a decision issued under Sections 14 and 15 of the Patents Act. A further argument concerned the conduct of the Assistant Controller in the pre-grant opposition proceeding initiated by a third party: the patent applicant submitted that the Assistant Controller unlawfully examined an additional ground of opposition ('insufficiency', under Section 25(1)(g) of the Patents Act) which had not been raised by any of the parties involved in the proceeding, thus committing a serious error of law.

The Intellectual Property Appellate Board held that '[t]he reading of the [...] provision [of Section 14] makes it crystal clear that the above said provision contemplates of an opportunity of hearing and as such the said provision is mandatory but unfortunately in the instant case such a mandatory requirement of affording opportunity to be heard was denied to the appellant'. According to a previous judgment of the High Court of Delhi, which the board considered to be 'squarely applicable to the facts of the instant case', the provision at issue 'casts a duty on the controller to give a hearing to an applicant, before exercising any discretionary power, which was likely to affect an applicant for a patent adversely'. The IPAB added that, as an order under Sections 14 and 15 is indeed appealable (while a decision rendered in a pre-grant opposition proceeding, under Section 25, may not be equally appealable, or may force the applicant to defer its appeal), Abraxis was deprived of its right to appeal the adverse order. For these reasons, the board concluded that the Assistant Controller passed the contested decision 'in flagrant violation of the Principle of Natural Justice'.

The second argument raised by Abraxis was also upheld. Reciting previous case law, the IPAB noted that '[w]hen the facts necessary to make out a particular claim, or to seek a particular relief, are not found in the plaint, the Court cannot focus the attention of the parties, or its own attention on that claim or relief, by framing an appropriate issue'. Thus, the Assistant Controller erred in extending the perimeter of its review to an argument which had not been raised by any of the parties.

Friday, 25 October 2013

Patents and right to health - Brazil and South Africa follow in India's footsteps

Just a few months ago, the judgment of the Supreme Court of India in the Novartis' Gleevec case fueled an international debate on the protection of innovation in the pharmaceutical sector and its compatibility with the right to health. The discussion frequently focused on Section 3(d) of India's Patents Act, which sets out a test of 'enhanced efficacy' (therapeutic efficacy, for pharmaceutical substances, according to the Supreme Court) for the patentability of new forms of known substances:
3. The following are not inventions within the meaning of this Act,—

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

The Supreme Court explained that the test constitutes 'a second tier of qualifying standards for chemical substances/pharmaceutical products', designed as a filter to prevent repetitive patenting and 'evergreening' practices. The ample historical re-construction, and the comments of the judges on the development of patent law in India, clarified that Section 3(d) sets the balance between the protection of IP and the safeguard of public health from a wide perspective, which includes access to medicines and development of a national generic industry. From this point of view, the provision represents India's attempt to comply with its international obligations arising from the TRIPS Agreement, in light of the Doha Declaration on TRIPS and public health and of its own national interests as a developing country.

Recent reform proposals, currently under discussion in Brazil and South Africa, show that other countries are likely to follow in the footsteps of India. The Projeto de Lei n° 5.402/2013 (a brief overview here) seeks to apply significant changes to Brazil's Industrial Property Law (Lei 9.279/1996), which comprise (i) the exclusion of term extensions to compensate for regulatory delays either in the granting of a patent or in the approval of a medicine (revoking Article 40), and the adoption of (ii) a provision (Article 10.XI) identical to India's Section 3(d), (iii) higher standards for inventive step (amending Article 13), (iv) a pre-grant opposition procedure (amending Article 31), (v) a provision (Article 195.3) rejecting data exclusivity. Further changes include the necessity of prior consent from the National Sanitary Agency (ANVISA) for granting patents on pharmaceutical substances or processes, and the establishment of governmental use licenses.

Main changes introduced by the Projeto de Lei n° 5.402/2013
Patent term
Revocation of Article 40 (‘The term shall not be less than 10 years for an invention patent and 7 years for a utility model patent, beginning on the date of granting […])
No extension of the patent term for regulatory approval of new drugs
Test of enhanced efficacy for new forms of known substances
Article 10.XI (new)
'The following are not considered to be inventions or utility models:
XI – new forms of known substances that do not result in the enhancement of the known efficacy of the substance.

For the purposes of this Article, salts, esters, ethers, polymorphs, metabolites, pure form, size of particles, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance shall be considered the same substance, unless they significantly differ in terms of properties regarding efficacy.'
Inventive-step
Article 13 (amended)
'An invention is endowed with inventive step provided that, to a technician versed in the subject, it is not derived in an evident or obvious way from the state of the art, and that it represents a significant technical advancement in relation to the state of the art.'
Pre-grant opposition
Amendments to Article 31
The opposition may be filed after the publication of the application and before the end of the examination
Technical opinions may be asked to public administration, organisation, scholars and experts
Data exclusivity
New Article 195.3 authorises 'the use, by governmental entities, of test results or other undisclosed data, for market approval of products equivalent to the product for which they had been initially presented.'
Consent of the National Sanitary Agency for approval of pharmaceutical patent
New Article 229-C requires ANVISA’s consent in light of public health considerations
ANVISA may refuse its consent if the grant of a patent application is contrary to public health
Public, non-commercial governmental use
New Article 43-A allows the government to use the subject matter of a patent or patent application without the owner’s consent, for reasons of public interest

The explanation attached to the reform proposal takes the view that such changes are essential to allow Brazil to pursue policy objectives (increasing access to medicines, lowering health care expenses, promoting domestic innovation, stimulating the development of generic competition in the internal market, etc.) which differ from those of more economically developed countries. The idea, according to the policymakers that promoted the reform, is to follow the paths of India and Argentina, rather than that of the United States.

Brazil's proposal, which is supported by numerous international scholars, addresses some of the issues examined by the Center for Strategic Studies and Debates in a recent report ('Brazil's Patent Reform - Innovation Towards National Competitiveness'). The study highlighted that the current regime appears to favour foreign innovators, and that the grant of pharmaceutical patents determined a drop in foreign investments and technology transfer agreements, undermining the development of a domestic pharmaceutical industry. Further, the report underlined the benefits deriving from generic competition, as well as the interplay between a restriction of the patentability of pharmaceutical substances and the increased availability of essential medicines at lower costs.

Similar issues are also under consideration in South Africa, where the Department of Trade and Industry presented, in September, a 'Draft National Policy on Intellectual Property', which suggests modifications in many areas of IP law. Inter alia, the draft focuses on the reform of patent law, in light of public health policy considerations, contemplating the introduction of a new Search and Examination Office, pre and post grant opposition procedures, stricter patentability requirements, and other provisions aimed at fostering generic competition and facilitating access to medicines. 

Draft national policy on IP of South Africa – Recommendations
Technology – Public policy
Establish a new Search and Examination Office
Develop human-resource capacity for the handling of technology, including technology transfer
Adopt rules to regulate technology transfer agreements related to restricted/prohibited technologies
Do not support international patent reforms which undermine South Africa’s public policy
Address parallel importation and compulsory licensing in line with Doha Declaration
Promote schemes and regulations to encourage use of patents and help achieve developmental goals (poverty alleviation and health)
Do not enter into bilateral agreements that may impair the flexibility granted by TRIPS
Pre and post opposition of patents
Introduce a dual opposition procedure (pre/post grant)
Patents and public health
Incorporate the flexibilities contained in the TRIPS and Doha Declaration
Do not grant patents on medicines that may be expiring
Adopt a cost and benefit analysis (monetary/non-monetary) through processes and benchmarks in line with those used in India and Brazil
Amend the Patent Act to take into account public health
Data protection
Maintain commitment to protection of data under Art. 39 TRIPS but refrain from conceding clinical data exclusivity
Generic medicines
Use of the Bolar provision before expiry of the originator’s patent
Raise awareness that generics are not counterfeited medicines

In particular, the second chapter of the Draft Policy analyses the relationship between IP and public health, admittedly from the point of view of 'a developing country like South Africa'. The drafters identify three main mechanisms to ensure access to medicines at lower prices and to facilitate generic competition: compulsory licensing, parallel importation, and limitations to the patentability of pharmaceutical substances. Accordingly, they essentially propose (i) to introduce compulsory licensing provisions, (ii) to facilitate parallel importation from other jurisdictions, (iii) to adopt provisions aimed at increasing generic competition (e.g. Bolar provision and a fast procedure for generic approval), (iv) to implement strict requirements for patent protection, which should exclude diagnostic, therapeutic and surgical methods, including new uses of known products, from patentability, and (v) to ensure that the protection of intellectual property does not conflict with public health policies.

In an open letter addressed to the Department of Trade and Industry, several organisations and academics welcomed the proposals contained in the Draft Policy, suggesting an even more radical approach. The signatories supported the introduction of a search and examination system, especially in relation to the pharmaceutical sector, the implementation of pre and post grant oppositions, and the use of compulsory licensing and parallel importation. They also highlighted the importance of improving transparency during the application procedure (including disclosure of the INN - International Nonproprietary Name - of the pharmaceutical subject matter) and of avoiding the conferral of data exclusivity.  On patentable subject matter and patentability criteria, the letter endorsed the adoption of stricter rules aimed at preventing 'patent evergreening' and the patentability of DNA and cDNA sequences:
[We] recommend that additional criteria also be put in place in South Africa, to exclude from patentability or to clarify lack of inventive step with respect to new forms of known medicines or their components (salts, polymorphs, esters and other derivatives), new dosages and formulations, and new combinations of known medicines or components. These exclusions from patentability or clarifications of inventive step are all compliant with Article 27.1 of TRIPS, and countries such as India, Argentina and the Philippines have already put such criteria in place. Strict subject matter exclusions and patentability criteria prevents originator pharmaceutical companies from obtaining multiple patents on the same drug—a practice known as “patent evergreening,” which keeps medicine prices high by preventing the entrance of generic competitors. [...] Both DNA and cDNA sequences should also be explicitly excluded from patentability, as they are products of nature—cDNA sequences in particular are relevant to developing therapeutic products. Adopting this exclusion is essential if South Africa is to develop a rich biotechnology/biosimilars sector. In addition the DNPIP must reject the introduction of utility model patents in South Africa in regard to pharmaceutical products [...].
The reform proposals examined above showcase a fundamental issue which prevents a global harmonisation of patent law. Disparities in the economic and social development of many countries inevitably prompt reactions inspired by the protection and promotion of national interests and priorities. The debate on Brazil's and South Africa's reforms offers a significant occasion to reflect on these elements and their interplay, a necessary step towards an internationally harmonised system of patent protection.