Streamlining the Patent Process in Startups: A Pressing Priority

India has leveraged the startup ecosystem by offering a conducive environment to make them powerhouses of innovation. According to the Economic Survey 2021-22, the number of new recognised start-ups increased to over 14,000 in 2021-22 up from 733 in 2016-17. The survey further emphasized that intellectual property (IP), notably patents, was the key to a robust knowledge-based economy.

Similar to any other business undertaking, startups interact with various stakeholders, including employees, who regularly exchange ideas and develop key IP. Hence, business operations that significantly rely on IP exchange need an optimized and watertight structure of intellectual property rights protection, especially when they aspire to cater to international markets. In line with the growing importance of startups and IP, the government of India has launched the “Start-up India, Stand-up India Scheme” to support early-stage startups.

 

Recognition as a ‘Startup’

 

Entities to qualify as a ‘startup’ need to be recognized by the competent authority under the START-UP INDIA initiative and fulfil all the criteria for the same. For the sake of more clarity, the Department of Promotion of Industry and Internal Trade issued a notification in 2019[1] according to which an entity incorporated as a private limited company, a partnership firm, or a limited liability partnership in India can be considered a startup for up to ten years if its turnover since its incorporation has not exceeded one hundred crore rupees.

Further, such an entity should be actively working towards “innovation, development or improvement of products or processes or services, or if it is a scalable business model with a high potential for employment generation or wealth creation.” Notably, an entity formed due to restructuring or splitting up an existing business cannot be deemed a startup.

A foreign entity can also be considered a start-up if it fulfils the criteria of turnover and specified period of incorporation/registration and submits a valid declaration to substantiate the requisites as per the provisions of the START-UP INDIA initiative.

 

Minding the IP of Business

 

An important criterion for getting startup registration is that the entity should be working to innovate, develop or improve products, processes or services. To protect technical innovation, patent registration is crucial, especially for startups, where the start-up’s success is tied to the novelty of their product and process. The DPIIT has recognised a total of 69,492 startups to date. In addition, startups have filed a total of 6000+ patent applications.7

A product or process with patent protection helps create a solid business model, enabling them to earn a good market reputation, a return on investment (ROI), and access new opportunities for expansion and generate funds.

To this effect, businesses can undertake the following best practices to optimise their inventions and ideas:

  1. Build an IP culture that drives innovation in the organization. For instance, implementing rewarding ownership strategies, implementing IP incentive schemes, encouraging teams to research and identify areas where valuable IP protection can be secured, etc.
  2. Foster IP awareness within the organization.
  3. Build an IP protection system that is driven by strong policy and practice. Organisations should focus on structuring agile protection strategies that prevent knowledge leaks. Undertaking regular IP audits and compressive risk analysis should be the focus.
  4. Once the IP is protected, its commercialization should be the focus. Additionally, organisations should be aware of their IP infringement and take proactive measures to enforce their rights effectively.

 

Gaining Traction with DPIIT Recognition

 

Benefits from Intellectual Property Rights (IPR)

 

A startup recognised by the DPIIT is eligible for tax breaks on:

  • Prior Turnover
  • Prior Experience
  • Earnest Money Deposit

DPIIT recognised startups can now get listed as sellers on the government e-Marketplace.

Self-certification Under Labour & Environment Laws

  • Startups are allowed to self-certify their compliance with nine labour and three environmental laws for 3 to 5 years from the date of incorporation.
  • In respect of three environmental laws, units operating under 36 white category industries (as published on the website of the Central Pollution Control Board) do not require clearance under three Environment-related Acts for three years. Hence, startups can focus on their core business and keep compliance costs low.

Fund of Funds for Startups (FFS)

  • The government has set up a corpus fund of INR 10,000 Cr. INR 5409.45 cr has been committed to 71 VC firms. In total, INR 5811.29 Cr was invested in 443 startups. 

Faster Exit for Startups

  • As per the Govt Notification, startups are now notified as “fast track firms”, enabling them to wind up the operations of their startups in 90 days.

Seed Fund Scheme

  • Grant up to INR 20 lakh to validate proof of concept, prototype development, or product trials.
  • Grant up to INR 50 lakh for market entry, commercialisation, or scaling up.

Tax Relief

  • Recognised startups are exempted from Income Tax for 3 consecutive years out of the 10 years since incorporation.
  • Startups incorporated on or after April 1 2016, but before April 1 2022, can apply for an income tax exemption under Section 80-IAC of the Income Tax Act.

 

Patent Incentives for Start-ups in India

 

Patent Facilitators

 

The government has identified over 226 local patent facilitators[2] to extend their expertise to DPIIT-recognised startups. The government would reimburse these facilitators for their services.

Patent facilitators are responsible for:

  • Providing general advisory services on a pro bono basis
  • Providing pro bono assistance with IPR filings
  • Assisting with the filing and disposal of IP applications at the National IP offices under CGPDTM
  • Drafting specifications (provisional and final)
  • Preparing and filing responses to examination reports and other queries, notices or letters by the IP offices
  • Appearing at hearings as may be scheduled
  • Contesting opposition, if any, by other parties
  • Final disposal of the IP application. 

 

Fee

 

The government has provided 80% rebate on the patent filing fee to make the process more attractive.

 

Expedited patent registration process:

 

Expedited Examination can be made by filing Form 18A accompanied by Form 9 (Publication). A request filed under a Regular Examination request via Form 18 (rule 24B) can be converted to an Expedited Examination by submitting Form 18A and Form 9.

The IPO has significantly reduced the duration of the patent timeline.

  • Publication: Within 1 month from the date of filing of Form 9.
  • Issuance of the First Examination Report (FER) to the Applicant: Within one month, but no more than two months, from the date the patent application is assigned to the Examiner; and within 45 days from the date, the Examiner submits the FER to the Patent Controller.
  • Response to the First Examination Report by Applicant: Within 6 months of receiving the FER from the IPO.
  • Disposal of the First Examination Report (FER) by the Controller: Within 3 months from the receipt of the last reply from the Applicant.

 

Conclusion

 

The objective of innovation and promoting patent filing by startups is simple, i.e., a patent is directly related to innovation and contributes to significant economic growth for a startup. The upsurge of startups has also led to massive employment generation, with over 5,60,000 jobs in 2016-2020. Hence, it is imperative to have an enabling ecosystem where entrepreneurs are encouraged to file more IPs seamlessly. While launching incentivized schemes and actively working towards reducing the compliance burden for new businesses when filing IP applications is a step in the right direction, there is still a pressing need to address the issues of procedural delays and complex patent processes to tap into the intellectual prowess of the country.

The objective of innovation and promoting patent filing by startups is simple, i.e., a patent is directly related to innovation and contributes to significant economic growth for a startup. The upsurge of startups has also led to massive employment generation, with over 5,60,000 jobs in 2016-2020. Hence, it is imperative to have an enabling ecosystem where entrepreneurs are encouraged to file more IPs seamlessly.

POST A COMMENT

Delhi HC Draft Rules for Patent Suits, 2021: Streamlining the Procedure

The Delhi High Court has witnessed a surge in the number of patent infringement actions filed before it across various scientific and technological fields including pharmaceuticals, diagnostics, mechanical engineering, telecommunications, electrical /electronics, wind technology etc, since the past 10-15 years.

In a bid to address the growing complexities concerning patent suits and actions, the Delhi High Court vide its notification dated 10th December published the Rules governing Patent Suits, 2021 in the public domain and has invited inputs and suggestions of the relevant stakeholders, by 17th December 2021.  

The main objective of Drafting a new set of rules is to streamline the procedure for filing patent suits and establish a uniform structure of provisions and governing mandates concerning patent litigation in the city’s adversarial system, following the establishment of IPD.   

Key Highlights of the Draft Rules Governing Patent Suits, 2021

The Draft Rules clarify that the published rules will apply to all patent suits in India which lie before the Intellectual Property Division of the Delhi High Court. As per the issued notification, in case of any inconsistency occurs over the Delhi High Court (Original Side) Rules, 2018 and the Delhi High Court Intellectual Property Division Rules, then in that case the present rules will prevail.

Further, the General Clause of the Rules (Rule 17) states that “Procedures and definitions not specifically provided for in these Rules shall, in general, be governed by The Civil Procedure Code, 1908 as amended by The Commercial Courts Act, 2015 and the Delhi High Court (Original Side) Rules, 2018 as also the Delhi High Court Intellectual Property Rights Division Rules, 2021, to the extent they are not inconsistent with the present Rules.”

As per the Definition Clause Rule 2(b), it is maintained that all suits seeking relief under Section 48, Sections 105, 106 including counterclaims under Section 64, Section 108, 109, 114 in the Patent Act, 1970 are governed by the provisions of the Rule. Additionally, the provision of Priority Patent Application has also been provided for in the Rules. It is defined under Rule 2(j) as, “ A parent application, a Convention application or a Patent Cooperation Treaty application from which the suit patent claims priority.”

Rule 3 elaborates upon the mandated contents of the pleadings and Rule 4 provides the details of the documents to be attached with the respective pleadings discussed under Rule 3. It also highlights the specifications that are crucial to mention in the pleadings.

  1. The Plaint (Rule 3 A) shall discuss a brief background of the technology and relevant technical details, ownership details, corresponding suits/applications emanating from the innovation and the respective requisite details of the suit. An infringement analysis through a claim’s vs product chart, list of experts and details of the royalties received qua the suit/ patent portfolio also has to be mentioned.
  1. Written Statement (Rule 3 B) shall be inclusive of arguments comprehensively challenging the claim of infringement. Technical analysis with specifics of the product/process used by the defendant shall be included in the written statement while claiming non-infringement. Further, if the defendant is willing to obtain a license from the patentee, quantum for the same has to be elaborated upon. Details of the sales of the allegedly infringing product/process also have to be provided.
  1. Counter Claim (Rule 3 C) shall be precise as to the grounds that are raised under Section 64 of the Patent Act. The ground claiming lack of novelty or inventive step shall have to be supported by ‘art documents. If a counter-claim is filed seeking relief on the ground of noninfringement, then the requirements for a Suit under Section 105 of the Act shall be followed.
  1. Replication ( Rule 3 D) shall initially summarize Plaintiff’s case and Defendant’s case. Subsequently, it shall provide a para-wise reply to the written statement.
  1. A suit seeking a declaration of non-infringement under section 105 of the Act, shall specify the scope of the claims, the product/process being implemented by the Defendant claimed to be non-infringing and the technical/legal basis on which declaration is being sought
  1. A suit under section 106 of the Act for an injunction against groundless threats shall contain the nature of the threat, whether oral or documentary; details of any challenge made to the validity of the patent and an invalidity brief pursuant to the challenge and details pertaining to correspondence that may have taken place between the parties.

It is pertinent to note that, strict directions and guidelines for the governance of relief applications under the Patent Act, 1970 saves judicial time and resources and improve the quality of judgements delivered by the court.

Further, the Draft Rules segregate the suit adjudication into three case management hearings, apart from the first listing, namely First Case Management Hearing, Second Case Management Hearing, and Third Case Management Hearing. The Rules enumerates specific directions that may be given by the Court at each stage, and also provide guidelines on when certain specific documents may be filed, officers may be appointed, etc. 

A key concept of Hot-tubbing has been discussed under Rule 9 (iii) that provides that expert testimony can be directed by the Court if it deems fit, on its own motion or application by a party to be recorded by Hot Tubbing technique guided by Rule 6, Chapter XI, Delhi High Court (Original Side) Rules, 2018. Further, the rule also discusses the recording of evidence through video conferencing, by a Local Commissioner or at a venue outside the Court’s premises; all subjected to the discretion of the court.

The current Draft under Rule 12 has provided for “compulsory mediation”. It provides that at any stage of the proceedings if the court is of the opinion that the parties ought to explore mediation, it shall appoint a mediator/ a panel of mediators and technical experts to explore the pathway of amicable dispute resolution.

Under Rule 13 the court has been empowered to prepare a list of scientific advisors that shall assist the Court in the adjudication of patent suits. The list shall be subjected to periodical review. When the assistance of the expert is sought, they would have to submit a declaration of integrity and impartiality. 

Under Rule 16, In addition to the provisions in the Commercial Courts Act, 2015 for Summary judgment, Summary Adjudication of Patent suits can be undertaken in the following conditions;

(a) Where the remaining term of the patent is 5 years or less;

(b) A certificate of validity of the said patent has already been issued or upheld by the erstwhile Intellectual Property Appellate Board, any High Court or the Supreme Court;

(c) If the Defendant is a repeat infringer of the same or related Patent;

(d) If the validity of the Patent is admitted and only infringement is denied.

Conclusion

The Draft Rules present adaptability to the technological revolution that has enveloped the industry sectors across the world by simplifying litigation and increasing flexibility of the procedural aspect of the law. The contents of the pleadings are unambiguously discussed, leaving no room for confusion, as all the requisite information can be obtained by the parties at the first instance. Further, the clearly earmarked list of mandatory documents to be filed by the litigants saves judicial time wasted in adjournments owing to the lack of availability of documents.

Incorporation of methods of video conferences, hot-tubbing etc. for the purpose of collecting evidence while providing for the filing of technical primer, makes the case more comprehensible and streamlines judgment quality across the patent suit. The Draft has also successfully addressed the issue of a lengthy litigation process by providing for Summary adjudication of Patent suits.

Since the Rules are currently open to the opinion and suggestions of the stakeholders, it is yet to be seen how the final rules would shape up.

Image Credits:  Photo by Markus Winkler from Pexels

The Draft Rules present adaptability to the technological revolution that has enveloped the industry sectors across the world by simplifying litigation and increasing flexibility of the procedural aspect of the law. The contents of the pleadings are unambiguously discussed, leaving no room for confusion, as all the requisite information can be obtained by the parties at the first instance.

POST A COMMENT

Small Entity Status- Can Foreign Companies Claim It?

The government of India has been aggressively pushing for the development and promotion of entrepreneurship in the country. In the Intellectual Property Domain, various concessions have been made for small and upcoming entities. Organizations claiming a ”small entity” status or a “start-up” status while applying for registration are entitled to some additional benefits pertaining to fees and filing requirements.  Here, we briefly look upon the small entity status as per the Indian patent and design rules. 

Intellectual Property Related Government Initiatives to Encourage Small Entities & Startups

In 2020, the Scheme for Facilitating Start-ups Intellectual Property Protection, was launched as an experimental initiative to encourage start-ups to develop and protect their intellectual property, which was extended for a period of three years (April 1, 2020 – March 31, 2023).

Further, the Patent (Amendment) Rules, 2020[1] were notified on October 19, 2020 to simplify the procedure of submitting priority applications and their translations and filing of working statements under form 27. These changes were introduced in consequence to the Delhi High Court’s order in the case of Shamnd Bashir v UOI[2], that resulted in a stakeholder’s consultation.

On November 4, 2020 the Ministry of commerce and Industry[3], notified Patents (2nd Amendment) Rules, 2020[4], making additional filing and prosecution concessions for start-ups and small entities.  The status of start-ups was discussed critically, extending their life for up to ten years. These amendments are set to make protection of intellectual property affordable to every category and class of business. Finally, the government also notified Design Amendment Rules 2021,[5] which recognized start-ups as applicants. The current Locarno classification system[6] and simplified fee structure were introduced specifically to benefit small entities.

 

Categorization of ‘Entities’

 

1.1 Natural Person

Under the Indian Patent Act, natural person includes an individual human being. In this context, the patent application can be filed in the name of one or a group of individuals. Here, the inventorship and ownership lies solely with the inventor and he is entitled to:

  1. Sell
  2. Transfer
  3. License, or
  4. Commercialize their patent as per their want.

1.2 Small Entity

The Indian Patents Rule, 2003 under Rule 2(fa)[7] define ‘small entity’ as:

  • in case of an enterprise engaged in the manufacture or production of goods, an enterprise where the investment in plant and machinery does not exceed the limit specified for a medium enterprise under clause (a) of sub-section (1) of section 7 of the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006); and
  • in case of an enterprise engaged in providing or rendering of services, an enterprise where the investment in equipment is not more than the limit specified for medium enterprises under clause (b) of sub-section (1) of Section 7 of the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006).

In calculating the investment in plant and machinery, the cost of pollution control, research and development, industrial safety devices and such other things as may be specified by notification under the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006), shall be excluded.

1.3 Start up:

A start-up is an entity recognized as a ‘startup’ by the competent authority under the Startup India initiative and fulfills all the criteria for the same.

A foreign entity shall fall under the category of start-up if it fulfills the criteria of turnover and specified period of incorporation/registration, and submission of a valid declaration to that effect as per the provisions of Start-up India initiative. (In calculating the turnover, reference rates of foreign currency of Reserve Bank of India shall prevail.)

As per the Notification of Department of Promotion of Industry and Internal Trade[8], an entity is considered a start-up  

  1. Up to a period of ten years from the date of incorporation/ registration, if it is incorporated as a private limited company (as defined in the Companies Act, 2013) or registered as a partnership firm (registered under section 59 of the Partnership Act, 1932) or a limited liability partnership (under the Limited Liability Partnership Act, 2008) in India.
  1. Turnover of the entity for any of the financial years since incorporation/ registration has not exceeded one hundred crore rupees.
  2. Entity is working towards innovation, development or improvement of products or processes or services, or if it is a scalable business model with a high potential of employment generation or wealth creation.

Provided that an entity formed by splitting up or reconstruction of an existing business shall not be considered a ‘Startup’.

How to apply for Small Entity Status in India:

 

Any business can apply for the status of small entity under the MSME Development Act, 2006 at udyamregistration.gov.in. Subsequent to a successful registration the business shall be issued a Udyam registration certificate, that can be furnished as proof for availing various government subsidies and benefits. 

A foreign company can also register as an MSME on the same government portal. However, as a preceding step such a company shall register itself as per the provisions of the Companies Act, 2013[9].

Any Indian entity wishing to declare themselves as small entity for the purpose of Patent registration has to furnish the following documents:

  1. Form 28 of the Indian Patent Act:
  2. Proof of Registration Under MSME Act 2006 (Micro, small and medium enterprise development Act, 2006).
  3. Form 1 of the Indian Patent Act (if Fresh Patent Application is being filed).

Any Indian entity wishing to declare themselves as small entity for the purpose of Design registration:

  1. For an Indian entity to claim the status of small entity, it must be registered under the MSME Development Act, 2006.
  2. To file an application as a start-up, the entity should be recognized as startup by a competent authority under the Union government’s Start-up India Initiative.

 

Can a Foreign Company claim Small Entity Status in India?

On a plain interpretation of the requirements under the Patent rules and Design rules, it is clear that a foreign enterprise can claim the status of a small entity or a start-up, provided it is registered and incorporated in India and is engaged in the manufacture of goods and services as specified in the first schedule of the 2006 Act.[10]

Under the MSME Development Act, 2006 an enterprise is defined as:

enterprise” means an industrial undertaking or a business concern or any other establishment, by whatever name called, engaged in the manufacture or production of goods, in any manner, pertaining to any industry specified in the First Schedule to the Industries (Development and Regulation) Act, 1951 (55 of 1951) or engaged in providing or rendering of any service or services;[11]

With an objective to incentivize the incorporation of OPC (One Person Companies), the Ministry of Corporate Affairs amended the Companies (Incorporation) Rules. The move empowers OPCs to grow without any restrictions on paid up capital and turnover, thereby facilitating their conversion into any other type of company at any time. Additionally, reducing the residency limit for an Indian citizen to set up an OPC from 182 days to 120 days and also allowing Non-Resident Indians (NRIs) to incorporate OPCs in India has paved the way for foreign entities to enter Indian markets[12] [13].

 

Application Process for Small Entity Status in India? (Foreign Company):

Patent Rules

A foreign applicant seeking the status of ‘small entity’ for the purpose of filing patent in India, has to submit duly filled Form 28[14], along with the requisite documents of proof.

As per the requirements of Form 28, a foreign applicant has to attach evidentiary documents that verify their status as ‘small entity’ for the want of Rule 2 (fa) of the Patent Rules, 2003. For this purpose, the said documents can include a certified copy of financial statement from a Chartered Accountant, that proves that the investment in plant and machinery and the annual turnover of the entity on the date of filing the application does not exceed the limitations specifications under the MSME Development Act, 2006.

Design Rules

For the purpose of recognitions as a start-up the foreign entity should satisfy the following criteria:

  1. The entity must be a private limited company, limited liability partnership, or partnership firm.
  2. Its turnover at any point during the course of its business (from inception) should not exceed INR 100 crores (approximately USD 13.7 million as on date)
  3. The entity would be considered a start-up only for a period of 10 years from the date of incorporation.
  4. An entity formed by splitting up or reconstruction of an existing business shall not be considered a “Start-up”

For a foreign entity to claim the benefit of being a start-up, an affidavit (which under Indian practices would need to be notarized, although this has not been explicitly mentioned in the Amendment Rules) along with supporting documents must be submitted at the time of filing the application[15], to be submitted with Form 24[16] of the Designs Rules.

References:

[1] https://pib.gov.in/Pressreleaseshare.aspx?PRID=1668081

[2] writ petition No. WPC- 5590

https://www.scconline.com/blog/post/2020/10/28/patents-amendment-rules-2020-patentee-would-get-flexibility-to-file-a-single-form-27-in-respect-of-a-single-or-multiple-related-patents/

[3] https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Patents__2nd_Amendment__Rules__2020.pdf

[4] https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Patents__2nd_Amendment__Rules__2020.pdf

[5] https://www.foxmandal.in/wp-content/uploads/2021/08/Indian-Designs-Amendment-Rules-2021.pdf

[6] https://www.wipo.int/classifications/locarno/locpub/en/fr/

[7] https://ipindia.gov.in/writereaddata/Portal/IPORule/1_70_1_The_Patents_Rules_2003_-_Updated_till_1st_Dec_2017-_with_all_Forms.pdf

[8] https://dpncindia.com/blog/wp-content/uploads/2019/02/DIPP-Notification-dated-19-Feb-2019.pdf

[9] https://www.indiacode.nic.in/show-data?actid=AC_CEN_22_29_00008_201318_1517807327856&sectionId=185&sectionno=2&orderno=2

[10] https://www.startupindia.gov.in/content/sih/en/bloglist/blogs/How-a-foreign-national-from-China-can-start-and-register-company-in-India.html

[11] https://www.indiacode.nic.in/show-data?actid=AC_CEN_46_77_00002_200627_1517807324919&sectionId=9884&sectionno=2&orderno=2

[12] http://164.100.117.97/WriteReadData/userfiles/Notification%201.pdf

[13] http://164.100.117.97/WriteReadData/userfiles/Notification%202.pdf

[14] https://ipindia.gov.in/writereaddata/Portal/IPOFormUpload/1_40_1/form-28.pdf

[15] https://www.foxmandal.in/wp-content/uploads/2021/08/Indian-Designs-Amendment-Rules-2021.pdf

[16] https://www.ipindia.gov.in/writereaddata/Portal/IPOFormUpload/1_109_1/Form_24.pdf

Image Credits: Photo by Startup Stock Photos from Pexels

 

On a plain interpretation of the requirements under the Patent rules and Design rules, it is clear that a foreign enterprise can claim the status of a small entity or a start-up, provided it incorporates itself under the relevant schemes and statutes and is able to furnish documents for proof to the same effect

POST A COMMENT

The Orphan Treatment of Orphan Drugs

“Orphan drugs” are pharmaceutical products used for the diagnosis, prevention or treatment of rare diseases. The definition of rare diseases varies from country to country. e.g. in the United States, a rare disease is defined as a condition that affects fewer than 200,000 people whereas in Europe it is less than one person per 2,000. Nevertheless, it is generally accepted that a disease having fewer than 100 patients per 100,000 population is a rare disease. It is assessed that internationally, around 6000 to 8000 rare diseases are in existence with new ones being discovered quite regularly. Moreover, it is estimated that there are approx. 4000-5000 rare diseases for which there are no treatments available.

In India, the rare disease and disorder population is between 72 to 96 million and up to 450 rare diseases have been recognized[i]. Because rare diseases affect a very small population of individuals and the profit potential is poor, pharmaceutical companies often do not take much interest in developing molecules for the treatment of these diseases. The shelving of these molecules and ignorance of the small patient pool gave rise to the concept of ‘pharmaceutical orphans.’

Orphan drugs and policies in India

In India, almost all orphan drugs are imported. The primary reason being lack of infrastructure, high cost and time, no cost of return, and no clear policy on orphan drugs and rare diseases. Although the disquiet around the development of orphan drugs resulted in an Orphan Drugs Act as early as 1983 in the United States, India has lagged behind for decades with the first ‘National Policy on Treatment of Rare Diseases’ coming out as late as 2017. Further, there are no epidemiological data, no figures on the burden of rare diseases and morbidity and mortality associated with them. In fact, until last year, India did not even have a definition of ‘orphan drugs.’ The new Drugs & Clinical Trial Rules 2019 finally defined it as “a drug intended to treat a condition which affects not more than five lakh persons in India”.

Drugs and Clinical Trials Rules, 2019:

In March 2019 Central Drugs Standard Control Organization (CDSCO) released New Drugs and Clinical Trials Rules, 2019. As per these new guidelines, local clinical trials (data) may not be required for orphan drugs permitted to be imported for sale or distribution. Further, the Expeditious Review Process could be sought for approval of a new drug after clinical development (applicable for Orphan Drugs). Furthermore, no fee shall be chargeable in respect of an application for conduct of clinical trial for orphan drugs.

New Drug Exemption Rule, 2019:

Further encouragement for orphan drug development could be seen in the New Drug Exemption rule released in January 2019. Under this rule, all new drugs patented in India were to be exempted from price control for five years. The five-year window starts from the date when the manufacturer starts commercial marketing in India. The Government has also exempted such drugs from price control that are used for the treatment of a disease that qualifies as Orphan Disease in the opinion of the Ministry of Health and Family Welfare (“Orphan Drug Exemption”). However, these rules are not devoid of shortcomings which may bring about issues during implementation. The requirement of the use of the exemption for five years from the “date of commencement of commercial marketing by the manufacturer in the country” is ambiguous as there is no legal definition of what amounts to ‘commercial or business marketing’ in India. The second issue that needs clarification is the exemption from price control available to ‘manufacturers’ of the patented new drug rather than the ‘drug’ itself. As a result, multiple manufacturers, importers, marketers of the same drug would seek to benefit from the exemption which could pose a challenge when the date of commercial marketing of different manufacturers would vary from each other. The third most important issue with absolute market exclusivity is that cost of orphan drugs per treatment episode could be extremely high.

Rare diseases as a public health issue

When a person contracts a rare disease, it not only puts an emotional strain on him/her, it also puts a heavy financial strain on his family. In addition to this, the unavailability of proper treatment remains a big challenge. Internationally, there are very few pharmaceutical companies, which are actively working on orphan drugs or rare diseases. And in India, the problem is more worrisome because there are hardly any pharmaceutical companies engaged in the development of these drugs. In addition, lack of awareness among the medical fraternity, lack of epidemiological data, lack of dedicated healthcare policies, schemes, and diagnostic facilities are some of the major hurdles that Indian pharmaceutical companies have to deal with.

The new drug exemption policy along with the CDSCO released new Drugs and Clinical Trials Rules, 2019 could provide the necessary impetus to the research and development of orphan drugs in India. However, there are still major strides that could be taken in line with other international governments which provide incentives ranging from tax credits to priority review vouchers in addition to fast track approvals by regulatory agencies, market exclusivity, fee reductions for regulatory approvals. Nevertheless, incentives should be balanced so as not to encourage pharmaceutical companies to exploit them to manufacture drugs for sub-categories of existing diseases to maximize profits by making existing drugs outrageously costly and inaccessible.

Hence, a more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. Particularly, in areas of – obtaining requisite funding, creation of an extensive database, for cost estimation of the treatment; research and development for the treatment and diagnostic modalities, including through international/regional collaborations; training of health care providers; awareness generation; creating a conducive environment for drug development and measures for ensuring affordability of treatment, etc. With the necessary government action, hopefully, the orphan treatment of orphan drugs will minimize to give some respite to the patients.

A more robust policy is imperative to devise a multipronged and multisectoral approach to build India’s capacity to tackle rare diseases comprehensively. 

POST A COMMENT