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. 

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Developments in the Indian Patent Law in 2019

As per the latest WIPO report, India has emerged as one of the top 10 countries in the ranking of filings of intellectual property applications while showing an increase of 7.5% in the number of patent applications.

The year 2019 saw some drastic widening of the scope and horizons of the patent laws. Various rulings and legislations were laid down making the sector more efficient in its functioning. The Patent Law has been liberalised to a great extent thereby providing a conducive atmosphere for start-ups and other small entities to hit the ground running. Also, the offer of 450 patents for free access to industries by DRDO for commercial exploitation was a shot in the arm.

The legislative developments together with the policies and significant case studies instrumental in widening the ambit of the patent laws are listed hereunder:

LEGISLATIVE AND POLICY DEVELOPMENTS

 

  • Publication of A New List of Scientific Advisors by the Patent Office[i]

 As per the Patent Rules, 2003, a list of Scientific Advisors must be released and updated annually. The list was last updated in 2010 and after nearly a decade, the list was issued in 2019 with 37 new enrolments. The list includes 2 Patent Agents. The duty of these advisors broadly includes guiding the Court and providing reports on questions involving technical substance.

 

  • Bilateral Patent Prosecution Programme[ii]

The Government approved the Bilateral Patent Prosecution Highway Programme between India and Japan. This programme enables accelerated examination of applications as it cuts down on duplication of work. Once a patent is granted in one country, the process of approval gets easier when filed in another country as it is assumed that the application must have gone through the rigorous process of exhaustive searches and technicalities in the previous country thereby enabling speedy disposal of applications. The process becomes much simpler, quicker and economical.

Under this pilot programme, Indian Patent Office can receive patent applications in certain specified technical fields only, like electrical, electronics, computer science, information technology, physics, civil, mechanical, textiles, automobiles and metallurgy, however, Japan Patent Office can receive applications in all fields of technology. This programme is initially restricted to a period of 3 years. If there are no major implemental gaps, this will be highly beneficial to Indian inventors including start-ups and MSMEs.

 Accelerated / expedited examination process

The amended rules include additional categories of applicants who can avail of expedited examination of their patent application. Such categories being small entities/MSME’s, Women applicants, Departments of Government, Institutions owned or controlled by the Government, Institutions wholly or substantially financed by the Government, Government companies; and Applicants of those countries whose patent offices are in an agreement / arrangement with the Indian Patent Office.

Fees and documents for start-ups and small entities

The second proviso to sub-rule (1) of Rule 7 has been substituted to clarify that start- ups and small entities must submit Form 28 along with the documents requiring a discount on the official fee. However, this amendment was merely expository in nature as, in practice, the Patent Office had already mandated the filing of the said form.

Medium of transmission of documents by patent agents

Rule 6(1A) was substituted and now provides that patent agents will have to file duly authenticated documents only via electronic medium. However, any document that is specifically asked to be reported/submitted in original by the Patent Office should be filed within 15 days of such request.

Transmittal and certified copy fee no longer applicable

In order to encourage electronic filing of PCT application, the Rules have been amended by deleting transmittal fees which the applicants were required to pay to the Indian Patent Office earlier. However, if the applications are filed physically then the same transmission fee as prescribed under the principal Patent Rule shall be applicable.

SIGNIFICANT CASE LAWS

  • Nuziveedu Seeds Ltd. And Ors. Vs Monsanto Technology LLC and Ors[iv]

The Hon’ble Supreme Court held that cases involving technical and scientific questions about patentability and exclusion of a patent were to be duly considered and examined at the stage of the final hearing. Expert advice and extensive inputs on technical aspects of a patent were purely unnecessary for granting injunctive relief. In the instant case highly complex question regarding the technical aspects of a patent was involved along with the compliance of a sub-licensing agreement between the plaintiff and the defendant. The patentee had terminated the agreement abruptly and filed for injunction restraining the defendants from using the patent as per the agreement. The single judge bench ordered compliance with the agreement and did not allow injunction. On appeal, the Division bench investigated the technicalities and ruled in favour of the plaintiffs. However, when appealed to the Supreme Court, it held that the judgement by the learned Single judge bench was in order and did not merit any interference.

  • Bayer Corporation v. Union Of India & Ors[v]

The Delhi High Court held that export of patented invention is also included under section 107(A) of the Patents Act, 1970 i.e., Bolar exception (rights granted to a patentee-making, using, constructing, selling and importing of their patented invention). However, the inclusion of ‘export’ needs to be duly regulated through the reasonably related test which shall differ from case to case to ensure that such exception is not misused. The ‘export’ should be reasonably related to research, development and submission of the information for obtaining regulatory approval from the authorities. In the present case, the issue was whether export of patented products for the purpose of research and development amounted to infringement and whether the export fell within the Bolar exception. The concept of patent linkage was extensively discussed. The case was decided in favour of the Respondents and exporting of the patented product for R&D was interpreted to be well within the Bolar exception under Sec 107(A).

  • Natco Pharma Limited v. Bristol Myers Squibb Holdings Ireland Unlimited Company and Others[vi]

The Hon’ble Delhi High Court reiterated the importance of considering the three-element test for the grant of an interim injunction (Prima facie case, the balance of convenience, irreparable injury). Such reiteration was considered essential to regulate the grant of injunction orders, especially in cases of pharmaceutical patent infringement. In the present case the respondents filed a suit seeking an interim injunction restraining the appellants from commercialising and initiating the sale of the appellant’s patented product. The Single Judge bench ordered interim injunction but on appeal, the Hon’ble High Court declared that interim injunction could not be granted merely on peripheral consideration of facts without applying the three-element test of interim injunction.

  • Ferid Allaniv Union of India And Ors[vii]

In this case the Petitioner had filed a patent application for a computer-related invention and the same was rejected. On appeal to the IPAB, the application was again rejected on the grounds of lack of novelty and lack of technological advancement or technical effect. The petitioner further appealed to the High Court of Delhi where the scope of Section 3(k) of The Indian Patent Act, 1970 and the term ‘technical effect’ was examined. The Court held that there existed no absolute bar on the patentability of computer-related inventions. However, it was subject to technical effect and advancement derived via such invention. The court directed for a re-examination of the patent application in accordance with the law.

  • Communication Components Antenna Inc. v. Ace Technologies Corp and Ors.[viii]

This landmark judgement emphasised on the necessity of a wide claim. It was further clarified that claims granted in India would take precedence over claims granted in a foreign jurisdiction while determining an infringement suit. In the present case the plaintiff sought permanent injunction claiming infringement of one of its patents that he had acquired in India. The product was granted a corresponding patent in the US. When a conflict over infringement of the Indian claim came up, the High court strictly stated that an infringement in such claim would be strictly confined and viewed in accordance with the claims granted in India and not the foreign claims although they might persist.

  • Pharmacyclics LLC v. Union of India & Ors.[ix]

In this landmark case, the Delhi High Court issued wide guidelines on post grant opposition. In this instance, the court allowed evidence to be produced considering the dates for the final hearing were fixed and evidence was filed prior to the hearing which was eventually adjourned at the request of the party. Further, there existed a reasonable time for the parties to respond to the filings previously made. The Hon’ble court while disposing of the matter laid down certain guidelines to be duly complied with in cases dealing with post grant oppositions. These included the filing of initial pleadings by the parties by relying on various documents and expert testimonies. Moreover, Rule 59 was to be strictly adhered to. Further evidence was not permissible once the material was transmitted to the opposition board. In addition, further evidence would only be entertained prior to the issuance of hearing under Rule 60. Moreover, publicly available documents can be provided 5 days prior to the hearing by highlighting the relevant portions. Also, the authenticity of the document is important.

 

 

References 

[i] http://ipindia.nic.in/writereaddata/Portal/Images/pdf/List_of_Scientific_Advisers_as_on_6Sept2019.pdf

[ii] https://dipp.gov.in/sites/default/files/PressBrief_Japan_21November2019.pdf

[iii] http://www.ipindia.nic.in/writereaddata/Portal/News/569_1_The_Patent_Amendment_Rules_2019_.pdf

[iv] CIVIL APPEAL NOS.4616¬4617 OF 2018

[v] LPA No.359/2017, CM Nos.17922/2017, 20160/2017, 33383-84/2017, 47167/2017 & 660/2018

[vi] FAO(OS) (COMM) 160/2019 and C.M.No.31063/2019

[vii] W.P.(C) 7/2014 & CM APPL. 40736/2019

[viii] CS (Comm) No. 1222/2018

[ix] CM APPL.54097/2019

 

 

Image Credits: Paul Skorupskas on Unsplash

The year 2019 saw some drastic widening of the scope and horizons of the patent laws. Various rulings and legislations were laid down making the sector more efficient in its functioning. The Patent Law has been liberalised to a great extent thereby providing a conducive atmosphere for start-ups and other small entities to hit the ground running.

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