This Article has been written by Ms. Bipasha Choudhary, 4th year student of Dewan Law College, Meerut.
Abstract
The claiming of any inventions, discoveries or anything so created through the human brain must be echt and it could be deep-rooted through the inter-functioning with Intellectual Property Rights (IPR) and pharmaceutical industry. The rising tide of patent applications can be witnessed globally in the industry as the need for such protection and licensing has become imperative so as to safeguard the rights of the of the inventors and also to promote new talents, inventions , and innovations which can be the boon for the economy. The bailiwick of biotechnology is an evolving science creating revolutionaries in human lives, medicines, agriculture and pharmaceutical industry. The Indian Pharmacy sector is the fastest-growing sector in the country. Pharmacy Companies are facing stiff competition and their cost of marketing and branding is even increasing with each passing day. The trademark registration for Pharmacy Company is one of the most effective tools used for securely enlarging the Pharmacy business in India.
Keywords:- claim of invention, safeguard rights, boon for the economy, evolving science
Introduction
The role of a proactive Indian National Regulatory Authority (NRA) is important in facilitating access to good quality safe medical products worldwide.
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PHARMACEUTICAL REGULATORY FRAMEWORK: DRUG APPROVALS AND IPR IN THE INDIAN REGULATORY SYSTEM.
The Indian drug regulatory system originated in 1940, when The Drugs and Cosmetics Act, 1940 was passed to regulate the rapid expansion of pharmaceutical production in the country. The drug rules were framed in 1945 to give effect to the provisions of the Act. The Drugs and Cosmetics Act, 1940, regulates import, manufacturing, licensing, testing, distribution, and sale of drugs in India.
The products must display its ingredients in the prescribed manner on the label or container as mentioned in the Drugs Rules. This Act contains the general standards have been laid concerning tablets, capsules, liquid oral, and injections. The Act was the amended several times and the legislature passed more regulatory laws subsequent to it namely:-
- The Pharmacy Act, 1948.
- The Drugs and Magic Remedies (Objectionable and Advertisement) Act, 1954.
MINISTRY OF HEALTH AND FAMILY WELFARE
The Central Drug Standards and Control Organization (CDSCO) functioned under the guidance of Ministry of Health and Family Welfare. The CDSCO lay down the standards and measures for ensuring safety, efficacy, and quality of the drugs, cosmetics, diagnostics and devices in the country. It also regulates the clinical trials,
Authorization of new drugs in the market and supervises its imports. The central government is also planning to introduce all medical devices including implants and contraceptives under the purview of CDSCO.
The authority under which the nominative procedure is done is the Drug Controller General of India (DCGI). It looks into the approval regarding import, manufacturing, sale and distribution and clinical trials and Good Manufacturing Practices (GMP) certification.
- Schedule ‘M’.
The requirements specified under Schedule ‘M’ for GMP have become mandatory for pharmaceutical units in India w.e.t. July 1, 2005. Schedule ‘M’ classifies various statutory requirements mandatory for drugs, medical devices and others as per the GMP. It also includes the details about the infrastructure and premises, environmental safety and health measures, production and operation controls, quality control.
- Schedule ‘Y’.
It specifies the guidelines for clinical trials, imports and manufacture of new drugs.
THE ESSENTIAL COMMODITIES ACT, 1955.(“ECA”)
The ECA regulates the controls of the production, supply and distribution of, and trade in commerce in certain commodities. The State Government have issued various control orders to regulate various aspects of trading in essential commodities such as food grains, edible oils, sugars and drugs.
NARCOTIC DRUG AND PSYCHOTROPIC SUBSTANCE ACT, 1985.
Narcotic Drug & Psychotropic Substance Act, 1985, prohibits the production, manufacture, possess, sell, purchase, transport, warehouse, use, consume, import inter-state, export inter-state, import into India, export from India or transport any narcotic drug or psychotropic substance, except for medical or scientific purposes as provided.
DRUG PRICE.
- Drug Prices Control Order, 1995 (“DPCO”)
- National Pharmaceutical Pricing Authority (NPPA).
Drug Prices Control Order, 1995 (“DPCO”)
The prices of drugs in India are regulated under this Act. Under this Order, Government of India regulates the equitable distribution and increased in supply of bulk drugs, regulates the availability and fair price mechanism at which drugs are to be sold.
National Pharmaceutical Pricing Authority.(NPPA).
The prices of decontrolled bulk drugs and formulation are fixes or revises under this Department.
- BIOTECHNOLOGY STARTUPS AND IPR CHALLENGES IN INDIA.
India is home to over 300 biotech companies with a total bioscience investment of more than $500 million and India may claim 8% of the world’s biotechnology companies by 2010. The major players in the Indian Industry include: Biocon, Serum Institute of India, Panacea Biotech, Nicholas Piramal, GlaxoSmithKline, Abbott, Ranbaxy etc. Recently, Serum Institute of India Ltd., has announced an investment of Rs.1200 crore at the inauguration of India’s first biotech SEZ in Pune.
Here are the top 12 emerging startups in India:
CEO and Co-founder – Tuhin Bhowmick.
The company is located in Bangalore, Karnataka, Pandorum Technologies is creating functional human tissues using 3D printing technology, working on creating human liver tissue that can act as a replacement during liver transplantation or failures.
CEO and Co-founder – Saleem Mohammed
Located in Chennai, Tamil Nadu, X Code Life Sciences develops testing kits that provide genomic information about information on nutrition, exercise, health, and ancestry.
CEO & Founder: Manjiri Bakre
Located in Bangalore, Karnataka, Oncostem Diagnostics creates predictive and prognostic tests intended to identify patterns of cancer recurrence risk.
CEO and Co-founder – Kavitha Iyer Rodrigues
Located in Bangalore, Karnataka, Zumutor Biologics aims to provide targeted NK cell (Natural Killer cells are effector lymphocytes of the innate immune system) therapies.
CSO and Co-founder – Sri. Sailaja Nori
Located in Bangalore, Karnataka, Sea6 Energy focuses on producing ethanol from seaweed and converting it into biofuel, plant growth stimulants, animal feed ingredients, and other renewable resources.
CEO – Venkat Nelabhotla
Located in New Delhi, Delhi, Vyome Therapeutics develops novel medicines and treatments for the treatment of inflammatory illnesses with locally active therapeutics.
Founder – Binay Panda
Located in Bangalore, Karnataka, Ganit Labs uses genomic sequencing to sequence and interpret data from various organisms.
CEO – Vedam Ramprasad
Located in Bangalore, Karnataka, MedGenome operates a genomics diagnostics and research platform to understand the genetic markers for metabolic disorders, cancer, and rare diseases.
CEO and Founder – Anu Acharya
Located in Hyderabad, Andhra Pradesh Mapmygenome provides molecular diagnostics services, detailed genetic insights on drug responses.
CEO- Mohit Malhotra
Located in Bangalore, Karnataka, Farcast Biosciences uses its innovative platform to preserve the tumour microenvironment. This enables doctors to evaluate the correct therapy.
CEO and Co-founder – Anand Anandkumar
Located in Bangalore, Karnataka, Bugworks Research develops novel antibiotic drugs to tackle problems associated with AMR (Antimicrobial Resistance).
Chairman & Managing Director – Dr. Krishna Ella
Located in Telangana, Hyderabad, Bharat Biotech develops bio therapeutics and vaccines. (COVAXIN – a vaccine against Covid-19).
TRADEMARKS AND BRANDING IN INDIAN PHARMACEUTICALS.
Trademark registration provides protection from the identity theft of business. Trademark registration ensures registration of brand name, logo, mark, symbols of the company under government records and restraints its use by any of the third parties. A trademark once registered can only be used with prior approval of the trademark owner. if it is copied without permission of the owner, severe penalties can be imposed by the trademark authorities.
REGISTRATION OF TRADEMARK IN INDIA.
There are 45 different trademark classes, with 34 different classes for items and 11 different classes for services. In order to ensure registration of trademarks, the Trademarks Act, 1999 was passed. Trademarks in India can be used indefinitely and are registered for ten years, but they can also be renewed on a regular basis.
The Registration process for a Trademark involves several steps.
- Authority letter for authorized person of the company.
Firstly, the applicant must file a written application with the Registrar, accompanied by the necessary fees.
- Details about the company.
The application can cover multiple classes of goods and services and should be submitted to the relevant Trade Marks Registry.
- Proofs by the Authorized person of the Company.
Address proof of business (Utility Bill & Premises ownership documents); Mobile No. & Email ID of an Authorized person for company; Copy of Identity Proof & Address Proof. The Registrar will then review the application and either accept or reject it, with the possibility of requesting amendments or modification.
- User Affidavit is required by trademark authorities for confirming the use of Trademark by the applicant.
If accepted, the application will be advertised in the Trademark Journal to invite objections. Interested parties have four months to submit written opposition, followed by a hearing where evidence is presented.
- Issuing the Certificate.
If there is no valid objections or if the applicant successfully defends against them, the Registrar will proceed with the registration and issue a certificate. The entire process will take up to 18 months from the date of filing the application.
BENEFITS OF TRADEMARK REGISTRATION FOR PHARMACY COMPANY
- Legal security to drug manufacturers.
- Help buyers to choose the right medications.
- Help drug manufacturers to take legal action against counterfeits.
- Helps in better marketing & branding of goods.
- Helps creating positive image of the company.
Registering Trademark in India before starting a business is not required. Without a Trademark, however, it is risky to grow your business internationally because someone else could abuse your company’s branding.
BIOTECHNOLOGY AND IPR IN PHARMACEUTICALS: BIOTECHNOLOGY INNOVATIONS AND PARENT PROTECTION IN INDIA.
Technically, Patent means granting an inventor sole rights to an invention. Trademark, copyright, patent, GI, industrial designs are some of the forms of IPR. But the most popular form of IPR corresponding to biotechnology is patent.
Thus, the use of microorganisms to prepare substance to utilized products with the help of the human brain and technological support is protected under the biotechnological patent, under the Patent Act 1999.
CRITERIA FOR PATENTS
According to this definition of a new invention, the act talks of absolute novelty, i.e. the invention should have neither been used anywhere in the world nor published in any part of the world. Thus, there are four criteria under the Patent Act, 1999 for patent protection.
- Novelty
- Non-obviousness
- Economic significance
- Technical advancement
The inventions relating to traditional knowledge are excluded from the criteria of “inventions” by the Patents (Amendment) Act, 2002, as is defined under Section 2(1)(l) of the Patents Act, 2005.
ISSUES RELATING TO IPR IN BIOTECHNOLOGY
Although biotechnology plays an important role in saving, improving, and extending human life, the process behind the work of patenting these scientific advancements is an extremely complicated one. The vast investment involved in the form of R & D personnel, infrastructure, financial investment, to create the results exploiting biotechnology. To promote such results and to give monetary stability and reimbursement for their intellectual efforts to the growing research sector, patenting the inventions in the said field is important. Unless your invention fits in the above-mentioned four corners of patentability, you may not be able to apply for a patent.
E.G.:- Fruit juice is a mixture of fruits plus sugar which the only aggregation of the original taste of fruits and sugar. Thus, this cannot be an invention.
E.G.:- Single cell technology, Stem Cell Application, Current Cell Therapies, are inventions.
INVENTIONS AND COMPLIANCE WITH TRIPS
As we know mere discovery of already existing things is not patentable under the law. The Indian biotech industry at present is facing great challenges of Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant patent system in India.
Article 27.3 (b) of TRIPS excludes biological processes for the making of plants or animals as patentable material, but patents can be granted to the microorganisms, and microbiological processes utilized in the production of plants and animals.
With advancements in biotechnological research and the pharmaceutical industry, policymakers have started allowing the patent of some basic life forms to encourage research and development spirit, because of which the unrecognized commercial utility of such life forms came to light.
E.G.:- Genetically Modified Plants and animal species, genes, cell lines, etc.
According to the TRIPS Agreement, the following are some of the patentable micro-biological inventions:
(i) Process of producing a new microorganism,
(ii) New microorganism itself,
(iii) Process of growing or otherwise using a known or new microorganism to,
(a) A formation of multiplied microorganisms itself, for example, vaccines,
(b) A by-product of microbial growth, for instance, an antibiotic or an otherwise useful industrial product.
NOVELTY AND DISCLOSURE REQUIREMENT
Biotechnology patents fall into the scope of utility patents. A utility patent is available for the invention of a new and the useful machine, manufacturing process, etc., and especially for improvements to an existing process to be considered as new and useful.
Since patent protection is granted only for invention and not for discoveries, in the case of biotechnology innovations. Rejection of biotechnological patent application may be on the ground that the same is only a creation of nature or when it comes to genetically modified organisms, tissues, and cells he can simply say that it is an apparent variant of what organically occurs in nature, and therefore that is ineligible for a patent. Therefore, for inventions involving microorganisms, a specific requirement of deposit of biological material must be made in a recognized institution. i.e., International Depositary Authority as recognized in Budapest Treaty which is an international treaty signed in Budapest, Hungary, on 28 April 1977 and administered by WTO. According to this treaty, the applicant needs to only deposit the biological material at one recognized institution and this deposit will be recognized in all countries that were party to the Budapest Treaty. Thus, the patenting process of biotechnological inventions becomes multistep and complex.
CRISPR-CAS9 AND GENE EDITING: IPR IMPLICATIONS FOR PHARMA.
Genome editing is a type of genetic engineering in which DNA is deliberately inserted, removed, or modified in living cells. The name CRISPR (Clustered Regulatory Interspaced Short Palindromic Report) refers to the unique organization of short, partially repeated DNA sequence found in the genomes of prokaryotes. CRISPR and its associated protein (Cas-9) is a method of adaptive immunity in prokaryotes to defend themselves against viruses or bacteriophages. Before the discovery of CRISPE/Cas-9, scientists were relied on two gene-editing techniques using restriction enzymes, zinc finger nucleases (ZFN) and Transcription Activator-Like Effector Nucleases (TALENs)
Doudna, Charpentier and their collaborators used this general CRISPR technology, claimed for U.S. Patent on priority date of 25 May 2012. Charpentier, along with the University of California, the University of Vienna filed an application at the US Patent and Trademark Office (USPTO) on 15 March 2013. They were named as co-inventors, after the application was filed. The patent application was particularly broad in scope, listing 155 claims to the general CRISPR technology.
Later on, Zhang and Church’s Broad Institute patent application to the USPTO, was filed later with a priority date of 12 December 2012, seven months after the Doudna, Charpentier and collaborators’ priority date. The Broad Institute also filed an application for patent, was nevertheless deemed eligible and the patent was issued by the USPTO on 15 April 2014. The USPTO granted the key patent over the foundational CRISPR technology to the Broad Institute following interference proceedings with the University of California. The outcome of the USPTO Patent Trial and Appeal Board (PTAB), rendering judgment that there was no interference-in-fact between the claims in interference between the University of California and the Broad Institute. Broad Institute persuaded the PTAB that the parties claim patentably distinct subject matter, rebutting the presumption of interference. Broad convinced the PTAB that its claims, which were all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as the University of California’s, the latter which were all directed to CRISPR-Cas9 systems not restricted to any environment. The PTAB terminated interference proceedings upon accepting Broad’s argument that its claims pertaining to eukaryotic cells are sufficiently distinct from the University of California’s claims for use in any environment, meaning there was no “interference in fact,”.
The first European patent granted to the Regents of the University of California, the University of Vienna and Emmanuelle Charpentier (EP2800811), concerning the basic CRISPR method, was granted on 7 April 2017. It claims a DNA-targeting RNA that comprises a targeting sequence and, together with a modifying polypeptide, provides for site-specific modification of a target DNA and/or a polypeptide associated with the target DNA. Opposition Proceedings at the EPO were filed subsequently by seven parties, with oral proceedings taking place on 5–7 February, 2020. The outcome of the EPO Opposition Proceedings was, taking account of the amendments made by the patent proprietor during the opposition proceedings; the patent and the invention to which it relates were found to meet the requirements of the EPC.
The second European patent, with claims that are directed to compositions and uses of a chimeric version of the Cas9 protein, most often associated with use in regulation of gene expression as opposed to direct editing of the genetic code itself, was granted on 26 January 2018. Opposition proceedings against the grant of the second European patent have been initiated by four parties, while the most recent European patent for a CRISPR-related invention, which claims methods and compositions of using CRISPR-Cas9 to modify DNA and regulate gene activity in eukaryotic cells, including kits to carry out such work, was granted on 1 March 2019, with the first opponent filing an EPO Opposition almost immediately on 1 April 2019. At the time of writing, the date for oral proceedings relating to the second and third European patents granted to the Regents of the University of California et al has yet to be set and, overall, this is likely to be a lengthy process.
Excluding Genome Editing Technologies from Patentability
The Agreement on Trade-Related Aspects of Intellectual Property (the TRIPS Agreement) introduces a “necessity test” to assess whether protection of an overriding social interest is justified. Specifically, Article 27.2 permits World Trade Organization (WTO) Members to “exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect public order or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law”.
The scope of Article 8.1 was elaborated on by the WTO Dispute Settlement Panel Report in Canada—Patent Protection of Pharmaceutical Products, whereby the prohibition on discrimination as to the field of technology contained in Article 27.1 of TRIPS “does not limit the ability to target certain products in dealing with certain of the important national policies referred to [in Article 8.1].” The Panel therefore confirmed that there is considerable scope for WTO Members to include in national legislation exclusions based on measures necessary to protect health and to promote the public interest as set out in the permissible public order or morality exceptions set out in Article 27.2 of TRIPS.
CONCLUSION
It is concluded that Pharmaceutical companies are the rapid-growing industries deliverance human life, plants, agriculture and animals. With new technologies like GMO, Stem Cell Application, biotechnology is advancing and boosting economy in India. When a scientist or researcher invents new subject matter, to appreciating their work, Legislature is making laws to assaying their achievements. Patenting the works is a legal obligation through registration, a researcher/discoverer can have an actionable claim in his subject matter. Promoting innovations is the key to drug discovery and IPR helps in achieving this goal of having a competitive edge.
The Indian Courts also provide clarifications for ensuring the protection of Intellectual Property Rights, in order to promote protection in every industry, including the Pharmaceutical Industry.
Case:-
This legal position was subject to confirmatory judgment by the U.S. Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (more) 100 S. Ct. 2204; 65L. Ed. 2d 144; 1980 U.S. LEXIS 112; 206 U.S.P.Q. (BMA) 193, with the seminal conclusion that statutory subject matter under 101 includes “everything under the sun that is made by man”.
Reference. [Title of the Book: – ACCESS TO MEDICINES AND VACCINES.
Implementing Flexibilities under Intellectual Property Law
Editors:-
- Carlos M. Correa South Centre Geneva, Switzerland
- Reto M. Hilty Max Planck Institute for Innovation and Competition München, Bayern, Germany
ISBN 978-3-030-83113-4 ISBN 978-3-030-83114-1 (eBook)]