Areas of Service
Pharma & Life Sciences
Our Pharma and Life Sciences Expertise
As one of the fastest growing sectors in India, the pharmaceutical and biotech industry is witnessing exponential growth. A key component of such growth is India’s ability to provide lower cost research and development to multinational companies. India’s rich talent pool of nearly 13.5 million science graduates, growing at the rate of 36% provides an ideal platform for global pharmaceutical companies to outsource drug development processes. Manufacturing costs that are 30-40% lower than those in the United States and Western Europe in addition to labor costs that are one-seventh of that in the United States make India an attractive destination for global multinational drug makers to outsource their business activities to India.
The 2005 Amendment to India’s Patent Act significantly catalyzed drug discovery by allowing protection for products. The subsequent increase in the number of issued patents has in turn increased the number of patent litigations between multinational players and domestic generic drug makers. The industry has witnessed a shift in traditionally “generic” companies who are now seeking global recognition by investing in drug discovery rather than being recognized as “copycat” companies. India is in the midst of a never before seen number of mergers and acquisitions in the pharmaceutical space where domestic companies have intensified discovery research in order to strengthen product pipelines. In addition, the number of clinical trials taking place in India is expected to contribute to 5% of the number of global clinical trials by 2012.
Stemcell research and medical device sectors which are not regulated are likely to get regulated soon. This would significantly increase India activities for companies which would lead to increase in legal advice.The capability of NDA’s Pharma and Life Sciences team to understand the scientific technicalities that are ingrained in pharmaceutical and life sciences and healthcare industry transactions position NDA as a leading multi-disciplinary law firm for the Life Sciences practice.
The Pharma and Healthcare team at Nishith Desai Associates (“NDA”) advises international and Indian companies on the legal, IP, regulatory, corporate laws and tax. The Pharma & Healthcare group is led by Dr Milind Antani with 14 years of experience as medical surgeon . The team also includes an international commercial law expert, Indian Patent Agents, a United States Patent Attorney, chemical and biomedical engineers and IP attorneys. The ability of NDA’s Pharma and Life Sciences team to understand the scientific technicalities that are ingrained in pharmaceutical and life sciences and healthcare industry transactions position NDA as a leading firm for the Life Sciences practice. The firm’s multidisciplinary philosophy whereby each attorney is well-versed on each of the firm’s practice groups creates a cutting edge advantage that provides comprehensive services to its clients.
Dr. Milind Antani and Mrs. Gowree Gokhale have authored a book on Contract research and manufacturing services (CRAMS) in India: The business, legal, regulatory and tax environment in the pharmaceutical and biotechnology sectors. The book has been published by Woodhead Publishing.
Dr. Milind Antani has also authored along with other Pharma core team members a book on Indian Pharma and Life Science Industry – Legal and Tax Framework published by CCH India, Wolters Kluwer (India) Pvt Ltd.
Some of the accolades include:
Scope of Services
We, at NDA, represent life science clients at every phase of their growth cycle, including formation, early stage financing, technology transfer, technology licensing, research and development, development of intellectual property portfolios, initial public offerings and follow-on securities offerings, the protection and litigation of intellectual property and the development and financing of manufacturing facilities as well as tax and IP structuring. The firm is well equipped to provide the legal and tax services associated with multinational clients setting up operations in India.
The firm represents life science and healthcare clients in a wide range of services including the drafting and negotiation of research and collaboration agreements, intellectual property protection and litigation and numerous public finance, Joint Venture, M&A, private equity and venture capital transactions.
2. Regulatory Issues
We advise our clients on various regulatory issues and compliances related to clinical trials, research and development, manufacturing activities, marketing & distribution, medical devices, stem cell research and collaborations in India. We also advise life sciences companies on regulations related to proposed activities in India in the form of joint ventures, partnerships and collaborations.
3. Documentation and Advisory Services
Our team advises clients in the structuring, drafting and negotiation of various contracts including contract manufacturing agreements, contract research, service agreements, marketing and distribution agreements, outsourcing agreements and IP assignment and license agreements. NDA services a number of life sciences companies conducting clinical trials in India in the drafting, structuring and negotiation of clinical trial, master service, non-disclosure, sponsored research, material transfer, and confidentiality disclosure agreements in addition to informed consent forms and other relevant documents apart from conducting due diligence of CRO..We also assist companies in employment related issues in addition to drafting, reviewing and negotiating term sheets, shareholder, share purchase, joint venture and other corporate agreements.
Our knowledge and expertise in the Pharma and Healthcare space has been the main stimulus in the growth of our funds and private equity practice. We advise overseas private equity investors and venture capital funds on their investments in the life sciences sector. We provide our services from Term sheet, Due Diligence, Documentation and Negotiations. We were involved in certain important deals in recent past.
5. Corporate Transactions
Our team provides advice and assistance in various corporate transactions which include Mergers& Acquisitions, Joint Ventures and various collaborations related to the licensing for drug developments in the pharmaceutical, biotechnology and healthcare sectors.
6. IP Advisory
Our team assists clients in the drafting, filing and prosecution of intellectual property applications. We routinely handle the drafting of complex patent specifications for a wide array of technologies in addition to filing domestic, PCT and National Phase patent applications and assisting in the filing of foreign patent applications and freedom to operate opinions. We assist clients in identifying their intellectual property in order to formulate comprehensive strategies to help clients protect and leverage such intellectual property. We also assist companies managing patent compliance, patent landscape study as well as trademark portfolio management with uniquely designed software. Our life science team also assists clients in conducting detailed IP audit of the portfolio of a company.
7. Patent Litigation
The Pharma and Life Sciences team at NDA offers clients an extensive litigation practice that focuses on the protection of patents and other intellectual property. The firm’s intellectual property litigation team that includes a surgeon, chemical and biomedical engineers, Indian patent agents, a Pharmacist and a U.S. Patent Attorney is active in the space of Pre-Grant and Post-Grant patent application challenges in India. The firm’s Pharma & Life Sciences team brings substantial expertise in fields such as pharmaceuticals, chemical technology, biotechnology, and medical devices.
Our funds team is well equipped with the expertise of structuring and positioning life sciences funds in India. We guide our clients in order to maximize investment decisions in addition to servicing them in all aspects of tax and legal issues that arise when delving into venture investments in India.
9. Due Diligence
Due diligence plays an important role in the service and representation of our clients. By specializing in the due diligence of pharma, life sciences and CRO entities, we are able to offer our clients extensive advice in the compliance of intellectual property and corporate regulation. Our expertise in the pharma and life sciences sector enables us to identify critical issues that a financial or strategic investor in life sciences companies should carefully understand and address.
Our team advises clients on structuring transactions in view of the tax, legal and regulatory regime in India. On the tax structuring side, we routinely advise and determine tax favorable jurisdictions for investment purposes, permanent establishment, and transfer pricing instruments. We also facilitate the establishment of business in India, including the incorporation of companies and logistical operations of setting up branches and liaison offices in India. We have and continue to advise several new life sciences clients on their India-related operational activities.
Our team assists and advices our clients regarding pre-litigation strategies with respect to the current IP and regulatory landscape in India. We represent our international and domestic clients in IP litigation and alternate dispute resolution. We have extensive experience representing clients at every level of the judicial system and virtually all disputes, from relatively simple matters to highly complex cases in product liability, patent infringement, antitrust and securities.
We conduct workshops for employees of pharma and life sciences companies on intellectual property laws and confidentiality issues as well as competition law.
As a research-based law firm, NDA continues to author Life Science reports and NDA has contributed extensively on pharma and life sciences related issues in various publications both domestically in India and abroad. The firm is active in presenting and characterizing the current pharma, life sciences and IP landscape at national and international seminars.