The healthcare and life sciences industry is vital to the national economy and people’s livelihood, and is one of the most heavily regulated industries with the strictest compliance requirements. The research and development, registration, manufacturing, and distribution of chemical drugs, biological products, traditional Chinese medicines, and medical devices are all governed by highly specialized legal requirements at every stage.
In particular, as the pharmaceutical industry transitions toward innovation-driven development, pharmaceutical product patents have become key assets underpinning the core competitiveness and market valuation of pharmaceutical companies. From the layout of compound patents, polymorph patents, and indication patents, to the application of the drug patent linkage system, patent term extension, and the Bolar exemption, and from generic drug market entry to freedom-to-operate analysis for innovative drugs going global, legal issues surrounding pharmaceutical patents run through the entire product lifecycle. At the same time, clinical trial compliance, contract manufacturing under the Marketing Authorization Holder (MAH) system, GMP compliance, the two-invoice system and centralized volume-based procurement, and the boundary between academic promotion and commercial bribery are also legal challenges that companies must confront directly.
Tyglobe Law Firm has a professional team well-versed in the laws of the healthcare and life sciences industry, capable of providing clients with legal services covering the entire pharmaceutical and medical device products lifecycle and the full chain of intellectual property. In the pharmaceutical field, we provide pharmaceutical companies, research institutions, medical institutions, and others with full-cycle legal services from R&D project initiation to product launch and discontinuation, including clinical trial contract drafting and ethical compliance review, human genetic resources approval and filing, MAH contract manufacturing and contract sales agreements, distributor agreements and centralized procurement compliance, and academic promotion compliance systems. In the patent domain, we have deep expertise in the special rules governing pharmaceutical patents, providing innovative drug companies and generic drug companies with in-depth support in patent portfolio strategy, confirmation of patent rights, enforcement, and patent linkage dispute resolution.
I. Full Lifecycle Legal Services for Pharmaceutical and Medical Device Products
1. R&D and Clinical Stage: Providing legal support for CRO contract drafting, ethical compliance review, and informed consent of trial subjects; handling approval and filing for the collection, preservation, and export of human genetic resources; assisting with freedom-to-operate (FTO) analysis and prior art searches;
2. Registration and Manufacturing Stage: Drafting and reviewing legal documents related to drug registration applications, MAH contract manufacturing and contract sales agreements, technology transfer and commercialization cooperation contracts; handling legal disputes arising during the registration application and manufacturing process;
3. Distribution and Promotion Stage: Reviewing distributor agreements to ensure compliance of distribution under the two-invoice system and centralized volume-based procurement policies; handling legal issues related to academic promotion compliance, pharmaceutical representative filing, and drug advertising review; responding to commercial bribery investigations and infringement disputes.
II. Intellectual Property (Patent) Protection Services for Pharmaceutical and Medical Device Products
1. Patent Portfolio Strategy and Patent Rights Confirmation: Providing patent application portfolio strategies, patent stability analysis, and patent rights confirmation strategy design for innovations such as compounds, polymorphs, formulations, indications, preparation methods, and medical devices;
2. Patent Linkage and Dispute Resolution: Deeply participating in the practice of the drug patent linkage system; assisting marketing authorization holders with patent information registration and patent declarations; handling generic drug patent challenges and patent term extension (PTE) disputes; representing clients in patent validity litigation, infringement litigation, and administrative adjudication;
3. Patent/Asset Operations and Transactions: Providing legal support for pharmaceutical patent licensing, technology transfer, contribution of patent rights as equity, asset-based business development (BD) transactions, and corporate M&A due diligence; drafting and reviewing related contracts; and providing professional opinions on the application of the Bolar exemption.
III. Emerging Healthcare and Life Sciences Services
1. Internet Healthcare and Pharmaceutical E-commerce: Providing legal support for internet hospitals and pharmaceutical e-commerce platforms on online prescription management, online drug sales compliance, user agreements, and privacy policies;
2. Medical Data and AI Healthcare: Providing data compliance and personal information protection legal services for digital healthcare businesses such as healthcare big data and AI-assisted diagnosis and treatment; handling related regulatory response matters.
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