Introduction to Legal Considerations and Terms

Intellectual Property in Biotech and MedTech

• Patents in Biotech/MedTech: Patents are crucial for protecting new inventions, including medical devices, pharmaceuticals, and biotechnological processes. You can only file a patent if you have not publicly disclosed what you wish you to patent, and it will only eb granted if it does not infringe on other patents, and if it is non-obvious to an expert. 
• A patent is a legal right that grants the inventor exclusive control over their invention, typically for a period of 20 years from the filing date. This exclusive right enables the patent holder to prevent others from making, using, selling, or importing the patented invention without permission.
• The range of inventions that can be patented in these sectors is broad, but they must meet key criteria: the invention must be novel, non-obvious, and have practical utility. Here are some common examples of patentable items in biotech and MedTech:
  • New Medical Devices: This includes any innovative tools, machines, or instruments developed for medical use, such as surgical devices, monitoring equipment, or prosthetics.
  • Pharmaceutical Compounds: These are new chemical compounds used for medical treatment, including their composition, formulation, method of delivery, or dosage form.
  • Diagnostic Methods: Procedures and techniques developed for diagnosing diseases or medical conditions, which may include both invasive and non-invasive methods.
  • Biotechnological Processes: Techniques used in biological processing, genetic engineering, or bioprocessing. This might involve novel methods of producing biopharmaceuticals or manipulating genetic material.
  • Genetic Material: Patents can be granted for specific DNA sequences, genes, or genetically modified organisms, as long as they have a demonstrated and specific utility.
  • Protocols or Methods: Unique methods or protocols used in medical, biotechnological research, or clinical applications are patentable. This can include laboratory techniques or novel clinical procedures.
  • Software and Algorithms: Especially in MedTech, software or algorithms integral to the functioning of medical devices or used in diagnostics can be patented. These must offer a new technical solution to a medical problem.
  • Surgical and Medical Techniques: Innovative procedures in surgery or medicine can be patented, although this varies by jurisdiction and often entails ethical considerations.
  • The patenting process requires a comprehensive disclosure of the invention, including how to make and use it, which becomes public information. This disclosure is a critical aspect of the patent system, as it contributes to the overall advancement of scientific knowledge while protecting the inventor's rights.
• Types of IP: Beyond patents, IP encompasses trademarks for brand protection, copyrights for original works, and trade secrets for proprietary knowledge.
• Early Exploration of Patenting: Start-ups should explore patenting opportunities before publishing research papers, as public disclosure can hinder the ability to secure patent rights.

Confidentiality and Its Impact on Patenting

• Role of Confidentiality: Maintaining strict confidentiality is key in the early stages of development, especially prior to patent filing. Public disclosure, even in academic publications, can invalidate patent eligibility.
• Non-Disclosure Agreements (NDAs): Utilize NDAs when discussing your innovation with potential partners, investors, or employees to protect your IP and preserve patent rights.
• Trade Secrets: Certain aspects, like manufacturing methods or algorithms, may be better protected as trade secrets, requiring stringent internal confidentiality measures.

Spinning Out and Equity Considerations

• Spinning Out from Academia: Transitioning from an academic project to a commercial entity often involves transferring IP rights and establishing an initial equity structure.
• Equity and Cap Tables: Equity distribution, outlined in cap tables, should reflect the contributions of founders, employees, and advisors. Effective curation of cap tables is crucial for delineating ownership and aligning incentives.
• Managing Equity during Growth: As the start-up grows, managing equity and understanding its implications for future funding rounds and partnerships becomes increasingly important. We look forward to sharing a detailed dive on this soon.

In the biotech and MedTech industries, legal acumen in IP management and confidentiality is not just a protective measure but a strategic advantage. Start-ups should prioritize understanding and navigating these legal aspects to safeguard their innovations, secure investment, and successfully transition from academic research to commercial viability.