Biotechnology is a an emerging field with the potential to be quite lucrative, making it particularly exciting for entrepreneurs. However, the field is also rife with complex legal issues, from acquiring financial backing to negotiating business agreements and securing intellectual property rights. Even more difficult are the often convoluted, drawn-out regulatory approval and inspection proceedings that biotech firms face. Dealing with the regulatory and compliance challenges of this industry requires a wide range of legal knowledge and experience, something that can be challenging for many new biotechnology companies. If you are developing biotech products, a Priori biotechnology lawyer is essential to ensuring you navigate these legal requirements successfully.
About Biotechnology Law
Biotechnology regulations are rapidly evolving. Most biotech developments take years to get to market—sometimes even upwards of a decade, which makes compliance and IP protection, not to mention funding, legally and strategically complex. As biotechnology can have industrial, medical, and agricultural uses, biotech compliance requires highly specialized knowledge in a variety of legal areas.
Regulatory Requirements for Biotech Research
The biotechnology field is subject to particularly stringent documentation requirements. Failure to comply could lead to rejection of a product by the FDA. This means that research agreements, informed consent documents, material transfer agreements and other authorizations must be in place before any work on the product is carried out. Even in the earliest stages of research, you should take care to properly document all developments for ultimate approval. A Priori lawyer can help you understand FDA research standards from the beginning to get your company off on the right foot.
Any medical, pharmaceutical or agricultural biotech product must be approved by the Food and Drug Administration (FDA) and companies must follow all FDA regulations during their development. FDA rules for biotech are very complex and change regularly, which is why it can be helpful to hire a specialized biotechnology attorney to work with you on FDA compliance issues.
The Coordinated Framework for Regulation of Biotechnology
Under the Coordinated Framework for Regulation of Biotechnology, the FDA is required to only set limitations on genetically modified foods and organisms that are based on verifiable scientific risks. Within this process, companies wishing to market new GM or bioengineered products must issue a premarket notice, meet with the agency to identify and discuss relevant safety, nutritional, or other issues and then submit a summary of its scientific and regulatory assessment of the food. This requires specific technical documentation and properly filed legal forms.
Federal Food, Drug, and Cosmetic Act
Almost all biotech products are regulated by the federal Food, Drug, and Cosmetic Act, which means biotech companies must strictly adhere to their premarket notification and approval processes in order to get devices or products in the market. This can be a long and arduous process, so getting the paperwork done right the first time is important.
The Environmental Protection Agency has a particular interest in the development of certain biotech products, especially pesticides and agricultural products. This means that biotechnology companies need to comply with all EPA regulations, including completing necessary filings. Even if your company is not strictly an agricultural company, it may be considered one under the EPA’s definition, which means that you would be subject to their approvals and inspections as well as the FDA’s. Make sure that you know your EPA compliance status before taking any steps towards notification and approval.
Once you have successfully developed a biotech product, your company will want to protect its IP investment. You can do this through biotech patents. Depending on your invention, it may qualify under a plant patent, drug patent, or a utility patent, which, if granted, should last for 20 years. This will give you exclusive rights to market the biotech invention and develop it further, as well as license the technology to third parties.
Knowing when to file for a patent can be challenging in the biotechnology field, because it must be soon enough to protect the invention, but late enough in development that it is ready to be accurately patented. In general, however, you must file your patent application before submitting the product for any sort of public approval. In certain circumstances, a provisional patent may also be appropriate for your biotech product. In the meantime, don’t forget to protect your IP through other means, such as non-disclosure agreements.
Depending on the complexity of your product and research and development processes, the cost of working with a lawyer can vary significantly. When you hire a lawyer in the Priori network with a background in biotechnology, hourly rates can range from $300 to $495 per hour. In order to get a better sense of cost for your particular situation, put in a request to schedule a complimentary consultation and receive a free price quote from one of our lawyers.
How is pharmaceutical law different from biotechnology law?
While pharmaceutical law and biotechnology law overlap a great deal, since biotech applications are vital to many developing drugs and treatments, biotechnology law encompasses many more areas than pharmaceutical law alone. If you work in biotech research and development for non-pharmaceutical use, you may need to comply with many regulations not covered in pharmaceutical law.
What other legal issues do biotech companies face?
Biotech companies are businesses like any other, which means that there are a number of corporate compliance issues not mentioned here that require attention. If your biotech startup is not sure what regulatory issues it may be facing, connect with a Priori lawyer today to avoid any potential legal pitfalls.
How can I avoid making misleading public statements about my biotech company’s fiscal health?
Biotech firms are especially vulnerable to charges of misleading public statements about its financial status, in large part because these products take a long time to commercialize. The best way to comply with securities law is to consult a qualified third party to help with these filings, such as a securities lawyer. An experienced professional will be able to help you present information in the most accurate way possible, so you don’t run into problems later.