What is Biotechnology Law?

Biotechnology law is the broad name for the area of law practice that encompasses biotechnology. It is a relatively new field of legal practice as it has only been around since about 1970. Lawyers that practice in this area often will be involved in a biotechnology project from the beginning, throughout the development process, marketing, and bringing the idea to fruition. Biotechnology law includes several aspects such as contract, tax, real property, corporation, and intellectual property.

Biotechnology is technology that relates to the development and manipulation of living things for human use and gain. Biotechnology is any human use or application of biology for human or environmental advancements. The advancements may apply to medicine, animals, aquatic applications, agriculture or industry.

For example, when humans manipulate the genes in a crop in order to produce a larger yield, it’s biotechnology. When humans manipulate stem cells in order to try to create new medicines or reduce genetic birth defects, it’s biotechnology. In addition, when humans develop biological compounds to treat and clean water, it’s biotechnology.

There are regulations, processes and business structuring that goes along with biotechnology. A company must do many things in order to make sure that biotechnology research and use happens in ways that are both legal and advantageous for the companies doing the work. Biotechnology law can also involve litigation or other hearings when disputes arise.

Areas of practice

Within the practice of biotechnology law, there are a number of different specific niche areas of law where an attorney might practice. Because most biotech companies are large, it’s likely that an attorney can find one, two or a handful of niche areas to focus on rather than providing a full range of legal services as a company’s only in-house counsel. Biotech companies likely have needs in all or most of the following areas:

Contracts and business law

Creating enforceable and carefully-worded contracts is critical to the success of a biotech company. Biotech lawyers might draft agreements for clinical trials. They might create an agreement with a partner or a vendor to undertake certain work. They may contract with others for the use of their technologies. In addition, biotech companies need careful and precise legal work when they create companies, subsidiaries and affiliates. All of these tasks are things that biotech companies depend on attorneys to understand and accomplish with their best interests in mind.

Regulation and compliance

The federal government regulates use of biotechnology. There are many federal agencies with things to say about biotechnology, and biotech companies need help making sure they know what regulations exist and how to comply with them. The U.S. Office of Science and Technology Policy, the U.S. Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency are just some of the government agencies that regulate biotechnology research and use.

These organizations make and pass regulations that companies have to follow. Regulations can change quickly. Because regulations come from a variety of agencies and sources, lawyers have to know where to look for regulations and also how to determine whether or not a regulation applies. In addition to ensuring compliance with regulations, companies may want to make public comment on proposed changes to laws and regulations.

Litigation

With any business venture, disputes are inevitable. A biotech company may need to take action in order to enforce a patent. There may be disputes with vendors or other companies that the biotech companies work with. A company may also need to defend themselves from allegations of wrongdoing. This work might involve traditional litigation in both state and federal courts to address these issues and advance the interests of the company.

Patent law

The Biotechnology Patent Protection Act allows companies to pursue patents for biotechnology. This is a critical area of biotech law that allows companies to realize financial gain for their efforts. Biotech companies depend on attorneys to help them secure the patents that they need in order to make their efforts financially successful and stay in business. Securing a patent is a technical and often tedious process. Companies depend on attorneys to master the process in order to help patent applications succeed.

Special requirements for patent law

Because biotech law often involves developing new technologies, it involves the practice of patent law. If you’re considering a career in the biotech industry, it’s important to keep in mind that there are special requirements to practice patent law. It’s not enough to graduate from law school and pass a state’s bar.

Instead, you must have an undergraduate degree with a science major. You must also sit for the patent bar exam. The U.S. Patent and Trademark Office lists all of the specific requirements in 37 CFR ยง 11.7. Even if you don’t meet these requirements, there are still many opportunities to practice biotech law in other areas.

Government employees

Just like companies need lawyers in order to show that they’ve complied with government regulations, the government needs lawyers in order to make and enforce regulations. You might work for one of any of the number of agencies that create regulations for biotechnology activities. You might bring accusations of violations in order to bring companies into compliance. Working in biotech law for the government can allow you to help shape public policy as it relates to biotechnology development and uses.

Other areas of practice

Most biotech companies are large companies. That means that they have all of the legal needs that any large company has. They might need attorneys to help them ensure compliance with human resources issues. They may need to litigate personal injury complaints. There are tax issues that impact biotech companies, and tax attorneys may be both in-house counsel or contract attorneys. Whatever their needs are, you may have the chance to practice these areas of law for a biotech company.

Ethical and constitutional implications

Because biotechnology law addresses new and developing technologies, biotech attorneys may work on ethical and constitutional issues that relate to both development and use of new technologies. Biotech attorneys may even be called on to advocate to lawmakers to allow certain technologies or uses of technology. For example, the Stem Cell Therapeutic and Research Act of 2005 was widely debated before being signed into law.

Biotech attorneys may be called on to litigate the constitutional implications of biotechnology law. An example of biotech constitutional litigation is Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, 495 F.3d 695 (D.C.Cir. 2007). In that case, the courts had to answer the question of whether individuals with illnesses have a constitutional right to access experimental medicines if the medicines aren’t yet proven to be both safe and effective. In that case, the court decided that there is no constitutional right for an individual to have experimental medicine.

Why practice biotechnology law?

There are a number of reasons that biotechnology law may be right for you. If you enjoy science and creative thinking, you might find your niche in this field of law. There are a number of reasons that you might choose this area of practice:

A great choice for science enthusiasts

Many people come to law school following undergraduate work in the sciences. Others are casual science fans who enjoy reading and learning about medicine and biotechnology. Working in the biotech industry can be a great way for an attorney to pursue their interests in both biology and in law.

International opportunities

Biotechnology doesn’t just happen in the United States. In fact, there are international meetings and agreements regarding biotechnology and the laws that relate to it. In addition, many biotech companies have a presence in multiple countries. If you enjoy travel, speak a foreign language or want the opportunity to influence laws on an international scale, you might enjoy biotechnology law.

Stable employment and opportunities for advancement

When you practice biotechnology law, you might find yourself working for a large company. This can come with all of the benefits and excitement that comes with a large business including lucrative compensation, opportunities for promotions and growth along with the company. You can be on the forefront of new technology.

A growing industry

The biotech industry is growing and changing. Biotechnology law is an exciting area of practice that can both improve the quality of life for people and improve the environment. Biotech lawyers practice in a wide range of business and litigation areas with special involvement in patent law. Biotech lawyers help companies in the industry comply with the myriad of federal regulations that address biotechnology uses and practices. Lawyers in the industry can have careers involving both law and science with career stability and opportunities for advancement.