Rising drug prices have led to major issues with providing broad access to medicine around the world. While these issues receive significant media attention, it is important to understand fully why these problems exist in order to come up with real solutions. My perspective is shaped in large part by my background as a scientist. As a researcher, I viewed the issue purely through a scientific lens. I was focused on how to improve the drug development process through the technologies we were creating. However, I realized that there were also legal issues constraining technology development that spurred my interest in attending law school to pursue a career in patent law. As a first-year law student, my perspective has already broadened. I now know about legal barriers that can inhibit the impact of those technologies on global access to improved and cheaper medicine.

A Researcher’s Perspective on Improving Access

Scientists can help reduce costs of drugs without any need to pass new laws. How? Scientists can develop tools to make drug discovery and manufacturing more efficient and cheaper. I often discussed this with colleagues during the course of my PhD research. Much of our research sought to develop a new system that could make new and improved drugs at a reduced cost. By reducing costs, we hoped to improve access to affordable medicine.

Since I started law school, my former colleagues have made great strides towards this goal with an efficient synthesis designed to help reduce drug shortages on a drug that has recently had price hikes of nearly 1400 percent. The drug, called Lomustine, is used to treat brain tumors and other types of cancer. The recent price hike has made Lomustine inaccessible to many patients in need of it. Since the method developed by my colleagues is more efficient at making Lomustine, it should be cheaper to make, and thus could be priced cheaper.

Additional Legal Complications to Improving Access

In law school, I have begun to learn the various legal barriers that stand in the way of improving access to medicine. As a result, I can now more fully appreciate the challenges my colleagues at Purdue University will face in their pursuit to improve access to affordable drugs.

I was certainly aware as a graduate student of the roles that patents and regulatory authorities played in the drug development process. However, I did not fully comprehend the legal barriers to creating low-cost generic medications. Since generics are versions of a drug that has already achieved regulatory approval, the manufacturer is only required to establish bioequivalence. This basically means that the two drugs have the same active ingredient, dosage, and will behave equivalently in the human body. Proving bioequivalence is significantly less costly and time-consuming compared to the clinical tests required for new drug approval. However, establishing bioequivalence is often not the only barrier to obtaining marketing approval for a generic.

While there is no question that my former colleagues’ Lomustine synthesis is more efficient and cheaper than what is currently used, legal barriers may still remain in the way of it making a major impact on improving access to affordable medicine. The situation is tricky for reasons I’ve learned in my first year of law school in the class “Global Access to Medicine: A Patent Perspective.” I always knew patents can bar entry of lower-cost generic versions, but law school has opened my eyes to further complexities that can bar generic approval.

Even though Lomustine is available as a generic, which typically is cheaper when there are multiple manufacturers, I have learned about two strategies that companies sometimes use that may create barriers to regulatory approval of generics. These strategies do not seem to be responsible for Lomustine’s price hike, but do explain some issues involved with high prices of many other drugs.

One such barrier is a strategy often referred to by drug manufacturers as life cycle management and sometimes called evergreening by its critics. Basically, a drug manufacturer will seek sequential patents on a drug to effectively extend the time of patent protection, during which low-cost generics may be precluded from entry due to patents. One way this can be done is by patenting many aspects of one drug, such as the compound itself, followed by the formulation and/or coating in subsequent patents. Alternatively, variations of the original drug compound may also be patented. While some may contend these strategies do not preclude the generic manufacturer from making the original drug (whose patent had expired), this argument fails to recognize patent linkage, a regulatory law in some countries, such as the US. Basically, this law precludes regulatory approval of a generic that allegedly may infringe one or more patents. Patent linkage laws are an effort to prevent expensive and time consuming patent infringement litigation by baring regulatory approval of a product that would infringe a patent. However, as applied in the US, patent linkage can be a bar for legitimate generic entry into the market based solely on allegations that activity might infringe without any government entity or court typically assessing these claims.

Improving Access is Scientifically and Legally Complex

The potential impact of improved developments of making drugs affordable can be stunted by legal barriers beyond the term of a single patent. In graduate school, I became intimately familiar with the scientific challenges associated with drug development. After only one class in law school, my eyes have already been opened to the legal complexities in the way of increasing access to affordable medicine. I look forward to learning more about these challenges as I continue my legal education.

 

 

 

 

Bradley Loren
Assistant Blogger
Loyola University Chicago School of Law, JD 2021