Pharmaceutical Innovation Policy

-- By StephanieZielinski - 29 Apr 2023

Introduction

From a young age, I endeavored to become a scientist. I was fascinated by the natural world and wanted to know how and why everything worked the way it did. I brought this curiosity with me to college, where I discovered a passion for chemistry and biopharmaceutical science. One day in Chem 101, we spent the afternoon synthesizing aspirin in the lab. I realized that if such a prolific drug could be made so easily from preexisting building blocks, what other life-changing novel therapeutics could I help create and bring to patients? However, I soon realized that academic scientific research is often frustrating and slow. Scientists might spend decades on a particular query just to contribute an infinitesimal amount of knowledge to their field, and might never see the tangible impact of their work in society. I began to research other ways in which I could use my scientific background to contribute to the effort of bringing life-saving medicines to patients, and thereupon I discovered the field of intellectual property law.

When I began law school, my cursory understanding of IP law was the following: Drug companies rely on patent protection to remain profitable enough to fund the long and expensive drug development process, and lawyers with a science background become IP Litigators, who defend these venerated companies from the evil patent infringers of the world. This was the path of least resistance; the path that I understood was expected of me. I never questioned it. However, once I began law school, I realized that the pharmaceutical patent system, which I had expected to be herded into as an active participant, was actually creating more harm for patients than it was helping them. Patent protection has enabled greedy corporations to charge exorbitant prices for medicines that cost pennies to make. And all that money “needed to fund R&D” somehow ends up being spent on campaign contributions, marketing, executive compensation, and shareholder distributions. On the other end of the spectrum, when an innovative product requires access to multiple upstream patents (think protein receptors or DNA sequencing techniques), the tragedy of the anticommons can have particularly devastating effects on biomedical innovation.

One Potential Solution

The current patent system is mostly an artifact of the 19th-century regulatory environment. And today, while pharma is the only industry with an even plausible explanation for the patent system’s continued existence on account of the risks and costs of biomedical innovation, regulatory hurdles, and speed of entry, it is clear that the system no longer benefits society as was initially envisioned. With an identified problem, the question remains: what is the best solution?

Talha Syed is currently writing a book on Pharmaceutical Innovation Policy whereby he imagines a pharmaceutical industry without patent law. He proposes that drug development be divided between “Information Good 1” and “Information Good 2.” Good 1 is the scientific knowledge of new drug compounds; their structure, function, and synthesis. Good 2 is the knowledge of the drug’s safety and efficacy in all stages of clinical trials. Currently, only Good 1 is patent protected. Once a company has patented its molecule, the patent race is called off and that company alone shepherds the drug through clinical trials. However, Good 2 requires a much larger financial investment than Good 1. Thus, today, the exclusivity granted from Good 1’s patent essentially funds the Good 2 of their molecule and the Good 2 of other molecules that end up failing (90% of drugs do not survive clinical trials).

However, this is extremely inefficient, because it results in duplicative and wasteful R&D. Furthermore, he argues, these two innovations are fundamentally different in cost, certainty, and economic policy, and should therefore be treated differently by innovation policy. Syed proposes that Good 1 ultimately be entirely patent-free, which would result in decentralized research to find promising compounds. He further suggests that Good 2 should be protected using data exclusivity rights rather than patents, which would allow companies to recoup the cost of clinical trials (which the current patent system completely ignores), create more transparency in clinical trial research, and reduce the cost of the patent system on society (litigation, abuse, and evergreening). Ultimately, this system would incentivize coordinated effort in clinical trial research rather than in R&D.

Alternative Solutions

Alternatively, many advocate for the entire abolition of the patent system. This might result in an entirely public pharmaceutical sector with socialized research, itching the scratch that private exclusion in such a critical industry is morally wrong. Luckily, important work in this space is currently occurring at Columbia Law School. Christopher Morten, Associate Clinical Professor of Law at CLS, works on the frontline of such issues, and I plan to join his efforts in the Science, Health, and Information Clinic next year. Students in this clinic work together to advocate for fair drug pricing, the disclosure of clinical trial costs, and equitable access to scientific data.

Conclusion

In conclusion, my understanding of patent law has drastically shifted in the past year. Law school, and this course in particular, has forced me to challenge my understanding of a meaningful career in patent law. Now, even if I ended up following the well-trodden path, I would never be entirely fulfilled, knowing that the mission that pharmaceutical clients purport (“to bring life-changing therapeutics to patients”) could never actually be true, as the entire patent system is designed to make profits at the expense of innovation. While my ultimate goal of bringing life-changing medicines to patients has not changed, my plan of accomplishing it has. Instead of participating and becoming complicit in the system, I hope to contribute to the force advocating for the restructuring of innovation policy in this country. Ideally, that path will bring a greater tangible effect to patients than any IP Litigator ever could.

Yes, this is certainly a practice pathway that makes sense. You didn't mention patent breaking, but that too is a skill you should acquire.

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