Intellectual Property – It’s Important to Your Health

Is it me or does it seem like lately, everything I’ve written about has been another complicated, hard to understand part of America’s healthcare system? Well, get ready for one more—the part intellectual property plays in keeping you and me healthy.

In our healthcare system intellectual property (IP) is an asset that can be protected by a patent that allows the discoverer/creator/developer of a new drug/technique/medical device/etc. to have the exclusive rights to the profits of her/his idea for a period of time. This concept of granting a patent has been around for centuries and was determined to be so important to the growth of our new country that it was incorporated into the Constitution, ratified in 1783, in what is known as the Intellectual Property Clause, Article I, Section 8, Clause 8, which reads:

“[The Congress shall have Power . . .] To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”

Senators Bob Dole and Birch Bayh, in the late 1970s, recognized that our country wasn’t taking advantage of our constitutional and patent IP protections because many of the new ideas, generated in different institutions in our country, weren’t making it into the marketplace. They wrote the Bayh-Dole Act, a law enacted in 1980, that paved a way for private industry to fund the expensive process of bringing a new drug to market. The Bayh-Dole Act is almost universally credited with enabling the United States to become the worldwide leader in new prescription drug development.

The importance of IP to our healthcare system was further magnified by the enactment of the Hatch-Waxman Act in 1984 which sought to strike a balance between the right to exclusivity of the original discoverer of a medicine and the value of allowing the development of a generic alternative. As I discussed in an earlier blog, some lawmakers have sought to upset this balance by using language in the Bayh-Dole Act to arbitrarily insert price controls into our innovation ecosystem. These types of actions only serve to weaken our IP protections.

So, what’s the status of our IP protections these days? Are they under attack and should we still be worried? Yes, and yes. It seems that our lawmakers, and the world in general, want to ignore the long-term benefits of IP protection to serve some short-term and often ill-defined goal. Early in the pandemic the World Trade Organization (WTO) wanted to override the TRIPS (Trade-Related Aspects of Intellectual Property Rights) laws by granting a waiver which would distribute the IP protected secrets to other countries in the misguided belief that it would accelerate the creation and distribution of vaccines in other countries. A modified TRIPS waiver was approved in 2022, but it never lived up to its promise of increased patient access to COVID-19 vaccines. In fact, the WTO has not documented a single instance of the TRIPS waiver resulting in increased vaccine production. Yet today, members of the World Health Organization want to expand the waiver to include the ongoing therapeutics associated with COVID-19. The pandemic emergency has been formally declared over, yet the worldwide IP protections are still under attack.

There is another place where innovation is being attacked. As mentioned above, the Bayh-Dole act was pivotal in helping the U.S. become the world innovation leader in medicine discovery. Some lawmakers and the current administration are proposing that certain language in that law allows them to arbitrarily dictate the price of some prescription drugs. This language was never meant to allow price fixing. In fact, Senator Bayh and Senator Dole both have declared that no language in the Act or even the basic concept of the Act was never meant to allow for any form of price setting.

It is amazing to me that our government is willing to grasp at any straw available to insert themselves into our healthcare under the guise that it will lower drug prices. It seems that bending the intent of established laws or resorting to executive orders is becoming a common way for our leaders to govern. They prefer to work in the grey areas of the law (knowing that they will be challenged in court) to ram through these dubious and unproven changes. It is especially disconcerting to observe that the frequency and the decibel level increase just happens to occur in a major election year. Our leaders seem unable to take the long-range look at anything. They are willing to dilute intellectual property protections when they were the very reason that we were able to discover, test and manufacturer the life-saving vaccines in less than a year. A tenth of the time that it historically took to bring a vaccine to market. One key reason, that everyone seems to forget, is that private investment had been financing the research into the mRNA technology, the basis for the first and most successful COVID-19 vaccine, for over a decade. This investment was feasible because of the worldwide IP protections that were in place. A short-term sound bite in an election year shouldn’t take priority over the future promising benefits of the mRNA technology in the development of new medicines for cancer, HIV, hepatitis C, rheumatoid arthritis, and others.

The issue of IP protections and how its role during a pandemic is complicated, I wish it were simpler. This issue boils down to the fact that the protection of patents and intellectual property were deemed important 241 years ago, and they have been the engine of innovation ever since. We need to do everything in our power to preserve this powerful concept.

Best, Thair