Gerard Scimeca – Chairman, CASE
October 4, 2019
America has long led the world in groundbreaking innovation and life-altering inventions. From watershed ideas such as the light bulb and telephone to indispensable conveniences like Velcro and intermittent windshield wipers, if a product needs to be invented or improved, America ingenuity has been there. But our nation’s exceptional track record of innovation is no accident.
Patent protections and intellectual property rights are embedded in our Constitution, which since our nation’s founding has given inventors the green-light to know the hard work, sweat, financial resources, and vision they invest into their innovations will be protected in the marketplace.
In the arena of medicine and healthcare, this has been especially true. Though our healthcare system is far from perfect — notably in the area of containing costs within the complex maze of market participants that impact drug prices — no one can dispute that medications today have not led to better treatments, more cures, and a better and longer quality of life for U.S. families. We are living in the age of miracle cures, with the promise of even greater breakthroughs to treat and prevent disease always around the corner.
This is what makes legislation that weakens patent protections on medical innovation so troubling, and so dangerous. The latest attempt at an end-around patent rights came this week from a bill introduced by Rep. David Cicilline (D-RI). Cicilline wants to inject Congress into the role of the U.S. Patent Office, and nullify patent protections for incremental yet critical improvements in existing medications. Deriding drug makers as “product hopping,” Cicilline’s bill assumes that small improvements in medications are unworthy of further patent protections that give the inventors exclusive rights to the medications they create. His goal is to speed up the timetable by which drugs enter the market less expensively through a generic equivalent. If successful, Cicilline’s bill will be nothing short of devastating to future medical innovation, and serve as a powerful headwind against the race for new cures and treatments.
It should be noted the U.S. Patent and Trade Office (USPTO) does not grant patents lightly, and approves only those applications that represent genuinely new and useful ideas. It is an agency renowned for being free of frivolity, and serves as an able guardian to ensure patent applications are legitimately innovative.
Cicilline is further off base in failing to grasp the current situation regarding generic drugs entering into the healthcare market. As of today the U.S. is adding generic drugs to approved lists and formularies at a near record clip, with the FDA approving hundreds of new patent equivalents each of the past few years as pharmaceutical patents expire. The rapid approval of generics is reassuring evidence that this process is working as it should, without need of political interference.
Cicilline and the other self-appointed patent czars in Congress are oblivious to just how critical improving existing drugs is to the health of our nation. Nearly every medical procedure and treatment has made great strides over the past decades, from anesthesia, to chemotherapy, to antibiotics, precisely because it took enormous innovation to make even incremental improvements. This happened because drug makers knew they could invest the billions of dollars in research needed to improve the efficacy of drugs with the full protection of our patent laws.
If Cicilline’s legislation had been in effect years ago, it’s unlikely a failed cancer drug called AZT would have been reformulated to become the miracle drug in the battle against AIDS, saving millions of lives in the process. It would have thwarted the improvement of countless other medications to prevent and reduce side effects, manage pain, and react better with other medications. Worse still, it would remove thousands of current drug formulas from consideration as active agents for new cures. As medical knowledge expands, it is impossible to know that a drug that has been around for years won’t be the basis of a cure for a pernicious disease, for example, such as Alzheimer’s or ALS. But if patent protections are weakened to the point of making it financially impossible for drug makers to examine new uses for older drugs, we will never know.
Patent protections are a critical pillar of America’s hugely successful system of medical advancement, a nexus of law and science that encourages innovation and helps speed critical medical treatment to the patients who need it most. It is complex in nature, and organic in its application, meaning no one has a crystal ball as to how technology will benefit us tomorrow, least of all if we stand in its way. Political opportunism has no place in telling the Patent Office how to do their job, or in playing doctor from Capitol Hill. Cicilline’s bill is reckless legislative malpractice. Its mindless dismantling of America’s enormously successful patent protection regime should make us all feel more than ill.
