Congress should not punish drug innovation with weakened patent protections
by Mark Schultz and Jennifer Brant · The Washington TimesOPINION:
This week, a House Judiciary subcommittee will hold a hearing to examine patents and prescription drug prices.
Expect lawmakers to hear the usual complaint: Pharmaceutical companies file patents on incremental improvements to medicines to keep generic competitors off the market.
This is a politically convenient narrative. It is also profoundly misleading.
Critics portray post-approval drug innovation as little more than legal maneuvering — superficial changes designed to generate additional patents and extend exclusivity.
That story ignores the unpredictable, iterative nature of biopharma research and development, as well as the costly scientific and clinical work required to improve medicines for patients.
Many of the most important advances in medicine occur after a drug’s initial Food and Drug Administration approval. Therapies become easier to administer, more effective or useful for entirely new diseases.
None of these improvements is automatic. Each requires years of additional research and clinical testing.
Congress should be careful not to weaken the patent incentives that enable continuous innovation. If lawmakers treat post-approval pharmaceutical research as mere “gamesmanship,” patients will ultimately pay the price with fewer improved therapies and slower medical progress.
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One of the clearest examples is Keytruda, now the world’s bestselling drug. When the cancer immunotherapy was first approved in 2014, patients could receive it only through intravenous infusion, requiring repeated trips to infusion centers and lengthy appointments every few weeks.
Scientists believed there was a better option: a version injected under the skin in minutes rather than hours. Yet developing it required overcoming difficult scientific challenges. Researchers had to reformulate a large, complex biologic medicine so that it would remain stable at high concentrations and be absorbed safely and effectively after injection.
The company conducted additional clinical trials over the years before regulators approved the new formulation.
The resulting improved version of Keytruda was approved last year, more than a decade after the original medicine reached the market. Years of scientific research have delivered this dramatically more convenient treatment option for dozens of cancers, especially for cancer patients who live far from treatment centers or have difficult vein access.
Patent critics portray these kinds of advances as cynical attempts to file more patents and “evergreen” exclusivity. The reality is that companies undertake expensive, risky post-approval research to help patients, and patent protection creates a reasonable opportunity to earn a return on these investments.
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Remove that incentive, and much of this research may no longer be feasible.
Keytruda is not unique. Neupogen, a medicine used to help chemotherapy patients avoid dangerous infections, originally required repeated injections over several days. Scientists later developed a longer-acting version that requires only a single injection per chemotherapy cycle, followed by a wearable device that automatically administers the medicine and spares patients additional clinic visits.
Other post-approval breakthroughs have expanded medicines into entirely new disease areas. Jardiance was initially approved in 2014 as a treatment for Type 2 diabetes. Additional clinical trials later demonstrated that it could also reduce cardiovascular mortality and slow the progression of kidney disease, dramatically expanding its benefits for patients.
Still other advances have come from combining existing medicines into simpler, more effective therapies. Atripla brought together three HIV medicines into a single, once-daily pill, making treatment easier to follow and helping transform HIV into a manageable chronic disease.
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None of these improvements was inevitable. Every one required years of investments in scientific work and clinical testing, substantial uncertainty and risk.
Drug development fails far more often than it succeeds. Building on proven medicines — improving formulations, discovering new uses and simplifying treatment — is often one of the most effective ways to amplify the benefits of scientific research for patients and healthcare systems.
Weakening patent protections for post-approval innovation would not address critics’ allegations of patent abuse. It would punish the scientific work that produces better treatments for patients.
• Mark Schultz is the faculty chair of the IP Policy Institute at the University of Akron. Jennifer Brant is a senior adviser at law firm Sidley Austin and a practitioner in residence at the IP Policy Institute.
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