Big Pharma’s patent games are costing patients. Congress must act.

A recent article published in The Daily Record highlighted how big pharma’s patent games are costing patients. Read the article below:

As a physician pathologist, I have spent my career looking closely at what lies beneath the surface. When we do the same with the high price of prescription drugs, one culprit becomes impossible to ignore: Big Pharma’s abuse of the patent system. Brand-name manufacturers set their product prices, and patent abuse gives them the power to raise those prices while blocking competition from more affordable alternatives.

We physicians see the consequences every day. Patients delay filling prescriptions, split pills, or walk away from the pharmacy counter because the medicine their doctor prescribed is more than they can afford. Families make impossible choices between their health and other necessities. The right treatment means little when the patient cannot afford it.

The patent system is supposed to reward genuine innovation. Drug discovery is difficult, expensive work and companies that develop lifesaving treatments deserve a reasonable period to recoup their investment and profit from their success.

But a patent is not a blank check, and innovation is not the same as manipulation. Too often, brand-name drug companies build dense webs of secondary patents around a single medicine, covering dosage, delivery methods, formulations, packaging or other incremental changes. These practices make it extraordinarily expensive and risky for generic or biosimilar competitors to enter the market, even after the original patent on the drug’s core innovation should have expired.

Drugmakers also engage in product hopping: Moving patients to a slightly modified version of a medicine just as the original product is about to face competition. Some modifications provide legitimate clinical benefits. But when a company times or markets a minor change primarily to shift the market away from a lower-cost alternative, that is not a medical breakthrough. It is a business maneuver designed to preserve monopoly pricing.

The pharmaceutical industry calls these practices innovation. But it forces patients to pay higher prices.

The cost is not theoretical. A study published in JAMA Health Forum examined just four top-selling drugs and estimated that delays in generic competition caused by extended market exclusivity produced $3.5 billion in excess spending over two years. That burden fell on patients, employers, health plans, Medicare and taxpayers. And that was only four drugs. Nationwide, academic data compiled by DrugPatentWatch reveals that patent thickets (a dense web of overlapping intellectual property rights that a company or group of companies holds over a single product or technology) delay generic entry by an average of three to five years per blockbuster drug, costing the American healthcare system billions annually.

This financial crisis has triggered aggressive pushback from state governments weary of federal gridlock. States like Colorado, Minnesota and my home state of Maryland have established pioneering Prescription Drug Affordability Boards tasked with reviewing high-cost drugs and placing upper payment limits on what state programs will pay.

Yet, state-by-state patches cannot completely fix a fundamentally broken federal framework. This crisis should trouble lawmakers in both parties. Republicans should reject using government-granted monopolies to block free-market competition. Democrats should reject practices that put corporate profits ahead of affordable access to medicine. Patients do not pay Republican or Democratic prices at the pharmacy counter. They simply pay too much.

Congress does not need to weaken legitimate patents or undermine biomedical research. Greater competition from generics and biosimilars is the most effective market-based way to bring prices down, and Congress should remove the artificial barriers Big Pharma has constructed to prevent it. Lawmakers must permanently limit duplicative patents, curb abusive product hopping, improve transparency around pharmaceutical patent claims and give competitors a fair opportunity to challenge questionable patents.

Bipartisan proposals capable of delivering this relief are already within reach, including the ETHIC Act, which would help address patent thickets that can delay competition, and the Biosimilar Red Tape Elimination Act, which would help remove barriers to greater competition from more affordable biosimilars. The current bipartisan support behind these efforts is encouraging and suggests there is room for Congress to make progress on reforms that foster competition and help lower prescription drug costs for patients.

Pharmaceutical companies will argue that nearly any reform threatens innovation. Congress must distinguish between protecting a genuine scientific breakthrough and protecting a pricing strategy.

As president of MedChi, I represent physicians across Maryland who want their patients to receive the treatments they need. We value the scientists and companies responsible for developing new cures and therapies. But respect for innovation does not require silence when the patent system is exploited to keep affordable competitors off the market.

Big Pharma has had years to perfect these tactics while families have watched prescription costs climb. Congress now has a bipartisan opportunity, and a responsibility, to stop rewarding legal gamesmanship at the expense of patients. The patent system should serve innovation and the public good, not become a tool for extending monopolies long after the original bargain has run its course.

Dr. Eric Wargotz is a practicing physician; clinical professor emeritus of pathology at the George Washington University School of Medicine and Health Sciences; Senior staff pathologist and immediate past Chief of Pathology and Medical Laboratory Director at Luminis Health Doctors Community Medical Center; Judge of the Orphans’ Court of Queen Anne’s County, Maryland Judiciary; former Elected President of the Queen Anne’s County Board of County Commissioners; and the 178th president of MedChi- the Maryland State Society. The views expressed in this article are solely his own and may not represent the official positions of any of his affiliates.