Sen. John Cornyn introduced legislation that attempts to address problems he sees with the patent protections afforded to American drug companies. While well-intentioned, the bill overreaches and would limit the ability of pharmaceutical firms to develop and improve medicines.
Intellectual property protection is crucial to innovation. Currently, drug manufacturers receive 20 years of patent protection on new products. If those products receive Food and Drug Administration approval, the innovator company has an exclusive right to sell that brand-name drug until the patent expires. After that, generic companies are free to create and sell knockoff versions.
That patent countdown clock starts as soon as a company files a patent application. At that stage of the research process, a medicine is better described as a hope than a product.
On average, it takes 10 years and costs about $1.7 billion to develop a new drug and move it through clinical trials. Only a fraction of potential medicines actually receive FDA approval.
Intellectual property protections, like patents, were included in the Constitution to encourage creators to dedicate time and financial resources to innovation.
Importantly, drug manufacturers have been shifting their focus to more complicated, hard-to-cure diseases; think Alzheimer's, cancer, and many rare diseases. That's exactly what we want.
But more complicated diseases require more complicated drugs, which opens the door to multiple patents.
Some of those patents may come later in the development process, which may effectively extend the company's intellectual property protections. It's the experts at the U.S. Patent Office, not lawmakers, who determine whether a patent application is valid.
In addition, drug companies are sometimes able to offer improved versions of products, and minor improvements can provide significant benefits.
For example, drug firms sometimes develop ways for medications to be safely taken just once daily rather than twice. Making it easier for patients to comply with their drug regimen is a benefit. Patient noncompliance causes an estimated 1-in-10 hospitalizations and costs between $100 billion and $289 billion annually, according to the Annals of Internal Medicine.
Offering improved medicine doesn't extend the patent life of the original drug. Generic manufacturers may sell a generic version of the original, just not the new version.
Cornyn's bill would essentially deter companies from making improvements to their medicines.
Another Texas lawmaker, Rep. Lloyd Doggett, D-Austin, introduced a measure that could bring medical innovation to a standstill. Doggett's bill would allow the federal government to nullify the intellectual property protections afforded to drug companies. Some developing countries seize patents when facing public health emergencies, but developed economies don't.
Yes, abuses of the patent system should be addressed. But without strong protections, drug companies would have little incentive to search for new cures and treatments.
If Congress weakens patent laws, patients may never benefit from new treatments or cures.