American innovation depends on a strong, robust intellectual property system that allows health care advances to save and enhance lives. The U.S. medical ecosystem also contributes significantly to the economy and our leadership in innovation globally.
Policymakers must recognize this crucial factor in our economic success and urgently protect and maximize the value of intellectual property in America. Unfortunately, we continue to see lawmakers consider legislation that undermines the IP infrastructure critical to U.S. leadership in biomedical innovation. This is a particular concern as China and other nations seek to overtake the U.S. as the world’s biomedical innovation leader and present unprecedented levels of competition in the development and manufacturing of new treatments and technologies.
Two such bills that will further erode the U.S. medical innovation infrastructure by undermining intellectual property are:
· Biosimilar Red Tape Elimination Act (S. 2305); and
· Medication Affordability and Patent Integrity Act (S. 2780).
The Biosimilar Red Tape Elimination Act is ostensibly aimed at reducing barriers to introducing new biosimilars in the marketplace. All biosimilars would be considered interchangeable with the original reference product without requiring a determination by the Food and Drug Administration (FDA) about possible risks to patient safety. Removing the requirement for FDA studies, however, undermines FDA authority, risks patient safety and won’t even fulfill its intended purpose to deliver biosimilars to patients more swiftly.
Under current law, the FDA has the expert discretion to require clinical studies for biosimilars or to deem them unnecessary based on the agency’s scientific expertise and judgment. In fact, the FDA recently licensed numerous interchangeable biosimilars without requiring studies. FDA should continue to have this discretion to ensure safety and efficacy of new products.
This bill is unnecessary and risks future development of biologic medicines by making the agency’s process for approving complex biosimilars more burdensome. As this area of science rapidly evolves, deliberately hindering progress by enacting S 2305 would be an imprudent step. Instead, to improve patients’ access to biosimilars, the committee should address the practices of pharmacy benefit managers (PBMs), which regularly exclude coverage of biosimilars by steering patients toward more expensive drugs that generate greater PBM profits.
The Medication Affordability and Patent Integrity Act raises a different set of IP protection concerns. This bill would add extensive new reporting requirements for the U.S. Patent and Trademark Office (USPTO), supposedly to prevent the USPTO from issuing patents for so-called inherent aspects of drugs.
Under this legislation, an already overburdened USPTO faces unyielding volumes of new information that further slow its examination and processing of patents. Worse yet, drug companies would be forced to share highly confidential information and trade secrets with the USPTO, even though the FDA already has this information as part of the drug approval process. This risks public exposure to our foreign adversaries, which would have a detrimental effect on global competitiveness. The concept is entirely unnecessary because current law already penalizes companies by rendering their patents unenforceable if they seek to deceive the USPTO.
We share and commend efforts to make prescription medications more accessible and affordable for patients. These two bills, however, would not accomplish those objectives, but would instead undermine the innovation so many need. These bills attempt to address issues already addressed and enshrined into law while jeopardizing the security of intellectual property in America in the process. Ultimately, the entire system will be less effective at meeting patients’ health care needs if this legislation progresses.
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