The bill’s primary target is the practice where drug companies make slight modifications to their products—changes like tweaking the dosage or switching up inactive ingredients—just in time to dodge the expiration of their patents. This forces patients and healthcare providers to switch to the newer, often more expensive versions, ultimately stymying the creation of more affordable generic alternatives. In short, it’s a high-stakes game of keep-away, and the average consumer is losing.
The proposed amendments to Section 271(e) of Title 35 of the United States Code aim to clip the wings of product hoppers. The legislation would set a patent litigation cap, limiting to 20 the number of patents a pharmaceutical company—referred to as the reference product sponsor—can assert in a patent infringement lawsuit. Out of these 20, no more than 10 patents may have been issued post the deadline outlined in the Biologics Price Competition and Innovation Act.
But there are exceptions to this cap, including if the courts deem that the “interests of justice” require more patents to be considered, or if the generic—termed the subsection (k) applicant—has withheld information that would enable a fair assessment of a potential infringement. Those safeguards are a nod to the complexity of patent law but are meant to prevent pharma giants from burying their competition under a mountain of litigation.
The bill also makes clear which patents can be considered in these lawsuits: those that cover the biological product itself, its usage, or the manufacturing process. This does not leave the door open for drug companies to bring in patents that are tangentially related, which would stretch the legal battle indefinitely.
So, what does this all mean for you and your wallet? If enacted, this legislation has the potential to open the floodgates to more generic versions of biologic drugs—the notoriously expensive types used to treat severe conditions such as cancer and autoimmune diseases. Increased competition should, in theory, drive down prices. With lower drug prices, healthcare costs for everyday people might finally see a downtick, easing the financial bite that often comes with managing chronic or severe illnesses.
On the flip side, pharmaceutical companies argue that patent protections are essential for encouraging innovation. They argue that the revenue from patented drugs funds the colossal R&D efforts required to bring new therapies to market. Striking that delicate balance between innovation and affordability has always been the billion-dollar question in drug policy, and this legislation is the latest attempt to find an answer.
Moreover, the bill comes with a budgetary measure to bolster the Medicare program, which should pique the interest of anyone worried about the sustainability of that essential safety net. Section 1898(b)(1) of the Social Security Act gets a neat touch-up, changing the balance of the Medicare Improvement Fund from a stark “$0” to a more comforting “$1,800,000,000.” Talk about a makeover!
The legislative journey, however, is just beginning. Having been referred to the Committee on the Judiciary and, additionally, to the Committees on Ways and Means and Energy and Commerce, the bill faces scrutiny on multiple fronts. Each committee will weigh in on different aspects of the bill, given their unique jurisdictions, before it even sees a vote. Then, of course, it will need to pass the Senate before landing on the President’s desk for a signature—a winding road but well-traveled in the world of Washington lawmaking.
In the grander scheme, this bill plays an interesting card in the continuous tug-of-war over healthcare costs. In a landscape where prescription drug prices have consistently outpaced inflation and wage growth, any legislation aimed at curtailing those costs is more than just a legal adjustment—it’s a potential game-changer for public health policy.
Between the promise of more affordable medications and the concern over stifling pharmaceutical innovation, this bill is bound to ignite lively debates in town halls and homes across the country. While it’s still early days, one thing is clear: the Affordable Prescriptions for Patients Act of 2024 puts another spotlight on the pressing issue of drug affordability, and that, by itself, is worth some attention.
