This bill makes it easier for companies to create and sell cheaper copycat versions of expensive biologic drugs (medications made from natural sources like proteins). Right now, when a company wants to sell a biosimilar—basically a generic version of a biologic drug—the original drug maker can sue them using many different patents to block the competition. This bill limits how many patents the original manufacturer can use in that lawsuit, but only in certain situations. Specifically, if the copycat company follows the FDA's streamlined approval process and shares information about their product with the original maker, then the original company can't use patents that were filed more than four years after their drug was first approved for sale. However, this limit doesn't apply to patents about how to use the drug—those can still be used in court. A judge can decide to allow more patents in the lawsuit if they think it's necessary for fairness or if there's a good reason to do so. The practical effect is that it becomes somewhat less risky and expensive for generic drug makers to develop biosimilar alternatives, which could lead to lower prices for patients who need these often-costly biologic medications.

Affordable Prescriptions for Patients Act

Cornyn, John

Affordable Prescriptions for Patients ActThis bill limits in certain instances the number of patents that the manufacturer of a biologic drug can assert in a lawsuit against a company seeking to sell a biosimilar version of that drug. (A biologic drug is produced through natural processes or isolated from natural sources. A biosimilar version is substantially similar to the original biologic, which is the reference product, and is often marketed as a less expensive alternative.)The bill's provisions apply to an existing framework that gives the biosimilar manufacturer an abbreviated path to Food and Drug Administration approval to sell the biosimilar. Specifically, if the biosimilar manufacturer completes certain actions under the framework, such as sharing certain information about its product with the reference product manufacturer, the bill limits the number of certain patents that the reference product manufacturer may assert in a lawsuit, such as patents that were filed more than four years after the reference product received market approval. The limit shall not apply to patents claiming certain methods for using the biologic drug.The court in which the infringement lawsuit is filed may increase the limit if justice so requires or if there is good cause for the increase.