Perspectives

1. Biosimilar products are defined as "no clinically meaningful differences between the biological product and the reference product" as well as "interchangeable" biosimilars, defined as a product that can be "switched one or more times" with the reference product "without an expected increase in the risk of adverse events."
2. Incentives for brand companies to continue to develop new therapies. Specifically, similar to the current structure for approved drugs, it would provide five years of exclusivity for a novel molecular structure before any biosimilar could be approved.
3. There is a three-year exclusivity for certain modifications of a previously approved product (such as a new condition of use) and a six-month pediatric exclusivity period.
4. The first biosimilar applicant gets at least six months of exclusivity (similar to chemical generics) if an interchangeable biosimilar product is approved.
5. For resolving patent disputes, a process has been outlined.
   
   1. A biosimilar applicant has to send a written request for patent information to the BLA holder.
   2. Within 60 days, the BLA holder must provide the applicant a list of all patents relating to the approved product, including patents claiming the biological product, formulations, and methods of using and manufacturing the product, even if the claimed methods for manufacturing are not used to make the reference product.
   3. The BLA holder must update the patent list for two years after receiving the request.
   4. At any time thereafter, the biosimilar applicant may provide notice of the biosimilar application with respect to one or more patents, either listed by the BLA holder or not. This notice, which the applicant sends to the BLA holder, patent owner, and the Federal Trade Commission (FTC), must include a detailed statement of the factual and legal basis for applicant's belief that the listed patents are invalid, unenforceable, or not infringed.
   5. Within 45 days of receiving the biosimilar applicant's notice, the BLA holder or patent owner may sue for patent infringement, but only with regard to patents listed in the notice. If the BLA holder/patent owner does not file suit within 45 days, the biosimilar applicant may bring an action for declaratory judgment that the patent(s) are invalid or not infringed. If the BLA holder/patent owner sues after the 45 days, the BLA holder/patent owner is entitled to damages only in the form of reasonable royalties in the event that a court finds infringement by the applicant.
   6. The bill also states that if a patent owner/licensee fails to disclose a patent in response to an applicant's request for patent information in a timely manner, the patent owner/licensee may not bring an action "under this title" for patent infringement.