Ensuring Effective U.S. Biogenerics Legislation: Timely Patent Dispute Resolution and Patent Disclosure

Providing timely access to affordable, safe and effective products should be the central purpose of U.S. legislation that introduces a regulatory pathway for the approval of generic substitutes for biologic pharmaceuticals (also known as “biotech drugs”). Provisions that extend the monopoly protection period of brand-name companies, making it unreasonably difficult to sell affordable biogenerics to patients as soon as possible after patent expiration, would defeat the purpose of the new rules.

To meet these objectives, U.S. biogenerics legislation should include provisions that encourage rapid resolution of patent disputes. Requiring brand-name companies to disclose all relevant patents is one key element to ensure potential generic competitors have sufficient information to make an informed assessment of the potential barriers to competition. Several of the biogenerics proposals under consideration by Congress do not require such disclosure as part of the proposed patent dispute resolution system, or do not contain any provisions governing patent dispute resolution related to biogenerics. Essential Action recommends that biogenerics legislation should incorporate the four principles outlined below.

Click here to download a fact sheet on this topic:Biogenerics_Patent_Litigation.pdf

Ensuring Effective U.S. Biogenerics Legislation: Avoid Inappropriate Marketing Monopolies (Data Exclusivity)

Providing timely access to affordable, safe and effective products should be the central purpose of U.S. legislation that introduces a regulatory pathway for the approval of generic substitutes for biologic pharmaceuticals (also known as “biotech drugs”). Provisions that extend the monopoly protection period of brand-name companies, making it unreasonably difficult to sell affordable biogenerics to patients as soon as possible after patent expiration, would defeat the purpose of the new rules.

What is Data Exclusivity?

When a generic company seeks approval from the Food and Drug Administration (FDA) for a generic drug, it shows that its product is the same as, or essentially similar to, a brand-name product. It then relies on, but does not repeat, the clinical tests performed by the brand-name maker. Data exclusivity prohibits the generic firm from relying on the brand-name test data, effectively barring the generic competitor from the market for a set period of time and extending the monopoly period. Data exclusivity can delay the introduction of generic competition — keeping prices high longer — for drugs that are not able to obtain patent protection, or for which the patent term has expired.

The Legislative Landscape and Data Exclusivity
All but one of the legislative proposals introduced by Congress to amend the Public Health Services Act (PHSA) over the past two years call for significant and unprecedented periods of data exclusivity prior to marketing approval of biogenerics (for periods ranging between 8 to 15 years, plus extensions in some cases). Essential Action believes that data exclusivity provisions should not be included in U.S. biogenerics legislation.

Click here to download a .pdf version of a fact sheet on this topic: Biogenerics_and_Data_Exclusivity.pdf

Click here to download a .doc version of a fact sheet on this topic: Biogenerics_and_Data_Exclusivity.doc

Ensuring Effective U.S. Biogenerics Legislation: The Cost-Sharing Approach to Compensation for the Cost of Clinical Trials is Preferable to Data Exclusivity

If U.S. policymakers wish to create an additional incentive in biogenerics legislation specifically to cover the cost of the clinical trials required to obtain FDA marketing approval of new biologic drugs, there are approaches — such as sharing the cost of clinical trials — that satisfy the public policy rationale for providing data exclusivity to innovators, at a much lower cost and while avoiding data exclusivity-conferred marketing monopolies that undermine access to medicines and other public health objectives.

If a policy decision were made that innovator companies need investment protections beyond those afforded by the patent system, the cost-sharing approach would be an efficient and pro-public health alternative to the data exclusivity (marketing monopoly) approach. This approach gives generic firms an automatic right to use brand-name originators’ data, but requires them to pay a share of the documented costs of generating the data, proportionate to the size of the markets in which they are selling their product.

Click here to download a fact sheet on this topic:Biogenerics_RD_Cost_Sharing.pdf