Big Pharma’s War on Generics uses many different types of schemes to undermine the patent system, all with one objective: Block generic drugs from entering the market.

The Bipartisan Policy Center (BPC) is the latest organization to call attention to Big Pharma’s patent abuse games. In a new report, BPC lays out three high-level types of patent abuses drugmakers use to extend barriers to entry for generic drugs and maintain high prices.

Patent Thickets:

“The accumulation of overlapping patents on a single product, commonly called “patent thickets,” is a strategy that has received scrutiny for discouraging competition… However, critics contend that dense patent portfolios can discourage competitors from entering the market due to the time, expense, and uncertainty of challenging a significant number of patents and the risk of litigation for generic and biosimilar entrants.”

Pay-for-Delay:

“Another strategy, pay-for-delay (or reverse payment) settlements, occurs when a brand-name drug company settles patent litigation by paying a would-be generic competitor to postpone its market entry. The Supreme Court’s decision in FTC v. Actavis, Inc., 570 U.S. 136 (2013) affirmed that such settlements are subject to antitrust review, recognizing that pay-for-delay agreements can suppress competition and maintain high drug prices.”

Product Hopping:

“Product hopping, also known as product reformulation, is a strategy that can affect the dynamics of generic competition. Under this approach, a manufacturer introduces a modified version of an existing brand-name drug—often called a follow-on or reformulated drug—shortly before the expected entry of generic versions of the original formulation.”

BPC explains how this tactic circumvents automatic substitution laws that allow pharmacists to substitute lower-cost generics in place of brand name drugs:

“If prescribing patterns shift to the reformulated version prior to generic entry, pharmacists cannot automatically substitute the reformulated drug with a generic version of the original formulation. This would require prescriber authorization and add friction that may limit generic substitution. As a result, generic manufacturers may face a smaller potential market if demand has already migrated to the reformulated product.”

Policymakers on both sides of the aisle know that competition lowers prescription drug prices, and that’s why Big Pharma is trying to prevent it. BPC notes that in response to these patent abuse games, “lawmakers have introduced a suite of bipartisan proposals aimed at enhancing competition, reforming patent litigation, and strengthening regulatory clarity.” It’s time for Congress to take action and stop big drugmakers from gaming the patent system to delay generic competition and keep prescription drug prices too high for Americans.

Read the full report HERE.