Not Your Grandfather’s Orphan Drug Status

Medical Patents Broker Inc.
By Kenneth Pearce, President

Orphan pharmaceuticals treat rare medical conditions affecting fewer than 200,000 Americans. Years ago, many companies concluded the market was too small to break even. But times have changed.

As with almost every other medical patent, the orphan medical patent needs a bridge to the right patent holder—the one who sees possibilities others miss. Beyond the business there is a real sense of helping others who have been overlooked.

U.S. Government Benefits for Orphans:

• Market Exclusivity: A successful Orphan Drug can receive seven years of market exclusivity. This is separate from the patent’s term and can be a powerful shield for a company.
• Tax Credits: There are significant tax credits for clinical testing costs. For a Phase I or Phase II company, this significantly reduces the "burn rate" of their capital.
• Waiver of Fees: The FDA can waive the multimillion-dollar user fees required for a New Drug Application (NDA).

The Small Market Myth Many inventors and investors think a tiny patient population equates to a lower-value patent. Before becoming a broker, I thought the same thing—until I realized the playing field was different. For the right owner or licensee, a small market of 100,000 patients where you are the only supplier can be more profitable than large-scale "improvements" for the masses.

Through the years, I observe the massive scale dilemma. It’s the "N-(4-hydroxyphenyl)acetamide" problem. That’s just a fancy name for the same pain pill everyone else is selling with different packaging.

Why compete in a crowded room? When an orphan drug is the only one in the space, it’s almost a monopoly within a monopoly.

Regardless of the type of medical patent, MPB brokerage services can assist in moving the medical invention to the patient.