How the Finale’s Curtain for an Old Drug is Raised for the Second Overture

Medical Patents Broker Inc.
By Kenneth Pearce, President

Naysayers breathe, "No way; there’s no second overture?"

After the medical patent finally expires and the Hatch-Waxman extension is put to rest, the public can make, use, and sell the old drug for FDA-approved treatments. That’s true. However, a different score—such as more brass and violins, with the twist of two harps—creates the second overture.

So the old drug is put to rest without being dead. That’s right: the second overture of an improved opera (a new pharmaceutical that has similarities to the old drug, but with a new twist that is patentable).

🎼 1. The Prodrug Transformation (Changing the Delivery)

One of the most effective ways to secure a new patent on an old drug is to turn it into a prodrug. The prodrug is a modified version of the original molecule that is pharmacologically inactive when the patient swallows it. It only becomes active after it enters the human body and is metabolized by the liver or enzymes.

The scientists just keep on inventing. Adding an ester or an amino acid is like adding the flute—small but potent.

🎻 2. Isomers and Chiral Chemistry (Cleaning Up the Molecule)

Many pharmaceutical molecules are a mixture of isomers. When I was a lab tech many years ago, part of my job was to track the rotation of the carbons and look for racemic mixtures. Sometimes the carbon chains form two mirror-image molecules that were the foundation of the first medical patent.

This is akin to a $3,000 violin and a $100,000 high-end violin—they look the same, but only the high-end violin gets the solo. The high-yield therapeutic isomer is patentable and has the possibility of providing better treatment for the patient.

🥁 3. Fixed-Dose Combinations (The Percussion Rolls)

When the old drug cannot otherwise be altered into a single new composition, there is a piano concerto accompanied by the bells and drums option. If nothing else, the old drug is beaten, mixed, played, spun, filtered, and then an additional active ingredient is stirred into the mixture.

Commonly, this is known as a Fixed-Dose Combination (FDC). By proving these two distinct molecules together provide a synergistic benefit—or make it vastly easier for a senior patient to stay compliant with their regimen—the FDA and the USPTO may grant approvals.

🏛️ The President’s Viewpoint

Early in the game, I learned medicine was first and foremost to do no harm. Yet, many treatments appear to cause harm before they help.

Changing the old into something new has potential for increased market share, but sometimes it results in the opposite.

Increased market share depends on treating more ill patients than the competition. For patients with agonizing pain and the fear of death, there is the hope of saving lives while increasing market share. That seems to be the real win-win, and likely is part of the reason the United States has the best healthcare system on the planet.

The medical patent conducts the symphony that makes this possible.