The Medical Patent, The FDA, The Supply Chain Collapse; It’s Not A Dream!

Medical Patents Broker Inc.
By Kenneth Pearce, President

In the global economy, not everything needed to manufacture many medical inventions is available in the United States. Inventions consistently push current technologies into newer frontiers that require previously unavailable or exotic materials.

Medical inventions can require highly specialized components, such as a specific medical-grade polymer, a rare-earth element, or a unique biological substrate. Sometimes, there is literally only one facility in the world (frequently in Europe or Asia) that can manufacture these materials in accordance with strict FDA standards. When that single plant shuts down due to a fire, an environmental violation, or a geopolitical trade dispute, the global supply chain becomes a Level One trauma for the manufacturer—and especially for the patient.

The FDA is the FDA. Manufacturing and supply issues do not drive their decisions; patient safety does. While the Agency can modify its regulations, it must always operate within the strict parameters of Title 21 of the United States Code, where the protection of the patient remains foremost.

When a core material of a medical invention is changed, the FDA generally considers it a major modification. The Agency is always looking to determine if an identical or fraternal twin material alters how a device degrades in the body, causes an unexpected allergic reaction, or changes how a drug is released. In chemistry and medicine, one enantiomer heals, and its mirror image can kill.

1. The Regulatory Race: FDA Post-Approval Changes

The manufacturer faces the FDA regulatory wall. Changing a core material or supplier requires a formal submission:

• The Process: Depending on how critical the material is to the device or drug, the manufacturer must file a Prior Approval Supplement (PAS) or a Changes Being Effected (CBE) supplement.
• The Probability: The FDA will likely require new bio-compatibility testing, stability testing, or even fresh clinical data to prove the substitute material behaves exactly like the original. This process can take months, or even years, while production is completely halted. Shareholders and patients do not favor this grueling reality.

2. The Patent Dilemma: "Designing Around" Your Own Claims

Always Keep One Pending: Many years ago, a brilliant patent attorney told me that for an important line of inventions, "It’s always better to keep a patent application pending."

Filing a Continuation or CIP: If one of the children of the parent patent is still pending in the pipeline, a Continuation-in-Part (CIP) application can be rushed to the USPTO to explicitly include a newly sourced substitute material, protecting your intellectual property landscape.

3. That "Force Majeure" Clause

Most of the time when I read those boilerplate clauses in international contracts, I think to myself, "Hopefully, we will never need this." Some of these clauses can cover a full page and include disruptive possibilities you never would have considered.

In a true supply-chain collapse, a Force Majeure clause can help a little by temporarily pausing your contractual liabilities. However, it doesn't solve the underlying issue. Without delay, your scientists and buyers must scramble to find an acceptable replacement for the originally approved material.

🎽 The President’s Viewpoint

Even with the best possible planning, these dismal situations happen. The world is full of curveballs tossed directly at our heads and when you are riding on top, it is a hard fall to the ground.

I have immense empathy for the innovators and executives thrown into this corporate furnace, and most importantly, for the patients caught in the middle.

For a scenario like this one, when a rare material must be internationally outsourced: buy well ahead of your expected needs while it is still possible. Any leftovers could eventually be sold down the line for more than the original purchase price. And for long-term international manufacturing resilience, invest early and build the necessary specialty processing plants closer to home.

Of course, building such specialty facilities is easier said than done. Many Americans want new plants, unless it’s in their backyard.