Invention in Dermatology: A Review

September 2019 | Volume 18 | Issue 9 | Original Article | 904 | Copyright © September 2019

Spencer A. Bezalel MD, Clark C. Otley MD

Mayo Clinic, Rochester, MN

Evaluation of the current state of “prior art” through the search of patent databases is necessary to determine whether the proposed invention is truly new and “non-obvious,” requirements for obtaining a patent. If no prior art exists and the invention is truly novel, then a patent application is filed to capture related intellectual property. Finalization and receipt of a patent takes many years and is associated with substantial costs, ranging from $25,000 to $100,000 depending on the jurisdictions in which the patent is sought. With a patent application filed, further development of the invention technology is conducted, often in partnership with colleagues from other disciplines or from industry, including engineers, technology development managers, regulatory advisors, legal advisors, and stakeholders. Commercialization of medical technologies is a long and arduous process requiring passage through minimally-viable prototyping; animal- or laboratorybased studies; phase 1, phase 2, and phase 3 human studies; manufacturing; marketing; and distribution.

The time frames for invention commercialization can range from 1 to 5 years for health care information technology and up to 1 to 2 decades for pharmaceuticals, devices, and diagnostic or prognostic tests. Depending on the technology, a device may be cleared by the FDA for marketing in America through one of five routes: 1) Exemption from premarket submission for Class I devices, 2) the 510(k) process for Class II devices, 3) Premarket Approval (PMA) for Class III devices, 4) “De Novo” approval, and 5) Humanitarian Device Exemption (HDE).8 Funding for the development of technologies through the various phases is technology dependent but can range from hundreds of thousands to hundreds of millions of dollars. It is currently estimated that the cost to develop a new prescription drug that gains FDA approval is approximately $2.6 billion.9

Advice for Inventors
The following advice to potential dermatologic inventors has been shared from one of Mayo Clinic’s most experienced inventors, Richard Ehman, MD, as well as from the technology development managers, licensing managers, and business development managers at Mayo Clinic Ventures.

1. Choose an uncrowded field or area of opportunity.

2. Be aware of new technologies in other fields that may represent opportunities to translate technology into your field.

3. Focus on clinically-relevant problems.

4. Target common problems with large-market opportunities.

5. Cultivate your imagination and intuition through the engagement of mentors, colleagues, and students.

6. Engage with multidisciplinary colleagues to access different perspectives.

7. Recognize and learn from failures.

8. Invention takes a lot of time and effort, so focus on the best ideas and let bad ideas go.

9. Be persistent if you have an idea that has unrecognized value.

10. When confronting stalled ideas, consider putting them aside and coming back with fresh eyes later.

11. Always seek to translate ideas for the benefit of patients in hospital and clinic settings.

Inventions and Inventors in Dermatology
At one time or another, all of the medications used by dermatologists have been invented by colleagues within or outside our specialty. We owe great appreciation to these inventive colleagues as their technologies provide the basis for effective dermatologic therapy.

It is interesting to consider the many dermatologic therapies that have been repurposed from other specialties including methotrexate and cyclosporine, which were originally used for rheumatoid arthritis. Topical nitrogen mustard was originally a chemical warfare agent and was adapted successfully for the topical treatment of cutaneous T-cell lymphoma. Calcipotriol ointment was developed after it was observed that a patient treated with vitamin D for osteoporosis experienced significant improvement in psoriasis.10 Likewise, the utilization of beta blockers for the treatment of infantile hemangiomas followed an observation of unanticipated regression of hemangioma in a patient treated with beta blockers for hypertension.11 Botulinum toxin was originally used to treat blepharospasm with the observation that surrounding periocular musculature seemed to relax, resulting in reduction of overlying wrinkled skin.12

The invention of cortisone, one of the most commonly used classes of medications in Dermatology, dates back to the mid-20th century when the compound was identified by Drs. Kendall, Mason, and Hench at Mayo Clinic, awarded of the Nobel Prize in 1950.13 Reichstein, Wintersteiner, and Pfiffner had previously isolated the compound of cortisone but had not recognized its biologic significance. The researchers at Mayo Clinic did not pursue patent protection for cortisone, which was first produced commercially by Merck.