by Jeffrey K. Mills, Ph.D., Esq.1
Medler Ferro Woodhouse & Mills PLLC
8201 Greensboro Drive, Suite 1060
McLean, VA 22102
Treatment regimens and therapies available to dermatologists and their patients include prescription, as well as over the counter products, often in the form of topical and parenteral compositions. In addition, various instrumental methods ranging from the use of heat and light (including lasers), to cold treatments and different types of surgical interventions, all fall within the dermatologist’s tool box. While innovation and invention in the areas of topical and oral treatments have generally progressed at a fairly steady rate, factors related to U.S. patent law may begin to shift development in dermatologic sciences to instrumentation and devices.
A review of patenting in the field of dermatology demonstrates inventions in this area encompass innovation in biotechnology and organic chemistry, as well as materials science. These technologies are most evident in new molecules or formulations, as well as methods of treatment. The patenting of devices for use by dermatologists involves technical spaces including optics, electronics, and traditional mechanical engineering. In general, the breakdown of patents has traditionally been more heavily weighted toward chemistry and life sciences, with some of the larger patent portfolios held by traditional pharmaceutical companies. A cursory search of patent applications filed in the dermatology space over the past 20 years demonstrates that approximately 1.6 times more applications were filed in the area of dermatologic medicines (topicals, orals, parenterals) relative to device-related patents in the years 1996-2012. However, in the last four years, the number of patent applications filed in the dermatologic device area is only about 1-fold less.2 As discussed below, this increase in filings in the device area (or decrease in biotech and chemical filings) may be linked to recent decisions made by the U.S. Supreme Court related to patentable subject matter.
In order to obtain a patent on an invention, the innovation must meet certain criteria. For example, the idea must be new and non-obvious, and must be able to be described sufficiently such that someone working in the same technical field can understand, and make and use of the invention.3 Recently, several cases from the U.S. Supreme Court have focused on an additional requirement, addresing how to determine whether or not inventions are in fact “eligible” for patent protection.
According to the relevant United States legal statute, a patent can be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”4 For many decades in the life sciences space this included being able to patent “natural products,” including nucleic acids, proteins, and other things found in nature.5 So long as the natural product was claimed as “isolated,” or otherwise did not exist in nature in the form that was being claimed, it was eligible for patent protection.6 Similarly, methods of utilizing information or characteristics of a patient (e.g., genetic characteristics, reactions to certain drugs or treatments) were also eligible for patenting. This extended to the concepts surrounding what is traditionally known as “personalized medicine” or the Obama administration term, “precision medicine.”7
Two decisions by the United States Supreme Court over the past four years may, however, provide a cooling effect to dermatologic innovation based in biotechnology and chemistry. The first decision in 2012, Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., related to the patentability of the relationships between the concentration in the blood of certain drug (thiopurine) metabolites and the likelihood that the drug dosage would be ineffective or induce harmful side-effects.8 The Court found that because the claims of the patent simply applied a “natural correlation” (the relationship of a level of drug metabolite to a side-effect) and did nothing more that was “inventive,” the methods of determining the relationship were not patentable.9
The second decision, Assoc. for Molecular Pathology v. Myriad Genetics, addressed the patenting of isolated nucleic acids (specifically DNA) that relate to the proteins encoded by the cancer marker genes BRCA1 and BRCA2.10 The Court determined that while Myriad Genetics “may have found an important and useful gene . . . separating that gene from its surrounding genetic material is not an act of invention.”11 However, cDNA, which differs structurally from DNA found naturally in an organism (lack of introns), was found to be eligible for patenting.12
Since these decisions, the United States Patent & Trademark Office (USPTO) has issued a number of guidance documents for its Patent Examiners to use during the review of applications for patents. In the most recent, released in May 2016, the USPTO indicated that the decision in Myriad Genetics, would extend to limiting the patentability of other “biologic” materials, including proteins, cells, viruses, natural products (i.e., plant extracts) etc., if those materials do not possess “markedly different characteristics” from what exists in nature.13 The guidance document also discussed that while methods of detecting the presence of a naturally occurring product (e.g., protein, drug metabolite), may be eligible for patent protection, use of this information to diagnose a disease or condition of a patient would not be, because the correlation was simply the consequence of a natural process.
As a result of these decisions from the Supreme Court, and the subsequent cases from the lower courts and analysis from the USPTO, patenting of biologically-based inventions and methods related to the use of patient information for personalized medicine, has become increasingly difficult. In areas related to dermatology, these cooling effects may be felt the most in innovation related to isolating or developing skin-relevant proteins or peptides, as well as extracts from natural products such as plants, nuts, roots, etc.
From the cosmetic chemistry perspective, those working in formulation chemistry and development should still be able to pass the eligibility requirement for patenting. Generally, the use of natural products in a formulation, so long as the formulation contains some unique combination of elements or addresses an unmet need related to solubility or delivery characteristics, will be found to be eligible for patent protection. However, in instances where the claims of a patent are simply directed to a natural product itself, or the use of a natural process in a method of diagnosis, something more must be provided in order to elevate such innovations to patent eligible inventions.
While biologically-based patents may decrease, innovation in the device area of aesthetic dermatology may, instead, increase. Patents directed to new devices, applications, or instrumentation and technology for improving skin appearance or treating skin diseases in general do not face scrutiny for the use of natural products or natural processes. This development, along with the ability to obtain direct patient payment for treatments, rather than fight for insurance reimbursement, may cause companies developing devices and technology for the aesthetic dermatologist to increase their desire to innovate and obtain patent protection.
It remains to be seen how the courts and Congress may address the shift in patent eligible subject matter that has occurred within the last four years. However, the changes in judge-made law, in combination with the pressures from insurance reimbursement, may place device companies in the aesthetic dermatology arena in a prime position to increase their market position.
Footnotes
1. Jeffrey K. Mills is a Principal of Medler Ferro Woodhouse & Mills, an intellectual property law firm in the metropolitan Washington, D.C. area. The opinions expressed in this article are solely those of the author and should not be attributed to any client, or other principal or employee of the firm.
2. Patent searches were conducted using the database PatentLens. Official statistics from the United States Patent & Trademark Office may be different.
3.
See 35 U.S.C. §§ 102, 103, and 112.
4. 35 U.S.C. § 101.
5.
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
6.
See, e.g., id.
7.
See https://www.whitehouse.gov/precision-medicine, accessed August 1, 2016.
8.
132 S. Ct. 1289, 1294 (2012)
9.
Id. at 1297.
10.
133 S. Ct. 2107, 2117 (2013).
11.
Id.
12.
Id. at 2119.
13.
See USPTO, "Subject matter eligibility examples: life sciences," May 2016, pages 4, 18; available
at: http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-sme_crt_dec_1.pdf.
14. Id. at page 12.
15.
Whether or not a formulation is novel, non-obvious and meets other requirements of the Patent Laws is a separate inquiry.
16.
See, e.g., L. Pilla, "Cosmetic vs. medical dermatology: a widening gap?," The Dermatologist, 11(6) (June 2003).