Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious. See 35 U.S.C. §§ 102 and 103. Thus, innovative step-improvements to, and new applications of, existing technology may be patentable. Moreover, these step-improvements may prove lucrative, particularly when the underlying technology has entered the public domain, e.g., due to the expiration of the original patents. This concept is illustrated time and time again in the pharmaceutical industry where companies therein typically pursue competitive advantages by attempting to extend the patentable life of key technologies. One recent story illustrating this point was amplified in recent news when the FDA cleared a new pill produced by Aprecia Pharmaceuticals—the first pill of its kind produced using patented 3D printing technology.
3D Printing Patents
3D printing technology is everywhere. The technology has become increasingly popular over the last few years as printer prices have dropped, making the technology accessible to the average consumer. One driver for this increase in accessibility has been the expiration of several core 3D printer technology patents that protected the technology. For example, U.S. Patent Nos. 5,569,349 owned by 3D Systems Inc. for “Thermal Stereolithography,” U.S. Patent No. 5,587,913 owned by Stratasys Inc. for a “Method Employing Sequential Two-Dimensional Geometry for Producing Shells for Fabrication by a Rapid Prototyping System,” and U.S. Patent No. 5,597,589 owned by the University of Texas System for an “Apparatus for Producing Parts by Selective Sintering,” have all expired within the last five years. Thus, 3D printing technology has become available in the general market.
The FDA Approves Spritam ®
On August 3, 2015, the FDA approved Aprecia Pharmaceutical’s Spritam® (levetiracatam) “as the first 3D printed drug product.” Spritam® is a pill used to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. See Spritam® [package insert]. East Windsor, N.J. Aprecia Pharmaceuticals Company; 2015. According to Aprecia Pharmaceuticals, applying 3D printing technology to the formation of the Spritam pill improves patient experience and decrease overall costs by “enabling the delivery of a high drug load, up to 1,000 mg in a single dose.” Accordingly, patients are more likely to adhere to treatment plans. Specifically, 3D printing technology enables pharmaceutical companies to more precisely control key parameters of pill formation, such as surface area-to-volume ratios, which are important to controlling the kinetics of drug release. Thus, Aprecia can manufacture a pill with 1000 mg in a single does that dissolves in water in less than 5 seconds. The technology may similarly be applied to many other cutting-edge pharmaceutical applications, e.g., bioprinting of stem cells, or even entire human organs.
Extending the Patentable Life of 3D Printing Technology
Just as many pharmaceutical innovators have learned to extend patentable life of technology by innovating new applications or improvements for known pharmaceuticals, Aprecia has applied similar principles to innovate new patentable life into 3D printing technology. Specifically, on November 18, 2014, the U.S. Patent and Trademark Office granted US Patent No. 8,888,480, assigned to Aprecia Pharmaceuticals, for a “Three-Dimensional Printing System and Equipment Assembly” (the “’480 Patent”) designed to print pharmaceutical products. Specifically, claim 1 recites multiple build modules “adapted to form incremental powder layers,” and the specification explains that, in some embodiments, “the powder comprises one or more pharmaceutical excipients, one or more pharmaceutically active agents, or a combination thereof.” In some embodiments, the three-dimensionally printed article is a pharmaceutical dosage form, medical device, medical implant, or other such article as described.” (’480 Patent, Col. 28, Lines 55-62.) According to the patent, previous attempts at leveraging 3D printing technology to produce pharmaceuticals had been overly complex because they “employ[ed] radial or polar coordinate-based-printing” which resulted in variances in product uniformity. (Id., Col. 2, Lines 46-62.) The claimed improvement in Aprecia’s ’480 patent incorporates a Cartesian-based printing system that creates uniform pills one layer at a time. (See id. Col. 2, Lines 46-62, Claim 1.)
New Horizons in Bio-3D Printing
With its approval of Spritam®, the FDA has paved the way for new innovations in bio-pharmaceutical related 3D printing technology. Aprecia has already filed several patent applications in various jurisdictions, and we expect that other pharmaceutical companies will follow suit. Indeed, new innovations to old technologies can be patentable, lucrative, and important—in some cases, these innovations may even save lives.
Conclusion
Taking a lesson from Aprecia, and many other similarly positioned patent owners, innovations often times come in the form of small step improvements over existing technologies. Indeed, any one of these step improvements may be patentable, and could pave the way to a new market opportunity. Talking to a good patent attorney is always a good first step.