Physicians hoping to commercialize their inventions should have a basic understanding of the patent system by which those inventions may be protected. All modern patent systems rest on a foundation of some simple, yet crucial, principles and objectives and understanding them is helpful to understanding the fabric of rules and laws that build on that foundation. It will help the physician inventor to participate constructively in the patenting process. The basis for the patent system can be illustrated by the example of the state of childbirth in seventeenth century England.
Childbirth, at that time, was a very risky procedure. The child’s mortality, as well as that of the mother, was an ever-present risk. Although midwives often attended, their ability to successfully aid a mother having a difficult delivery often was limited. One family, however, the Chamberlens, stood out among the others. They had established a reputation for a midwifery practice that was so successful and lucrative that they were called on by British royalty. How did they achieve their success? By keeping their techniques to themselves, maintaining them in secret and passing them down through three generations of Chamberlens, the family was able to hold a preeminent midwifery practice for nearly one hundred years.
What the Chamberlens had, but others did not, was the obstetrical forceps that had been invented by Peter Chamberlen. When in attendance at a delivery, at an appropriate time, everyone was required to leave the room except, of course, the mother and Chamberlen. The mother was blindfolded. If the forceps was needed, Chamberlen would remove the instrument from a carefully guarded box in which it had been concealed, use it as needed, and then return it to the box. Although obstetrical forceps eventually became known outside the family, their ability to keep it secret assured the Chamberlen family of their competitive advantage for many years. Those who could not obtain the services of the Chamberlens were at greater risk.
But what does that have to do with patents? In seventeenth-century England there was no established patent system. There was no inducement at that time for public disclosure of the forceps. To make such disclosure would have meant giving up their lucrative advantage. Others likely would have copied and used the invention. Similar considerations concerned the trade guilds that sought to keep the practices and techniques of their trades closely guarded among its members in order to protect the competitive advantage of their skills.
In contrast to protecting innovation by trade secret, as did the Chamberlens, the foundation of all modern patent systems is not only to encourage invention but, more importantly, to encourage disclosure of that invention to the public so that all may benefit from its use. The encouragement typically takes the form of a grant of exclusive rights to the invention, but only for a limited time and only for the features of the invention that are new and advance the technology. When the exclusivity expires the invention becomes free for all to exploit. Perhaps if such a system been in place Peter Chamberlen might have availed himself of it and the forceps would have been available to all at a much earlier time. Such a system was not established in practice in England until the following century.
The framework for the patent laws of the United States has its foundation in the U. S. Constitution in which the founding fathers had the foresight to include the following clause in the powers granted to Congress:
The Congress shall have power…To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries; [Article I, Section 8, Clause 8]
Pursuant to this authority, the first U. S. patent law was passed in 1790 and, with subsequent amendments and revisions, its principles have been a cornerstone of America’s technological and economic development to this day. The most recent revision, the Leahy-Smith America Invents Act (“AIA”) was enacted on September 16, 2011 and is being implemented in stages until March, 2013 when all of its provisions will be in full force and effect. Of the many changes in the AIA the most significant is that it changes our system, effective March, 2013, from the “first-to-invent” system that has been in place since 1790 to a “first-to-file” system. In other words, the sole determining factor as to who will be entitled to a patent between two inventors of the same invention will be who was first to file a patent application for that invention in the U.S. Patent & Trademark Office. The inevitable “rush to the patent office” is certain to affect the way patent applications are prepared as well as the frequency with which they are filed. I will have much more to say about this and other changes made by the AIA in following posts.
A patent may be considered as an agreement between an inventor and the government, acting on behalf of the public, in which the inventor agrees to disclose the invention in return for a right of exclusivity for a limited term. A patent is treated, by law, as personal property and can be sold or licensed to others. Thus, an inventor can reap her reward by making and selling products incorporating the invention or by licensing or selling the patent rights in the invention to others. The right patent at the right time in the right industry can be a highly valuable asset. The power of a patent enables its holder or exclusive licensee to sue for infringement and, if successful, obtain an injunction against further infringement as well as damages for past infringement. Evidence of the power of these remedies can be seen in judgments and damages awards in the hundreds of millions of dollars and some in the billions. The power of an injunction against infringement can put even large competitors out of business. Broadened awareness of the power of patents was raised when, in the 1980s, Polaroid Corporation sued Eastman Kodak for infringement of patents relating to instant camera technology. Polaroid eventually won that case, obtaining an injunction against infringement as well as nearly one billion dollars in damages. The injunction put Kodak out of the instant camera business. In the nearly thirty years and numerous patent infringement cases since Polaroid v. Kodak, the business community has come to respect the leverage that a solid patent position can bring to an enterprise.
From the perspective of a physician inventor, the recent Saffran cases are of exemplary interest. In 1993 Dr. Saffran, as a resident in interventional radiology at Massachusetts General hospital, conceived of and patented inventions relating to combining drugs with polymers to control drug delivery. Upon learning that Johnson & Johnson and Boston Scientific were selling drug-eluting stents that he thought infringed, he sued. He was fortunate in finding lawyers willing to take the cases on a contingency basis. They were successful. In 2008 a jury awarded Dr. Saffran $431 million against Boston Scientific and in January 2011 another jury awarded him $482 million against J & J. There is reason to believe that Dr. Saffran wrote his patent application largely by himself and it is fair to assume that he had a good understanding of the patent laws to have done so.
Understanding the foundation for and the reasons why we have a patent system is helpful to understanding the nuances to the laws, the rules and the patenting process. Patents are essential to development of commercially successful inventions in the medical device industry. The better a physician inventor understands them, the greater the prospects for success and I hope to address them in more detail and on a regular basis on the Healing Innovation Blog.
Arthur Z. Bookstein