understand regulations and its own jargon like “505(b)(2) filing” and “Phase III clinical trial”, is not much better.
The following Dilbert carton does a pretty good job of illustrating how many people think about patents: somehow important, but at the same time not very understandable.
DILBERT © 2012 Scott Adams. Used By permission of UNIVERSAL UCLICK. All rights reserved.
Furthermore, when you need an answer to a patent question, you ask a patent lawyer. If the question also involves FDA regulatory issues, you will generally be told that that is an area outside the expertise of the patent lawyer and you should consult an expert in FDA law or regulation. So you find such a person and they will tell you all you need to know about FDA law and regulations, but if the question also involves patents in any significant way, they will tell you it is outside their area of expertise, so please to consult a patent lawyer.
This Catch 22 problem for pharmaceutical managers and executives is that there are an increasing number of important “you bet your product” issues that depend on fully understanding how patent and regulatory laws and regulations and statutes such as the Hatch Waxman Act interact to influence the long-term success of a pharmaceutical product.
That means pharmaceutical managers and executives alike who want to succeed in their jobs have no choice but to become knowledgeable in these matters, so that they can plan for the successful development and long term success of their company’s pharmaceutical products. This book might also be helpful to the regulatory lawyer or patent lawyer (who can save time by skipping the chapter on his or her specialty) who wishes he or she had a better understanding of the interaction of patent law with regulatory law so that they can better see the bigger picture and help achieve the goal of successful pharmaceutical product lifecycle management.
This book is intended to explain those subjects in understandable language so that you, the reader, will be able to ask the right questions and understand the answers you receive. Keep in mind this book is not intended to be, nor could it be, a substitute for competent counsel in patent law and FDA regulatory matters, nor is it a substitute for expert consultants in pharmaceutical product life-cycle management.
The first three chapters are on patents. Chapter 1 is an Overview of Patents. Chapter 2 covers Patent Enforcement and Infringement and Chapter 3 describes Pharmaceutical, Biologic and Medical Device Patents. These chapters provide the necessary basic background in patents for understanding pharmaceutical product life-cycle management. The next two chapters relate to regulatory matters. Chapter 4 is an Overview of FDA and Chapter 5 covers Exclusivity for Brand Name Innovative Drug Products. These chapters provide the basics for understanding how FDA regulations and brand name product exclusivities affect product life-cycle management. Chapters 6 and 7 discuss the final pieces of the puzzle. For conventional generic drugs: Generic Drugs: Hatch Waxman Act; and for biologic generics: Generics for Biologic Drugs, covering the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which for the first time authorizes generics (or “biosimilars”) for biologically produced branded drugs in the United States. Then Chapter 8 synthesizes the previous seven chapters in Putting it All Together: Product Life-Cycle Management. Finally Chapter 9 closes with some Conclusions and Final Thoughts.
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Overview of Patents
The invention all admired,
and each, how he
To be the inventor missed,
so easy it seemed
Once found, which yet unfound
most would have
thought impossible.
John Milton
Paradise Lost
“Genius is one percent inspiration and
ninety-nine percent perspiration.”
Thomas A. Edison
ORIGINS OF U.S. PATENTS
Patents have been around longer than you may think. Article I, Section 8 of the U.S. constitution provides that
“Congress shall have the 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.”
As an interesting historical tidbit, President George Washington signed the first patent bill in 1790 which laid the foundations of the modern American patent system. The U.S. patent system was unique; for the first time in history the right of an inventor to profit from his invention was recognized by law. Previously, privileges granted to an inventor were dependent upon the prerogative of a monarch or upon a special act of a legislature.
In that same year, one Samuel Hopkins of Pittsford, Vermont, was granted the first U.S. patent on an improved method of making potash. The reviewer of this patent was none other than Thomas Jefferson, the then Secretary of State. Jefferson granted the patent after obtaining signatures from the Attorney General and from President Washington. Well, enough history.
IS A PATENT A LEGAL MONOPOLY?
Classically, a patent is often described as a legal monopoly. We will find later that this description of a patent is not so accurate. Technically, a patent is a governmental grant that provides the holder for a limited period of time the exclusive right to prevent others from making, using or selling the patented product or process in exchange for his disclosure of the invention to the public. The careful reader will note we did not say the patent granted the owner the right to make, use or sell the invention. That basic distinction is a hard one to understand and will be discussed further. Patents are also intended to benefit the public, as they encourage less secrecy, so that important information is not lost when its owner dies, and to provide a means to encourage capital formation and investment in new ideas resulting in new industries, jobs, etc.
EDISON PATENT FOR THE ELECTRIC LIGHT BULB
Probably the most famous invention of all is the Edison patent for the electric light bulb shown on the following page, along with a standard front cover of a U.S. patent. Not only has the invention lasted for well over a hundred years, but the electric light bulb has become the icon for invention itself! Edison was a prolific inventor and during his lifetime he amassed a record 1093 patents: 389 for electric light and power, 195 for the phonograph, 150 for the telegraph, 141 for batteries and 34 for the telephone.
You will notice the Edison patent is fairly short, consisting of only a few pages and only four claims. These days, patents tend to be longer, some running to hundreds of pages and often including hundreds of claims, but brevity, as in some other forms of human communication, can often be wiser, and in any case less expensive, as patent lawyers are usually paid by the hour.
WHAT IS A PRODUCT OR PROCESS?
So
