describe exactly how to make it and what the chemical and physical characteristics of the new compounds are. If it is about a new medical use, it will describe dosage forms, suitable formulations and concentrations of drug to be used and the disease or condition to be treated.
Claims Define the Scope of the Invention
At the end of the patent document are numbered paragraphs known as “claims”. Claims are the heart and soul of a patent and define the rights granted to the patent holder as a deed to a piece of real property defines the property lines of the property. Litigation concerning a patent always focuses on the claims and each and every word in them. Skilled patent litigators often refer to infringers as trespassers on the property of the patent owner. So to understand a patent, you must first understand the claims.
The claims of a patent define the scope of the invention. Much time and attention is given to claims and that is what 95% of patent prosecution is about. When you submit the patent application, an Examiner reads it and must make a decision on whether to allow the claims you have presented to become part of a granted patent. Claims tend to be long-winded because the regulations require each claim to consist of a single sentence.
The broadest patents have the shortest claims. That is because the more you say about something, the more specific you become, which narrows the claim. The broadest claim is one that requires the least said about it. With claims, as with certain other matters in the field of human endeavour, the less said the better.
For example the shortest and therefore broadest claim I am aware of is in U.S. Patent No. 3,156,523 for an element, Americium, discovered by Glenn T. Seaborg and colleagues at the University of California at Berkeley (a little plug here for my alma mater). Claim 1 reads “Element 95”. You might think an element could not be patented, but recall the transuranium elements are not naturally occurring, so element 95 is man-made and thus patentable. Now that is a broad claim. Seaborg also discovered elements 94–102 and 106 including plutonium (94) and was awarded the Nobel Prize for Chemistry in 1951. His name will live on forever as he also got possibly the longest lasting award one can think of: element 106 was officially named Seaborgium in 1994.
The goal of a typical patent attorney is to cover the invention with as broad a claim as possible, usually claim 1. After claim 1, a number of more detailed claims typically follow, i.e., narrower claims until the last claim that is generally the narrowest. There is no law requiring this order, so occasionally a broader claim may come later in the series.
For pharmaceutical patents covering commercial drug products, it is a good idea to have some narrow claims in your patent which cover the commercial drug formulation more or less exactly. While such narrow claims would be relatively easy to design around, it can be the best way to protect a commercial drug against a generic copier who simply copies the commercial formula.
5. First page of U.S. Patent No. 3,156,523
6. Last page with claims of U.S. Patent No. 3,156,523
There are generally two types of claims. One is called independent and the other is called dependent. The independent claim stands on its own, while the dependent one refers to another claim. The dependent claim is a shorthand way of claiming a new feature of the invention without reciting all the old features again. For example claim 1 below is an independent claim followed by claim 2, a dependent claim:
1 A method for treating spasticity comprising administering to a spastic patient an effective amount of a botulinum toxin.
2 The method of claim 1 wherein the botulinum toxin is botulinum toxin type A.
There are other forms of claims with names and much more could be said about them, but the take home on claims is that claims define the scope of the invention and that is what a patent covers, no more and no less. When someone asks what does the patent cover, you must read the claims to find out.
WHAT IS NOT PATENTABLE?
Laws of Nature
Abstract ideas, physical phenomena and laws of nature are not patentable, as well as mathematical expressions and purely mental steps such as algorithms and computer programs, except when patented in combination with hardware. Recently, the courts have allowed so-called “business method” patents, such as the one-click ordering of merchandise on the internet, which previously were denied as being purely mental steps. Cloning methods are patentable, but not cloned human beings, though genetically engineered bacteria and mice, among other living things, have been patented.
The famous Harvard “onco-mouse”, altered to develop cancer, was the first patented transgenic mammal, patented in the U.S. in 1988 under U.S. Patent No. 4,736,866, but it still bothers some people that “life” can be patented. In 2004, the European Patent Office finally upheld the corresponding European patent, which initially had been approved in 1992, against objections by church, environmental and animal protection groups, including Greenpeace, who had argued for cancellation on the grounds that it violated the dignity of living beings.
The U.S. Supreme Court weighed in on the issue of what is patentable in 2010 in the case of Bilski v. Kappos by ruling a method of hedging risk in the energy market was not patentable as an attempt to patent an abstract idea.
In 2012, the Supreme Court also unanimously decided the important Mayo v. Prometheus pharmaceutical case. The Prometheus invention related to a method of optimizing therapeutic efficacy for treatment of a medical disorder by identifying relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a certain drug (thiopurine) would prove either ineffective or cause harm. Claim 1 for example stated that if blood levels of a certain metabolite exceeded a certain level after a specified dose of that drug, then such dose would produce toxic side effects.
The Court found that the claimed relationship was a consequence of the way in which thiopurine compounds are metabolized by the body, which is an entirely natural process. And so a patent that simply describes that relation sets forth a natural law and is therefore not patentable. The conclusion here is that a newly discovered law of nature is not patentable and the application of that newly discovered law is also not patentable if the application merely relies upon known elements.
Natural Substances
What about newly discovered naturally occurring compounds in plants, frog skins, ocean sponges or the human body itself? Until recently, the answer was that an otherwise novel, naturally occurring compound was patentable if the discovery was in identifying and separating it in practical quantities if that had not been done before. I previously called that the “compound-in-a-bottle” test. If a naturally occurring compound or protein in the body did not previously exist in practical quantities in a bottle, you could probably patent it in the U.S.
However, in 2013, the U.S. Supreme Court finally took up the question of whether isolated natural human genes were “new”, as required by the patent laws (35 USC 101). As background, a company called Myriad had discovered the precise location and sequence of two naturally occurring genes (BRCA1 and BRCA2). Myriad used these newly discovered natural genes to devise an expensive cancer diagnostic test to detect mutations in those genes which are responsible for many hereditary breast and ovarian cancers.
The District Court held that Myriad’s gene claims were invalid because they covered products of nature and were therefore not “new” and therefore not patentable. The Federal Circuit reversed and held both isolated DNA and synthetic DNA were “new” and therefore patent eligible because the act of isolation created a new product sufficiently different,
