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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 now we know a patent is a time-limited right to exclude others from making, using or selling a product or process. So what is a “product” or “process”? The U.S. Supreme Court has broadly interpreted it as “anything under the sun made by man” when they agreed that the first man-made bacteria engineered to eat oil could be patented. More specifically, a “product” can be a medical device such as an artificial heart or a composition of matter, such as a new chemical compound or biologic agent, such as a vaccine, or formulation for a drug product or anything manufactured including a mouse genetically engineered to get cancer. A typical pharmaceutical product would consist of a patented chemical, known as a new chemical entity (NCE) and a patentable new formulation, such as an oral or topical dosage form, for delivery of the new chemical entity to the body.
1. Cover page of a U.S. Patent
2. Edison’s Electric Light patent
A “process” as applied to pharmaceutical products is a method of treatment of persons or materials to produce a given result. Included in patentable processes are methods of manufacturing a new chemical entity or a new method of manufacturing a known compound. A process is also a method of treating a condition or disease with either a new drug (first medical use) or an old drug that was previously known for treating a different condition or disease (second medical use).
A PATENT IS A SWORD, NOT A SHIELD!
The next sentence is the most important thing to know about patents. A patent is a sword, not a shield! That is, a patent is primarily an offensive weapon that allows its owner, by enforcement of the patent, to prevent others from making the patented item or using or selling the patented method during the life of the patent. However, the patent has little or no defensive character and thus it cannot protect you from being sued for infringement under someone else’s patent. Most people find this concept the most difficult one to understand. If I have a patent on my gizmo, how can I be sued for patent infringement? The answer is simple. A patent is a sword, not a shield. As mentioned earlier, a patent does not grant its owner the right to do anything. Instead, it grants the owner the right to prevent others from doing something.
The following example may help explain this counter-intuitive concept. If I owned the patent for the first carburetor, which I designed to have two barrels, and later you improved my carburetor and obtained a patent on the first 4-barrel carburetor, what happens? I can keep your 4-barrel carburetor off the market with my general patent covering carburetors, but you can prevent me from selling your 4-barrel version of my carburetor with your patent. So if we both want to sell 4-barrel carburetors, we must cross-license our patents to each other or neither of us can make or sell them. My broad carburetor patent does not shield me from your 4-barrel carburetor improvement patent and your improvement patent does not give you any rights to make or sell your improvement.
Note that this dynamic system encourages others to make improvements of your invention so they can potentially negotiate entrance into the market. This technique of patenting improvements is practiced to the point of frustration in Japan where obtaining a patent can take 5–10 years and by the time the originator has patented the basic concept, there may be 20 patents in the hands of others covering a myriad of minor improvements. As a result, the patented article is difficult to make without running into one of the improvement patents thus forcing a cross-license.
BASIC TERM OF A PATENT
In the U.S., patents used to have a term of 17 years from the date the patent was granted. This was set in stone. There were some exceptions, such as a shorter term where Patent Office rules require a patent owner to voluntarily agree to shorten his patent life in order to obtain the patent, but in general the rule was 17 years from date of grant. That was fair because if your patent application were held up in the Patent Office by government red tape, you would still get your 17 years once it was finally granted.
The rest of the world, on the other hand, gives 20 years from the date of filing the patent. This can allow quite a bit of mischief since it may take years to get the patent granted and any time lost is just hard luck for the patent owner. And competitors are happy to assist in any delays at the Patent Office through oppositions and other such procedures that allow competitors to challenge the grant of a patent. As a result it typically takes five to ten years to get a patent fully and finally granted in Europe and Japan, compared to only one to three years in the U.S.
However, that has also recently changed, as the U.S. now also provides for oppositions after grant called Post Grant Review (PGR), where competitors can challenge the validity of your patent within nine months after grant in the Patent Office, on patent applications filed on or after March 16, 2013, as discussed later in this chapter.
HARMONIZATION
Then along came harmonization, a catchy word, but one that can lead to trouble. In the interests of harmonization, the U.S. agreed to match the other countries’ rules so, effective June 8, 1995, any patents filed on or after that date had a life of 20 years from date of filing. Patents filed before that date got the longer of the two ways to compute their life (if only we all had that choice).
There was one catch and that was that the filing date the term of the patent was based on was the earliest effective filing date for the patent. This is because patent holders in the U.S. can file follow-on patent applications based entirely (continuations) or in part (continuations-in-part) on the former patent application and get the benefit of the date of filing of the first-filed patent application for all common subject matter. If you file a string of patent applications as continuation (CON) applications or continuations-in-part (CIP) applications, the patent life for the last patent in the string is based on the filing date of the first patent application.
Typically, a patent attorney will use a continuation application to try to get claims granted in a follow-on patent application when time for prosecution before the Patent Office has run out on the originally filed application or when only some of the claims he or she wanted were granted in the originally filed application (thus a second bite at the apple). A continuation-in-part application is typically used to add something to an already existing application, such as a new preferred formulation or some additional examples of compounds that were not disclosed in the original application.
Also in the interests of harmonization, the U.S. joined the international community in publishing patent applications 18 months after they are filed, unless you ask not to be published and agree not to file the patent outside the U.S. If you recall the beginning of the chapter where the granting of a patent was a reward for disclosure of the invention, there seems something basically wrong with forcing the disclosure of the invention without first granting the patent! But that is now the law and the only way to get around it is to agree not to file abroad.
SUBMARINE PATENTS
These new rules also solved a problem that had been invented by a man named Lemelson. Lemelson filed numerous patent applications in the 1950s on a variety of forward-thinking concepts and then he did an unusual thing. Instead of being in a hurry to get his patents granted, he took his time and re-filed the applications as continuation applications and kept adding subtle refinements to the claims and kept doing so for 40 years until, in the early 1990s when he finally allowed his patents to be granted, they covered important modern inventions. Since his patents were based on the old rules, he got a 17-year life from the date of grant.
After his patents were granted, he asked just about every company in the U.S. for royalties and got them after suing many. He collected over a billion dollars in royalties. His inventions ranged from Hot Wheels track to bar coding (the black and white bars and numbers on just about every box of something sold today), and his patents covered something that just about every commercial enterprise did. He may have had more patents than Edison, but unlike Edison, he never actually made or perfected any of these inventions himself.
This kind of patent jokingly became known as a “submarine” patent because it stayed hidden under the surface for a long time and then arose and blasted you out of the water when you least expected it. That was because at the time, patent applications were kept secret in the U.S. until they were granted and Lemelson never filed his patents outside the U.S. where they would be published. By making the date of a patent based on its earliest effective filing date instead of its grant date, and by publishing pending patent applications, it essentially ended new submarine patents starting June 8, 1995.
And while the courts of justice grind slow, they grind fine. In Symbol Technology v. Lemelson (Fed. Cir. 2005), the Court of Appeals for the Federal Circuit, which handles all patent appeals from the Federal District Courts, ruled that Lemelson’s patents were unenforceable because of the way he got them, namely by intentional delay or as the courts have been calling it “late claiming”. This undoubtedly caused his successors to suffer some heartburn at their Aspen ski lodges, but presumably not Mr. Lemelson, as he is likely too busy filing further continuing applications in the heavenly Patent Office.
So to recap, in the U.S., a patent having a filing date on or after June 8, 1995 has a term of 20 years from its earliest effective filing date. Patents filed before June 8, 1995 have a term which is the longer of 20 years from its earliest effective filing date or 17 years from its date of issue. In the rest of the world, patents typically last 20 years from their filing dates. In Japan, patents are also granted for 20 years from their filing dates, but not longer than 15 years from their grant date.
PATENT TERM ADJUSTMENTS AND EXTENSIONS
There are also complicated Patent Office rules which provide for patent term adjustments which add additional patent life to compensate for certain Patent Office delays. For example, if there were excessive delays in prosecution caused by the Patent Office, or if you successfully appealed an Examiner’s adverse ruling, the time taken for appeal will be added to your patent’s life. As a result, just about every patent has a different life from every other one and you can buy software to help you make sure the Patent Office calculated your patent term correctly.
A pharmaceutical patent can also have a longer term based on a patent term extension, which may be granted based on national laws which provide additional patent life to make up for some of the time lost on a patent during drug registration. Typical patent term extensions are for up to five years in the U.S. (called “Patent Term Restorations” in 35 USC 156) and other similar patent term extensions are available in major countries such as Europe, Australia and Japan. Canada is an exception and allows no additional patent term. Recall Canada strongly favors generics over innovative pharmaceuticals, so it is being consistent in not encouraging pharmaceutical research by refusing to provide extended terms for pharmaceutical patents.
Patent term extensions do not necessarily extend the patent term for all of the claims of a patent. Instead, the patent term is extended only for claims covering the approved drug product. Thus a patent term extension will not keep competitors from filing for similar drugs to the innovator’s drug after the original term of a patent, but it will help protect the approved drug product from becoming a generic drug.
An unanswered question is whether a completely different approved use for the same product would be covered during the patent term extension. The courts have not ruled definitively on this issue, but with the current trend of re-purposing older approved drugs for new uses, it is likely to come up soon.
The FDA takes the position that any subsequently approved drug containing the same “active moiety” as the approved drug product is also entitled to the same patent term extension and indicates this in an online listing for all approved drug products called the Orange Book. (“Active moiety” refers to the portion of the drug molecule that is biologically active. Different salts, esters and hydrates of the same active drug contain the same active moiety.)
Patent term extensions in the U.S. are allowed only for patents that cover the first approval of a drug product and must be filed in the U.S. within 60 days of the date that the drug product was approved. If you miss that date by even one day, only a private Act of Congress can help. In addition only one patent may be extended for an approved drug product and remaining patent life including extension cannot exceed 14 years. Details for obtaining such extensions may be found in the statute—just Google “35 USC 156”. There is one exception for veterinary drugs. A patent for a new veterinary drug product may be extended even if the same drug was previously approved for human use.
In two recent cases, Photocure v. Kappos and Ortho-McNeil v. Lupin (Fed. Cir. 2010), the Court expanded the scope of patent term extensions by confirming eligibility for patent term extensions for new patents covering new approved products consisting of isomers or esters of drug compounds which had been previously approved.
In Europe, there are similar rules for obtaining patent term extensions (called “Supplementary Protection Certificates”), but in addition, under recent European Court cases, one can obtain patent term extensions for patents covering a new use of an old drug or covering new combinations of old drugs. Those two important additional types of extensions are not available under U.S. law.
HOW ARE PATENTS OBTAINED?
First-to-invent v. First-to-file
Patents are typically filed first in one’s home country. In the U.S., the first to invent used to be entitled to the patent. Outside the U.S. the first to file is awarded the patent. Effective March 16, 2013 in accordance with the America Invents Act (AIA), the U.S. joined the rest of the world and now awards patents to the first to file.
Previously, if there was a dispute between inventors in the U.S., it was resolved in a proceeding called an “interference” in which each party tried to establish it invented first. Interferences occurred in very few cases and were fought in the U.S. Patent and Trademark Office (PTO) in a formal procedure which was expensive, time consuming and contentious. They also could be settled using a private arbitrator if both parties agreed to do so, often with the understanding that the winner, whoever it turned out to be, licensed the loser. Outside the U.S. there is no need for such a procedure since the first to file is entitled to the patent, unless the second to file can prove the first to file had stolen the invention from him.
The new U.S. rule on first to file thus puts the emphasis on prompt filing in the U.S. While the one year so-called “grace period” still remains, it is now personal to the inventor and generally does not cover third party disclosures of the invention made prior to the date of filing.
One of the urban legends about patents is that the way for an inventor to prove his date of invention is to mail to himself a sealed envelope containing his invention disclosure to get a postmark establishing his date of invention. Some inventors tend to be secretive and even a little paranoid (in a good way) so they like this idea. The only problem is that such a procedure cannot legally establish a date of invention. This is because the patent laws provide that a date of invention can only be established if a third party, who is not an inventor, corroborates the date of the invention in writing.
Today one does not even have to establish a date of invention as the first to file is awarded the patent regardless who invented first. But if you want to establish a date of invention, prepare a written disclosure of it and have a non-inventor read it and sign and date it. That establishes the legally required corroboration.
Provisional Applications
The current trend in filing patents in the U.S. is to first file a provisional application because the governmental filing fees are low and it is not necessary to provide claims or other formalities. To perfect the provisional application, you must file a complete application within a year of the filing date of the provisional and you get the benefit of the earlier filing date of the provisional. You can file anything as a provisional application, such as a scientific paper, and use it as the basis of a patent application within the year provided. The only catch is that the provisional must provide the proper legal disclosure for a patentable invention in order to get the benefit of its filing date when you file the complete application later.
If you don’t file the complete patent application within the year, the provisional dies in secret and has no further use. A bonus for filing the provisional application is that it does not count towards the life of the patent, so you really get 21 years from the filing date of a provisional patent application if you perfect it with a regular patent application filing within one year.
Foreign Filings
Currently the U.S. Patent Office publishes only regular applications within about 18 months of the first filing. Foreign patent applications are typically filed in foreign countries within 12 months of the date of the first provisional or regular filing if there was no provisional. This is based on an international treaty (Paris Convention) that most countries belong to which provides that the first filing date of a patent becomes its effective filing date in all other countries, so long as it is filed in those other countries within one year of its first filing anywhere.
3. First page of a European Patent
4. Front page of a PCT Application
In order to file outside the U.S., you must first obtain a license to do so from the U.S. Patent Office. Licenses are automatically granted after filing a patent application, unless your patent happens to relate to national security, atomic bombs, and the like. In the unlikely event you do not get the automatic license, it would not be wise to file abroad until you’ve seen your patent lawyer, since your U.S. patent could be invalidated and you will likely have violated data security laws. If you do file abroad by mistake without a license, you can request a retroactive license if the subject matter is not of the kind to raise an issue and without having the FBI call for a chat.
Patent Cooperation Treaty (PCT)
There is also another treaty, the Patent Cooperation Treaty or “PCT”, which allows a single place holder application to be filed within one year of the earliest filing date of a patent application or provisional application, which effectively preserves the right to file in most countries in the world within 30 or 31 months after the earliest filing date. This gives you more time to evaluate the invention without loss of any rights before having to file it abroad at significant expense. Filing a PCT also entitles you to receive an international search report on patentability which is useful in deciding whether to incur the expense of national filings abroad.
The rules are very unforgiving. If the 12-month PCT date is missed by even one day, the right to the earlier filing date may be lost forever, though some countries including the EU provide for a short grace period for inadvertent mistakes. If it is lost and if there was an intervening publication, even your own publication, disclosing your invention between your U.S. filing date and your late foreign filing date, your foreign patent may not be valid.
A typical PCT application is relatively inexpensive to file as foreign patent costs go (typically under $5,000) and it reserves your rights in most major countries worldwide. Remember that within about six months after filing a typical PCT it is published for all to see. If you want to keep your invention a secret until it is patented, don’t file it abroad and don’t file a PCT.
Costs of Filing
Filing, obtaining and maintaining patents is not cheap. In addition to lawyer fees for preparation and prosecution before the Patent Office, there are governmental filing fees, examination fees, grant fees and periodic maintenance fees over the life of a patent. Current costs for obtaining a U.S. pharmaceutical patent including legal fees and government charges average about $25,000: $7,500 to $15,000 for preparation and filing, the same for prosecution and grant, plus maintenance fees due at the 4th, 8th and 12th year anniversaries of the patent totalling another $13,000 or less if one qualifies for discounts under Patent Office rules as a “small” or “micro” entity.
In the U.S., “Small Entities” (individual inventors or companies with less than 500 employees and Universities), and “Micro Entities” (individuals with a certain gross income limit who have filed fewer than 4 patent applications or persons associated with an institute of higher education) also get a break on U.S. Patent Office fees, and are generally charged 50% and 25% respectively of the fees charged to “Large Entities”. The catch is that if and when a small or micro entity becomes a large entity e.g., by licensing the patent to a large entity, normal fees are due from that time forward. This can be a trap for the unwary as fee mistakes can invalidate a patent. In non-English speaking foreign countries the costs are generally higher due to translation costs and higher government application and issue fees and annual maintenance fees over the life of the patent.
An agreement between member states of the European Patent Organization (EPO) called the London Agreement went into effect May 1, 2008 for patents granted in Europe on or after that date. That Agreement provides that you only have to translate the claims of an EPO filed patent into the language of the European country in which it is granted, rather than translate the whole patent document (except for Spain and Italy). This has brought about a significant reduction in the cost of obtaining patents in Europe by substantially reducing translation costs which typically accounted for as much as 80% of the cost of issuing a patent in non-English speaking countries in Europe.
In 2012, the European Council came to an agreement on the European Union’s proposed “unitary patent system” which would provide a single patent filed in either French, German or English, covering all EU member states (except Spain and Italy who were pouting about their language being left out) and a single European patent court with branches located in Paris, London and Munich, having exclusive jurisdiction of infringement and revocation proceedings. No translations would be required. Following ratification by at least 13 member states including France, Germany and the UK, the unitary patent system was expected to come into force in 2017. To date it has been ratified by eight countries including France, with Germany and the UK indicating their ratifications will soon follow, though that might now be in doubt in view of the UK’s probable exit from the EU.
Currently one has to sue infringers in each EU country under each national patent with the potential for different results in different countries under differing national laws, not to mention the time, expense and uncertainty of multiple litigations. When implemented, this new system should greatly simplify obtaining, enforcing and defending patent rights in Europe.
PATENT CONTENTS
A patent consists of a multi-page printed document which gives the basic information about itself on the cover page followed by the specification and ending with the claims. The cover page also provides a summary of the invention, but it is written when the patent is filed and it is rarely changed. Since it is a summary of the application when filed rather than a summary of the patent when granted, it is rarely an accurate summary of the granted patent.
Specification
The specification or body of the patent describes the invention and how it is to be used. It typically starts with a description of the field of the invention and describes what was known in the field before the invention was made, the so-called “prior art”. It then describes the invention generally and then again in detail and offers examples of how it works. If it is a patent on a new chemical entity (NCE), it will 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, both structurally and functionally, from that which existed in the natural genome, so that the isolated DNA was no longer a natural product. This decision was expected in light of similar rulings in Europe and Australia and the fact that the U.S. Patent Office had granted thousands of such patents in the past.
But in Association for Molecular Pathology v. Myriad Genetics (Supreme Court 2013), the Supreme Court again reversed and held in a unanimous decision that a naturally occurring DNA segment, i.e., a gene, is a product of nature and therefore not new and therefore not patent eligible merely because it has been isolated and while Myriad discovered the location of the BRCA genes, that discovery, by itself, does not render those genes “new” and therefore patent eligible.
However, the Court also ruled that synthetic or complimentary DNA (so-called “cDNA” which is DNA with non-coding segments removed) is patent eligible because it is made in a laboratory and is not naturally occurring. Complementary DNA is commercially valuable because it is generally used to genetically engineer cells. The Court also carefully noted this case did not address the patentability of method claims or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
This Supreme Court ruling will likely have significant effects on the patentability of other “naturally occurring” chemicals, such as hormones, antibodies and other biological molecules first discovered and isolated from humans, plants or animals. Note that isolated natural DNA, as well as naturally occurring compounds isolated from nature, remain patentable in Europe and Australia and elsewhere outside the U.S. under their respective national laws.
In 2014, following the Myriad case, the Federal Circuit ruled that Dolly the sheep, the first successfully cloned mammal from an adult somatic cell, was not patent eligible under section 101, ruling that Dolly’s genetic identity to her donor parent rendered her un-patentable. Also in 2014, the U.S. Patent Office issued a Guidance on factors to determine whether an invention satisfies the Supreme Court’s interpretation of what is “new”.
Inherency
Also not patentable are inventions that are inherent e.g., the discovery of the actual mechanism of action of a drug for treatment of a given cancer, when it was previously known to use the drug to treat the same cancer. The mechanism of action was inherent in the previous use of the drug and is therefore not separately patentable, even though it was never known before. However, knowledge of such a mechanism could be used to discover a new compound to treat the same disease or a new use for the same cancer drug (e.g., for a new type of cancer or another disease) and that would not be inherent and so could be patentable. In short, discovering why something works may be good science, but it may not be patentable. A good example of this concerns the world’s first synthetic drug.
Story of Aspirin
The glycoside salicin, the bitter principle in willow leaves and bark, had been used for thousands of years as a folk remedy for treatment of pain, inflammation and fever. In the body, salicin is metabolized into salicylic acid, which was effective, but was hard on the stomach. This much was known on August 10, 1897 when Felix Hoffmann, a chemist at a German dyestuffs company called Bayer, added an acetyl chemical group to the salicylic acid molecule and came up with acetyl salicylic acid or aspirin. Arguably, this was the beginning of the modern drug era. Hoffmann got a patent for aspirin too, U.S. Patent No. 644,077 granted in 1900.
7. Patent for Aspirin
In more recent times, my friend the late Sir John Vane, the British pharmacologist, was awarded the Nobel Prize in Medicine in 1982 and a British Knighthood for discovering the precise mechanism of action of why aspirin worked, through inhibition of certain enzymes that produced inflammatory compounds called prostaglandins. While the discovery was brilliant, it would not have been patentable as being inherent. A discovery or invention may also not be patentable because it doesn’t meet the basic requirements for patentability.
BASIC REQUIREMENTS FOR PATENTABILITY
The rules are deceptively simple. Apart from the requirements for a proper written disclosure of the invention (a written description and an enabling disclosure), an invention must be:
new
useful
novel
non-obvious
invented by the applicant for the patent
New
The requirement for “new” relates to what is considered patentable subject matter, which was discussed immediately above.
Useful
Just about any alleged use for an invention is sufficient to meet the legal obligation for an invention being useful, though it must have a “substantial utility” and provide a specific benefit in currently available form (Brenner v. Manson (Supreme Court 1966)). A pharmaceutical patent will typically allege a number of possible medical uses for the invention and the patent is valid even if only a single use is ultimately found to be practical. In biotech, portions of genes involving simple sequences of amino acids known as “expressed sequence tags” (ESTs) useful only for research have been rejected as not having met the legal requirement for being useful (In re Fisher (Fed. Cir. 2005)).
Some promising drug candidates have the opposite problem; too many uses or as I call it, “a drug in search of a disease”. While they seem to have great potential for use as a drug for a variety of medical indications, they rarely become commercially useful for the reason that they are too non-specific and have too many side effects. As a colleague of mine once said, it is hard to come up with a melody when you play all the keys of the piano at the same time. However, the usefulness required by the patent laws does not mean commercially useful or even FDA approvable, so that is not an issue for patenting such a compound.
Novel
For U.S. patents filed before March 16, 2013, the requirement for “novelty” means that no one patented or published the exact same invention anywhere in the world or used it or sold it or offered it for sale in the U.S. or had public knowledge of it more than a year before the invention was made.
For U.S. patent applications filed on or after March 16, 2013, the one year grace period only applies to disclosures by the inventor or by others who derived their information from the inventor and foreign use and sale are also bars to patentability.
Outside the U.S., there is generally no so-called “grace period” of one year, though there are limited exceptions. Therefore public disclosure of an invention by anyone including the inventor before filing a patent will generally act to invalidate the patent outside the U.S. Private disclosure without a secrecy agreement or non-disclosure agreement could also have the same result.
The publication date of an article is considered to be the date it became available to the public and not the date it was submitted for publication. Any public presentation, for example, at a scientific meeting, that discloses an invention acts as a bar to a patent on that invention outside of the U.S. if the patent has not been filed before the disclosure. However, the one year grace period could allow the patent to be obtained in the U.S. if a patent application was filed within a year of the disclosure by the inventor on applications filed on or after March 16, 2013.
Experimental Use Exception
An exception to this general rule on novelty is if the invention was being tested before completion (the so-called “experimental use” exception), but reliance on that exception could result in loss of patent rights if it is determined the invention was already perfected and was therefore a “public use”.
In the pharma field, clinical trials have been held not to be a public use where the inventors did not know if their formulations would work for their intended purpose until after the clinical trial (In re Omiprazole Patent Litigation (Fed. Cir. 2008)). More recently, in Dey v. Sunovion (Fed. Cir. 2013), the Federal Circuit likewise held a clinical trial was not a public use due to confidentiality with the clinical trial administrator and the fact the subjects were given only a general description of the treatment formulations.
However, in Pronova v. Teva (Fed. Cir. 2013), the Federal Circuit held a patent invalid as a public use where a shipment of the drug product that was claimed in the subject patent was sent to a skilled outside researcher for testing to confirm its content without any restrictions, and the product’s formulation was disclosed in detail to the researcher, and that the confirmatory testing was performed by the researcher, even though he did not test it for its indicated use to reduce triglyceride levels.
Does the America Invents Act affect the foregoing? Effective March 16, 2013, clinical trials conducted outside the U.S. which do not meet the experimental use exception could be used to invalidate the patent if the clinical trial was found to be “available to the public”. As a result, the safest thing for an inventor to do is to file at least a provisional application in the U.S. before conducting any clinical trials to avoid making any inadvertent public disclosures of the invention.
Non-Obvious
This is almost always the main question concerning patentability. Typically, an invention is new, useful and novel or no one would bother filing a patent on it. The law says non-obviousness must be viewed from the perspective of one of ordinary skill in the subject matter to which the invention pertains, with knowledge of all prior public uses and publications relating to such subject matter, taken as a whole. The law of non-obviousness fills whole libraries so thankfully this book is not intended to go into it in any detail. However, that is what patent attorneys spend most of their time and your money on: trying to convince patent examiners that the invention in front of them is not obvious, or in front of judges and juries trying to convince them that it is.
In order to be rejected in the U.S. Patent Office on the grounds of non-obviousness (known in the trade as a “103 rejection” after the code section, 35 USC 103, which defines non-obviousness), an Examiner may combine any number of prior publications that relate to your invention and reject your claims as being obvious in light of the combination. This is in contrast to a rejection for lack of novelty that requires that the disclosure of the invention in the prior publication be contained within a single document.
For example if you were claiming the first metal tennis racquet, the Examiner could reject you by combining one reference showing a conventional wooden racquet with a second reference showing that it was known to replace wood with metal in other sports equipment, such as skis. That would establish what the Patent Office would call a “prima facie” case of obviousness or obvious on its face. In order to overcome this rejection, the inventor would have to submit further argument as to why it would not be obvious to substitute metal for wood in a tennis racquet or that by doing so, one obtained certain unexpected results such as superior accuracy or faster ball speed off the racquet or whatever.
A finding of unexpected results typically overcomes the prima facie case of obviousness. That is why patent lawyers are always looking for unexpected results as it is often the key to obtaining a patent. (A friend of mine, a pilot, once told me that actors were always looking for inspiration and pilots were always looking for a place to land. I asked what about lawyers? He said lawyers were always looking for a situation in which a great deal of money was about to change hands!)
In 2007, the Supreme Court handed down its first new decision on obviousness in 40 years. The new case, KSR v. Teleflex concerned the validity of a patent covering a variable-height gas pedal. In holding the patent invalid, the Supreme Court made clear that “the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. In other words, if common sense tells you something is obvious, and there are no unexpected results, then it is probably not patentable.
The KSR case overturned an important line of cases which the Court of Appeals for the Federal Circuit (CAFC or Federal Circuit) had long advocated as the standard for determining obviousness, the so-called “teaching-suggestion-motivation” (“TSM”) test. The TSM test requires evidence of some teaching or suggestion or other motivation to combine prior art references to show obviousness, since otherwise any invention could be considered obvious by hindsight if all you had to do was find the parts of the invention in separate documents and simply say it would have been obvious to combine them to make the invention.
The KSR case concerned the patentability of a variable-height gas pedal that substituted an electronic means for controlling speed for a conventional mechanical cable. In restating the law of obviousness, the Supreme Court did not say that the TSM test was necessarily always a bad test, (though Mr. Justice Scalia said in oral argument that he thought the test was “gobbledygook”), the Court concluded it was too rigid a test and it was certainly not the only test that should be applied, and although there had to be some reason articulated to combine references, that reason might even be just plain old common sense.
In fact the Supreme Court suggested in KSR that one of the reasons for combining references could even be “obvious to try”. However, an “obvious to try” standard essentially substitutes hindsight for a more intellectually rigorous analysis to determine whether an invention would have been obvious to an ordinarily skilled artisan at the time the invention was made, a bit like Monday-morning quarterbacking. Since KSR, the Federal Circuit and the lower courts have been working out the modified standard for obviousness.
