Generic Challenge:. Martin a. Voet

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