While there are some basic characteristics common to all patents, the drug industry is such that drug patents, also known as pharmaceutical patents, are a unique subset of patents all their own. Patents are particularly important in the pharmaceutical industry because of the heavy research and development costs associated with bringing drugs to the market. If a pharmaceutical company were to risk having their innovations reverse engineered, copied, and sold at a discount every time they brought a drug to market, there would be no incentive to make those up front investments in research and development in the first place. As a result, the patent system is viewed by many to be integral to the development of the pharmaceuticals we use on a daily basis, as well as for the advancement of medicine as a whole.

Pharmaceutical patents, like other utility patents, must meet the basic requirements for patentability, including patentable subject matter, novelty, utility, nonobviousness, etc. Drug patents can be obtained on the actual drug itself, as well as on medical procedures that include the use of certain drugs in certain quantities, and in tandem with other medical procedures. While medical procedures are patentable, the medical procedure exception allows a medical practitioner to perform a medical activity without actually infringing on the patent. Courses of treatment are also potentially patentable, though the Supreme Court’s recent decision in Mayo v. Prometheus, where the court found that patent claims on a method of determining the proper dosage of a particular drug was not patentable. Following this decision, it is unclear to what extent such patents will be enforceable, though it may very well be the case that the USPTO will grant such patents in the first instance.

The expiration of pharmaceutical patents is a major component of the drug industry, as that expiration makes way for the creation of generic drugs. Generic drugs can be legally produced only when the patent has expired, when the generic drug maker certifies the brand company’s patents are either invalid, unenforceable or will not be infringed, or where the drugs are produced and sold in countries where a patent is not in force. Generic drug makers will often file what is referred to as an Abbreviated New Drug Application (ANDA), which contains data to be submitted to the FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, for generic drug approval. Rather than including preclinical (animal) and clinical (human) data to establish safety and effectiveness, the entity filing the ANDA need only show that the generic drug is “bioequivalent,” thereby substantially lowering the costs associated with the production and sale of generic drugs. Of course, as long as the original innovator’s rights have not yet been extinguished, the patent holder can prevent the generic drug maker from producing the generic drug, and as a result premature ANDA filings often give rise to ANDA litigation.