The field of life science patents is an important, emerging area that involves many small and startup companies. Moreover, patents in this area have unique attributes, hence this dedicated section.
A. Definition of a Life Science Patent
Patents claiming subject matter that includes drugs, biological research assay tools, medical devices, agricultural products, biofuels, food, and cosmetics are sometimes described collectively as “life science patents.”
B. Value of a Life Science Patent
Patents are the lifeblood of any innovative life science company. Patents and their licensing play critical roles for organizations as diverse as pharmaceutical companies, medical device companies, and manufacturers of instruments and reagents. Increasingly, universities conducting life science research are using these patents to generate income.
However, patents do not serve the same purpose for all organization.
• Life science startups and smaller companies generally need to raise capital to fund their R&D efforts long before a product is ready for sale. An intellectual property portfolio likely will be necessary to attract investors who want to see some evidence of significant future earnings potential.
• On the other side of the equation, large pharmaceutical companies do not need to garner venture capital, since they use profits from existing products to fund new projects. The investment required to fund these new research efforts and to bring a drug to market is high; current estimates put the cost at around $800 million. A strong patent portfolio is needed to ensure that the innovator company can protect the return on investment necessary to fund those future research efforts.
• There is a trend where these two interests are coming together— large pharmaceutical companies or medical device companies are acquiring or partnering with smaller life science companies to develop new products.
• Universities play a role in generating intellectual property for both life science startups and large companies. Many universities have established or are in the process of establishing technology transfer offices in order to capitalize on the intellectual property generated by their faculty. The universities seek to out-license intellectual property to companies or, in some cases, to develop the intellectual property internally to generate revenue to fund research at their respective institutions. In recent years this effort has been spurred by a decrease in government funding for research.
C. Trends in Life Sciences and Intellectual Property Needs
Trends in this evolving area include:
1. Alliances. More and more large pharmaceutical companies or medical device companies are making alliances with smaller life science companies in order to develop new products. These agreements must be carefully drafted in order to properly allocate intellectual property rights and responsibilities.
2. Biologic Drugs. Biologic drugs are becoming more common, and along with them come unique patent challenges. The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted as part of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), created an abbreviated pathway for the U.S. Food and Drug Administration (FDA) to approve biosimilars.
3. Medical Devices. Medical devices are being coupled with drugs in products such as drug-coated stents and drug-nanoparticle delivery systems. In addition to separate drug and medical device patents, patents for the combined systems may provide additional intellectual property protection.
4. Biostrategies. Companies are turning to biostrategies in an effort to cut greenhouse emissions,. For example, companies are using bacteria to transform plant matter into usable fuel. Protection of the intellectual property related to such biostrategies is critical in order to spur investment.
The requirements for obtaining patents on an invention in the life science area are the same as those for any other patent; the invention must be novel, nonobvious, and useful. However, there are several areas related to the prosecution and patent term of life science patents that may be different and that may require a higher level of disclosure.
1. Utility. As in other technologies, the specification must disclose the invention’s utility. For life science inventions, however, this can be difficult. For example, in order to claim a particular chemical compound as a drug, information about its utility is given, generally in the form of data relating to the compound’s activity. The data does not need to show that the drug is safe and effective; it is enough to provide information that enables one of skill in the art to determine that the compound is useful as a drug. Another example where utility is not immediately obvious is when the invention is directed to a newly discovered DNA sequence. The fact that the sequence is new does not necessarily make it patentable. In addition to being novel, the specification must describe a credible and substantial use for that DNA sequence. Often this requires performing tests to determine the DNA’s function.
2. Detailed Description of the Invention. As with all patents, there is a requirement for a full and clear description of the invention, which enables one of skill in the art to make and use the invention (“enablement requirement”). In general, reduction to practice is not actually required because a full and clear disclosure of the application can be given without actually constructing the invention. In most cases, the provision of drawings is sufficient to show that the inventor had possession of the invention at the time of filing. However, for certain life science inventions the courts have required a heightened level of disclosure (the “written description requirement”). Fulfillment of this requirement may require disclosure of more specific embodiments of the invention than are necessary for other types of invention, and often may require disclosure of data to show that the invention works for its intended purpose.
E. Patent Term
1. Patent Term Adjustment (PTA). As is the case for other patents, the term of a patent may be lengthened to make up for USTPO delays in issuance. This increase in the patent term is referred to as a “Patent Term Adjustment” or PTA.
2. Patent Term Extension (PTE). Patent Term Extensions are available only for patents covering inventions that must be approved by the FDA before being marketed. Generally, life science patents can be separated into two areas depending on whether regulatory approval is required before the invention may be sold. Inventions that are used in the discovery of drugs or biologics, or the development of medical devices, generally do not require FDA approval in order to be sold, whereas drugs, biologics, and medical devices do require FDA approval before being marketed. FDA approval requires extensive testing, which can take approximately three (3) to ten (10) years to perform. Because patents are generally filed well in advance of FDA approval, the patent term is effectively shorted by the delays to gain approval.
To compensate for the delay, the Hatch Waxman Act of 1984 provides for a PTE for a patent covering an approved drug. Subject to certain limitations, the patent term may be extended up to five (5) years for a new drug, depending on the length of regulatory delay. An additional six months of exclusivity may be obtained if the drug developer submits certain FDA-requested information relating to the use of the drug in a pediatric population.
To balance out the benefit to the innovator patent owners, the Hatch Waxman Act also provides a path by which generics companies can enter the market with the same drug immediately upon the patent’s expiration (including PTAs and PTEs) or after the patent is invalidated by a court. The generics company need only show that the approved drug and the generic drug are bioequivalent; that is, that they are identical molecules that act in the same way.
In addition, with the passage of the BPCIA, an abbreviated regulatory pathway is now available by which generic companies can gain approval of biologic drugs such as antibodies, nucleotides, siRN A, etc., often referred to as “biosimilars” or “biogenerics.” Because of the difficulties associated with manufacturing a biologic with exactly the same structure, the FDA’s general stance is that there are no true “generic biologics” but rather biosimilars.
The complete details of the Hatch-Waxman Act and the BPCIA are beyond the scope of this section, but it is worth noting that while the biosimilars pathway is similar to some aspects of Hatch-Waxman, there are differences in several key provisions. For example, the BPCIA sets forth very different provisions governing the notice requirement, the mechanics of challenging patents covering approved biologics, and the length of “data package exclusivity.” Data package exclusivity is the term used for the timeframe after market approval during which the FDA cannot approve the same drug for the same indication if the generic applicant relies on the innovator’s data for approval.
F. Regulatory Protection
In addition to PTEs, a new drug may be eligible for three (3) or five (5) years of data package exclusivity, and a biologic is eligible for twelve (12) years of data package exclusivity regardless of whether a patent is in force. In addition, biologics receive four (4) years of market exclusivity that runs concurrently with the 12-year data exclusivity. Both biologics and drugs that are approved for treatment of a patient population of < 200,000 (i.e. orphan drugs) receive 7-year market exclusivity for the approved indication.
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