Preparing Biotech Patent Applications - Ten Strategies for Success
Written by Scott Siera, Ph.D. and Michael L. Fuller
Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property from the patent office. Strategic planning in conjunction with your patent counsel at the early R&D stage can help maximize your chances of success. By planning early, biotech innovators can streamline patent application preparation and examination, which can lead to more robust patent protection.
1. Test a variety of different molecules or assay conditions. Even if the commercial product will be a single compound, experiments testing related compounds are valuable evidence that a patent application is entitled to broader claim scope. For example, if the compound is a DNA molecule, including testing data from variants of the DNA may support a claim that covers the compound and its variants. Similarly, if the invention is an assay, data from a variety of samples (such as different cell types or organisms), dosage curve data, or performing an assay across a range of operating parameters can support broader claim scope. Broader claims can provide protection against design-arounds by competitors, and also create prior art against competitors that may prevent them from obtaining their own patent coverage in the space.
2. Quality of research is often more important than quantity. What an applicant gets out of a patent application will generally be proportional to what they put into it. Robust experimental data can be valuable for understanding how an invention works, describing and protecting it from several angles, and supporting broad claim scope. However, at some point, generating more and more confirmatory data may not be a wise use of resources. For example, in the case of an antibody, testing several independently-derived antibodies can support a broader claim to a class of antibodies (See Ex Parte Gately). On the other hand, there may be less value in testing numerous minor variants of a lead antibody. In one case, a panel of judges found that 200 variant antibodies that each differed by only a single point mutation could not support a claim to a broad class of antibodies, but rather, were qualitatively “similar” to each other (Abbvie Deutschland v. Janssen Biotech “Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”).
3. Identify structural features of representative molecules prior to filing. Claim scope will depend on what the Applicant possessed at the time that the patent application was filed. A patent application that includes structural features of molecules, such as a DNA or protein sequence, the chemical formula of a small molecule, or a crystal structure, will be in a position to support claims to those molecules, and potentially a broader class of molecules that share those structural features (see, e.g., Ariad Pharmaceuticals v. Eli Lilly). That said, there is no strict requirement to test, or even produce, a molecule prior to filing a patent application. For example, if an Applicant has a DNA sequence of interest, disclosing the DNA sequence in a patent application can support a claim, even if it the DNA has not yet been synthesized.
4. Perform structure-function mapping. Supporting a broad claim scope does not require making and testing every possible product that falls within the claim scope. If a patent Applicant can establish a correlation between structure and function, that Applicant may be able to obtain broad patent protection for a class of molecules with that function. For example, by performing mutagenesis experiments to determine which portions of an enzyme are catalytic and which are dispensable, an Applicant may be able to claim a broad class of enzymes, even if the Applicant has not actually synthesized and tested every possible enzyme in the class.
5. Comparative data are helpful, but can often wait. Comparative data showing that a new molecule or process is superior to conventional molecules or processes are valuable for supporting patentability, especially in a crowded space. Nevertheless, under our current first-to-file patent regime, an Applicant waiting to collect comparative data may risk losing patent rights if a competitor files or publishes first. At the time of filing a patent application, the Applicant will need to describe the structure of the product they wish to protect. On the other hand, the Applicant can use data obtained after a patent application is filed to show that a patent application is inventive and entitled to be granted as a patent. If an Applicant is up against time and/or budget constraints, it may be advantageous to nail down the structure of the molecule or product first, and hold off on head-to-head comparisons with conventional products.
6. For molecular diagnostics, collect data in addition to diagnostic predictiveness. Patent protection for molecular diagnostics is still very much available, but several recent court decisions have made it more challenging to obtain a patent for a molecular diagnostic (see, e.g., Alice v. CLS Bank; Ass’n for Molecular Pathology v. Myriad Genetics; Mayo Collaborative Services v. Prometheus Laboratories; Ariosa Diagnostics v. Sequenom). While the initial inclination may be to obtain extensive data demonstrating that a molecular diagnostic can accurately predict a certain disease state or clinical outcome, other types of data may be useful from a patent perspective. For example, evidence that the new diagnostic method overcomes a previous artifact or technical shortcoming can be helpful. Does the new diagnostic strike good balance between false negatives and false positives? Does the new diagnostic produce results more quickly or use smaller amounts of consumables than conventional approaches? Does the new diagnostic result in a complex or intermediate that does not occur in nature?
7. Helpful experiments for a patent application are not necessarily the most interesting ones from a technical perspective. Sometimes, the most helpful experiments for supporting a patent application may not be the most interesting ones from a scientific perspective (or vice versa). Many companies can use this to their advantage by sponsoring basic studies with the academic collaborators, while obtaining IP protection focused on their clinical data. Conferring with patent counsel before initiating a course of research can be helpful in balancing costs, timelines, and interests in publishing. For example, experiments in support of a patent on a method of treatment may ascertain which substance is administered, how much, how frequently, and to whom. On the other hand, studies on a drug’s mechanism of action may be less commercially interesting from a patent perspective, but may yield a prestigious journal article.
8. Maintain laboratory notebooks and records. Although the United States is now a first-to-file patent system, documentary evidence of inventorship remains very useful. First, there are still numerous pending patent applications that were filed under the old first-to-invent system, for which obtaining a patent could depend on the timing of invention. Furthermore, under the current patent system, public disclosures within a certain time period can be addressed by a showing that the disclosed subject matter was derived directly or indirectly from an inventor. Additionally, the default rule is that any inventor can practice or license a patent. From time to time, accused patent infringers may attempt to avoid liability by arguing that an inventor was omitted, and obtaining a license from that allegedly omitted inventor. Records showing inventive contribution can counter the efforts of such accused infringers.
9. Notify patent counsel of possible publications (and not just journal articles). Public disclosures about a patent application, even by an inventor, can jeopardize patent rights, especially for patent protection outside of the United States. While pending journal articles are one type of potential disclosure to keep in mind, some others include conference abstracts, demonstrations at trade shows, postings on internet message boards, social media, electronically published grant proposals, evidence filed in one of the company’s other patent applications, draft manuscripts or laboratory reagents sent to colleagues, or even the internet publication of slides from a dissertation defense. With advance notice, patent counsel can develop strategies for balancing costs and preserve patent rights ahead of potential disclosures.
10. Keep patent counsel apprised of post-filing developments. Once a patent application has been filed, providing continued updates to patent counsel can help to increase the value and strength of a patent portfolio. For example, notifying patent counsel of new data can permit them to use these data to persuade a patent examiner to allow broader claims. Additionally, for most patent applications, there is a window of time after the application is filed but before it publishes (typically 6-18 months) in which follow-on patent applications can readily be filed to protect improvements. Have additional molecules been tested? Has efficiency or throughput been improved? Is there a new prototype? A follow-on application can provide an opportunity to pursue patent protection that closely tracks the commercial product, while offering additional scope of protection and a longer patent term to complement the earlier-generation patent application. Keeping patent counsel apprised of all activities can help strengthen the validity of the granted claims.