22 Jul The top 10 misconceptions of life-science patents
Over the last 15 years in patent law, I have encountered many misconceptions about the process of obtaining and enforcing U.S. patents that cover life-science inventions.
The following is a list of some of the most common and most important misconceptions, surrounded by reality. Like most legal analysis, there are exceptions to any rule or guideline. I’m hopeful, however, that the reader will find this information useful and thought provoking.
Misconception # 1: Inclusion of shotgun disclosures and prophetic examples always is the best strategy.
Reality # 1: In the unpredictable arts (such as pharmaceuticals and biologics), therapeutic utility must be demonstrated with “some” actual data. In many cases, therapeutic utility may be shown by data obtained from in-vitro assays and/or animal models. Shotgun disclosures also may become prior art, which can prevent a client from acquiring future patents to formulations, new indications, and other life cycle extension opportunities.
Misconception # 2: All examiners at the United States Patent and Trademark Office apply the same consistent and rigorous standards of patentability.
Reality # 2: This misconception is probably the root cause of many other misconceptions. For example, regarding the first misconception, many inventors have asked me, “Why do I need data to support my invention when so-and-so’s patent doesn’t even have any data?”
Many unsupported claims end up in issued patents, creating a false impression that they are bulletproof. Patents are presumed valid under the law. However, weak, unsupported claims probably will be invalidated when they are litigated, leaving you with no patent protection.
Misconception # 3: All examiners at the USPTO conduct a thorough, exhaustive, and competent prior art search, and the best prior art is always made of record.
Reality # 3: As a corollary to the second misconception, the reality is that the quality of the prior art search and examination varies significantly from one examiner to the next. At the end of the day, it really is the applicant’s ultimate responsibility to ensure that all of the best prior art is of record, that the claims are adequately supported, and that the claims are novel and non-obvious over the prior art.
Misconception # 4: Patent examiners never seem to understand why the claims in our application are patentable.
Reality # 4: Patent examiners have a tough job. Most have only 10 to 15 hours to read the application, conduct a prior art search, read the prior art, and draft an office action. Communication about inventions, particularly those involving difficult science, is challenging in an ever-changing legal landscape. The most effective way to hasten and improve the examination process is to conduct a telephonic or in-person meeting with the examiner (called an “Examiner Interview.”)
Misconception # 5: Once our original (i.e. parent) application has been allowed by the examiner, the process is over, and we can relax.
Reality # 5: It is quite common for applicants to file several applications derived from the parent application. Such offspring applications (referred to as Continuations, Continuations-In-Part, and Divisionals) are used to claim aspects of the invention not covered in the claims of the parent application. Offspring applications commonly are made necessary by an examiner’s restrictive requirements.
Misconception # 6: New data and information cannot be added to our pending patent application.
Reality # 6: There are two ways to add data and other information to a pending application. In response to an office action rejecting or objecting to the application, an inventor may submit a Rule 132 declaration containing data and other information pertaining to the invention. The data and other information then become part of the application. More commonly, data and other information may be added to the specification of the parent application and filed as a Continuation-In-Part (CIP) application.
Misconception # 7: Any contribution to the invention makes me an inventor.
Reality # 7: Inventorship determinations can be quite fuzzy. Start by looking at the claims. Your contribution must relate to some aspect of at least one pending claim.
Misconception # 8: Longer applications with more information always make stronger patents.
Reality # 8: A certain amount of detailed description and supporting data is necessary to obtaining strong, broad claims. However, if your patent is ever litigated, you may be grilled about any statements made in the application. Erroneous, misleading, or unsupportable statements will reduce credibility. Other extraneous statements may narrow the interpretation of your claimed invention. Like depositions, saying more than is necessary can cause serious problems.
Misconception # 9: All sections of the patent application are equally important.
Reality # 9: Many inventors focus on the background of the invention, perhaps because manuscripts devote significant text to history and background. However, with very few exceptions, the background section of a patent is probably the least beneficial. Applicants also must be very careful not to make unnecessary admissions concerning the prior art in the background section, which can prevent patentability or invalidate the patent.
Misconception # 10: It’s a good idea to save money by not filing so many claims.
Reality # 10: Infringers infringe claims, not the specifications. However, fewer claims will be needed if they are well-drafted and strategic. During litigation, you can never have enough valid claims. The cost of litigating patents is enormous and growing. In comparison, the cost of obtaining additional claims is “de minimus.” Numerous strategic claims also can be an effective deterrent to infringement.
The intersections between science, inventions, the Patent Office, the courts, and the law are complex and fascinating. Patents also are the lifeblood of any innovative life-science company. Hence, there is a tremendous premium on acquiring patents and other intellectual property that is strong, broad, comprehensive, and strategically aligned with the company’s business plan and goals. A collaborative and well-informed relationship between the patent counsel and the client is perhaps the most effective means to achieving or even exceeding those goals.
Disclaimer: This article presents general information concerning legal issues and does not constitute legal advice. Accordingly, this article should not be relied upon as legal advice applicable to a specific issue, policy or circumstance. It is recommended that you retain legal counsel if legal advice is needed.