Patenting an invention is an odyssey. It requires time, money, intellect, tactics, patience, and the ability to deal with uncertainty. The name of this odyssey is patent prosecution.
Patent prosecution is the process of obtaining a patent on an invention. It is, in essence, a protracted negotiation between an inventor (and her attorney) and a patent examiner. Like all negotiations, both sides begin the process with objectives that are far apart but, ideally, in the end, reach a point at which these objectives converge. In this case, the inventor seeks protection on an invention claimed as broadly as possible within the bounds of good faith. The examiner, on the other hand, seeks to allow only patent claims that are shown, through rigorous examination, to satisfy all requirements of patentability. These objectives are not diametrically opposed, since examiners do strive to allow claims, after all. Yet, they are different enough to require ample time, consideration, and flexibility from each side.
In the biotech and pharmaceutical industries, obtaining a single patent on a technology is seldom the end of this process. Typically, filing a patent application is merely the first step in building a family of many patents, each claiming a distinct feature of the new technology. Continuing-application practice, as this is known, is covered in chapter 7. Similarly, filing a patent application on an invention in one country is usually accompanied by filing counterpart applications in other countries to create an international patent portfolio on the invention. International patent prosecution, particularly Patent Cooperation Treaty (PCT) practice, is covered in this chapter. Patent portfolios are covered in chapter 12.
The following are some of the major events on the road from an invention to an issued patent.
The road to any patent begins with a scientific event. This is usually a scientific discovery or breakthrough that might be the subject of an upcoming presentation or publication. In the biotech and pharmaceutical industries, this could be a discovery of a new phosphorylation pathway, a new correlation between a disease state and a biomolecule, a new class of therapeutic compounds, a new synthetic method, or a new DNA-detection method. Of course, some discoveries form the bases of patentable inventions, and some don’t.
Determining whether a scientific discovery can support a patentable invention is the province of patent attorneys. Likewise, it is the attorney’s role to determine just what that invention is.
Understanding and defining a scientific discovery is a fundamentally different task from defining a patentable invention supported by the discovery. A scientific discovery, by itself, can be immensely important to the scientific community and can contribute deeply to our understanding of the world around us. Often, however, the greatest science, such as the long-sought elucidation of a known phenomenon, does little to give rise to a patentable invention. Conversely, many a lucrative patent have claimed an invention based on an incremental discovery scarcely worthy of kudos from the scientific community. Here, the inquiries that matter are whether a patentable and commercially meaningful invention exists, and, if so, what it is.
Answering these questions involves assessing a number of relevant factors. For example, what is the new science? Has the scientist generated a new protein, discovered a new function for a gene or noncoding region, elucidated a new metabolic pathway, or identified a new disease marker?
Based on the new science, is there an invention that can be patented? Specifically, is there an invention that, if properly claimed, would be patent eligible, useful, novel, and nonobvious? If so, could the claims also be supported by a specification that would enable and describe the invention (e.g., by providing sequences or structures)? Or, is there only a naked discovery, an invitation to do further research, or an elucidation of a known phenomenon without a new composition or method? If there is a patentable invention, what is it exactly, and what are its embodiments? Is it a molecule, a composition, a drug, a device, a method, or all of the above? Are there particular indications, formulations, or species that are most likely to succeed?
Finally, if there is an invention believed to be patentable, is it commercially meaningful? Is it something that could be made and sold for a sufficient profit? Could enforceable patent claims be drafted? Would the invention’s commercial life sufficiently overlap with the patent’s term?
EXAMPLE 5.1
Scientist A discovers a phenomenon whereby a drop in serum Protein X levels causes the onset of Alzheimer’s disease.
The discovery itself—that is, the newly found causal relationship—is not an invention at all and cannot be patented. However, this relationship might support an invention that is patentable and commercially meaningful.
Some possible embodiments of this invention include therapeutic compositions; therapeutic, diagnostic, and prognostic methods; screening assays; and related kits. Therapeutic compositions could include (i) Protein X analogs, and (ii) agents that increase Protein X production and/or serum levels. Therapeutic methods could include treating Alzheimer’s disease by administering these compositions. Diagnostic and prognostic methods could include measuring serum Protein X levels in patients and comparing them to standards for healthy and Alzheimer's disease states. Kits for practicing these diagnostic and prognostic methods could include labeled antibodies for measuring Protein X. Finally, assays could be claimd that screen for compounds that increase Protein X production and/or serum levels.
Among the many tactical considerations is whether claims to each embodiment would be commercially meaningful. For example, competitors might practice the claimed assay for only a few years, and, by the time a patent issues, most infringing activity may have ceased. In addition, even if infringing activity were to continue well past patent issuance, it would likely be carried out internally, making it difficult for the patentee to know of, or prove, infringement or to collect monetary damages sufficient even to justify an infringement suit.
In the wake of the U.S. Supreme Court’s limitations on patent-eligible subject matter, another key tactical factor for each embodiment of this invention is whether it would be deemed patent eligible or merely a natural phenomenon. Of particular concern would be the fate of diagnostic and prognostic claims in view of the Court’s Mayo v. Prometheus decision.
Once an invention is defined, the attorney must determine who invented it. Inventorship is governed solely by who conceived of the invention actually claimed. Chapter 8 covers this fascinating and challenging topic.
Typically with abundant technical input from the client, the attorney drafts a patent application and reviews it with the client, including the inventors. This approach helps ensure that the science is presented correctly, the claims properly encompass the invention’s embodiments, and the definitions and supporting examples are accurate and complete.
The attorney then files the completed patent application with the Patent Office. This establishes a filing date for the application. An application’s filing date has important consequences. First, it determines what publications and other documents are considered prior art against the application. As we know from chapter 3, and depending on the facts, prior art can anticipate a claimed invention and/or render it obvious. Second, the filing date establishes that the named inventors are the first to file a patent application on the claimed invention. Third, and as explained in chapter 6, the filing date governs when the resulting patent will expire.
In the United States, utility patents are essentially the only patents relevant to the biotech and pharmaceutical industries. Plant and design patents are far less common in these fields and have different substantive requirements, terms, and scope. Therefore, we focus here solely on the three applications leading, directly or indirectly, to utility patents. These three—provisional, nonprovisional, and PCT applications—overlap in their required features yet serve distinct roles in the prosecution process.
A U.S. provisional patent application is never substantively examined and never issues as a patent. Although it may contain claims, it need not. A provisional application cannot claim temporal priority of an earlier filed application, although it can serve as a priority application for a later-filed nonprovisional or PCT application (discussed later in the chapter). Once filed, a provisional application remains pending for twelve months. After that, it goes abandoned.
A U.S. nonprovisional (i.e., regular) patent application is substantively examined and must contain at least one claim. It issues into a U.S. patent if allowed. A nonprovisional application can claim temporal priority back to the filing date of an earlier application (e.g., a provisional application). Doing so permits the nonprovisional application to, in effect, predate—and thus evade—publications and other disclosures arising after the earlier filing date that would otherwise be considered prior art. A nonprovisional application can also serve as a priority application for other, later-filed, nonprovisional applications. Chapter 7 discusses the importance of this feature for building patent families.
Like most countries, the United States is a member of the Patent Cooperation Treaty, which governs international patent applications. Thus, U.S. practice also permits filing a PCT international application, which can then enter prosecution in the United States as a national-stage application. The PCT application plays a vital role in pursuing international patent protection.
A PCT application is by far the most convenient and cost-effective way to prosecute the various counterparts of a single patent application in multiple countries. Again, most countries in the world are members of the PCT. The PCT permits an applicant to file a single international application with one of several receiving offices in the world, such as the U.S. Receiving Office, housed within the Patent Office.
Like a U.S. nonprovisional application, a PCT application must contain at least one claim and is substantively examined. It can also claim priority of an earlier-filed patent application and can serve as a priority application for a later-filed nonprovisional patent application.
Unlike a nonprovisional application, though, a PCT application does not itself become a patent. Instead, it goes abandoned. Before this happens, the applicant must file her PCT application in one or more designated states (e.g., the United States or Canada) as a national-stage application by either thirty or thirty-one months from the earliest claimed priority date, depending on the country. From that point on, each national-stage application is examined by the patent office in that country according to that country’s patent laws and, ideally, issues as a patent in that country. Analogously, an applicant may also enter the regional stage. This occurs, for example, when an applicant files her PCT application with the European Patent Office. If successfully prosecuted, the application grants as a European patent that can then be validated in one or more of the European Patent Organisation’s member countries.
In addition to streamlining entry into the various countries where patent protection is desired, the PCT application serves other functions. Importantly, it can serve as a placeholder to delay paying hefty national prosecution fees until the applicant has acquired money and established a commercial basis for going forward. And, should the applicant instead decide to jettison the PCT application for scientific or commercial reasons, the application’s long pendency gives the applicant ample time to do so before it would otherwise have to enter the costly national and regional stages.
Since a provisional application goes abandoned after twelve months and never issues as a patent, why would an inventor ever wish to file one? The answer lies in its connection with the term of the resulting patent. A patent’s term begins on the date of issue and ends twenty years from the earliest claimed nonprovisional filing date, subject to exceptions covered in chapter 6. That is, the earliest filed nonprovisional application starts the patent-term clock by setting the date on which the patent’s term will end. A provisional application, however, has no such effect. Instead, a provisional application, once filed, establishes a filing date without starting the term clock of any patent that issues from a later-filed nonprovisional application.
Often, a biotech or pharmaceutical invention reaches its greatest commercial value at the end of the twenty-year patent term rather than at the beginning. So, a common approach to protecting such an invention is to first file a provisional application, followed after twelve months by a PCT application designating the United States and other countries, or a U.S. nonprovisional application concurrently with a PCT application designating foreign countries. This way, the provisional application effectively extends the U.S. patent term by one year. Depending on the product, this one-year addition to patent term can be worth a fortune to the patentee.
EXAMPLE 5.2
Company X invents Drug X on September 1, 2020, and wishes to pursue patent protection for its new product in Canada, Japan, and the United States. If approved for use in the United States, Drug X would have a commercial life of well over twenty years. The following is a reasonable strategy that Company X could follow to patent Drug X.
Company X files a U.S. provisional application on January 2, 2021. For the next twelve months, this provisional application will remain pending but will not be examined. The provisional application will expire after January 2, 2022.
Company X files a PCT application on January 2, 2022, claiming priority of the provisional application. The earliest claimed priority date of the PCT application is thus January 2, 2021, the provisional application’s filing date. The PCT application will be substantively examined but will not itself issue as a patent in any country. Instead, it will later expire.
While the PCT application is still pending, Company X enters the PCT national stage in the United States, Canada, and Japan on the July 2, 2023, deadline for doing so (i.e., thirty months after the earliest claimed priority date). In each of these countries, there are now patent applications pending that ultimately can issue into a U.S. patent, a Canadian patent, and a Japanese patent, assuming that prosecution in those countries is successful.
The resulting U.S., Canadian, and Japanese patents will all expire on January 2, 2042, which is twenty years from the earliest nonprovisional priority date (i.e., the PCT application filing date of January 2, 2022).
The answer to this question depends on many factors. For each contemplated country, one must consider the nature of the claimed invention, the likelihood of patenting it, the state of the country’s technological development, contemplated production and sales activities, anticipated competition, the ease or difficulty of patent enforcement, and the likely cost of patent prosecution and enforcement.
For biotech and pharmaceutical inventions, popular countries and regions for patent protection include the United States, Canada, the European Patent Organisation, Australia, and Japan. The BRIC countries (i.e., Brazil, Russia, India, and China), especially Brazil, India, and China, are popular as well, as are smaller yet technologically advanced countries such as Israel and South Korea.
Once a nonprovisional patent application is filed, the Patent Office reviews it in numerous ways. Much of this review concerns formalities such as the use of appropriate organization and headers, correct pagination, acceptable figure quality, and completeness of the applicants’ biographical information.
After addressing preliminary formalities, the Patent Office begins reviewing the application substantively; that is, with respect to the claimed invention. The substantive review includes determining whether the claimed invention is patentable.
A patent may be issued for one invention and typically no more than one. So, before addressing patentability, the Patent Office will ask whether the patent application claims more than one invention. In the United States, if an examiner determines that more than one invention is claimed, she issues a restriction requirement. In some other countries and under the PCT, the requirement that a patent application claim only one invention is called a unity requirement, the violation of which results in a lack of unity.
In a restriction requirement, a patent examiner having the relevant scientific background asserts that more than one invention is claimed and lists these allegedly independent inventions. If substantively examining all of these inventions would unduly burden the examiner, the examiner will also require the applicant to elect a single invention for prosecution. This means that the claims to the elected invention will be the ones examined going forward and that any patent issuing from this application will claim only the elected invention. Under certain circumstances, the applicant can have at least part of the restriction requirement withdrawn but can choose to later rejoin one or more of the withdrawn claims with the elected claims.
Biotech and pharmaceutical inventions typically have many facets. For this reason, restriction requirements in these industries are the norm rather than the exception.
After an applicant makes an election in response to a restriction requirement, claims to nonelected inventions are withdrawn from the application. The applicant can separately pursue these nonelected inventions by filing one or more divisional applications. Divisional applications are part of continuing-application practice, covered in chapter 7.
EXAMPLE 5.3
Scientist A discovers a new epitope on Protein X, a breast cancer cell surface marker. Based on this discovery, she develops a synthetic antibody directed to the newly discovered epitope.
Scientist A files a U.S. patent application claiming (i) the synthetic antibody, (ii) a method for making the antibody, (iii) a method for diagnosing breast cancer using the antibody, and (iv) a kit for practicing the diagnostic method.
The Patent Office issues a restriction requirement. In the restriction requirement, the examiner asserts that four independent or distinct inventions are claimed, namely, the antibody, the method for making it, the diagnostic method, and the kit for practicing it.
In the restriction requirement, the examiner requires that the applicant elect one of the four inventions for prosecution in this application. Scientist A elects the antibody, and the claims to the remaining inventions are withdrawn.
Going forward, the examiner will examine only the antibody claims. The claims of any patent issuing from this application will be directed only to the antibody, not to any other embodiment of the originally claimed invention, such as an antibody-containing kit.
At any time before a patent issues from this application, Scientist A may file divisional applications to pursue protection for one or more of the antibody production method, the diagnostic method, and the kit. (Note: Depending on the facts, it might be possible for Scientist A to have at least part of the restriction requirement withdrawn and to later rejoin one or more of the withdrawn claims with the elected claims.)
FIGURE 5.1 In example 5.3, Scientist A has a pending patent application. It is designated “PAR” here since it can become the parent of one or more progeny applications. In response to the restriction requirement, Scientist A elects the antibody claims. This means that PAR now claims the antibody but not the method for making it, the diagnostic method that uses it, or the diagnostic kit that contains it. It is only the antibody claims that Scientist A may pursue in PAR. If Scientist A wishes to pursue patent protection for any of the three nonelected inventions, she may do so by filing one or more divisional applications (i.e., DIV-1, DIV-2, and DIV-3) while PAR is pending.
Once the examiner has determined that a patent application claims only one invention, substantive examination begins. In this process, also called examination on the merits, the examiner determines whether each claim is patentable. That is, for each claim, the examiner must determine whether the requirements are met for patent eligibility, utility, novelty, nonobviousness, enablement, written description, and definiteness.
When the examiner finds that a claim does not satisfy a requirement for patentability (e.g., nonobviousness), the examiner rejects the claim and explains the rejection in detail. The examiner makes these rejections in the form of a written office action. For biotech inventions, it is not uncommon for an office action to exceed twenty pages. In response to each office action, the patent applicant and counsel respond in writing, attempting to overcome each rejection. They may do this by canceling one or more rejected claims. They may also amend one or more claims to comply with the relevant patentability requirements and/or traverse (i.e., oppose) the rejection through argument. If needed, the patent applicant may also submit evidence of patentability, such as publications, data, and factual declarations. Typically, substantive examination involves at least two or three cycles of office action and response before the examiner allows the claims. In more difficult cases, far more cycles may be required to reach allowance. Allowance of a claim set without rejection is rare.
EXAMPLE 5.4
A U.S. patent application under examination has claims 1 and 2.
Claim 1 provides “a method for treating a subject afflicted with multiple sclerosis comprising intravenously administering 10 mg/kg per week of Protein X to the subject.”
Claim 2 provides “a method for treating a subject afflicted with multiple sclerosis comprising intravenously administering 2 mg/kg per week of Protein X to the subject.”
The examiner first rejects claim 1 as anticipated by a prior-art reference teaching the treatment of multiple sclerosis by intravenously administering 10 mg/kg per week of Protein X to the subject.
The application’s specification describes using alternative intravenous doses of Protein X that include 5 mg/kg per week. The specification also describes data showing that this dose is effective in treating multiple sclerosis.
In response to the examiner’s rejection of claim 1, the applicant amends claim 1 to recite a “method for treating a subject afflicted with multiple sclerosis comprising intravenously administering 5 mg/kg per week of Protein X to the subject.”
The prior-art reference does not disclose every element of the method as now claimed, since it does not disclose a Protein X dose of 5 mg/kg per week. Therefore, amended claim 1 is novel over the prior-art reference, and the applicant’s amendment overcomes the novelty rejection of this claim.
The examiner also rejects claim 2 as lacking utility, asserting that an effective Protein X dose of 2 mg/kg per week is not credible.
The application’s specification includes no data showing that this dose is effective in treating multiple sclerosis.
In response, the applicant traverses the examiner’s rejection of claim 2. In support of this traversal, the applicant submits a declaration by an expert in multiple sclerosis treatment, along with supporting data, showing that a Protein X dose of 2 mg/kg per week is effective in treating multiple sclerosis. Assuming the examiner finds the declaration persuasive, this response demonstrates the credibility of the claimed dosage and overcomes the utility rejection of claim 2.
Once all claims in an application are deemed patentable, and all formalities are in order, the examiner allows the claims. After the applicant pays a fee, the application issues, or grants, as a patent. It is the issued patent that can be used to sue a third party in federal court for patent infringement. We cover patent infringement in chapter 9.