From a pharmaceutical perspective, there are a few different types of patents.

Patents are by their nature a quid pro quo, in that the patentee provides full disclosure of the invention in return for a protected period of exclusion of others from practicing the invention. Another means of obtaining intellectual property protection, however, is the so called “trade secret,” where an invention (e.g., a consumer product formula like Coca-Cola) is maintained under
the highest level of secrecy, such that only someone with direct access to information by the inventor would know the details of the invention. Such demonstration of preserved and diligent maintenance of secrecy has validity in the eyes of courts, and individuals found divulging trade secrets are liable for damages that result.

Trade secrets are thus antithetical to patents because they maintain the details of an invention secret, such that the skilled artisan is unable to make and use the invention at hand, without further guidance.

Protection afforded by a trade secret may last as long as the secret is maintained and thus provides a longer term than a patent for such an invention. However, there are a number of significant drawbacks to reliance upon a trade secret, including the challenge in maintaining the trade secret and the fact that successful reverse engineering of an invention usually precludes the invention from being kept as a trade secret. For example, assume that a company has a “secret formula” for its flavored water soft drink. A competitor has successfully arrived at an essentially identical drink through trial-and-error experimentation in its laboratory. The competitor thus did not violate the company’s trade secret and cannot be sanctioned as a result.

Often a patent strategy involves the filing of a single application in a single jurisdiction as a means of reducing associated costs at an early stage of product development. This initial filing is usually in a country that is a contracting country of the PCT, and within one year from the initial filing date, an International PCT Application must be filed that claims priority to the initial regional application. The initial regional application preserves a date for defensive purposes, while the term of the patent is regarded to be up to 20 years from the PCT filing date. This approach earns the applicant an additional year of patent protection
without compromising that year for the term of the patent. The initial regional application is subject to the patentability standards of the region in which it was filed. For example, if the initial regional application is filed in Great Britain, it will comprise all elements of a British application, including a full set of claims that are novel and unobvious in view of the art, and contain industrial applicability and a specification that satisfies written description requirements. The initial regional application can mature into an issued patent if it satisfies the requirements of the patent office in that country.

Another practice undertaken is the filing of a provisional patent application in the United States. For a nominal filing fee, the provisional patent application also enables the inventor to secure a priority filing date for defensive purposes, yet does not compromise patent term. On the one-year anniversary of the provisional application, however, provisional patent applications expire. Provisional applications do not automatically mature into issued patents; rather, a utility application must be filed on or before the one-year anniversary of the provisional filing date, claiming the benefit of the provisional application.

In most jurisdictions, an application may claim priority of a prior filed application or applications, so long as not more than one year has passed since the effective filing date of the prior application.

In the United States, however, an application may claim priority of a prior filed application or applications for the duration while the prior application is pending. Such applications may be “continuation” applications, where there is no additional material incorporated in the latter filed application as compared to the prior application. However, a different aspect of the invention is claimed in the latter application, for example. Another means of continued prosecution in the United States is the filing of a “continuationin-part” application, where some additional material may be incorporated in the application; however, the scope of the claims are fully supported in the prior application. The number of such continuing applications that may be filed was limitless in the past; however, recently (August 21, 2007), the US Patent and Trademark Office (USPTO) published a final series of rule changes, which significantly limits this practice. The changes to the rules went into effect on November 1, 2007.

The parts and form of a patent are relatively comparable in different jurisdictions. A patent will have a background section, describing the state of the art in the field of the invention. Following the background section is a brief summary of the invention and a brief description of any drawings that are referred to in the invention. A detailed description is then provided, setting forth embodiments of the invention and providing sufficient detail for one skilled in the art to know how to make and use the invention, as well as supporting the notion that the applicant was in possession of the claimed invention at the time the invention was made. Some applications have figures, which are referred to in the description of the invention, and/or examples of embodiments of the invention. Patents will conclude with a listing of claims that set forth the boundaries of the invention. Claims are numbered in succession, beginning with an independent claim, which does not refer to any other claims and addresses the broadest scope for the matter being claimed. This is followed typically by dependent claims, which are narrower in scope than the independent claim and also refer to other claims. In general, patent claims start with broad claims and then list progressively narrower ones. An abstract of the invention is also provided, which describes the essence of the invention and the field to which the invention applies.

Following submission of a patent application, the receiving patent office will, in general, publish the application and initiate examination of the application. The initial examination entails consideration of whether the claims are directed to a single unified invention or have to be divided into two or more separate patent applications. A search of publications, patents, and patent applications follows to ascertain whether the invention is both novel and nonobvious and also has utility (i.e., practical application). The examiner will then issue a communication, commonly referred to as an “Office Action,” in which he advises the inventor about the status of the application in view of the examination procedure he has conducted.

It is typical for the claims to be rejected on the initial review. This initial rejection is often based on one or more of the following reasons:

The applicant or his representative then submits a response, where any allegations that the invention is not patentable are rebutted. Often, this response is accompanied by an amendment of one or more claims, for example, to further clarify points of contention. It is not unusual to have several such back-and-forth communications between a patent examiner and an inventor (or his representative). Following such correspondence, if the examiner agrees that the claims and application satisfy established patent requirements, then the examiner notifies the applicant that the claims are allowable, and prosecution is closed. The application then issues as a granted patent, upon payment of the appropriate fees.

The concepts of first to file and first to invent are at the heart of many patent problems where more than one person or group claims to have made the invention or discovery. Nearly all countries of the world, except for the United States and Philippines, can be characterized as first-to-file countries. This means that the person or group who files first in a member country’s patent office is awarded a patent regardless of who actually invented first. This issue is schematically shown in Fig. 109.3, where two different people could each obtain a patent for the same invention. In the United States, if one can demonstrate through laboratory
notebooks or other means that he invented a compound before someone else who has filed a patent application first, then the person who invented the compound first will be granted the patent.

Patent applications are sometimes filed based on a theory or hypothesis, even if no actual data have been obtained. This is called a constructive reduction to practice. If the basic criteria are met and the patent examiner does not require proof [e.g., that the novel compound(s) has the medical uses claimed], a patent may be granted. This is more likely to occur if the compound to be patented is a derivative of a known patented compound with a theoretical advantage. For example, a chiral form of a molecule may be hypothesized to have a theoretical advantage, and a patent may be obtained without actually demonstrating an advantage. Another example might be a segment of a known polymer that may be hypothesized to have advantages over the higher molecular weight parent polymer. In most cases, however, the patent examiner will require proof of new and unexpected properties to grant a patent for a variant of a known compound.

The standard by which a patent application is judged is whether it is able to be understood by “one of ordinary skill in the art.” An application has sufficient description if one skilled in the art would accept that the description provided in a given application is sufficient. The filing of a patent application is considered to be a reduction of an invention to practice because it provides a description regarding how to make and use the invention. While working models of a given invention may be highly illustrative, clearly one skilled in the art does not necessarily need such a model to comprehend and be able to make
and use an invention, in particular if the level of skill in the art is sufficiently high and the methods, materials, etc., used to obtain the invention are standard.

For example, assume that a specific device (e.g., a camera) is known by those skilled in the art to produce images of luminescent compounds given to humans as part of their treatment. Also assume that a new compound is identified that is highly luminescent and may be used as an imaging agent. Further assume that a new lens is created that eliminates much out-of-plane luminescence of this compound in benchtop models. One skilled in the art would likely accept that the level of skill in the art is sufficiently high, that incorporation of the lens in the device may be readily accomplished, and that a patent may be obtained on the lens. Thus, even in the absence of the inventor having proven successful incorporation of the lens into the complex device, claims about the lens should be patentable.

It has been stated (primarily in jest) that many basic scientists have switched their approach to conducting research because of the biotechnology revolution. In the years prior to 1975, a scientist would form a hypothesis, design experiments, collect data, and then apply for a patent. Since that time, it seems that scientists working in biotechnology first formulate a hypothesis, then apply for a patent, and lastly raise $15 to $20 million to conduct the experiments to test the hypothesis.

Companies do not want to rely on a single patent for protection of their huge financial investment in a potential or actual marketed product. In addition, they will continue discovery activities using a specific technology or studying a specific class or series of chemicals seeking improved compounds that can become second-generation drugs.

A company seldom files a single patent application in isolation; usually there is a series of applications. Within 18 months after global filings on invention A, there is publication of the patent application (e.g., the US or European patent application). If the research on invention A has progressed and a company wishes to file on invention B, the company should file before the publication occurs. If it does not file within this time, then the prior art established by the publication of the patent application on invention A may well make invention B unpatentable. Before the publication of the patent application on invention B, a company may file on invention C, and so forth. This is referred to as an invention cascade.