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Utility patents are granted to anyone who invents any new and useful process, machine, article of manufacture, composition of matter, or any new improvement thereof.
The intellectual property (IP) of a company is often its core asset. Acquiring, protecting, and enforcing IP involves decisions at the highest levels of the company, and IP commands a significant portion of the company's resources. For most life sciences companies, patents are usually considered to be the principle IP asset. In practice, however, these companies usually have extensive know-how, most often kept as trade secrets. If a direct comparison could be made, a typical life-sciences company probably keeps more than two-thirds of its proprietary information in the form of trade secrets. In early stage companies, particularly in relatively new technology areas such as nanotechnology, the proportion of trade secrets to patents is much higher.
This article reviews the complementary nature of patents and trade secrets, and explains how to preserve core trade secrets while acquiring enforceable patent rights. General concepts are first introduced, and specific examples of business situations are explored.
A patent is a grant of proprietary rights in an invention. The Constitution of the United States in Article I, section 8, provides that "Congress shall have power . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries." Congress established the United States Patent and Trademark Office (USPTO) to administer the law relating to the granting and maintenance of patents. Patents are granted to any person who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." The word "process" refers to a process, act, or method, and primarily includes industrial or technical processes. The term "manufacture" has been interpreted as referring to articles that are fabricated, and generally includes all manufactured articles. A "composition of matter" is a biological or chemical entity and may include mixtures, i.e., formulations or complex compositions. Generally, a patent has a lifespan of 20 years from the date on which the application for the patent was filed. Under certain circumstances, patent term extensions or adjustments may be available. US patent grants are effective only within the United States, US territories, and US possessions.
There are three types of patents. Utility patents are the most common, and are granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. A provisional patent application, common in the life sciences industry, is simply a specific type of utility patent application. However, the provisional patent application plays an important role in the preservation of invention rights, both for patents and for trade secrets.
John M. Garvey, PhD
The second type of patent is a design patent, which may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture. A design patent does not cover functional aspects of the article, which is properly the scope of a utility patent. Finally, a plant patent may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant. Often a utility patent is sought for cell lines and other biologics that may be of plant origin, even though plant patents are available.
To be patentable, an invention must be "novel." It cannot be patented if it was known or used by others in this country, or patented or described in a printed publication in this or a foreign country before the invention thereof by the applicant for patent; or the invention was patented or described in a printed publication in this or a foreign country, or in public use or on sale in this country more than one year before the application for patent in the United States. Other conditions apply and the novelty requirement is a complex point at issue in the prosecution of many patent applications. Even if the subject matter sought to be patented is not entirely described in the prior art, a patent may still be refused if the differences between the prior art and the claimed invention would be obvious to a person of ordinary skill in the relevant art. This is another requirement of the patent laws that provides subject matter for debate between the USPTO and patent applicants.
The rights conferred by Congress in the form of the patent grant is, "the right to exclude others from making, using, offering for sale, or selling" the invention in the United States or "importing" the invention into the United States. This right is solely exclusionary, and must be enforced by the patentee. In other words, in the grant of patent, the government is not conveying any exclusive rights to affirmatively make, use, offer for sale, sell, or import the patented technology, but rather the right to exclude others from practicing the invention. Once a patent is issued, the patentee must actively enforce the patent through the courts in order to stop infringement.
A trade secret is more conceptual and less tangible than a patent. Generally, it is agreed that trade secrets encompass the proprietary information of a company (or individual), regardless of whether it involves a composition or a process, or whether it is patentable. Almost all states have adopted parts or all of the Uniform Trade Secrets Act. According to the act, a "trade secret" is information, including a formula, pattern, compilation, program device, method, technique, or process, that: (i) derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use, and (ii) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.
Trade secrets derive their value (whether actual or potential) from being generally not known to, or readily ascertainable by proper means by other persons, who can or may obtain economic value or advantage over others from their disclosure or use. Therefore, trade secrets must be subject to reasonable steps to keep the information secret, in the sense that the information is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the industries that normally deal with the particular kind of information.
A trade secret should be protected from improper exploitation, by physical segregation of persons from certain confidential and proprietary information. An example of this might be assembly line or process development workers where each is exposed to only a specific part of a complex manufacturing process. Another way to protect trade secrets involves establishing contractual relationships, such as nondisclosure or confidentiality agreements, or this type of language within more complex agreements.
The remedies available for trade secret misappropriation address unfair competition from possession of the proprietary information. According to the Uniform Trade Secrets Act, misappropriation is characterized as:
(i) acquisition of a trade secret of another by a person who knows or has reason to know that the trade secret was acquired by improper means; or (ii) disclosure or use of a trade secret of another without express or implied consent by a person who (A) used improper means to acquire knowledge of the trade secret; or (B) at the time of disclosure or use knew or had reason to know that his knowledge of the trade secret was (I) derived from or through a person who has utilized improper means to acquire it; (II) acquired under circumstances giving rise to a duty to maintain its secrecy or limit its use; or (III) derived from or through a person who owed a duty to the person seeking relief to maintain its secrecy or limit its use; or (C) before a material change of his position, knew or had reason to know that it was a trade secret ad that knowledge of it had been acquired by accident or mistake.
Remedies for misappropriation or improper use of a trade secret include monetary damages, recovery of profits, a reasonable royalty, and injunctive remedies. Actual or threatened misappropriation may be enjoined. Upon application to the court an injunction shall be terminated when the trade secret has ceased to exist, but the injunction may be continued for an additional reasonable period of time in order to eliminate a commercial advantage that otherwise would be derived from the misappropriation.
A company can—and should—use both patents and trade secrets to protect different aspects of the same invention. There is a common misperception that the two forms of IP are mutually exclusive. But courts have long held that a published patent does not invalidate those trade secrets that are not disclosed in the patent. The key to leveraging both patents and trade secrets is to first understand the weaknesses of each form of IP and then to compensate for one with the other.
The historic weakness of a patent is determining whether a competitor is infringing in the first place. Patent enforcement is especially difficult if the invention relates to a method of manufacture and the end product by itself does not reveal how the product was made. In a situation like this, where "reverse engineering" is difficult, it is advisable to use trade secrets to protect the method and use patents to protect the product. To obtain this patent, however, the applicant will still need to disclose to the public how to make the product, but only to the minimum extent required by law. Three legal requirements—written description, enablement, and best mode—set the level of detail that a patent applicant must disclose in order to obtain a valid patent. A patent applicant can comply with these requirements without giving up its trade secrets.
According to the patent appellate court, "The written description requirement does not require the applicant to describe exactly the subject matter claimed, instead the description must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed." Pandrol USA, LP v. Airboss Ry. Prods., 424 F.3d 1161, 1165 (Fed. Cir. 2005) (emphasis added). Thus, trade secrets can still protect the "know how" surrounding the manufacturing process, so long as persons skilled in the art understand the scope of the patented product.
Similarly, "enablement" requires that a patent applicant describe how to make and use the invention in such detail as to enable someone skilled in the art to practice the invention without undue experimentation. The case Hayes Microcomputer Products is an example of a party withholding its trade secrets from a patent disclosure and still satisfying the enablement requirement. 982 F.2d 1527, 1534 (Fed. Cir. 1992). The opposing party argued that the patent applicant, who merely provided a flowchart of a software operation, did not describe the claimed "timing means" and thereby kept it as a trade secret. The court relied on the inventor's own assertion that "if you had experience in doing microprocessor programming, you would know how to implement what's in that diagram," and the court further noted that "an inventor is not required to describe every detail of his invention" (emphasis added).
Finally, the "best mode" requirement in patent law is most conducive to withholding later-arising discoveries as trade secrets. The patent applicant must disclose the best mode of carrying out the invention, but only at the time the application was filed. Thus, if a company continues to refine an invention after filing its initial patent application, all subsequent discoveries may be either held as trade secrets or pursued as additional patents.
In addition to using trade secrets to shore up the weaknesses of patents, an innovative patent strategy can be used as a hedge against the downside of trade secrets. Trade secrets are susceptible to both inadvertent disclosure and independent invention (i.e., a competitor later invents, patents, and sues you for practicing the trade secret). As discussed previously, a company may file provisional applications as placeholder patents. If either of the two adverse events occurs to the trade secret while the provisional application is sitting at the USPTO, then the provisional can be converted into a regular patent application in order to preserve the invention.
Patents can also be leveraged against a competitor's trade secrets. Historically, the law has treated patents more favorably than trade secrets when the two are pitted in a head-to-head contest. For instance, even if a competitor was the first to discover an invention, the law prohibits the competitor from later obtaining a patent on the invention if he "suppressed" or "concealed" it as a trade secret. Additionally, a competitor's secret commercialization of the trade secret triggers a one-year statutory bar that prohibits the competitor from later obtaining a patent on that invention. Fortunately, your competitor's secret activities do not prohibit you from seeking patent protection on the same invention, so long as you independently discovered the invention. One significant point needs to be made: there are no clear cases under US law, where a prior user (of a trade secret) has been successfully sued by a patentee for patent infringement. There is no legal prohibition, but perhaps the specific factual scenarios to date have illustrated potential prior art problems for the patentee based on the earlier uses by the trade secret holder, that resulted in negotiation strategies for dispute resolution rather than litigation. Nevertheless, despite a prior user holding a trade secret, the patentee may still enforce his or her after-acquired patent against third parties. It wouldn't be outside the realm of possibilities that a prior user and a subsequent patentee may team up to enforce the patent generally in the marketplace against third party infringers. Antitrust issue may appear in this scenario.
Many business agreements provide either explicit or implicit declassification of information as "confidential" when it falls into certain common categories. For example, information often is excluded from confidential treatment when it becomes known to the marketplace, without fault of the contracting party. Another common exclusion is information that was in the party's possession before disclosure by the disclosing party, as evidenced by written records. For this reason, it is important to memorialize trade secrets. One of the best ways of doing this is to describe these in provisional patent applications. A provisional patent application is essentially a placeholder application, and must be affirmatively moved into the examination process by the applicant. If a provisional application is not refiled as a regular utility application, or otherwise converted before the one-year anniversary of its filing date, it automatically lapses. Therefore, the information contained in that application is not disclosed to the public.
One very important point needs to be made. If the provisional application is moved into the examination process, unless certain precautions are taken, the utility application will eventually publish. If a patent issues from this application, the entire prosecution history, including the original provisional filing, will be accessible by the public. Therefore, the contents of provisional filings must be carefully tracked, and if a patent will eventually be sought for the invention, it should be based on provisional applications having only the appropriate information, not one disclosing globally the company's more sensitive material.
Before entering into any discussions with another party regarding potential business relationships, it is essential to do pretransactional due diligence on the other party. The appropriate level of investigation and its focus will necessarily depend on the particular transaction type, but with respect to IP, there are common steps. First, investigate the potential partner or target. Determine their key products, and inventory the patents, patent applications, trademarks, and all other publicly accessible information to gain insight as to their level of protection.
Against this background, a company must inventory its own information to determine areas of overlap, synergy, or competition and then must take steps to secure any gaps in its IP rights. There is a narrow window to cure deficiencies before commencing any negotiations. Where there is likely to be a significant exchange of information, and where trade secrets are involved, these need to be memorialized and inventoried in order to protect the confidential information of the company before commencing negotiation. It may also be appropriate to file provisional patent applications on more speculative ideas that involve the combined technologies of the two companies. Doing this before signing an NDA increases the strength of any argument that your company had developed these concepts prior to talking to the other company. This may also minimize a company's risk in a patent interference or litigation, should the relationship be less than amicable.
In collaborative relationships, beyond the complexities of working with another entity that may have very different goals and ways of operating, the primary difficulties involve the exchange and capture of technology. One of the most common structures involves some sort of joint ownership of the resultant IP. The two companies in a collaborative relationship will contractually apportion the roles and responsibilities of each party, and will either share the IP outright, or in some proportion to its creation (conception and reduction to practice). In fact, the CREATE legislation codified at 35 USC§ 103(c) promotes this type of relationship by removing an obstacle under the patent laws. It is also a common practice to vest ownership of the IP in one of the parties and license back rights to the IP.
While collaborative relationships are usually amicable, they can always devolve. Therefore, even collaborative relationships should be approached with the understanding that certain aspects of the joint effort might need to be delegated solely to one of the parties, and that an open exchange of information is neither productive nor desirable to both parties involved, unless the collaborative activities are dependent on such open exchange. Even then, confidentiality arrangements should be in place before any information is shared, and trade secrets should be inventoried and memorialized before initial discussions and certainly before significant information exchange.
Licenses are simpler to manage than ongoing collaborations, but many licenses also involve an accompanying exchange of know-how or other kinds of confidential information. Royalty obligations are often tied to the existence of patents, and a royalty can't persist after the expiration of patent rights unless there is some additional consideration. When patents expire, the underlying know-how can provide this consideration, but there needs to be some reduction in royalty rates to reflect the loss of the patents. Safeguarding this know-how therefore takes on new significance when there is no underlying patent. However, because this relationship is more controlled than collaborative projects, and the exchange of information is more intermittent, it can be easier to protect the company's trade secrets in this type of business setting. Nevertheless, confidentiality provisions should be included in any technology license, along with a clear delineation of responsibilities upon termination or expiration of the license.
Sponsored research agreements provide a different challenge to companies, since the results of the work aren't necessarily known or predictable at the outset and the parties are likely to have vastly different goals. This makes protection and control of IP rights generated a significant point that must be clearly delineated at the outset of the relationship. Most sponsored research occurs between a company and a nonprofit or academic entity. These types of organizations have different agendas than for-profit companies, and while the creation of IP is desired, the mission of these organizations is usually to disseminate knowledge.
This is contradictory to the preservation of trade secrets. Similarly, most nonprofit centers require ownership of any resultant patents and tangible IP, which is licensed back to the sponsor. Companies about to enter into sponsored research need to negotiate agreements that let the company redact confidential information from publications, or that delay publication in order to prepare and file patent applications. Likewise, the company needs to narrowly define the scope of the work to be performed, and clarify the existing inventory of company-owned IP to preempt subsequent claims that something was jointly invented. The best strategy for the company is to get information classified as a pre-existing invention, and characterize the research as simply being directed by the company. This reduces the sponsored research to a fee-for-services type of relationship, which may preclude claims of invention by the non-profit. Inventorship is a high standard defined by the patent laws, and the goal for the company is to reduce the nonprofit's claims to conception of the invention.
Ending a business relation-ship properly is also critical. Contractual obligations should address the return of all proprietary information and materials. In certain cases it is appropriate to permit retention of archival copies of information, to ensure continuing compliance with surviving confidentiality provisions or ongoing regulatory obligations. However, this potentially permits a company to retain the trade secrets of another. Complicating this, the owner may not have any control or insight into whether the retaining company is adequately protecting this information. The best scenario is not to exchange the really sensitive information, but if it is protected by incorporation into a provisional patent application, then the consequences of inadvertent disclosure can at least be offset by its conversion into patent rights.
While patents typically get the attention in a company, trade secrets can be the crown jewels of an IP strategy. They should be protected at all times, and shared only after a demonstration of necessity. Nevertheless, any exchange should be planned to minimize the consequences of misappropriation or inadvertent disclosure. Patents and trade secrets can coexist, and the combination creates an intelligent IP strategy.
John M. Garvey, PhD, is a partner with Foley & Lardner, Boston, MA, email@example.comAndrew S. Baluch is a law clerk at Foley & Lardner, firstname.lastname@example.org