Editor: What is the legal climate currently like for patents?
Trujillo: It is in a constant state of flux. Each new opinion from the Court of Appeals for the Federal Circuit ("CAFC," the appellate court for patent-related issues) seems to alter the playing field, in some cases retroactively. Additionally, there have been extensive legislative changes since 1995 that have greatly impacted patent practice. For example, the term of a patent used to be 17 years from the date of issuance. For applications filed on or after June 8, 1995, the term of a patent is 20 years from filing. This, and other changes, has been primarily driven by the attempt to harmonize patent laws throughout the world. There are rumored additional legislative changes in the works that could unfold over the next few years that may render one area of U.S. practice all but obsolete - interferences. These changes must be taken into consideration as companies develop their patent strategies/ portfolios.
Editor: Can you explain how interference works?
Trujillo: First, some background. The U.S. is the only country to still award a patent to the first to invent. Every other country in the world awards a patent to the first to file an application. This opens the door for challenging an issued patent by provoking an interference, which, although done in only a small percentage of cases, can be a very valuable tool. For example, there may be two or more groups working on patenting a similar biotech invention. If one group has an earlier filing date and gets the patent, the other party can provoke an interference to challenge that patent based on first to invent.
Editor: Does interference only apply to determining priority of invention?
Trujillo: No. Although interference is a means to determine priority of invention, the statute also allows one to question the validity of the patent. And, under certain circumstances, e.g., if you have a claim to substantially the same invention on file before the patent is issued and an interference is provoked, the burden of proof for proving the patent is invalid is the preponderance of the evidence, which has been described simply as the existence of the fact is more probable than its nonexistence. Contrastingly, if you challenge the validity of the patent in court in a normal litigation setting, not in an interference setting, the burden of proof is clear and convincing evidence, which has been described to be the amount of proof that gives the fact finder an abiding conviction that the truth of the factual contentions is highly probable. The lower standard of proof for proving invalidity often makes interferences an attractive option. If a company is getting ready to launch a product and identifies a patent which may be problematic, does it sit back and wait to be sued, or threatened with suit and file a declaratory judgment action, and have to meet the clear and convincing evidence standard to prove invalidity, or does it take a proactive approach and try to provoke an interference with the patent?
Editor: Arethereanyothermeans,shortoflitigation,forchallengingthevalidity ofapatent?
Trujillo: Yes.There are several other Patent Office proceedings one can initiate to challenge the validity of a patent. None, however, offers the advantages that an interference does. For example, there are two mechanisms for challenging thev alidity of a patent based upon prior art patents or printed publications.These are exparte and interpartes reexaminations.If, however, one wants to challenge the patent on other grounds, such as lack of enablement or lack of written description, one cannot do so in a reexamination. Additionally, one's active participation in an exparte reexamination effectively ends with requesting the reexamination.If a reexamination is granted, the requester will receive all papers filed by the patentee.One has more involvement in an interpartes reexamination, but is still limited in the bases upon which validity can be challenged. One can also file a protest to challenge validity of an application.The bases for protesting the application are not as limited as in a reexamination. The protest,however,will not be entered unless it is filed before the application publishes or a notice of allowance is mailed. And,one's involvement in a protest ends with the filing of the protest; one will not receive any acknowledgement regarding further proceedings.
Editor: Do you see any changes relating to interference in the future?
Trujillo: It is a hot topic right now. There is great pressure on the U.S. from other countries, as well as from various organizations within the U.S., to harmonize the patent laws, and move to a first to file system. There are rumors about a bill in the works proposing changes to the statute to accommodate this. The proposed changes would greatly alter interference practice and limit it to, primarily, derivation issues, i.e., that someone stole the invention from you. You wouldn't be able to challenge on first to invent if we moved to a first to file system. This could be worrisome for small companies and individual inventors, since a first to file system tends to favor larger corporations that have the machinery and finances in place to file patent applications early and often. If interference practice as we currently know it goes away, some, including the Patent Office itself, are proposing an opposition proceeding similar to what is done in Europe that would allow third parties to challenge the validity of patents. Indeed, the American Intellectual Property Law Association is proposing that parties in such an opposition have the same burden of proof for invalidating a patent as in an interference - preponderance of the evidence. Whatever happens, the landscape is definitely changing.
Additionally, new regulations, effective September 13, greatly change some aspects of the current practice.
Editor: What role does corporate counsel play in interference?
Trujillo: It would behoove counsel to take a close look at competitor's patents and published applications, to see if there is anything out there that could affect their company's position in a particular technology. Now would be the time to provoke an interference, if it is warranted. But you really need to work with someone familiar with this somewhat arcane area of the law. An experienced interference counselor can act quickly and seize an opportunity that a less experienced counselor may not identify, and can also guide clients through the potential landmines that interference practice can present.
In a recent case, one practitioner failed to follow the highly technical interference rules to his client's detriment. All he had to do was submit an accurate translation of a non-English application filed under the Patent Cooperation Treaty to comply with the requirements for showing entitlement to the filing date of that application, which he failed to do. The consequences were severe. He lost the interference and the right to a patent.
Similarly, if you get a notice that an interference has been declared with one of your existing patents, you need an experienced practioner to help you learn the lay of the land to act appropriately.
Editor: Is it going to become more difficult to provoke interferences in the future?
Trujillo: Most likely. A recent decision by the CAFC, citing a prior decision by the Board of Patent Appeals and Interferences, has already made it more difficult to provoke an interference between an invention directed to a species (e.g., the specific compound) and a genus (e.g., the class in which that compound falls) by approving the two-way test for an interference-in-fact. That is, not only must the genus be anticipated or obvious over the species, but also, the species must be anticipated or obvious over the genus. The latter is not always easy to show.
Further, currently, if you're trying to provoke an interference with an issued patent and your application filing date is less than three months from the effective filing date of the patent, you could do so without making a showing of entitlement to judgment on priority. Biotech and other complex technologies are sometimes given a greater cushion. Under the new regulations, if your filing date is later than the filing date of the issued patent or published application, by any amount of time, you have to make a showing of entitlement to priority which can often be the equivalent of proving priority even before the interference is declared. At that point, companies will have to decide they want to move forward and, effectively, reveal all their cards at the beginning of the process.
Additionally, under the new regulations, in order to enjoy the preponderance of the evidence standard, you must have a claim to the same invention on file not only before the issue date of the patent, but also before the publication date of the involved patent or application.
Fortunately, one proposed change that could have made it more difficult to succeed in an interference was not put into effect. Patents are awarded to the first to invent who hasn't abandoned, suppressed, or concealed the invention - essentially the patent is the reward for disclosure. Under the proposed rule, there would have been presumption of abandonment, suppression, or concealment if the filing date of the application was more than one year after the date of actual reduction to practice, i.e., preparation of the compound and showing it works as intended.
Editor: How important could interference be to a company's pending R&D?
Trujillo: Success in an interference could mean the difference between your company failing or succeeding in a given area of technology that it's worked on for many years. There are different measures of success, however, not always meaning that you end up with a patent. It may be that you end up with the necessary freedom to operate. Interferences, however, are not cheap. But, while an interference takes an investment, it is much less expensive than litigation and can be more attractive, especially if you consider the burden of proof for invalidating.