January 2010

Novelty Requirement of Patentable Inventions

Under the U.S. Patent Act, a patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” The requirement that the subject of a patent be new is referred to as the novelty requirement; the requirement that the subject of a patent be useful is referred to as the utility requirement.

To meet the utility requirement, an invention must provide a specific, known use that differs from the prior art, which is the body of information from which it is determined whether an invention is new. Speculative or possible future utility is not sufficient. Application requirements set out by the Patent Act provide that the patent applicant describe in detail the invention, how to make it, what it does, and how it is used, which if properly complied with should make it clear what the claimed utility of the invention is. It is not necessary that the use represent an improvement over the prior art; however, to meet the utility requirement, an invention must work as claimed.

The utility requirement is liberally applied to pharmaceutical compounds. In a leading case on the utility requirement, the U.S. Court of Appeals for the Federal Circuit reversed a decision of the United States Patent and Trademark Office that a pharmaceutical compound was not patentable because, although the compound had anti-tumor properties, the patent application did not specify any specific disease for which the compound might be used to treat. The court held that a compound that exhibits a desirable pharmaceutical property in animal testing has made a significant and useful contribution to the art and, thus ,meets the utility requirement. In addition, the court concluded that is to be expected that further research and development in a pharmaceutical compound will be necessary to fully determine the specific medical uses for the compound.

In examining a patent application for utility, a patent examiner determines whether there is a well-established utility for the invention or a utility that is asserted by the applicant that is credible. The credibility of an assertion of utility is measured by the standard of a person having ordinary skill in the field in which the invention is classified. If there is either a well-established or credible use asserted by the applicant, the patent application will not be rejected on the ground of lack of utility.

Reexamination of Patents

After a patent is issued by the United States Patent and Trademark Office (USPTO), the discovery of prior art or publications not noticed prior to the patent’s issue may raise questions as to the validity of the issued patent. In such a case, a patentee or a third party may file an application for reexamination of the patent in the USPTO. For a third party, reexamination provides a lower cost alternative to a conventional lawsuit for challenging the validity of a patent. If the third party is an unsuccessful infringement defendant, a reexamination that results in the invalidation of a patent may provide vindication of that defendant’s rights despite the results of the court case. For the patentee, the reexamination process may reveal the need to narrow a patent’s claims in order to be in a better position to fend off a challenge to the patent’s validity. In addition, the USPTO may take it upon itself to reexamine a patent without it being requested by the patentee or a third party.

The patent reexamination process has two stages. At the outset, the USPTO determines whether a substantial new question of patentability is evident from the prior art or printed publications. If a need for reexamination is found, the patentee is given two months to provide a response to the USPTO, and a third-party reexamination requester may reply to the patentee’s response. In addition, the patentee is allowed to propose amendments to the patent claim or claims at issue as long as the amendments do not broaden the scope of the claims. When the patent reexamination process was initiated in 1980, the process was anex parte process, meaning that once the process had been initiated and the parties’ responses were filed, only the USPTO was involved in the review of the reexamination application. Since 1999, an inter partes process has been allowed at the election of the applicant.

In an inter partes reexamination, the USPTO will send to the reexamination requester a copy of any communication that it sends to the patentee about the patent at issue. Each time a patentee files a response to any action by the USPTO concerning the challenged patent, the reexamination requester may file one response. In an inter partes reexamination, either party may appeal an adverse decision, in contrast to an ex partereexamination, where only the patentee may appeal an adverse decision.

Although the inter partes reexamination procedure allows greater participation by the party challenging the patent, there are several drawbacks to the procedure. The application fee is nearly four times greater than for an ex parte reexamination. In addition, in an inter partes reexamination, the reexamination requester may not remain anonymous as in ex parte proceedings. Finally, although the inter partes requester is entitled to appeal an adverse decision, once the appeal process has been exhausted, an adverse decision against the requester is considered absolutely final and the requester may not bring a court action to challenge the same patent.

Once the reexamination process is completed for either an ex parte or inter partes reexamination, the Director of the USPTO issues and publishes a certificate that cancels any claim of the patent that is determined to be unpatentable, confirms any claim determined to be patentable, and incorporates any amended or new claim proposed during the reexamination process that is determined to be patentable.

Trademark Use in Commerce

In the United States, subject to one exception, trademark rights arise from use in commerce, regardless of whether or not the mark is registered. The first user of a mark generally takes priority over all subsequent users with respect to use of the mark in that market.

The first user of a mark in commerce, labeled the senior user, will have priority over the use of that mark by any other user, labeled the junior user, within the geographic area of the senior user’s use. However, as soon as a senior user files an application to federally register the mark, the senior user will have nationwide priority over any junior users of the mark, except for any junior users who were already using the mark in a geographically remote area as of the filing date of the senior user’s application.

The one exception to the rule of priority based on use in the U.S. is that a prospective user can file an application for federal registration of a trademark on an intent-to-use basis. In that case, once the mark is used in commerce, the priority date will relate back to the date of the filing of the application, not the date of first use.

A federal trademark registration application should be filed immediately after a search is performed to ensure that the mark is not already in use. This is necessary to establish a nationwide priority date.


The following are required in order to claim priority based on an existing trademark registration:

  • A true copy, a photocopy, a certification or a certified copy of the applicant’s trademark registration in the country of origin must be provided.
  • A translation of the registration if not in English, signed by the translator, must be submitted.
  • The applicant must verify that the applicant has a bona fide intention to use the mark in commerce.
  • The scope of the goods covered by the U.S. application cannot exceed the scope of the goods or services in the foreign registration.
  • If the applicant is not domiciled in the United States, the applicant must designate a domestic representative, which is a person residing in the United States that may be served notices or process in proceedings affecting the mark.

Trademark Infringement Litigation

There are standards that must be met for admissibility of expert testimony in trademark infringement actions. Experts may have their methods challenged before they take the stand. Expert testimony may be excluded as speculative and unreliable if an expert’s methods are not based on sufficient facts or data, are not reliable, or are not applied reliably to the facts of the case.

The trial court judge acts as a “gatekeeper” to ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable. Every expert is subject to a reliability test. Courts analyze expert testimony using the following five, non-exclusive factors in order to determine whether an expert’s reasoning and methodology are reliable:

  1. whether the theory or technique on which the expert relies has been tested;
  2. whether the theory or technique has been subject to peer review and publication;
  3. the known or potential rate of error of the technique or theory when applied;
  4. the existence and maintenance of standards controlling the technique’s operation; and
  5. whether the theory or method has been generally accepted by the expert community.

Appellate courts review how the trial court judge tests an expert’s reliability under the abuse of discretion standard, which is the same standard used to review the admission or exclusion of expert testimony. When seeking expert testimony, it is critical that the expert’s credentials and methodology be sufficient to withstand court scrutiny.

The First Sale Doctrine under Copyright Law

A copyright owner’s right of distribution is limited by the first sale doctrine, which is an exception to the Copyright Act. The first sale doctrine is a legal principle that limits the rights to control content after a work has been sold for the first time. The first sale doctrine states that once a copyright owner sells a copy of his or her work to another, the copyright owner relinquishes all further rights to sell or otherwise dispose of that copy.

A distinction not always recognized is that ownership of the physical item, such as a book or a CD, is not the same as owning the copyright to the work embodied in that item. Under the first sale doctrine, ownership of a physical copy of a copyrighted work permits the owner of the item to lend, resell, give away and destroy the copyrighted item, but the owner is not granted the right to copy the item in its entirety. That is because the transfer of the physical copy does not include transfer of the copyright to the work. The legal principle applies to physical items as well as digital content that is downloaded over the Internet.

The first sale doctrine allows the purchaser to transfer a particular, legally acquired copy of protected work without permission once it has been obtained. That means the distribution rights of a copyright holder end on that particular copy once the copy is sold. The first sale doctrine prohibits renting and leasing recorded music and computer software, although private non-profit archives and libraries are allowed to lend these items provided they include a copyright notice on the copy. According to the Copyright Act, consumers cannot make copies of computer programs contrary to a license, but may resell what they own.

The Supreme Court unanimously ruled that the first sale doctrine applies to copyrighted goods produced in the United States and sold in foreign markets. The Court held that the first sale doctrine prevents copyright owners from controlling the importation of copyrighted goods sold outside the United States. The Court found that the Copyright Act gives copyright owners the right to control the importation of copies into the United States as an extension of the copyright owner’s exclusive right to distribute copies.