Medical Device Daily Washington Editor

FDA recently filed its report on the operations of the Office of Combination Products (OCP) for fiscal year 2006, and while the number of applications fell slightly from the previous year, the agency had to work harder to get the applications classified, hinting that combo products will stretch the agency’s resources for years to come.

In the cover letter, FDA commissioner Andrew von Eschenbach, MD, said that the agency “is receiving significantly more combination products for review as technological advances continue to merge product types and blur the historical lines of separation” between devices and other types of therapeutic products.

The FDA chief also noted that OCP “has made significant progress in enhancing the regulatory transparency and predictability of the combination product lead center assignment and review process.” The cover letter said that “one large industry trade association” wrote to FDA to state that OCP “has done an excellent job in meeting the goals outlined in MDUFMA in spirit and in practice.” However, the letter did not attribute that passage to a specific party.

In the document’s executive summary, FDA said that OCP had “issued 26 combination product RFD (requests for designation) in the last fiscal year” and that the agency had satisfied all those requests within the required 60-day period. The announcement did not say whether the 60-day period was of statutory or regulatory origin.

The number of RFDs tailed off slightly in FY 2006 from the previous year, dropping from 273 to 231. Still, that 15% decrease was offset by an increase in intercenter consultations from 275 to 335, perhaps a reflection of the complexity of the applications that OCP had to adjudicate. FDA approved five new combination products in FY 2006 and so far in the current fiscal year, only two.

FDA published a final rule in November 2005 that determined how OCP assigns jurisdiction over a combination product. A combination product is assigned to one of the centers based on the product’s primary mode of action, defined as the mode that “provides the most important therapeutic action.” Should an analysis of the primary mode of action prove indecisive, the product is assigned to the center with the most familiarity with products that raise similar safety/efficacy questions.

According to an appendix attached to the report, the most common type of application in FY 2005 by characteristic of intended use was for devices coated or impregnated with a drug, which accounted for 78 applications. Tied for second were pre-filled drug delivery/device systems and a category described as “possible combination based on mutually conforming labeling of separate products.” Other categories rounding out the 273 products that OCP handled in FY 2005 included devices coated/impregnated with biologics at 18, and convenience kits at 12 applications.

More than half the applications, or 156, ended up at the Center for Drug Evaluation and Review as investigational new drug applications, and another 78 were sent to the Center for Devices and Radiological Health (CDRH) as “original” 510(k) applications. CDRH also reviewed 26 applications from OCP as investigational devices.

OCP currently has seven full-time, dedicated staff members and anticipated the number will rise to 11 “when financial resources to support” the increase are available.

PTO proposes tighter application requirements

The U.S. Patent and Trademark Office (PTO) issued a set of proposed new rules for helping the agency’s patent examiners get a better handle on the language used to describe patents, and according to the press release that accompanied the publication of the rule in the Aug. 10 Federal Register, the proposed ruling may have a substantial impact on the filing of patents for healthcare products.

The proposed rule will give examiners better tools to examine “claims that contain more than one independent and distinct invention,” according to PTO, which indicated that “the current practice of listing multiple inventions in the alternative in a single claim” is “especially prevalent in the pharmaceutical, chemical, and biotechnology fields.” PTO proposes to require that applicants “identify, with more specificity, the claimed invention to be examined, thus promoting examination quality.

The commissioner of patents, John Doll, said that the agency “believe[s] such a rule change will lead to a more focused examination process that will effectively promote innovation.” PTO’s press release also said that the agency will accept comments until Oct. 9 and that no public hearings will be held. These proposed rules will be followed later this month by rules addressing continuations of patent claims, according to the press release.

The notice in the FR states that the use of Markush language in describing a patent application is one of the primary drivers of the proposed rule. Markush language is named for Eugene Markush, who in 1923 filed a claim for a patent for a method of dying wool and silk, and named a number of chemicals and even classes of chemicals as part of that process. Markush’s initial application failed for lack of specificity, but the Commissioner of Patents granted the claim on appeal the following year.

The FR notice states that while chemistry served as the origin for Markush-type claims, “claims that recite alternative [components] are now commonplace in all areas of technology,” and that many applicants use Markush language “to claim multiple inventions and/or to recite hundreds, if not thousands, of alternative embodiments of a single invention in one claim.”

The Patent Reform Act of 2007, which has passed both the House and the Senate and must now go to conference, does not mention Markush language.

The effort required by patent examiners at PTO is said to “consume a disproportionate amount of resources” compared to other claims, and the examination of such a claim often requires examination of each of the sub-claims. The flood of new technologies now coming out of labs all over the world has joined with the increasing use of Markush language to put PTO into a backlog on its patent applications, according to PTO.

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