Medical Device Daily Washington Editor

The Dec. 7 warning letter to BioCheck (Foster City, California) reflects FDA's tighter scrutiny of product labels, which has not been a common theme for makers of diagnostic test strips and reagents, but which has nonetheless cropped up a couple of times recently. In a situation with similar themes, ARJ Medical (Oldsmar, Florida) snared a July 16 warning letter for the labels attached to the test strips the firm sells (Medical Device Daily, July 30, 2010), and the agency cites BioCheck for making promotional claims on labels and in product inserts for several reagents that were apparently offered for sale, requesting that the company pull back any unused inventory from the market.

The inspection took place between June 10 and July 20, suggesting that FDA and the firm spent some time hashing out the related regulatory and/or legal issues, and the warning letter states that the product inserts for at least four reagents included “intended use statements, test, preparation, and calculation methods,“ which the agency argued made them marketed devices. FDA states further that BioCheck was “promoting and marketing these devices in violation“ of the law.

Among the violative promotions was for an enzyme immunoassay test kit for human cardiac-specific fatty acid binding protein, the product insert for which FDA says described the reagent as “a sensitive biomarker of myocardial necrosis that can be used to confirm or exclude a diagnosis of acute myocardial infraction and for monitoring of a recurrent infarction.“ The label is said to describe the product as “a potential serum biomarker for stroke that is superior to“ either of two other tests, including neuron-specific enolase.

The warning letter cites similarly violative label and product insert statements for enzyme immunoassay kits for prostate-specific antigen and carcino-embryonic antigen, and an enzyme-linked immunoabsorbent assay for rubella.

Toward the end of the warning letter, FDA acknowledges a response to the inspectional findings, although the date of that response is not listed. The agency apparently found the firm's responses to four of the findings on the inspectional form adequate, although it is not clear how those correlate to the findings listed in the warning letter. The warning letter states that BioCheck's response did not address an inspectional finding related to an internal investigation into a quality failure, and states further that “the establishment of a written agreement for products not cleared by the FDA does not exempt you from distributing unapproved devices.“

FDA further indicates that the company recalled its cardiac test kits, although the agency still had issues with the other kits, which the warning letter states were still in distribution. The agency closed the warning letter asking that the firm's response to the warning include information on what BioCheck intends “to do with existing stock and products in the field that have been previously shipped and are still in stock“ as well as any reagents that are not cleared, approved, or the subject of an investigational device exemption.

Anna Pao, director of administration at BioCheck, told Medical Device Daily, “we're going to have a meeting with FDA this morning with our consultants to see if our plans meet their requirements.“

EU taking aim at a unitary patent system

Patent harmonization has been the focus of a lot of effort at the U.S. Patent and Trademark Office, but innovators have grumbled for some time that there's little in the way of harmony in the approach to patent prosecution in the European Union. However, according to a Dec. 14 statement at the website for the European Commission, patent harmony may be en route on the continent.

The EC statement says that the commission has presented a proposal said to offer “enhanced cooperation“ in an effort to forge a patent system universal to all EU member nations, which could be obtained with a single patent application. The statement points out that obtaining a patent covering most of Europe “currently costs ten times more than one in the U.S. because of national validation and translation costs“ between the various languages dotting the continent, a state of affairs the commission acknowledges “discourages research, development and innovation, and undermines Europe's competitiveness.“ The commission had tackled a fully unified system earlier this year, the statement notes, but the EU Council of Ministers is said to have been unable “to agree unanimously on the EU patents' language requirements,“ hence the “enhanced cooperation“ approach.

The EC statement notes that a patent that is validated in only 13 member nations can run up a tab of €18,000, the bulk of which (nearly €10,000) is chalked up to translation fees, a state of affairs said to drive a lot of very selective patenting in the EU zone. The solution proposed by the commission is to “build on the existing language regime of the European Patent Office“ by making applicants eligible for “compensation“ for the cost of translating their applications into one of the three official languages, French, German and English, although the announcement offers no specifics as to how this might work in practice.

NIH reports inventions available for licensing

The National Institutes of Health is again offering a couple of inventions for commercialization, including an unusual offering for makers of cardiovascular devices. According to Tuesday's edition of the Federal Register, the agency is in possession of software “that provides the capability of efficiently extracting, visualizing and quantifying three-dimensional vascular networks from medical and basic research images.“

Noting that deregulation of angiogenesis “plays a major role in a number of human diseases, most notably cancer,“ NIH states that the software provides “new, semi-automated computer algorithms, statistical methods and user-friendly visualization tools for rapid and intuitive quantitative evaluation of vasculature in three-dimensional data sets“ obtained by several imaging modes, such as MRI, CT and confocal microscopy.

NIH says that it is not pursuing a patent for this program and is offering the software for licensing. Interested parties can contact either Uri Reichman, PhD (301-435-4616, or Michael Shmilovich (301-435-5019,

Abbott seeks five-year patent extension

Abbott (Abbott Park, Illinois) has applied for a patent extension of five years for its Freestyle Navigator continuous glucose monitoring system. According to an announcement in Tuesday's edition of the Federal Register, the company is in pursuit of a patent extension of 1,826 days based on the combined testing phase and regulatory review period.

The FR notice states that FDA is of the view that the total applicable regulatory review period comes to 2,320 days, 750 of which are chalked up to testing and the remaining 1,570 days were taken up during the FDA review. Abbott and FDA agree that the PMA for the device was approved March 12, 2008, but differ by one day on the day the application was initially submitted. FDA has that date pegged at Nov. 25, 2003, whereas Abbott claims the previous day is the appropriate date for the application.

Any parties interested in commenting for the record may do so by filing for the FDA docket. For further information, contact FDA's Beverly Friedman at 301-796-3602.

Mark McCarty, 703-268-5690