Medical Device Daily Washington Editor

Stent maker Cordis (Miami Lakes, Florida) recently won an appeal of a patent lawsuit filed against the firm in 2003 by Boston Scientific (Natick, Massachusetts) in a case that is widely seen as an indicator of the effects of a Supreme Court decision dealing with the obviousness of a patent.

Whether Boston Scientific will appeal the Jan. 15 decision by the Court of Appeals for the Federal Circuit (CAFC) is unclear. According to a Jan. 15 announcement at the company's web site, the firm "is considering its options for challenging the decision."

Boston Scientific's 2003 lawsuit against Cordis alleged that the design of the latter's Cypher stent infringed on two patents, one of which dealt with a dual-layer coating for drug elution and the latter with the geometry of the stent's struts.

According to CAFC documents, the district court upheld the jury verdict – and Boston Scientific's contention – that patents other than the plaintiff's did not teach or suggest a two-layer patent, which made the two-layer coating non-obvious and hence an infringement by Cordis. However, Cordis countered with the assertion that a patent owned by Medtronic (Minneapolis) known as the Wolff patent discussed a two-layer coating. This patent, which is said to have pre-dated Boston Scientific's Ding patent, was apparently not part of the filing Boston Scientific offered the U.S. Patent and Trademark Office in pursuit of its patent.

The first court case was decided by a jury in 2005 in favor of Boston Scientific. Cordis appealed to the U.S. District Court for the District of Delaware later that year, but the district court denied Cordis' motion to dismiss the case the following year.

The Jan. 15 CAFC decision is widely thought to hinge on the case of KSR v. Teleflex, a case the Supreme Court decided in April 2007. The KSR decision is seen as completely overturning the notion of patent obviousness and the fact that the Supreme Court's verdict was unanimous seems to have widely stamped a more lenient standard for claiming the obviousness of a patented article.

Boston Scientific and Cordis have tangled before. A number of sources cite lawsuits between the two firms over allegations that Boston Scientific's Taxus stent infringed on Cordis' now-expired Palmaz patent for balloon-expandable stents, a case that was decided in Cordis' favor in the Delaware district court in 2005. The same court is said to have rendered another blow to Boston Scientific that same year involving charges that the Liberté and Express bare-metal stents infringed on the so-called Gray patent by Cordis, which deals with flexible balloon-expandable stent designs.

However, the stent patent wars go beyond these two companies, as a search of federal district court filings at the web site dockets.justia.com shows, with patent lawsuits flying left and right between virtually all the major players in the coronary stent market.

KSR may or may not have played a role in Jan. 27 announcements by Boston Scientific and Medtronic that the two firms would drop a series of patent lawsuits between the two. However, two of the suits filed by Medtronic also named Abbott Laboratories (Abbott Park, Illinois), and Medtronic indicated it will continue its suits against Abbott. Both announcements, which were almost identically worded with the exceptions of statements attributed to company executives, noted that the firms had agreed to settlements in two of the cases and to stand down in the other three. Both firms also state that the agreement will have no material effect on company finances.

Calls to Boston Scientific had not been returned at press time.

FDA globalization bill resurfaces

Concerns over the ability of FDA to handle its continually expanding role have routinely been overshadowed – for much longer than a decade – by disinterest on the parts of the Bush and Clinton White House and Congress to boost the agency's funding, but that fact has done little to blunt interest in pushing the agency to do more.

According to a Jan. 28 statement released by Rep. Frank Pallone (D-New Jersey), the chairman of the health subcommittee of the House Energy and Commerce Committee, a new bill dubbed the Food and Drug Administration Globalization Act of 2009, is "a critical step toward equipping ... FDA with the authorities and funding it needs to regulate what is now a global marketplace for food, drugs, devices, and cosmetics."

The Jan. 28 statement also notes that the bill "requires parity between foreign and domestic drug and device facility inspections [and] increases the number of pre-approval drug inspections, a mandate that presumably applies to device facilities as well. The statement also notes that the bill "also creates a dedicated foreign inspectorate to increase FDA's ability to monitor foreign facilities producing food, drugs, devices, and cosmetics." Pallone also acknowledged that lack of attention to FDA's budget has resulted in "years of starving FDA of resources," but makes no mention of a specific increase in the agency's budget.

In a Jan. 29 statement, Steve Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), commended the bill's sponsors "for their leadership in introducing this important piece of legislation." Ubl also said AdvaMed "strongly support[s] a well-resourced FDA and the goal of ensuring the safety and quality of FDA-regulated products imported into the U.S." adding that AdvaMed "believes inspections are a core function of FDA's mission to protect and promote the public health and have long advocated that Congress provide appropriate funding for the agency."

Last year's iteration of this bill would have required that foreign drug and device facilities be inspected every two years, according to a discussion draft, and would have required documentation for imported drugs and devices as to the nation of origin. The FDA Globalization Act of 2009 would also have given the Department of Health and Human Services "the same authority for detention of drugs as is currently available for devices."

Calls to the House Energy and Commerce staff for further information were not returned.

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