Newsletter for Leaders in the Medical Device Industry – March 2011

24 March 2011 Publication
Authors: Nathan A. Beaver

Legal News: Medical Devices

Proposed Radio License Seeks to Advance Wireless Medical Device Innovation
By Michael S. Kramer (mkramer@foley.com)

The FCC has proposed a new experimental radio license that is intended to facilitate development of wireless medical devices. The medical program experimental license would allow institutions to conduct ongoing research and experimentation related to development of new medical devices that utilize wireless technology under a single FCC authorization. The license could streamline product development by eliminating the need to obtain multiple experimental licenses to develop and evaluate wireless medical devices. By establishing the new license, the FCC hopes to cultivate test beds for medical device innovation that will attract research and facilitate commercialization of new wireless medical devices. 

The proposal was announced in a Notice of Proposed Rulemaking published by the FCC on November 30, 2010. “Promoting Expanded Opportunities for Radio Experimentation and Market Trials under Part 5 of the Commission’s Rules and Streamlining Other Related Rules,” FCC 10-197, http://tinyurl.com/4hazob8. In the publication, the FCC also proposed two additional licenses intended to foster research and innovation: a research program license and an innovation zone program license

A licensee under the proposed medical program license would enjoy a blanket experimental use authorization that would offer significant flexibility over the types of tests and the range of products that could be evaluated. The license would be available to institutions that create and manage medical device test beds, such as research and teaching hospitals and other institutions. Device manufacturers, developers, and other researchers could partner with the licensed institutions to conduct testing under the institution’s license. By channeling licensing through institutions, the FCC looks to balance freedom of development with management of logistical and certain technical aspects of experimental radio testing activities.

The license would cover activities related to the evaluation of wireless devices for therapeutic, monitoring, diagnostic, or RF ablation purposes that have not been submitted for equipment certification. Developers of wireless medical devices teamed with licensed institutions would have broad ability to test and assess operational readiness of experimental and new devices under a single license without obtaining FCC pre-approval for evaluations. For example, devices tested, radio frequency bands used, and technical characteristics of evaluations may be established as appropriate without prior FCC approval. 

The proposed license would have a five-year duration that could be renewed. Licensee institutions would be required to comply with certain FCC reporting requirements describing testing that had been conducted. Although reports would be made available to the medical community in order to foster technical advances, confidentiality over proprietary technology and information would be maintained. Under the proposal, licensees would submit an annual activity report and submit a summary report of findings to the FCC within 30 days of completing a test. 

Because the proposed license is intended to facilitate innovation, testing would be limited to evaluation of new devices. Accordingly, the existing experimental radio license program will continue to be available to support other experimental activities as well as licensees that do not qualify for the proposed license. To further facilitate innovation of wireless medical devices, the FCC also is proposing to simplify existing rules and expand opportunities for market trials of wireless devices such as streamlining investigational device exemptions (IDE) for wireless medical devices evaluations involving patients. 

The wireless medical device field is viewed by the FCC as ripe for significant innovation that could lead to economic growth. The medical program experimental license is intended to accelerate innovation in this area and shorten the time needed to bring new wireless devices to market.

FDA Announces Plan to Improve 510(k) Process in 2011
By Nathan A. Beaver (nbeaver@foley.com)

On January 19, 2011, FDA released its “Plan of Action for Implementation of 510(k) and Science Recommendations.” See http://tinyurl.com/6hsd43h. This plan announced that the Center for Devices and Radiological Health (CDRH) intends to take 25 actions to improve the 510(k) program in 2011. This plan is the outgrowth of two internal working groups set up by CDRH in September 2009 to address industry concerns that the 510(k) process was too unpredictable, inconsistent, and not transparent enough, while also addressing concerns from consumer groups that the process was not robust enough to protect patients. At the same time CDRH undertook this review, it also asked the independent, nonprofit Institute of Medicine (IOM) to study the program. IOM’s review is still underway. While these actions should provide guidance in several important areas, they also may place significant new burdens on the industry that may not be well received.

The Plan states that between June and December 2011, CDRH will issue eight new guidance documents. The most significant of these are:

  • Issuing new clarification of when a device modification requires a new 510(k) submission, and which device modifications are eligible for a Special 510(k) (June 15, 2011). Though additional guidance is needed in this area, industry concerns are that the guidance may require industry to file additional 510(k)s not required under current guidance.
  • Streamlining the de novo process for lower-risk devices that lack a predicate but do not require a PMA (September 30, 2011). The current process is very lengthy, and the hope is this guidance will shorten the time needed for the process.
  • Clarification of the 510(k) Paradigm to provide greater clarity regarding when clinical data should be submitted to support a 510(k), the appropriate use of multiple predicates, resolving discrepancies between the 510(k) flowchart and the Federal Food, Drug, and Cosmetic Act, and development of 510(k) summaries to ensure their accuracy (September 30, 2011). This guidance, while potentially helpful, may lead to increased burdens on industry.
  • Clarification on how to appeal CDRH decisions, including decisions to rescind a 510(k) (October 31, 2011). Because there are currently no timeframes for CDRH to deal with appeals, such efforts often drag on too long.

FDA also has proposed the issuance of three new regulations before the end of the year:

  • A rule regarding implementation of a Unique Device Identification system, designed to permit the rapid and accurate identification of device to facilitate and improve adverse event reporting and device specific problems (June 30, 2011).
  • A rule to track transfers of 510(k) ownership (December 30, 2011). Currently 510(k) holders are not required to notify FDA when they transfer ownership though, in practice, many often do. This should ease the process and provide FDA with a mechanism to process such transfers.
  • A rule to clarify the statutory listing requirements for the submission of labeling (December 31, 2011). This regulation will likely require manufacturers to submit current labeling as part of their annual listing submissions.

Though the proposals that CDRH has indicated it intends to issue are significant, the plan also defers a number of the most controversial proposals, including:

  • A recommendation to seek greater authority to require post-market surveillance as a condition for clearance of some devices
  • Instituting a new IIb classification for devices in which clinical or other information would typically be required to demonstrate substance equivalence
  • New authority for FDA to consider “off-label” use when determining the “intended use” of a device
  • Defining the scope and grounds for rescinding a 510(k) clearance and/or to clarify when a device should no longer be permitted for use as a predicate

With respect to these more controversial proposals, FDA intends to wait until IOM issues its review later this year. Despite this deferral of certain proposals, it is clear that CDRH has publicly announced an aggressive schedule that has the potential to alter the regulatory landscape in significant ways. Key to these proposals is whether these will ease the regulatory burden for industry or create new hurdles. Though time will tell, that time is coming quickly.

Complying With Strict PTE Deadlines* 
By Jacqueline Wright Bonilla (jwrightbonilla@foley.com)

Patents can have a huge impact on business profitability and R&D decisions. Consequently, the term of a patent is critical. Avenues exist under statute to extend a patent term under certain circumstances, including patent term extension (PTE) under 35 U.S.C. § 156. Patentees may apply for PTE for patents directed to certain products including drugs, biologics, and medical devices that go through an FDA regulatory approval process before marketing.

One may recover a maximum of five years (where total term cannot exceed 14 years from FDA approval date) to compensate for patent term lost while the product undergoes the FDA investigation period and approval process.

In recent years, many have discussed when exactly a patentee must request a PTE from the USPTO. Under § 156(d)(1), a patentee must submit a PTE application “within the sixty-day period beginning on the date the product received permission” to commercially market or use the product. The USPTO determines the timeliness of the application. If a patentee misses the 60-day deadline, they miss the opportunity for PTE, which can have significant consequences.

Many believe PTE deadline provisions present a significant trap for the unwary. Such a trap panned out in Medicines Company v. Kappos. Here, PTE would extend the expiration of a patent from March 2010 to December 2014. Nearly four years of PTE is significant, especially for a blockbuster drug earning big dollars every day in the absence of generic products in the market.

In this particular case, the FDA faxed an approval letter to Medicines Company relating to Angiomax® on Friday, December 15, 2000, at 6:17 p.m. Medicines Company filed its PTE application on February 14, 2001. The USPTO rejected the application as untimely. Medicines Company argued that because the FDA sent its letter after hours on a Friday, the 60-day time period began on the next business day, i.e., Monday, December 18, 2000, thereby rendering the PTE application timely filed.

After years of back and forth, the USPTO issued a decision in 2007, again finding the PTE application untimely. Previously, when applying the 60-day deadline, the USPTO started the count on the first day after the FDA approval date. In 2007, however, the USPTO stated it would begin counting the FDA approval date itself as one of the 60 days. The USPTO likewise rejected the “business day” interpretation, and concluded Medicines Company filed its PTE application two days late.

The company eventually filed suit in 2010. The U.S. District Court of Eastern District of Virginia determined that the proper interpretation of § 156(d)(1) was a business day construction. The district judge explained that this interpretation “is consistent with the remedial nature of § 156(d)(1) by limiting the unnecessary and arbitrary loss of property rights,” as well as the “notice function” of the statute. Thus, nearly 10 years after filing its PTE application, Medicines Company achieved a favorable result.

This may not be the end of it, however. Although the government did not appeal, APP Pharmaceuticals (APP), an amicus curiae party, filed a Motion to Intervene on August 19, 2010. The district court denied APP’s motion in September, and APP appealed to the Federal Circuit.

By brief, Medicines Company argued that the court should deny APP’s appeal for lack of standing, or in the alternative, bifurcate APP’s appeal regarding intervention and stay its appeal on the merits. By Order on February 2, 2011, the Federal Circuit denied Medicines Company’s motions, potentially leaving issues up for grabs.

To date, no other patentees who have filed an “untimely” PTE application by one to three days have successfully taken advantage of Medicines Company. This decision could be used as evidence in a dispute regarding timeliness of a PTE application filing, especially as it relates to a business day interpretation, or even “the remedial nature of § 156(d)(1).” At least one judge wished to avoid “unnecessary and arbitrary loss of property rights” based on a procedural formality.

Genetics & IVF Institute (GIVF) filed suit in the Eastern District of Virginia on September 1, 2010, regarding an application for an “interim” PTE relating to a medical device still undergoing FDA regulatory approval. Section 156(d)(5)(A) provides that a patentee may apply for an initial interim PTE for up to one year while a product is undergoing FDA review if the patentee “reasonably expects” that the FDA review period “may extend beyond the expiration of the patent term in effect.”

A patentee also may apply for up to four subsequent one-year interim PTEs. Under § 156(d)(5)(C), each subsequent application “shall be made during the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension.”

GIVF filed a petition with the USPTO for an extension of time to file an application for a second interim PTE. The 30-day period for filing the second interim application ended on July 6, 2010. GIVF filed its petition on July 27, 2010, arguing that the USPTO had discretion to authorize the request under federal rules. GIVF stated that “with the exception of mild tardiness,” its application satisfied all statutory criteria. Thus, “the time window under § 156(d)(5)(C) is simply a matter of procedure.” The USPTO denied the petition, stating it did not have discretion to act. In its court case, GIVF argues, among other things, that the USPTO ignores Medicines Company “in which this Court definitively held that all provisions of a remedial statute, in particular those involving timing, should be construed liberally.”

It remains to be seen what the district court (or Federal Circuit) will do with such cases, or what exactly the USPTO will do going forward when considering close-call situations.

Legislative Efforts

Medicines Company also engaged in lobbying efforts for remedial legislation. In 2006 and 2007, it pursued legislation granting the USPTO discretion to consider PTE applications filed unintentionally late. While gaining some traction, efforts ultimately stalled. In 2008, lawmakers proposed that if an applicant files a request for acceptance no later than five business days after the 60-day period expires, the USPTO may accept an unintentionally late PTE application filed no later than three days after the 60-day period expires. The patentee must pay a hefty fee ($65 million in the case of Medicines Company), however, for the PTE to go into effect.

Medicines Company again lobbied for, and lawmakers proposed, similar legislation in 2009 and 2010. The latest version, introduced in May 2010, again died without passage. To move forward in 2011, lawmakers will need to introduce fresh legislation.

With Medicines Company’s potential win in court, it is not clear who, if anyone, will continue to push for such legislation going forward. That said, there are likely to be others who have fallen, or will fall, into the trap that ensnared Medicines Company.

Time periods for filing PTE applications are short and specific. Without meticulous attention, patentees can easily miscalculate, misinterpret, or miss filing deadlines. In light of the potential value of a PTE, those seeking market approval will want to encourage regulatory and patent representatives to communicate regularly.

Understanding the ease of potential misstep, it is helpful to those preparing PTE applications to be aware of relevant regulatory activity, and begin preparing a PTE application before a deadline clock starts ticking.

*Published by Genetic Engineering & Biotechnology News, March 1, 2011 (See http://tinyurl.com/6f3c8jt.)