PTO’s Proposed Rule Changes Halted (for Now)
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Limbach
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In the United States, the patent laws and rules for implementing them have traditionally been remarkably staid and free of drama. For the past several years, however, that long tradition has seemed destined to undergo significant change as a result of new rules proposed by the U.S. Patent and Trademark Office (PTO).
Implementation of those proposed changes has been on hold since last fall, when the federal district court for the Eastern District of Virginia issued a temporary restraining order. But a ruling issued by the court at the beginning of this month has now stopped PTO’s proposal in its tracks—at least for the time being. In this issue, Douglas C. Limbach and David C. Cohen of Shay Law Group LLP (San Mateo, CA) review the roots and implications of the court ruling in Tafas and GSK v. Dudas—and how PTO and Congress may be preparing to respond. [More]
The permanent injunction came as a relief to many medtech executives who were preparing revised patenting strategies in light of the rule changes. However, such relief may be fleeting, as PTO still has several options left in pursuing its desired patent rule changes. In this companion article, industry experts provide additional details on PTO’s possible courses of action. [More]
Positive Studies Boost Stent Manufacturers as
Market Competition Heats Up
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Weiner
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Following nearly two years of negative reports and speculation regarding the safety of drug-eluting stents, manufacturers of the devices had to be pleased with the almost universally positive clinical findings presented at the recently held joint meeting of the American College of Cardiology (ACC; Washington, DC) and the Society for Cardiovascular Angiography and Interventions (SCAI; Washington, DC) in Chicago.
The most significant outcome of the meeting was the general consensus among researchers and industry analysts that drug-eluting stents, while continuing to demonstrate superior performance in preventing restenosis, do not present a greater risk of late-term thrombosis than their bare-metal counterparts. Concerns regarding late-term thrombosis “have been largely put to rest now that we have a much larger body of data,” said SCAI president Bonnie Weiner, MD. [More]
Massachusetts Bill Would Ban All Gifts to Physicians
Sommer |
Last month, the Massachusetts State Senate unveiled a far-reaching healthcare reform bill that would, among other provisions, impose a ban on all gifts to healthcare providers and their immediate family members. The state senate passed the legislation on April 17, leaving the gift ban provision intact, says Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic; Boston). “In addition, an amendment was approved that would establish a licensing procedure that would require sales reps and any other life sciences company reps to obtain a license and pay an annual fee of $500 to interact with healthcare professionals in the state,” Sommer says. “We’re working with key members of the Massachusetts House to knock this provision out of the bill.”
Following the bill’s introduction in the senate, MassMedic sent a letter to all members of the Massachusetts State Senate, voicing strong opposition to the gift ban provision. In the letter, Sommer stated, “While MassMedic applauds the senate’s efforts to contain healthcare costs and promote transparency in the healthcare system, we are concerned that Section 22 of the legislation, the Pharmaceutical Industry Gift Ban, will have a negative effect on the ability of medical device manufacturers to provide the training and education necessary to operate a range of innovative medical products.” [More]
Remote Monitoring Market Poised for Growth
Ubl |
Earlier this month, Representative Anna Eshoo (D–CA) introduced the Medicare Remote Monitoring Access Act of 2008 in the House, which would provide reimbursement coverage for remote patient management services for certain chronic health conditions.
Stephen J. Ubl, president and CEO of industry association AdvaMed (Washington, DC), applauded the bill’s introduction, as well as the potential that remote monitoring holds for enhancing patient care and reducing healthcare costs. “What was once only science fiction is now patient care reality,” he stated. “With remote monitoring technologies, a physician can evaluate and manage complex chronic diseases from remote locations and provide real-time care for patients. Unfortunately, the adoption and widespread diffusion of such innovations have been stymied by antiquated reimbursement systems.”
Kalorama Information (New York City) reports that the development of remote monitoring technologies is being driven by current healthcare trends, including an aging population and a shortage of healthcare workers, as well as the advent of new wireless technologies. In a new report, High-Tech Patient Monitoring Systems, the market research firm reports that U.S. sales of new-generation patient monitoring systems added up to an estimated $3.9 billion dollars for device manufacturers in 2007—a figure that could more than double in five years. [More]
IP Watch: Appeals Court Upholds Victory for Stryker, Karl Storz
Surrette |
On April 10, the U.S. Court of Appeals for the Federal Circuit handed a definitive victory to Stryker Corp. (Kalamazoo, MI) and Karl Storz Endoscopy-America Inc. (Culver City, CA) in a patent infringement case that lasted nearly six years. In its ruling, the court affirmed that the companies did not infringe certain patents held by Luma Corp. because the patents were invalid.
The decision upholds an earlier summary judgment of noninfringement and invalidity by the U.S. District Court for the Southern District of West Virginia. According to McAndrews, Held & Malloy (Chicago)—Stryker’s legal counsel during the case—Luma filed the suit in September 2002, alleging that the companies infringed 10 claims of Luma’s U.S. Patent No. 5,740,801. The patent, titled “Managing Information in an Endoscopy System,” relates to a system for acquiring and storing images during a medical procedure. Bob Surrette, a shareholder at McAndrews, Held & Malloy, notes that the ruling effectively brings an end to the plaintiff’s case. “The federal circuit found that the district court did not commit any errors in construing the claims when granting the summary judgment,” he said.
Read more about this case and other industry patent news in this month’s edition of “IP Watch.” [More]
