In a battle of titans, Edwards Life Science and Medtronic have squared off in a patent infringement case in which Edwards claims Medtronic is willfully infringing on its patents in offering Medtronic’s CoreValve product.
Excerpt of article on “The Recorder”.
Thursday’s filings are the latest development in a case that vividly sets a private company’s patent rights against public access to potentially lifesaving technology. At issue is the fast-growing market for artificial valves that can be inserted via the transfemoral vein and inflated into place inside the aorta, without open-heart surgery. Though the devices were first approved by the Food and Drug Administration only three years ago, the market is already estimated to be worth $500 million in the United States.
U.S. District Judge Gregory Sleet of Delaware on April 11 enjoined Medtronic from selling its valves, which a jury found—and the Federal Circuit has agreed—willfully infringed a version marketed by Edwards. Sleet acknowledged that Medtronic’s CoreValve product can be used on a wider variety of patients, and that it’s “safer” and leads to “better outcomes with a lower risk of death.”
“At the same time,” Sleet said, “the court cannot downplay the strong public interest favoring enforcement of patent rights.”
Kroll, the risk management consulting firm, released its 2013 survey of the life science industry.
“After having some of the lowest fraud figures in the 2012 survey, in this year’s report the healthcare, pharmaceutical and biosciences sector has the third-highest overall sectoral incidence of fraud (74%), along with one of the largest proportions of respondents seeing an increase in fraud exposure (85%).”
Our friends at Bryan Cave have prepared the following update.
The Federal Trade Commission (“FTC,” together with the Department of Justice Antitrust Division, the “Agencies”) has published its final rule implementing amendments to its regulations under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (“HSR Act” or “Act”).
The amendments, which will become effective on December 16, 2013, provide that the transfer of exclusive patent rights in the pharmaceutical industry may be reportable under the HSR Act where “all commercially significant rights” to that patent, for use in any therapeutic area or indication, are transferred.
While it has long been the Agencies’ position that transfers of exclusive patent rights can potentially be reportable under the Act, the amendments formalize that approach and also clarify that the retention of limited manufacturing rights or co-rights does not impact the potential reporting obligation that may arise as a result of the proposed transfer.
More stringent HIPAA compliance rules went into effect on September 23rd following their announcement last January.
While many in the healthcare industry are compliant, a survey by Coalfire, a risk assessment firm, indicates that many firms that serve the healthcare industry and now fall under the definition of “Business Associates” are not fully compliant.
This gap in compliance by business associates, while likely unintentional, opens their healthcare industry customers to liability.
Monitoring the twists and turns of the battle between Myriad et al and competitors over the freedom to use genetic tests will run for some time and will likely have significant influence on the industry.
I’m monitoring this battle using genomeweb.com via a subscription obtained at the recent AACC in Houston, Tx.
The America Invents Act brings many significant changes to US patent law, the most fundamental of which is the shift from a first-to-invent system to a first-inventor-to-file system. Kenley K. Hoover, Ph.D., a director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox P.L.L.C., discusses issues and challenges the First-Inventor-to-File regime has brought to the biotechnology industry, as well as the strategies that members of the biotechnology sector have adopted in response to these challenges.