Informing

edtronic Inc. (MDT), the world’s biggest- maker of heart rhythm devices, said it is planning for a U.S. tax on medical products that will cost the company $125 million to $175 million annually starting next year.

Medtronic, which reports earnings on a fiscal calendar that ends April 30, will provide a forecast for the 2013 year in May. The estimate will include four months during which the company was subject to a 2.3 percent excise tax on medical devices that was part of the 2010 health-care law, Chief Financial Officer Gary Ellis said.

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As of 7 March, medical device and drug companies will have to start complying with a new US informed consent rule to notify potential participants in certain trials that information on the trial has been, or will be, included in the publicly accessible databank, www.ClinicalTrials.gov.

Thousands of heart patients can take advantage of new technology at two Piedmont hospitals that makes their lives much easier.

Cone Health and Forsyth Medical Center are part of a pilot program testing Carelink Express by Medtronic. Carelink allows doctors to collect information from defibrillators and pacemakers in five minutes, much faster than before.

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Look for new dealflow, new investor faces and new funds in Research Triangle Park throughout the year.  At the moment, the life science investing opportunities can look pretty dry. Intersouth Partners, a Durham, North Carolina venture capital firm, has about two deals left until its current fund runs out. The same probably goes for Durham-based Pappas Ventures.

But Intersouth and Pappas won’t be dry for long. Local members of the life science sector say both groups will start to raise new funds later this year (Intersouth said as much but wouldn’t confirm a timetable for the new fund; Pappas didn’t respond for comment).

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Life sciences property owner and developer Alexandria Real Estate Equities (NYSE:ARE) aims to create a network of life sciences hubs across the country and the firm has made a Research Triangle Park, North Carolina acquisition its first move in the strategy.

The Hamner Institutes for Health Sciences‘ headquarters has been sold to an Alexandria affiliate for $20 million. Alexandria is already RTP’s largest real estate player and operates 840,000 square feet of lab and office space. Overall, the firm operates more than 12.4 million square feet of space in key life sciences clusters including San Diego, San Francisco, the greater Boston area and suburban Washington, D.C.

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Patient advocacy group Consumer Union petitions the FDA to implement more stringent oversight for medical devices in the new medical device user fee agreements, to prevent the public from being used "as guinea pigs when it comes to something as important as a medical implant."

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The medical device industry, unsurprisingly, really hates a 2.3 percent excise tax that's going into effect next year. Industry groups and companies have warned for months that if the tax should drop in January 2013, as planned, it could drive jobs overseas as firms scramble for ways to control costs.

On Monday, 75 freshmen congressional Republicans wrote a letter to House GOP leadership asking them to bring to the floor H.R. 436, the Protect Medical Innovation Act of 2011, which would repeal the tax. The bill, introduced in January 2011, is the brainchild of Rep. Erik Paulsen, a Republican who hails from Minnesota, a med tech hub and home to industry giants like St. Jude Medical and Medtronic. The bill currently has 228 cosponsors, all but a handful of whom are Republicans, according to GovTrack, and it's still working through committee.

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I was talking with Steve Sarussi and Joe Milligan the other day and learned about the Leahy-Smith America Invents Act that was passed last September.  Cindy and Dan work more on the companies at that stage than I do and I thought there may be others that didn't know about this either. 

Here's what you need to know:

1.The AIA changes the system of awarding patents from a first to invent system to a first inventor to file system.

2.The AIA expands prior art to include foreign public uses and offers for sale. Under current law, third party uses and sales of the same invention abroad are not bars to patent protection in the U.S.

3.The AIA creates two new administrative procedures in the USPTO that enable third parties to challenge the validity of a granted patent.

4.The AIA eliminates failure to disclose best mode as an invalidity defense.

It's been a long year waiting, but the medical device industry and the FDA signed off on a tentative agreement for the next 5 years of med-tech user fees.  The result is the industry's expected buy-in will nearly double; and the FDA will be expected to do more than it has prior.

MDUFMA (Medical Device User Fee & Modernization Act) tentatively raises user fees to $595 million over five years.

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Ischemic stroke is the target of a new partnership between Oxygen Biotherapeutics (NASDAQ:OXBT) and Aurum Biosciences that aims to develop a diagnostic and a treatment for the condition.

The agreement will pair the companies’ respective technologies: Aurum’s magnetic resonance imaging (MRI) technology has the potential to map salvageable tissue in the brain after a stroke and Oxygen’s technology is being studied as a way to enhance oxygen delivery to the brain. The agreement expands a research pact reached last summer when the companies decided to work together on preclinical stroke research.

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