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May
9
Sandeep Singh Dhillon
Abbott announces CE Mark and first use of the world’s first smartphone compatible insertable cardiac monitor
Intellectual Property Rights, Pharma News
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ABBOTT PARK, Ill., May 8, 2017 /PRNewswire/ — Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm Rx™ Insertable Cardiac Monitor (ICM), the world’s first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. The Confirm Rx ICM is designed to continuously monitor a patient’s heart rhythm and proactively transmit information via the myMerlin™ mobile app, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias.

With the launch of the Confirm Rx ICM in European CE Mark countries, Abbott has established a new paradigm in the connectivity of cardiac devices by incorporating wireless technology, which allows the ICM to communicate directly and securely to the app downloaded onto a patient’s smartphone. Traditional remote monitoring has required bulky handheld or bedside transmitters, which limit patient mobility. The new interactive myMerlin mobile app replaces these passive transmitters and empowers patients to participate in their own care.

In addition to patient convenience, the device is slimmer than currently available ICMs. The Confirm Rx ICM also offers intuitive one-touch indication-based programming, and remote monitoring via the Merlin.net™ Patient Care Network, making the technology convenient for clinicians involved in procedure and follow up.

“The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations,” said Georg Nölker, M.D., head of electrophysiology at the Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark. “The simple insertion procedure and small device size make this technology convenient for both patients and providers. Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator.”

Christopher Piorkowski, M.D., head of the Department of Electrophysiology at the University of Dresden Heart Center in Dresden, Germany, and one of the first implanters, added: “The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF.”

The myMerlin mobile app, available in over 35 languages, makes it easy for patients to stay connected to their physicians. Patients can record their symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate. Patients can also confirm their data was transmitted to their physician and get automatic alerts when they have missed a scheduled transmission, saving the clinic from having to follow up with the patient. The device also offers secure transmission of patient data. Recently, Abbott’s Merlin.net Patient Care Network received one of the medical device industry’s first Service Organization Control certifications (SOC2 certification), further confirming the safety and security of the company’s remote monitoring network.

“Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance,” said Mark D. Carlson, M.D., chief medical officer of Abbott’s cardiac arrhythmias and neuromodulation businesses. “The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers.”

Currently the Confirm Rx ICM is available in select countries in Europe, with full European release expected during the second quarter of 2017. The device is currently under review by the U.S. Food and Drug Administration. The estimated 2017 worldwide insertable cardiac monitor market is approximately $800 million and is growing by more than $100 million a year.

About Abbott:
At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Jan
8
Sandeep Singh Dhillon
Could Amgen’s Patent Victory Be Bad For Medicine? – Forbes.com
Intellectual Property Rights, Pharma News, Pharma Notables
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Matthew Herper

Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol medicine that is on the market and used by patients to be withdrawn because it infringes on the patents of a competitor. Some patent attorneys reacted with shock. (Read the ruling.)

“It’s very strange for a judge to take one product off the market when there are patients on the medicine already,” says Rachel Sachs, an associate professor of law at Washington University in St. Louis. In an extended thread on Twitter about the decision, New York Law School Associate Professor Jacob Sherkow wrote: “I am shocked.”

Regeneron and Sanofi, the biotech-Big Pharma pair-up that lost the decision, will appeal the decision, which could result in years more of legal wrangling. Despite this, Amgen, in a press release, is already saying that it can make enough of its drug, Repatha, to serve all the patients who get Regeneron’s Praluent. A 6% fall in Regeneron’s stock this morning has cost its founder, chairman and CEO, Leonard Schleifer, about $70 million of his fortune, now estimated at $1.3 billion.

But the stakes go far beyond these two companies and their investors. Drug firms frequently battle it out over drug patents. Yet it’s remained an article of faith among many executives and investors that medicines that could actually help patients are rarely actually blocked from being sold. This is why multiple teams of investors have backed different companies that seek to use the gene-editing technology CRISPR to create new therapeutics even though intellectual property around CRISPR is caught up in a high-profile patent battle between the University of California and the Broad Institute in Cambridge.

Sachs points out that in a recent case that Merck won against Gilead Sciences over hepatitis C drugs, Merck got a record $2.5 billion award. But the company didn’t even ask that Gilead’s Sovaldi be removed from the market, as is being suggested in this case. In fact, one needs to reach back a decade to find a precedent. In 2007, Tercica, a Genentech spinout, managed to get a competitor’s treatment for short stature removed from the market. Two years before that Amgen managed to block Roche’s competitor to its anemia drug Epogen from entering the U.S. market.

New drugs would not be invented and developed without strong patents. The process always costs hundreds of millions of dollars, and more than $1 billion when the industry’s failure rate is averaged in. But the patent system does not need to be so strong that it prevents any similar drug from reaching the market. In fact, usually the opposite is true. That’s why there are many similar drugs for conditions like high cholesterol, hypertension, and pain. Patients benefit because often the drugs are different from one another in important ways. Society also benefits because competition between similar medicines is one of the only things that can drive down price. Pharmacy benefit managers have been able to play these two cholesterol medicines off each other to get better bargains, which will all go out the window if this injunction holds.

In his Twitter commentary, Sherkow, the New York Law School professor, points to several weaknesses in the ruling that could result in it being overturned. The judge’s decision hinges on the idea that Amgen had suffered irreparable harm, that one can’t come up with an estimate of that harm so Sanofi-Regeneron could just pay, and that this outweighed the damage to the public interest. (Because Sanofi-Regeneron’s Praluent is available at a much lower dose than Amgen’s Repatha, it’s a different product even if the drugs turn out to be otherwise alike.) Amgen argued that because competition was lowering the prices of both drugs, the harm to it was immeasurable, but another court could disagree. It’s also possible that, rather than go through the appeal, the two companies will go back to the negotiating table to settle.

That could be what happens in the end. Sanofi-Regeneron certainly has a chance on appeal. But, as this ruling shows, you can never know for sure what a court will do. Analysts on Wall Street differ in their predictions. John Evanson at Cannacord sees a settlement being reached in which Sanofi-Regeneron pay a 6% to 9% royalty. Brian Skorney at Baird assumes a 20% royalty. But Phil Nadeau at Cowen & Co. says for Regeneron to win a stay of the injunction and the later case will be “an uphill battle” and that Amgen seems unwilling to settle.

In response to a strongly worded request for comment, Amgen pointed to a statement from its press release by Chief Executive Robert Bradway: “Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.” But that doesn’t require blocking every competitor from even begin marketed–even with infringement, a royalty would serve the same purpose, without depriving patients of choice.

One thing that the judge considered was potential damage to Amgen’s reputation. As Sherkow points out, Amgen’s reputation was not damaged by the existence of Praluent. But it may be damaged by winning. The joke about Amgen in biotech circles is that it is a law firm with a biotech company attached. That perception is only likely to get stronger now.

Then again: Never bet against a law firm with a biotech company attached.

Apr
5
ragupathyrenganathan
MorphoSys Sues Janssen Biotech and Genmab for Patent Infringement
Intellectual Property Rights, Pharma News
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Mar
24
ragupathyrenganathan
India defends right to issue compulsory drug licences
Intellectual Property Rights, Pharma News
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Nov
23
ragupathyrenganathan
Patent process to be speeded up
Intellectual Property Rights
0

Nov
5
ragupathyrenganathan
DCGI doesn’t infringe Indian patent laws !
Intellectual Property Rights, Pharma News
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Sep
14
ragupathyrenganathan
Vanda gets favorable Markman ruling in Fanapt patent infringement litigation
Intellectual Property Rights, Pharma News
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Jun
25
ragupathyrenganathan
Why orphan drug coverage reimbursement decision-makingneeds patient and public involvement
Intellectual Property Rights
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Jun
25
ragupathyrenganathan
What Is Wrong with Orphan Drug Policies?
Intellectual Property Rights
0
Jun
25
ragupathyrenganathan
Evaluating and improving orphan drug regulations in Europe: A Delphi policy study
Intellectual Property Rights
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