Appeals court upholds decision to OK ‘pay-for-delay’ deals
NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.
The U.S. Second Circuit Court of Appeals in New York decided not to reconsider a ruling it made earlier this year in the case of Arkansas Carpenters Health and Welfare Fund vs. Bayer AG. The case concerned the legality of a settlement between Bayer and Teva Pharmaceutical Industries subsidiary Barr Labs over the anthrax treatment Cipro (ciprofloxacin), but the court ruled that the deal between the two companies did not violate antitrust laws.
The appeals court’s decision is a major setback for the efforts of the Federal Trade Commission and members of Congress who have sought to ban such settlements.
In most cases, a generic drug company that wishes to market its version of a drug before the branded drug company’s patents expire will file an approval application with the Food and Drug Administration with a paragraph IV certification, a legal assertion that the patents covering the branded drug are invalid, unenforceable or won’t be infringed by the generic drug. In response, the branded drug company usually will sue, but cases frequently result in settlements whereby the generic drug company agrees to hold off launching its drug in exchange for payment of some sort by the branded drug company.
This often comes in the form of an agreement not to use an authorized generic, essentially the branded drug marketed under its generic name, to compete with the generic drug company during its customary six-month market exclusivity period. Legally, the generic company must launch before the patents expire or as soon as they do, and delaying launch after patent expiry would be illegal, though critics such as the FTC and The New York Times’ editorial board have often derided the settlements as “pay-for-delay” deals, with the FTC contending that they cost consumers billions of dollars a year. Nevertheless, most cases that are settled result in launch of the generic drug ahead of patent expiry. In the case of Bayer and Barr, Bayer paid Barr $400 million to hold off launching its version of Cipro.
“Patents, issued by the government, are given the presumption of validity,” read a statement from the Generic Pharmaceutical Association, the generic drug industry’s main lobby. “Any market entry of a generic drug before the brand patent expires –– whether as the result of a finding that the generic product does not infringe the patent, that the patent is not enforceable or through a patent settlement agreement with the brand company –– is a positive, cost-saving event for consumers.”
PwC: Americans would use mobile devices to track, monitor health
SAN DIEGO Three-in-10 Americans recently surveyed by PricewaterhouseCoopers’ Health Research Institute said they would use their cell or smart phone to track and monitor their personal health, and 40% would be willing to pay for a remote monitoring device that sends health information directly to their doctor.
The findings of the survey and new report, titled "Healthcare Unwired," were presented Wednesday by PricewaterhouseCoopers at the mHealth Initiative 2nd International mHealth Conference. According to the report, wireless technology, remote monitoring and mobile devices are changing the nature of health care, making it possible to deliver care anywhere in ways that are proving to reduce healthcare costs and keep people healthier.
PricewaterhouseCoopers’ research included a nationwide survey of 2,000 consumers and 1,000 physicians regarding their use and preferences for remote and mobile health services and devices. The survey found:
- 31% of consumers said they would be willing to incorporate an application into their existing cell phone or smart phone to be able track and monitor their personal health information;
- 40% of consumers said they would be willing to pay for a device and a monthly subscription fee for a mobile phone application that would send text and e-mail reminders to take their medications, refill prescriptions or access their medical records and track their health;
- 27% of consumers said they would find medication reminders sent via text to be helpful, and men are twice as likely as women to say they would use a mobile device for health-related reminders; 40% of consumers also would be willing to pay for a remote monitoring device and a monthly subscription that would send data, such as heart rate, blood pressure, blood sugar and weight, automatically to their doctor;
- 56% of consumers said they like the idea of remote health care, and 41% would prefer to have more of their care delivered via mobile device;
- 88% of physicians reported they would like their patients to be able to track and/or monitor their health at home, particularly their weight, blood sugar levels and vital signs; and
- 57% of physicians said they would like to use remote devices to monitor the patients outside of the hospital.
PricewaterhouseCoopers’ Health Research Institute estimated the annual consumer market for remote/mobile monitoring devices and services to fall between $7.7 billion and $43 billion, based on the range that consumers said they would be willing to pay.
"Remote and mobile technology is making it possible to move healthcare delivery outside the traditional settings of physician offices and hospitals to wherever patients are,” stated Daniel Garrett, leader of the health information technology practice at PricewaterhouseCoopers. “New consumer-oriented business models and technologies are emerging. Companies that will be well-positioned competitively are those that can integrate mobile health into healthcare delivery and create value in the health system by helping doctors and their patients better manage health and wellness through mass personalization."
"There are significant opportunities for physicians, hospitals, health insurers, pharmaceutical companies and medical device manufacturers to market and differentiate themselves using mobile health," Garrett added.
Active phone prompts spur Rx adherence rates among consumers, CVS reveals
WOONSOCKET, R.I. Consumers are much more likely to adhere to their prescription medication therapy if given “a clear and active choice” in recorded telephone prompts from their pharmacy, new research into patient compliance from CVS Caremark demonstrated.
The company announced Thursday the results of a long-term research project into patient behavior, conducted by its Behavior Change Research Partnership. Those findings, presented at a Pittsburgh Business Group on Health symposium, underline a clear connection between encouraging patients to get their maintenance medications refilled and improved adherence rates.
“Ongoing research into how behavioral economics impacts healthcare choices found that when consumers are presented with a clear and active choice in a voice-recorded message to select automatic prescription refills, rather than a passive default notification, they are twice as likely to choose the automatic option,” CVS said.
CVS established the BCRP in March to study how behavioral economics impacts consumer healthcare decisions. The research group also was created “to help the company better understand why some patients stop taking maintenance medications for chronic illnesses,” the company noted.
The research results were presented by Troyen Brennan, CVS Caremark EVP and chief medical officer. “The preliminary findings show that by making choices clear and by streamlining messages, consumers sign up at twice the rate of those who are passively presented opt-in choices,” Brennan told Pittsburgh business leaders Thursday. “This research will help us develop programs to encourage people to stay on their medications, because nonadherence is costing the healthcare system billions of dollars every year.”
The BCRP research, titled “Active Choice,” is testing options in four communication channels, CVS said. Those channels include interactive Web sign-ins, in-bound customer calls to care centers, automated outbound telephone calls and direct mail.
“The testing shows some options offered to consumers today are overlooked because the choices are not readily transparent,” the company said. “Past industry studies show one-quarter of people receiving prescriptions never fill their first prescriptions, and patients with chronic diseases, such as diabetes and coronary artery disease, adhere to their ongoing medication regimen about half of the time.”
The BCRP panel is led by Punam Anand Keller of the Tuck School of Business at Dartmouth College, George Loewenstein of Carnegie Mellon University and Kevin Volpp of University of Pennsylvania’s Medical School and The Wharton School of Business. The presentation in Pittsburgh continued discussion of BCRP research that was first presented at a Centers for Disease Control and Prevention symposium in Atlanta last month.