Supreme Court to hear patent settlements case
WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.
The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.
The FTC has long been an opponent of so-called “pay-for-delay” deals between brand and generic companies. When a generic company wishes to launch a generic version of a drug early, it will file a regulatory application with the Food and Drug Administration containing a Paragraph IV certification, an assertion that the branded drug’s patent protection is invalid, unenforceable or won’t be infringed. In virtually all cases, the branded drug’s manufacturer will sue the generic drug maker for patent infringement, but usually, the generic drug maker agrees to hold off launch in exchange for the branded drug maker agreeing not to launch an “authorized generic” — essentially the branded drug marketed under its generic name at a reduced price, usually through a third-party company — or, less commonly, monetary payment.
At any rate, supporters of the deals say, they typically result in generic drugs becoming available months or even years before patent expiry, and holding off launch of the generic after patent expiry would be illegal.
The Generic Drug Association on Friday filed an amicus brief with the court, saying that the deals benefit consumers. “We believe the court will find that patent settlements are pro-consumer, pro-competition and transparent,” GPhA president and CEO Ralph Neas said. “The proof is in the track record: When a patent settlement is reached, consumers gain access to the lower-cost generic medicines prior to patent expiration 100% of the time. These settlements have saved the healthcare system tens of billions of dollars over the past decade.”
Rite Aid expands NowClinic telehealth service to additional markets
CAMP HILL, Pa. — Rite Aid has expanded its telemedicine service to 58 more stores, the retail pharmacy chain said Friday.
Rite Aid said the NowClinic Online Care service were available at stores in Baltimore, Boston, Philadelphia and Pittsburgh. The service gives customers access to care, via a secure online video connection, from OptumHealth doctors and nurses. The company originally unveiled the program at nine stores in Detroit in 2011.
"Given the rapidly changing healthcare landscape, we believe that telehealth services, such as our NowClinic Online Care service, will play an extremely important role in health care of the future," Rite Aid EVP pharmacy Robert Thompson said. "Rite Aid’s NowClinic Online Care services provide customers with convenient, affordable and efficient access to medical care, whenever and wherever they need it. We are excited to bring NowClinic Online Care services to our customers in these markets as part of our continued mission to help them live healthier, happier lives."
The service allows customers to have private, one-on-one consultations via video, chat or phone with doctors who can discuss symptoms, provide guidance, diagnose and prescribe certain medications when appropriate. Nurses can address a range of healthcare needs, such as basic education, information on common acute issues and assistance in identifying appropriate provider options for care. A customer record is automatically captured at the end of each session and available for sharing with a primary care provider. The service also is accessible 24 hours a day and seven days a week at MyNowClinic.com/RiteAid.
Generics stifling pioneer drug development?
Has the explosion in generic utilization curbed pioneer-drug research and development? That’s one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.
Not so, says IMS Health. "Some claim that Hatch-Waxman [the 1984 Drug Price Competition and Patent Term Restoration Act] has worked too well for the generic side, at the cost of harming the innovation of new or improved medicines," IMS noted in a 2012 report. "But the facts do not support that claim."
Citing a cautionary article in the journalHealth Affairsthat urged Congress to take another look at Hatch-Waxman and consider amending the law to "delay generic competition by increasing the market monopoly for branded drugs," IMS countered that pioneer-drug R&D has surged in the face of generic competition.
"Although generic utilization has reached new levels, more new medicines were launched in 2011 than in any other year of the past decade," IMS reported. "New medicines launched last year brought improved efficacy, safety and convenience for diseases affecting millions of patients battling chronic conditions; important breakthroughs for rare diseases transformed treatment options through personalized medicines based on genetic markers for subtypes of cancer and individually cultured immunotherapies."
"Each of these new treatments represents vast improvements in therapy that were spawned by competition to the older medicines," the report added. "By creating a fair balance between innovation of new medicines and accessibility to lower cost generic medicines, federal law has established a win-win for providers and American consumers."
The brand-name drug industry concurs. According to the trade group Pharmaceutical Research and Manufacturers of America, more than 5,000 medicines are under development, 70% of which are potentially the first of their class.
In a report released Jan. 17, PhRMA called the drug pipeline "innovative and robust," with 158 drugs under development for ovarian cancer, 19 for sickle cell disease and 41 for small-cell lung cancer.
"Biopharmaceutical companies, working with other partners in the American research ecosystem, have made incredible progress in helping confront some of the most challenging and costly diseases facing patients around the world," said PhRMA president and CEO John Castellani.
The report also noted that personalized medicines accounted for an increasing proportion of the pipeline, with the number of potential new medicines for rare diseases averaging 140 per year in the last 10 years.