Court rules in favor of Watson over Concerta patent dispute
MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals scored a court victory Monday as an appeals court upheld a lower court’s ruling that a patent covering the branded version of an attention deficit hyperactivity disorder was invalid.
Watson said the U.S. Court of Appeals for the Federal Circuit affirmed a District Court decision from March 2009 invalidating a patent held by Alza Corp. covering Concerta (methylphenidate hydrochloride). Johnson & Johnson subsidiary McNeil-PPC markets the drug. Alza and J&J had alleged that the generic version marketed by Watson subsidiaries Andrx Corp. and Andrx Pharmaceuticals infringed the patent.
Concerta has annual sales of around $1.2 billion, according to Watson.
Anderson: Reform creates wellness ‘renaissance’
PALM BEACH, Fla. The collective efforts by the industry to create value have given way to a “health-and-wellness renaissance.” That was a key message that Steve Anderson, president and CEO of NACDS, had for attendees of Sunday’s business program.
“It is creating a rebirth. Let’s call it a health-and-wellness renaissance with innovations focused on patients and consumers,” said Anderson during his state of the association address.
Anderson touched upon the recent successes the industry has achieved as it relates to the twists and turns of healthcare reform and stressed that it presented a vital platform for NACDS to express the importance of pharmacy and the critical role pharmacy plays in the U.S. healthcare system. NACDS seized the moment, and the efforts did not fall on deaf ears among members of Congress, said Anderson.
“We realized that we had to stop whining and start winning. We realized that we couldn’t just go into Congressional offices and say what we were against,” said Anderson. “We had to describe the way that pharmacy improves lives and saves long-term healthcare costs.”
The achievements were not only rhetorical but also tangible (i.e. advancements in MTM, DME and AMP).
“The preliminary injunction won by NACDS and the National Community Pharmacists Association has blocked $5.5 million in cuts to pharmacy each day that are results of the deficit reduction act and the subsequent AMP rule,” Anderson said. “Our injunction has saved more than $4.6 billion in cuts to pharmacy from Jan. 1, 2008, to today.”
Looking ahead, healthcare reform will bode well for the industry, Anderson told attendees. Not only will there be an addition of 32 million people to the ranks of the insured as a result of the new healthcare law but, according to preliminary NACDS research, the increase in patients with healthcare coverage will result in between 90 million and 116 million new prescriptions per year in 2016 and beyond.
“I am completely convinced that people will look back 20 to 30 years from now and see these times — our times — as a historic watershed moment,” Anderson said.
In wrapping up his remarks, Anderson announced that the NACDS Foundation is contributing $150,000 to assist in the Haiti relief effort. The contributions include $50,000 each to organizations that have been immersed in this work since the January earthquake: Doctors Without Borders, AmeriCares and Convoy of Hope.
Anderson’s comments came on the heels of presentations by Jeffery Stone, global president and chief customer officer for Johnson & Johnson, and Andy Giancamilli, CEO of Rexall Pharma Plus and outgoing NACDS chairman. Gen. Michael Hayden, former director of the CIA and NSA, served as the keynote speaker.
Stone touched upon the opportunities that exist for retailers and suppliers in today’s challenging environment, such as taking share from competitors, taking value from trade partners and collaborating to create more value.
Meanwhile, Giancamilli summarized his tenure and reflected on three “positive lessons” that hit him during his tenure as NACDS chairman: NACDS is a member-driven association in the true sense, the association unites us more than divides us and the association is creating a legacy of greater success for the future. He highlighted the importance of getting involved and the successes of the first and second annual NACDS RxImpact Day on Capitol Hill, held in 2009 and in March 2010.
“These are thoughts that I think can be put into action to allow you to even get more from your investment in NACDS, and they are thoughts that I think can help NACDS get even stronger for your ultimate benefit,” Giancamilli said.
Anda symposium offers networking, reform insights
PALM BEACH, Fla. More than 250 executives participated in Anda’s Third Annual Supply Chain Symposium here Thursday and Friday, which included a keynote address around the projected impact of the healthcare-reform package with one of Washington’s leading policy experts. Additionally, more than 140 golfers had the opportunity to play 18 holes of golf on PGA’s Haig Course with former NASA scientist and golfing instructor Dave Pelz, who boasts 2010 Masters winner Phil Mickelson as one of his students.
The event kicked off the night before the golf festivities, however, with a series of one-on-ones that brought together Anda’s key customers and business partners. “The Anda Supply Chain Symposium is really designed to highlight Anda’s capabilities, bring together customers and manufacturers,” said Marc Falkin, VP marketing at Anda. “We shipped to an incredible amount of locations last year, and we just want to thank all of our manufacturers and customers for coming out.”
“[The symposium is a] great format to exchange business ideas [and] have a good time,” added Bill Versosky, Anda VP national accounts. “And we look forward to seeing everyone next year in Scottsdale, [Ariz.],” he added, for the fourth Anda Annual Supply Chain Symposium to be held before the National Association of Chain Drug Store’s 2011 Annual meeting.
Friday’s lunchtime keynote speaker was Raissa Downs, Washington policy expert and co-founder of Tarplin, Downs and Young, who addressed the potential impact from the recently passed healthcare reform bill. The bill’s authors may have set the stage for continued vigorous debate when it comes time to implement budget cuts across programs like Medicaid and impose taxes, the combination of which are supposed to fund the overall reform. “The political consequence of that I think we’ve seen a little bit of, but we’re going to have a better flavor for it in November,” she said, noting that while the healthcare legislation may have been bipartisan in the beginning, the final version was passed without a single Republican vote.
There are many items within the current healthcare legislation that are expected to have a lasting impact on the pharmaceutical distribution industry. “The Medicaid rebate was expanded somewhat significantly, [which] has meaningful implications for a lot of products,” she said.
Some of the other important provisions included exclusion of certain pharmacies from DME accreditation requirements and an approval pathway for follow-on biologics. “A lot of people have been watching [this issue] since serious negotiations took place on the creation of a pathway for generics and follow-on versions of biologics to be approved by the Food and Drug Administration,” Downs said. “The generic community, in all candor, wishes the number of years of data exclusivity were lower in the final bill, but the fact of the matter is the pathway was created — and that’s significant.”