The Supreme Court’s Patent Case That Has Pharma On Edge

CNBC: Here’s Why Apple, Big Pharma Are Paying Close Attention To A Supreme Court Case Over A Fracking Patent
When Tribal Chief Eric Thompson first heard about a new venture to get the Saint Regis Mohawks into the business of intellectual property, he was hesitant. "I had never heard of an IPR," Thompson recalled, referring to a system of challenging patents called inter partes review. Most people haven't — IPR resides among the intricacies of patent law that generally don't surface outside legal circles — but the system has been steadily increasing in popularity since it was introduced in 2011, championed by giants of the technology industry, such as Apple, Google and Facebook. They see it as a more efficient way of dismantling bad patents, often held by so-called patent trolls. It's come to be despised by many big pharmaceutical companies. (Tirrell, 11/27)

Politico Pro: Supreme Court Divided Over Patent Process Opposed By Brand-Name Drugmakers
In a case with major implications for the drug industry, Supreme Court justices appeared divided Monday along partisan lines on the constitutionality of the Patent and Trademark Office’s system for handling patent challenges outside the courts. Liberal justices during oral arguments appeared to favor keeping the agency’s process known as inter partes review, while conservative justices expressed concern with the process. (Karlin-Smith, 11/27)

Kaiser Health News: The Ratcheting Cost Of The Pneumococcal Vaccine: What Gives?
Every November, like clockwork, she gets the same letter, said Dr. Lindsay Irvin, a pediatrician in San Antonio. It’s from the drug company Pfizer Inc., and it informs her that the price tag for the pneumococcal vaccine Prevnar 13 is going up. Again. And it makes her angry. 'They’re the only ones who make it,” she said. “It’s like buying gas in a hurricane — or Coke in an airport. They charge what they want to." (Luthra, 11/29)

Axios: What A Lawsuit Over Fracking Equipment Means For Drug Prices
Pharmaceutical Research and Manufacturers of America, the drug industry's leading trade group, urged the high court to put a stop to patent cancellations. "The pharmaceutical industry invests hundreds of billions of dollars in researching and developing new treatments to improve the health and welfare of the public across the globe. Those investments make sense only because the resulting intellectual property is respected as property," PhRMA said in a brief. (Baker, 11/27)

The Wall Street Journal: Inside Valeant’s Efforts To Be A Normal Drug Company
Normalcy hasn’t been the norm at Valeant for a while. The company has been Exhibit A of corporate turbulence since 2015, a span when its drug-price increases and accounting were attacked, top executives ousted and market cap nosedived 94%. That erased about $84 billion in worth, more than the equivalent of Caterpillar Inc. [CEO Joseph] Papa, the low-key drug-industry veteran hired 18 months ago to turn around Valeant, said it has returned to pharmaceutical-business-as-usual and is now on a path to recovery. The company noted recent growth in its Bausch & Lomb eye-care and Salix gastrointestinal-drug businesses, which combined represent about three-quarters of the company’s revenue. (Rockoff, 11/28)

Stat: New Teva CEO Reorganizes With An 'Ax, Not Hedge Clippers Or Pruning Shears'
Facing a huge debt, pricing pressures, and various missteps, the new Teva Pharmaceutical (TEVA) chief executive on Monday overhauled his management team and reorganized key business units in a Hail Mary bid to revive the beleaguered drug maker. Underscoring the severity of the situation, those exiting at the end of next month include three key executives: R&D chief Michael Hayden; Rob Koremans, who headed the global specialty medicines group; and Dipankar Bhattacharjee, who ran the global generic drug business. (Silverman, 11/27)

Bloomberg: Express Scripts Sells Unit With Ties To A $35,000-A-Vial Drug
Express Scripts Holding Co. is trimming some of its ties to a $35,000-a-vial medicine made by Mallinckrodt Plc by selling a unit that helps patients access some high-priced drugs. Avista Capital Partners, a private equity firm, will buy Express Scripts’ United BioSource division, the firms said in a statement. United BioSource’s website says it helps “maximize product access and commercialization,” helps drug companies “overcome access and adherence challenges” and provides drug testing services. (Rausch and Langreth, 11/27)

St. Louis Post Dispatch: Express Scripts To Sell Subsidiary To Private-Equity Firm
Express Scripts Holding Co. said that it has reached an agreement to sell its subsidiary, United BioSource, to private-equity firm Avista Capital Partners.  Financial terms of the deal were not disclosed. UBC provides pharmaceutical and support services. The company was founded in 2003 and is located Blue Bell, Pa. Express Scripts acquired the firm as part of its blockbuster purchase of Medco in 2012. (Liss, 11/27)

Forbes: FDA Boss Aims To Close EpiPen Loophole
Scott Gottlieb, the commissioner of the Food and Drug Administration, this morning announced plans to speed generic versions of treatments that combine a drug and a device – treatments like EpiPen, which became controversial last year because its price had quintupled. One of the weirdest things about the EpiPen fracas was that it could happen at all. Teva, the generic drug firm, had tried to bring a cheaper copy to market. Copycat versions had been launched by other drug companies, but were not considered true generics, that is, they couldn’t be substituted at the pharmacy and required their own prescriptions. When a generic was finally introduced, it was by EpiPen’s maker, Mylan Pharmaceuticals. (Herper, 11/28)

Kaiser Health News: Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program
A 25-year-old federal drug discount program has grown so big and controversial that it faces a fight for survival as federal officials and lawmakers furiously debate the program’s reach. The program, known as 340B, requires pharmaceutical companies to give steep discounts to hospitals and clinics that serve high volumes of low-income patients. (Tribble, 11/28)

Stat: Netherlands Eyes Compulsory Licenses For 'Absurd' Price
Responding to rising concerns over drug prices, the Netherlands health minister wants to explore compulsory licensing in order to obtain certain medications at a lower cost. By putting this on the table, the Netherlands becomes at least the fourth country in little more than a year to consider this option, which typically riles the pharmaceutical industry over concerns that such moves may eviscerate patent rights. (Silverman, 11/27)