CRISPR patent fight takes a surprise turn

The fight over coveted CRISPR patents has for years been a familiar tussle between the University of California and the Broad Institute of MIT and Harvard. It's about to get more complicated. 

In a startling turn of events, MilliporeSigma, a unit of Germany-based Merck KGaA, has asked the U.S. Patent and Trademark office to open an interference proceeding between CRISPR-Cas9 patents that it applied for back in 2012 as well as patents that the University of California has applied for or been award, STAT’s Sharon Begley reports in an exclusive story this morning. 

The petition’s aim is to “highlight a fundamental unfairness” in how the company’s CRISPR patent applications “are being compared to others,” company attorney Benjamin Sodey told STAT.

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Alzheimer’s researchers let some new ideas in

There’s been far more failure than success when it comes to drug development for Alzheimer’s. So at the Alzheimer’s Association International Conference in Los Angeles last week — the field’s largest of the year — there was a distinct sense that researchers were still figuring out where to turn next. 

And with a string of failures based on the beta-amyloid theory, a number of research ideas that didn’t previously get much credence are now seeing the light of day. 

“We’ve brought together pharma, biotech, philanthropies, and multiple academic departments to work together to identify new targets for intervention,” Dr. Richard Hodes, director of the NIH’s National Institute on Aging, told STAT. “We’ve learned from the unfortunate failures in this space … the culture shift is really remarkable.”

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Taking Indian pharma to task

The Indian pharmaceutical industry is willfully ignoring egregious transgressions, according to Dinesh Thakur, the former director and global head of research information (and, ultimately, whistleblower) for Ranbaxy Laboratories. Generic drugs manufactured in India — such as those once made by Ranbaxy — rarely adhere to standard quality control measures, as outlined in a new book, “Bottle of Lies.” 

Thakur, opining for STAT, says that the infractions of the Indian generics industry are incontrovertible — and that the country’s regulatory authorities are largely unwilling to enforce change. Many of the generic medicines taken by Americans are manufactured in India — which makes this a major problem, stateside.

“The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account,” Thakur writes.

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Pharma bent on changing Medicare Part D

The pharmaceutical lobby is working doggedly to dismantle talks to reform Medicare Part D, health policy expert Avik Roy writes in Forbes. 

A bipartisan effort in Senate has been underway to restructure Medicare’s prescription drug benefit, capping seniors’ out-of-pocket costs at a fixed point. Doing that alone, however, would incentivize drug makers to jack up their prices, with taxpayers cumulatively paying for the difference. So the Senate has also proposed capping the growth of government subsidies to drug makers, based on inflation.

The idea is that, while pharma could increase prices faster than inflation, they’d have to return any subsidies they would receive above the inflation rate, Roy writes.

Drug makers are working to remove the cap on subsidies, arguing that it's effectively a “price control.”

More reads

• The four ordinary people who took on Big Pharma. (New York Times)
• Novartis licenses out early antiviral work to Gilead. (FierceBiotech)