DataExclusivityImage

Innovation Fact of the Week: US Leads World in Period of Data Exclusivity For Biologic Medicine Innovators

(Editor’s Note: ITIF features an “Innovation Fact of the Week” in each edition of its weekly email newsletter and on Innovation Files.)

In addition to awarding patents to creators of novel biologic medicines, countries also mandate varying periods of intellectual property protection for the clinical test data on the drugs. This “data exclusivity,” as it is commonly known, helps ensure that creators of biologic medicines have sole rights for a certain period to all of the underlying IP necessary to make and market the drugs. Once the patent on the original compound expires, other manufacturers are free to produce similar drugs—and they are free to generate their own clinical trial data in the process—but, until the period of data exclusivity expires, they cannot use the original patent holder’s clinical trial data to prove the safety and efficacy of their new “biosimilar.”

This additional period of data exclusivity is important because it makes the economics of drug development work. It gives the innovator more time to market the drug and recoup the costs of developing it, which today can approach $3 billion for innovative biologics. The United States offers 12 full

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Fibreoptic

The FCC’s Broadband Progress, a Ways Yet to Go

This afternoon the Federal Communications Commission voted on a Broadband Progress Report, which once again reaches the erroneous conclusion that the United States is not making reasonable and timely progress toward deploying “advanced telecommunications capability” (a.k.a. broadband). The report’s conclusions rest on a highly strained reading of the evidence, and do not conform to the statutorily-directed purpose of the report.

This is the second broadband progress report based on the controversial threshold, with only 25 Mbps or greater qualifying as “broadband.” I would call this an arbitrary benchmark, but it actually seems carefully chosen to paint a particular picture of industry, defining away competition and supporting a finding of slow progress to trigger the Commission’s authority to regulate broadband providers under its recently expanded section 706 jurisdiction. Even a quick glimpse of the National Broadband Map data from 2014 makes clear the different picture painted by a 25 Mbps standard vs. a 6 or even 10 Mbps definition.

On the other hand, to the extent the FCC genuinely believes that 25 Mbps should be the expected broadband standard, it shows the Commission as captured by the ideology of digital

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How Did Data Privacy Day Go From #PrivacyAware to #PrivacyScare?

Today is Data Privacy Day, an annual reminder to all of us to check our digital zippers. But while Data Privacy Day was originally devoted to educating consumers about how to protect their data online, in recent years it has become better known for the privacy activists who participate in such rowdy traditions as midnight Twitter rants and feats of endurance like “Who can sound the shrillest?” The kids might even get swept up in the festivities and help their parents build tin-foil hats.

Some years back privacy activists realized that Data Privacy Day was a perfect opportunity to further peddle their stories of a coming digital apocalypse brought about by Big Brother and Big Data. And faster than you can say “fundraising bonanza,” Data Privacy Day morphed from an attempt to improve people’s cyber hygiene to the activist-fueled orgy of fear, where everyone is invited and tips are appreciated.

Unfortunately, many people have fallen victim to these tales of doom.  While we’ve seen this before—the great grandparents of today’s privacy activists were decrying Kodak for inventing the portable camera—privacy activism has reached new heights and now

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Medicines

Innovation Fact of the Week: IP Protections Spur Innovation, Contribute to Better Health Outcomes in Developing Nations

(Editor’s Note: ITIF features an “Innovation Fact of the Week” in each edition of its weekly email newsletter. With this installment, we will begin featuring them here on Innovation Files, too.)

Stronger global intellectual property protection, such as the agreement on Trade-Related Aspects of Intellectual Property (TRIPS), which was signed in 1994, has helped spur innovation in health care and contributed to better health outcomes.

Although much work has focused on how the developed world has better health outcomes due to health care innovation, the developing world too has enjoyed overall welfare improvements. In the two decades following TRIPS ratification, improvements in life expectancy in lower-income countries more than doubled that of the global aggregate. The world’s average life expectancy rose from 66 years to 71 years, while lower income countries saw their average life expectancy increase by 10.5 years. In the previous 20 year-period, when there were less effective, if any global IP protections, life expectancy for lower-income countries increased by just 5.3 years.

Children also have been better off in the TRIPS era. With concurrent improvements in health care, infant mortality in lower-income countries has fallen

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AI

Artificial Intelligence and Robotics Poised to Destroy All Jobs but One

In the last few years a growing number of techno-futurists, like venture capitalist Vinod Khosla, former software executive Vivek Wadhwa, MIT professor Erik Brynjolfsson, and author Martin Ford have all asserted that advancing technologies like machine learning and robotics will destroy jobs. Khosla for example, recently stated that “machine learning will replace most jobs.” But they and others clearly “don’t get it” and are doing a real disservice to the public by sugarcoating the future.

Never mind that we have been automating work for hundreds of years and employment has kept expanding. This time, everything is different. In fact, these new technologies are so awesome and amazing that they won’t replace most jobs; they will replace all jobs, save one. That job will be held by Zhang Wei, who is now a 15-year-old boy studying computer science at his local high school in Nanjing, China. He will invent the best artificial intelligence system ever and then run the company that puts all other companies out of business. His technology (an AI robot more powerful than Asimov’s Daneel) will be so good that it will do

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