Summer is always a busy time for me. Between crisscrossing the country teaching the PLI patent bar review course, I also fit in a week teaching a class at John Marshall Law School. Between keeping up with the Federal Circuit, the inevitable end of term patent decisions from the Supreme Court and whatever nonsense Congress is thinking up (this year relating to patent trolls) I manage to stay pretty busy. What that means is a number of items typically fly under my radar screen until sometime toward the end of July. With this in mind I thought I would do a rundown of some of the more interesting items that perhaps didn’t support an entire article worth of attention.
1. Reed Tech takes over USPTO Contract from Google
Many are probably familiar the fact that the USPTO has wholeheartedly embraced the President’s Open Government Initiative (OGI) to provide increased transparency of government operations and information by making bulk data available directly to the public for no charge. To that end, the USPTO entered into a no-cost contract with Google a number of years ago. Under this no-cost contract Google scraped information from the USPTO servers, transferring the many image files into searchable text documents, which were then released to the public. But all good things must come to an end.
Once again, it is time to catch up on the news from the pharmaceutical industry. And so, here is the latest monthly compendium in which we attempt to highlight some of the more noteworthy and fascinating news with a focus on the Food and Drug Administration (FDA), preemption and the Supreme Court.
1. FDA to Allow Generic Drugmakers to Update Labeling
The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval.
The moves comes in response to a US Supreme Court ruling two years ago that generic drugmakers are not required to strengthen product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.
On July 1, 2013, Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets. The primary purpose of the FDA labeling requirements and regulations is to give healthcare professionals the information they need to prescribe drugs appropriately. See An Introduction to the Improved FDA Prescription Drug Labeling.
ISENTRESS is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination Human Immunodeficiency Virus (HIV) therapy. It is the first and only integrase inhibitor approved by the FDA. ISENTRESS had sales of $243,636,000 during Q1 of 2013, and has experienced growth quarter over quarter, which means that ISENTRESS is flirting with the $1 billion per year in sales that would make it a blockbuster drug. See Isentress Sales Data. The FDA approving new labeling seems likely to guarantee that during FY 2013 ISENTRESS will achieve blockbuster status.
The Food and Drug Administration (FDA), originally approved ISENTRESS on October 12, 2007, granting accelerated approval for raltegravir tablets (400 mg) for treatment of HIV-1 infection in combination with other antiretroviral agents. ISENTRESS received a priority review by the FDA, with the review and approval of the New Drug Application being completed within six months. At the time of the initial approval the FDA explained that when ISENTRESS is used with other anti-HIV medicines, it “may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight other infections.”
A variety of electronic cigarettes have hit the market in recent months, and lately it seems that I am seeing a lot of electronic cigarette commercials on TV. Retail sales for these tobacco alternatives are expected to eclipse U.S. market sales for tobacco cigarettes within the next decade. So there is a lot of interest in this technology as more and more states and cities ban smoking in public forums.
While there seems to be a lot of growing interest in electronic cigarettes from consumers, is there a commensurate level of interest in a patent portfolio covering the technology? We may soon have a definitive answer to that question. Last week ICAP Patent Brokerage announced that it would be selling a patent portfolio of heatless and smokeless cigarette technology that exclusively advances electronic cigarette science. The patent portfolio includes U.S. Patent No. 6,769,436 and related patents that are still pending. To view a demonstration of the technology covered by the ’436 patent click here.
The disclosed smoking substitute is designed to have the feel, draw, and full taste satisfaction identical to that of tobacco cigarettes, thus providing a realistic smoking experience for users. However, this technology operates using only inhaled air rather than cartridges or batteries that require replacement. The patented smokeless cigarette contains a filter system and distributor. Inhaled air passes through a nicotine-moistened distributor to release nicotine vapor that is completely invisible. Simultaneously, the aerodynamic distributor filter system within the cigarette tube automatically recharges itself. Plus, this smokeless cigarette can be used anywhere without restriction as it does not emit any smoke, mist, or odor. Mist-emitting electronic cigarettes (like smoke-emitting traditional cigarettes) are already banned for use in many areas.
Once again, it is time to catch up on the onslaught of news emanating from the pharmaceutical industry. By now, most are probably are aware of a pair of Supreme Court rulings, but we will very briefly recap those and then move on to some other highlights. Here you go…
After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position held by the Federal Trade Commission, which argued the deals are anti-competitive because generic drugmakers are given incentive to file lawsuits against brand-name rivals and then settle for a quick profit, rather than challenge a patent in court. The FTC calculated the reverse settlments, as some call them, cost consumers $3.5 billion annually.
“This court declines to hold that reverse payment settlement agreements are presumptively unlawful. Courts reviewing such agreements should proceed by applying the ‘rule of reason,’ rather than under a ‘quick look’ approach,” Justice Stephen Breyer wrote in a 5-to-3 decision. “…The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment and the lack of any other convincing justification” (here is the ruling).
Determine that the thing can and shall be done, and then we shall find the way. ~ Abraham Lincoln
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Countries, like people, have inherent potential assets for achieving success. The question life poses is what is actually done to utilize them. A tremendous potential asset the U.S. enjoys is possession of the greatest public research system in history. It’s staffed by some of the most creative people in the world working in state of the art facilities performing cutting edge research in every field of science. The system designed after World War II does exceedingly well in what it was intended to do: pushing forward the frontiers of science; and helping federal agencies meet their mission needs.
However, neither goal is oriented toward the commercialization of resulting discoveries by our private sector. And therein lies the rub. TheLab to Market Summit at the White House Conference Center held on May 20 spent a day looking to solve that conundrum.We have made significant strides over the past 30 years through laws like the Bayh-Dole Act, the Federal Technology Transfer Act, and supporting Executive Orders leading to the creation of 9,000 new companies around university inventions, the development of 153 new drugs from federal funding now protecting public health world-wide, the leadership of the U.S. biotechnology industry, the addition of $836 billion to our gross domestic product supporting 3million good jobs from university patent licensing between 1996-2012, etc.
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