Posts Tagged: "biotech"

Clinical Trials and Tribulations: Why IP Protection is Critical to the Future of Biologic Medicine

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.

Blue Ribbon Panel of Advisors Announced for Biden Cancer Moonshot Initiative

Earlier this week the National Cancer Institute (NCI), which is part of the National Institutes of Health, announced a Blue Ribbon Panel of scientific experts, cancer leaders, and patient advocates that will work to inform the scientific direction and goals for Vice President Joe Biden’s National Cancer Moonshot Initiative. “Thanks to advances in science, we are now in a historically unique position to make profound improvements in the way we treat, detect, and prevent cancer,” said NIH Director Francis S. Collins, M.D., Ph.D. He is correct, and here is why.

Amici led by Eli Lilly file brief in Supreme Court in support of Sequenom certiorari petition

Rather than use the word ‘conflate’ to describe the mongrel mixture of patentability requirements the Supreme Court undertook in Mayo, the Eli Lilly brief characterizes the analysis employed by the Supreme Court as including a separate, implicit ‘threshold test’ for patentability that is applied even before consideration of the statutory patentability requirements. Eli Lilly hypothesizes that this ‘implicit exception was imposed to assure that patents cannot validly protect—or preempt access to—laws of nature, natural phenomena, or abstract ideas.’

Injectable migraine treatment being developed by Alder, Eli Lilly, Amgen and others

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to lights, smells or sounds which characterize a migraine attack. Not much is known about the brain chemistry that directly causes a migraine, although it’s generally understood that hormonal fluctuations or environmental stimuli can act as triggers. News of successful mid-stage trials for a migraine treatment developed by Alder Biopharmaceuticals Inc. has been greeted with a warm welcome from news media. The results of the trial show that an injectable treatment known as ALD403 administered four times over the course of a year reduced patient suffering from chronic migraines.

NIH Pressured to Misuse Bayh-Dole to Control Drug Prices

Secretary Burwell and Director Collins are facing formidable pressure to reinterpret the Bayh-Dole Act for the compulsory licensing of costly drugs arising from federally supported research. And the pressure just increased another notch. On March 28, Senators Bernie Sanders, Elizabeth Warren, Al Franken, Patrick Leahy, Sheldon Whitehouse and Amy Klobuchar joined the leaders of the House Democratic Task Force on Prescription Drug Pricing urging Burwell and Collins to hold a meeting “to allow the public to engage in a dialogue with the Department of Health and Human Services and NIH in order to better understand its position on the use of march-in rights to address excessive prices.” If NIH joins in pursuing the swamp gas illusion that Bayh-Dole was intended to regulate drug pricing, we’ll quickly learn that it’s a lot easier getting into this morass than getting back out.

The Evolution of Food Safety: HOF Inventors John Silliker and Welton Taylor tamed Salmonella

The 2016 inductee class for the National Inventors Hall of Fame includes two microbiologists whose contributions to the field of food safety have helped to keep many foodborne pathogens, especially Salmonella, in check: John H. Silliker and Welton I. Taylor. These two scientists worked together to develop more effective monitoring techniques for food products in response to the growing concerns in the mid-20th century regarding Salmonella outbreaks, especially those which hit children the hardest. With the anniversaries for important patents issued to both of these food safety engineers having passed in early March, we thought we’d visit their scientific contributions from in our Evolution of Technology series here on IPWatchdog.

UN Panel on Access to Medicines Should Ensure Innovation by Preserving Market Incentives

The dilemma for developing countries is primarily a function of two things: lack of access to existing medicines and absence of innovation on the treatments and cures that are needed. Admittedly each of these can be linked to intellectual property rights, but poverty is at the heart of both issues. Fundamentally, drugs are not available because there is no market for them and the necessary market incentives are absent. To facilitate innovation, especially on ‘diseases of poverty’ the UN and member states need to commit to cultivating market incentives and removing obstacles.

Free Drugs: Bernie Sanders and the end of drug patent exclusivity

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food and Drug Administration (FDA). The bill would have allowed anyone in compliance with FDA requirements “to manufacture, distribute, or sell an approved medicine.” The bill says it would have continued to spur innovation by establishing a fund for medical innovation prizes. It would have required the Board of Trustees for the newly created Fund to award prize payments of unspecified amounts for medical innovations relating to a drug, biological product, or manufacturing process. In order to be an eligible award recipient one would have to be the first person to receive market clearance or be the holder of an issued patent.

Jim Greenwood to Chair BIO Ventures for Global Health Board of Directors

BIO Ventures for Global Health (BVGH) announced that Jim Greenwood, President and CEO of the Biotechnology Innovation Organization (BIO) has been elected as the new BVGH Board Chair for a term of three years. BVGH engages global health stakeholders in partnerships to accelerate the development of new drugs, vaccines, and diagnostics that address the unmet medical needs of the developing world.

VRC01 and broadly neutralizing antibodies are increasing options for HIV/AIDS treatments

Proteins like VRC01 are referred to as broadly neutralizing antibodies (bNAbs), a type of broad spectrum antibody which is effective in treating against infections of viruses with high mutation rates, such as HIV as well as influenza. It’s thought that VRC01 and other bNAbs useful in treating HIV-infected patients is capable of identifying the envelope spike of a single HIV viral agent to inhibit or neutralize its effects… Gene editing tools may also be part of the solution that rids HIV/AIDS from the human race for good. The discovery of clustered regularly-interspaced short palindromic repeats (CRISPR) and CRISPR-associated proteins (Cas) has given scientists hope that they’ll be able to efficiently edit genomes with a high degree of precision and flexibility.

Merger of Dow and DuPont set to make huge waves in agriculture, materials and plastics sectors

No one should get too used to seeing the name DowDuPont, however. Company executives plan on splitting DowDuPont into three separate companies, each with a specific industry focus. One will be a $19 billion company focused on the corporation’s combined properties in agricultural products, including fungicides, genetically modified seeds and herbicides. A $13 billion specialty products company will also be spun off to produce electronics materials, Kevlar, Tyvek, food additives and other biological products. The largest of the new companies, however, will be a $51 billion firm with a focus on construction materials, vinyl, packaging plastics and specialized chemicals for the automotive and pharmaceutical industries.

CAFC denies Sequenom en banc petition, Next stop SCOTUS

The law of patent eligibility is created by the nine least qualified people to make such a determination; the Justices of Supreme Court of the United States. The Supreme Court arbitrarily chooses which of its own prior decisions to follow and ignore, refuses to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 101), and they openly legislates from the bench by creating judicial exceptions to patent eligibility where no such statutory prerogative exists. If the Federal Circuit will not step up and do the right thing and limit the lawless Mayo decision, which instructs lower courts to ignore the patent statute and drive 100% of the analysis into 101, the U.S. will forfeit our lead in the biotechnology and medical device industries. That will be bad for the economy, but far worse for public health.

Distorting Innovation: Fixed Patent Terms and Underinvestment in Long-term Research

Drugs for the treatment of late-stage cancers are less expensive to develop, in part because late-stage drugs extend patients’ lives for a shorter period of time such that clinical trials are concluded more quickly. This means that such drugs require less time to research, develop, test and bring to market than drugs that treat earlier stage cancers, providing the innovator with a longer effective patent life. In essence, less research and development investment is directed toward drugs that treat patient groups requiring lengthy clinical trials, those with longer commercialization lags… It’s worthwhile to ask whether a ‘one-size-fits-all’ patent policy is optimal. How we can think creatively about patent protection in an effort to incentivize the innovation we want and push the frontiers of modern medicine.

Cell metabolism research starts path towards exercise pill, better cancer treatments

Although the American psyche may not always be interested in accomplishing the proper amount of exercise but it still craves the idea of being physically fit. And, as with most things, if there’s a quick shortcut to getting where we want to be, we’re going to try and take it. While some scoff at the idea of an exercise pill, but such an exercise pill could be useful for patients suffering from cardiovascular disease or diabetes for whom exercise is very beneficial but impossible to accomplish. And now the scientific world may be close to discovering chemical compounds useful for mimicking the biological processes stimulated by exercise, much to the delight of couch potatoes everywhere.

IP Protection for Biologics in the TPP: Trading Away Future Treatments and Cures

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.