In the past, researchers have developed an Ebola vaccine for monkeys and macaques, which are also affected by strains of the Ebola virus. The vaccine is so effective that many monkeys can be brought back to health even when injected with 100 times the lethal dose of Ebola after vaccination. However, with HIV, tuberculosis and many other diseases claiming more lives every year, research focus on Ebola has been low in recent years. So how long does it take a typical vaccine to go from concept to reality?
Here at IPWatchdog, we wanted to take some time in our Companies We Follow schedule to take a closer look at the incredible world of innovation in pharmaceuticals. In our perusal of Eli Lilly patent applications recently published by the U.S. Patent and Trademark Office, we got a close look at many of the medications created in recent months by this company. Leukemia, diabetes and Alzheimer’s disease are all addressed by innovative compounds which we explore in detail below. We also feature a trio of patent application related to improvements to injector pens for self-administration of medications. But perhaps most exciting is the patent that covers antibodies that could be used to treat the Ebola virus.
On the very same day that the U.S. jobs report shows unexpectedly weak growth, the Federal Court of Australia issued a ruling directly opposite to the ruling rendered by the United States Supreme Court relative to gene patents. In Yvonne D’Arcy v. Myriad Genetics, Inc., the Federal Court of Australia ruled that Myriad’s claims to isolated DNA are patentable under the laws of Australia. That is the correct ruling, and it is the ruling the U.S. Supreme Court should have reached in Association of Molecular Pathology v. Myriad Genetics. As the patent eligibility laws of the U.S. become increasingly inhospitable to high-tech innovative businesses we can expect more job losses and worse news for the U.S. economy on the horizon.
Patents encourage and protect innovation. That’s undeniable, but it’s naïve to believe that’s all we need to develop the new products that evolve into the industries that bolster the dynamic U.S. economy. Patents, and other forms of intellectual property protection, are a necessary prerequisite, but incentivizing innovation requires more. Just as plants require sunshine, water and nutrients to grow, innovation needs more than simply patent protection to thrive. To thrive innovation requires a climate that is conducive for business success.
Sadly, Capitol Hill is frequently the setting for both grandstanding and pandering, and given the prevailing political and public sentiment it is also frequently a place where businesses find an inhospitable welcome. A recent case in point: Three senior members of Congress (Henry Waxman, Frank Pallone Jr., and Diana DeGette) have started a joint investigation into the pricing of Sovaldi, a breakthrough drug for hepatitis C produced by Gilead Sciences (NASDAQ: GILD). Rather than applaud the health benefits that this drug will deliver, Congress is grilling the company on their pricing decision, striking fear in the investment community, and indirectly undermining the healthcare innovation that is so desperately needed.
Parkinson’s disease is a progressive neurological disorder that affects the nervous system of an affected individual and can cause devastating effects in a person’s motor abilities. Parkinson’s is the second-most common brain disease behind Alzheimer’s, and 1 in 100 adults over the age of 60 develop the disorder. Symptoms include tremors, slowed movement, rigid muscles, loss of automatic movements and speech impairments. These symptoms can be mild for years and can be barely noticeable in early stages, but they worsen in time and can bring about a list of complications including sleep disorders, dysfunction of bodily systems and cognitive problems.
One issue with treating and preventing the disease is the fact that the underlying cause of the disease is largely unknown, although many factors involved with the disease have been identified by researchers. The presence of Lewy bodies, or clumps of microscopic biological material, within a patient’s brain cells is a major indicator of Parkinson’s disease.
Another unknown factor in the progression of Parkinson’s disease is the role of the protein alpha-synuclein. In the brains of healthy patients, this protein is fairly common and may even play a role in brain functioning. Although it’s still unclear exactly how alpha-synuclein affects those with Parkinson’s, this protein is a major component of Lewy bodies. A lot of research has gone into attempts to understand the role of alpha-synuclein and Lewy bodies in this disease, and into the development of therapies that target the aggregation of alpha-synuclein.
Biologic medicines are fundamentally different from traditional “small molecule” therapies, presenting a host of new challenges in the design and enforcement of the intellectual property (IP) architecture that will protect them. Protecting the intellectual property of biologics is complicated, difficult, and essential to the future of medicine. This new frontier is also one of the remaining hurdles in the Trans-Pacific Partnership (TPP) Trade Agreement negotiations. The debate over protecting biologics focuses on a proposed twelve years of data exclusivity and the consequences this will have for international trade, global public health, and access to medicines.
The nuances of producing biologics greatly complicate the logistics of protecting their intellectual property, making patents alone inadequate for safeguarding their IP. Data exclusivity protection allows for a period of time following marketing approval during which competing firms may not use the innovative firm’s safety and efficacy data, from proprietary preclinical and clinical trial results, to obtain marketing authorization for a generic version of the drug. From the moment when the compound first shows medicinal promise, data is generated and compiled, a process that is both expensive and time consuming. Data exclusivity provides the innovative firm with a period of protection for their investment in clinical trials and data collection, regardless of the length of time required to bring the drug to market.
When the Supreme Court hands down a decision bearing on a hotly contested area of law, it means the work has just begun for any agency tasked with administering its consequences. Last term, the Court rendered such a decision in Association for Molecular Pathology v. Myriad Genetics, adding a new wrinkle to the already confounding question of patentable subject matter under §101 of the Patent Act.
As companies consider current cases related to patents before the Supreme Court, they would be wise to learn from the challenges the USPTO faced in implementing the Myriad decision. And for the reasons set forth below, we believe that the USPTO and the entire business community are well served by engaging in rigorous public debate about the guidelines that should be established to implement the decision from the Supreme Court.
Recently IPWatchdog.com published an article that cited the work we do at the Infectious Disease Research Institute (IDRI) as an example of how dedicated individuals and corporations can work together to transform science into global health solutions. By integrating capabilities, we strive to create an efficient pathway to bring scientific innovation from the lab to the people who need it most.
I write today to explain more about what IDRI does and why leveraging spin-out companies supports global health initiatives.
One of the most important engines in populating and growing the life sciences sector within the United States is the practice of universities spinning out new technologies into startup biotechnology companies. This, in turn, drives the development of new drugs, vaccines and other much-needed health products.
A team of law students, who are members of the Intellectual Property Law Fellowship at the Thomas Jefferson School of Law in San Diego, California, are working on a Research Project directed toward aiding patent practitioners in developing international patent filing strategies for biotechnology and pharmaceutical companies. The team is working to amass statistically significant survey data on the countries patent practitioners are filing patents in for their biotechnology and pharmaceutical clients most often, and the factors considered when making the decisions to file.
As countries modernizes their economy, and more particularly the life science industry keeps growing, the demand for biotech and pharmaceutical products will likely increase. With increased demand, the market competition and incentive for companies to patent their research and products will likely increase as well. Once the results of the survey are published, policy makers will have more information on the factors patent attorneys from different countries consider most important when making their filing decisions. The results will also give life-science patent practitioners better information as to where in the world they can promote their legal services and partner with foreign law firms for patent applications being filed.
The survey is open to patent practitioners from any country who prosecute patents in the biotechnology or pharmaceutical sectors. The survey can be found by following the hyperlink below. All personally identifiable information will be kept confidential. It should take approximately 15 minutes to complete. We will appreciate if you take the survey prior to March 7, 2014.
James Madison, father of the Constitution and proponent of strong patent rights.
As the end of 2013 approaches and I look back on what has transpired I am saddened to see that through the year patent rights have continued to erode. It is difficult to comprehend just how far the pendulum has swung. At one time strong patent rights were viewed by our Founding Fathers as obviously necessary. Now any patent rights are ridiculed as a relic of the past that simply stands in the way of innovation. The reality, however, is that patents don’t stand in the way of innovation; patents foster innovation. But so many won’t even take the time to inform themselves. Rather they equate “innovation” with a new consumer product. But to innovate is to do something new. Innovation has nothing in and of itself to do with a new products or services.
What those urging a weaker patent system want is the ability to release products and establish services regardless of whether they are infringing others. But those who infringe are not innovators, at least not in the most broad sense. Sure, they may have improved something, but if they are infringing then what they have done is copy an innovator. How and why that isn’t self-evident is a mystery. Copying is not innovating!
And if patents were getting in the way of innovation then why aren’t we seeing a standstill in the smartphone industry? The arguments made by the anti-patent crowd are ridiculous on their face, yet decision makers just nod their head in agreement as if they speak the gospel. The truth is the smartphone industry started with the iPhone in late 2007. It is just 6 years old! The phones from 2007 look and function nothing like the smartphones do today, and every new version has new improvements, better battery life, stronger structural integrity, glass that is harder to break, operates faster, has better cameras, etc. etc. For an area that is allegedly being suffocated by patents there sure is a lot of readily apparent improvement.