Posts Tagged: "biotech"

What we saw when putting together our most recent Companies We Follow feature on AT&T showed us a great collection of innovations regarding television services. Interactive television services were discussed by a trio of patent applications published by the U.S. Patent and Trademark Office, including one providing on-demand language translation services for locally broadcast content. Other patent applications describe mobile services for event-based advertising as well as location-based services for mobile gaming applications.

A look into the recently published patent applications assigned to Dow from the U.S. Patent and Trademark Organization shows us that GMOs and herbicides have been a major area of focus for Dow and Dow AgroSciences, its chief subsidiary in agricultural chemical engineering. Plastics used for packing fragile items or for providing a barrier between soil and building foundations in construction projects. The patent portfolio of Dow has also been increasing recently, incorporating chemical engineering innovations designed for a wide range of industrial sectors. One patent protects a method of developing fragrances for laundry detergents which evaporate less quickly, helping clothes to retain a fragrance for a longer period of time. Oil-in-water emulsions were the focus of a number of patents which we decided to share today, including one discussing a herbicidal composition for agricultural uses. Another patent we noticed protects a topically-applied pharmaceutical drug designed to treat bacterial infections or acne rosacea.

It is tough to overstate the connection between the development of vaccines and public health, however. Since the use of vaccinations was first introduced by English physician Edward Jenner in 1798, many devastating diseases have either been eradicated or targeted for elimination, including smallpox, measles, rubella and mumps. The prevention of a wide spectrum of diseases by administering biological preparations of microorganisms meant to increase an immune response has been revolutionary for public health simply by reducing the costs incurred when treating diseases and caring for patients. It has been revolutionary in human terms by the number of lives saved, and lives significantly altered for the better. But the costs and time horizon are very real, as is the irrational vaccine fear that prevents many parents from immunizing their children.

We saw in our coverage of Eli Lilly’s patent applications a number of recently developed medications for the management of conditions like diabetes and inflammatory diseases, but the company is also focused on developing solutions to medical problems which are much more devastating. With the current West African outbreak of Ebola making major news headlines in recent weeks, we were greatly intrigued to see one Eli Lilly invention that could be used to treat Ebola and other major viral infections, like HIV. U.S. Patent No. 8796423, titled Anti-TSG101 Antibodies and Their Uses for Treatment of Viral Infections, protects a method of inducing the expression of antibodies to Tumor Susceptibility Gene 101 (TSG101) within a patient’s body. TSG101, which plays an important role in cell growth, can be inhibited to prevent the budding of HIV or other viral infections.

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.

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. 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.

The study looked at groups of patients receiving various levels of the PD01A vaccine and evaluated them over a 12-month period. Patients receiving the vaccine were given PD01A subcutaneously in four vaccinations, either in doses of 15 micrograms or 75 micrograms… Of those who were immunized, 15 patients out of every 24 saw an increase in alpha-synuclein-specific antibodies. Interestingly, the antibody response was greater in the group of patients receiving the lower 15 microgram dose as compared to the group receiving the 75 micrograms of PD01A per vaccination. Also important was the fact that the vaccination was tolerated at the dosage levels administered and that there were no signs of a negative autoimmune response…

Although complementary, patents and data exclusivity protection incentivize innovation in different ways and serve distinct purposes. Patents provide protection for innovations that meet the standards of patentability and are novel, nonobvious, and useful. In the context of biopharmaceuticals, patents protect both breakthrough discoveries as well as incremental improvements. Due to the length of the drug-development and patent-approval processes, effective patent terms rarely correspond to FDA approval. Accordingly, in some cases innovative therapies may experience patent expiry shortly after making it to market. In contrast, data exclusivity protects the tremendous investments of time, talent, and financial resources required to establish a new therapy as safe and effective. This is accomplished by requiring competing firms seeking regulatory approval of the same or a similar product to independently generate the comprehensive preclinical and clinical trial data rather than rely on or use the innovator’s data to establish safety and efficacy of their competing product.

Written by David J. Kappos, former Director of the USPTO: “The language of the Myriad decision did not on its face mandate drastic, innovation-dampening action. The Supreme Court chose to narrowly decide the Myriad case, stating that a DNA segment merely “found” from nature without further human innovative intervention is not patentable subject matter… Indeed, the stakes are high – the decision and the USPTO’s interpretation may impact a number of industries that depend on patent protection to provide products, goods and services to the market and jobs to Americans, not to mention the future of life-saving medical discoveries. Of the over 300 drugs on the World Health Organization’s Essential Medicines List, fewer than a dozen were brought to market without having received patent protection. From the ibuprofen ubiquitous in the world’s medicine cabinets to breakthrough treatments for epidemics like the HIV-inhibitor AZT, the patent system has long played a pivotal role in global health.”

IDRI granted license rights to its world-class vaccine adjuvants to Immune Design Corporation (IDC), which was established in Seattle in 2008 with a focus on cancer, allergies and certain infectious diseases. The royalties and other funds received from IDC have helped to support IDRI’s programs, and IDC’s clinical safety data relating to the adjuvants have been vital in IDRI’s ability to accelerate the development of vaccines for tuberculosis and leishmaniasis, two diseases with an immense global health burden.

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…

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. Make no mistake about it, at every turn patent rights are eroding. You might think that there has been some collective, open-air discussion about whether this is a good idea. Nope! It seems government you get is the government you can afford, and those who have the ear of decision-makers on Capitol Hill are the extraordinarily well funding big tech companies that want to weaken patent rights or do away with them altogether. Indeed, there has been scant consideration paid to the effect of weakening patent rights. The erosion of patent rights is exceptionally alarming given the fact that the Founding Fathers thought it was self evident that a strong patent system was essential for America. The Founders believed the importance of patent rights to be so self evident that little debate was had on the topic. How the pendulum has swung!