Posts Tagged: "Pharma & Chemical"

FDA rules updated on patent information, paragraph IV certifications for ANDAs and 505(b)(2) applications

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

Legal Threats to Strong Returns on Pharmaceutical Patents Grow, Threatening Innovation

Pharmaceuticals is the industry sector where a strong patent system, promising substantial returns to successful innovation, is of paramount importance. Regrettably, the weakening of pharmaceutical patent rights through legislative means and antitrust lawsuits is symptomatic of a broader and more general policy attack that antitrust enforcers have directed against patents in recent years. Antitrust enforcers and legislators clearly need a few remedial lessons in the economics of innovation before their myopic meddling cripples the (up-to-now) highly successful American pharmaceutical sector and other key U.S. industries, which have stood as a testament to the value of strong patent rights.

Innovation A, B, C’s: Amazon, Boehringer and Chevron Disrupt World’s Top Innovator List

According to Thomson Reuters 2015 list of Top 100 Global Innovators, Amazon and several other established players in mature markets are proving that it’s not just start-ups that have the potential to upend traditional business models and reinvent our world. In fact, several of the companies new to this year’s ranking of top innovators have been around a lot longer than Amazon, among them: Boehringer Ingelheim, Chevron, Exxon Mobil, Johnson Controls, Thales, and Yamaha.

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.

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.

Recent 3M patents showcase innovative developments in nanomaterials, glass, dental devices

During 2014, 3M received 517 patents from the U.S. Patent and Trademark Office, putting it in 80th place among companies petitioning the USPTO for patents that year. The company has received 143 U.S. patents in the past three months, according to Innography’s patent portfolio analysis tools. The text cluster provided here details widespread R&D in optical film, electrical cable, abrasive particles and curable compositions.

Bristol-Myers, AstraZeneca and AmGen maintain strong new drug pipelines

There’s been a lot of positive activity in recent months for Bristol-Myers Squibb of New York City. In early March, the U.S. Food and Drug Administration approved the use of BMS’s immunotherapy drug Opvido for the treatment of lung cancer. The approval came ahead of schedule after a clinical trial of the drug was ended due to a significant improval in survival rates. In the early days of April, the company announced a partnership with Dutch-based pharmaceutical developer uniQure that will see BMS pay uniQure $254 million for the successful development of a genetic therapy for congestive heart failure. Also in early April, BMS finalized the acquisition of Flexus Biosciences, a California firm focused on developing anti-cancer therapeutics.

Merck, Pfizer and Eli Lilly patenting to stay ahead of patent cliff

The early months of 2015 have been interesting ones for the pharmaceutical industry, an incredibly valuable industry sector that comes under our focus from time to time here at IPWatchdog. The first quarter of this calendar year has seen a number of mergers and acquisitions which are showing us that the patent market for pharmaceuticals is quite active right now.…

Dow Chemical Patents: From Genetically Modified Organisms to Construction Barrier Films

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.

The High Cost of Making Pharmaceuticals

It is nearly universally accepted (and for a reason) that the process from discovery to market is long and costly. Drugs to not invent themselves and there are significant costs associated with nearly 13 to 14 years awaiting approvals. But even that really doesn’t capture what transpires in reality. Pharmaceutical companies do not just passively wait for approval, they are required to take significant and costly affirmative steps. So the critics can do all the mathematical trickeration they want, they can bemoan tax incentives not being taking into account and further complain about pharmaceutical companies partnering with Universities to discover the next generation of life saving and life prolonging drugs. But if you are going to factor into the analysis tax incentives then you absolutely need to factor in the time-value of money into the equation, as well as the astronomical failure rate, which creates extraordinary risk.

Eli Lilly Patents Treatment for HIV and Ebola Virus

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.

The Case for Incremental Innovation: The Importance of Protecting Follow-on Pharmaceutical Discoveries

The value of such innovation is best measured through the improved health outcomes for patients. In this context, a few examples from the developing world are even more illustrative. Given that those who most vehemently oppose protection for incremental innovations frequently cite the need for treatments for neglected diseases and maladies of the developing world, it is important to note that many of the treatments that do exist for the world’s most vulnerable populations are themselves incremental innovations. Numerous incremental innovations have resulted in improvements that have specific application to neglected diseases and the maladies of the developing world.

RB Pharma Gains Rights to Oral Treatment for Alcoholism

The license agreement grants Reckitt Benckiser Pharmaceuticals Inc., a wholly owned subsidiary of Reckitt Benckiser Group plc, rights for the development and commercialization of XenoPort’s promising oral treatment for alcohol use disorders, a condition affecting more than 140 million people worldwide. Under the terms of the agreement, Reckitt will receive exclusive rights to develop and commercialize arbaclofen placarbil worldwide for all indications, subject to certain rights by XenoPort to negotiate with Reckitt Benckiser Pharmaceuticals on collaborations for non-addiction indications.

Acanya® Patent Litigation Settled, ANDA Approval Awaited

Actavis plc (NYSE: ACT) announced yesterday that it has entered into an agreement with Valeant Pharmaceuticals International (NYSE: VRX) to settle all outstanding patent litigation related to Actavis’ generic version of Acanya®… Actavis believes it was the first applicant to file an ANDA for the generic version of Acanya® Gel and, should its ANDA be approved, should be entitled to 180 days of generic market exclusivity.

Patents, Drugs and the Moral High Ground

There are millions and millions of people dying each year from all kinds of illnesses that are easily preventable using simple technologies and drugs that are off patent. None of the zealots or patent haters seem to want to help these people who were dying, sometimes from horribly painful diseases that are easily preventable in the first place and then easily treated even if acquired. Rather zealots and ignorant patent haters only want to help those dying of a disease that can only realistically be treated by a patented drug… Did you know that approximately 1.2 million children will die from diarrheal disease this year alone? That translated into 3,338 deaths a day, 139 every hour and one death ever 26 seconds.