Posts Tagged: "HIV-AIDS"

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.

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.

Over the past two years, India has invalidated or otherwise attacked patents on 15 drugs produced by innovative pharmaceutical firms. While the claim is that this promotes lower prices and expanded access to medicines, in truth this is industrial policy not health policy. The clear beneficiaries are local generic manufacturers, not Indian patients. The majority of Indians do not need Nexavar, or any of the other patented drugs being considered for compulsory licenses. They need doctors, nurses, clinics, and hospitals. Put simply, a functioning healthcare infrastructure. Basic health statistics clearly illustrate the real problem, India currently accounts for one-third of the deaths of pregnant women and close to a quarter of all child deaths.[3] The battle for health in India will not be won with compulsory licenses. It will be won with investments of resources on the ground in local communities.

The first patent received by an HBCU was on April 11, 1978, assigned to Shaw University of Raleigh, NC. Between 1969 and 2012, HBCUs received 100 utility patents from the U.S. Patent and Trademark Office in various fields, including energy, advanced manufacturing technology, nanotechnology and breast cancer treatment. Although this is a very small portion of patents issued by the USPTO during that period, the rate at which HBCUs have received patents has increased exponentially in recent years. In 2010, HBCUs received 10 patents; in 2011, 17 patents; and in 2012, 24 patents.

Kava Plant May Prevent Cigarette Smoke-induced Lung Cancer *** Conditional Approval for Treatment of T-cell Lymphoma in Dogs *** All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1 *** Favorable Markman Ruling for Dopomed in GRALISE® Patent Litigation *** More FDA Woes for Ranbaxy *** Inovio Develops DNA-based Immune Booster to Enhance T-cell Responses *** Fish & Richardson Wins Hatch-Waxman Litigation for Allergan *** FDA approves Mekinist with Tafinlar for Advanced Melanoma

South Africa currently faces a stark choice between protecting and incentivizing innovation and stymying life-saving therapeutic breakthroughs. Policymakers must choose between shoring up the protections that encourage the development of medicines that enhance and extend life, or sabotaging innovation through the weakening of the patent system. South Africa is purported to have the highest number of people living with HIV in the world, people who have the most to gain from breakthrough therapies. Innovative medicines have contributed to the 85 percent decline in the death rate from HIV/AIDS since 1995. The benefits of future medicines will become a reality only if these medicines are incentivized and developed. Strong, effective IP protection is essential to that process.

Innovation provides new therapies and breakthrough treatments that extend and enhance life. The scientific and financial resources required for these advances are an investment worth making and an important precedent for global health. Patents encourage those innovations, making cutting-edge treatments a reality. Patents give innovation life. Current efforts to amend existing intellectual property legislation to “fix” the patent system will only undermine the incentives that encourage innovation. All innovation, both breakthrough discoveries and incremental improvements, is valuable and should be protected and rewarded. India, Brazil, South Africa and other emerging economies should take note. Their proposed changes, aimed at weakening intellectual property rights protections, are misguided and potentially very damaging to public health.

While it is easy to point to patents and blame the industry and international trade agreements for barriers to access to medicines in developing nations, the reality of the situation is more nuanced and not nearly so straightforward.  In the debate over barriers to access, the focus must be broadened to include other important factors such as poverty, taxes and tariffs, corruption and pharmaceutical counterfeiting.  Each of these elements inhibits access to medicines, through financial challenges, higher prices, shortages, and spurious products.  For the most vulnerable populations it is essential to address all of the key barriers to access, and improve procurement and monitoring systems.  Without a wider focus and a solution to these problems, it is unlikely that efforts to improve access will succeed.

The conjugates covered by this patent could enable less frequent and better tolerated dosing of one of the most widely used treatments worldwide for relapsing-remitting multiple sclerosis, interferon-beta-1b. The invention described in the European Patent relates to methods for the preparation of conjugates of poly(ethylene glycol), and derivatives thereof, with interferon-beta-1b. Compared to the corresponding unconjugated bioactive components, the conjugates of the invention have increased stability (i.e., longer shelf life and longer half-lives in vivo). In addition, compared to conjugates of the same bioactive component prepared with polymer chains that are attached randomly to solvent-accessible sites along the polypeptide chains, the conjugates of the invention have increased receptor-binding activity and increased potency.

One of the critical issues in the Stanford case that is glossed over (or at least not addressed directly) by the Supreme Court majority (as well as others in the patent “blogosphere”) is what happens when you have a present assignment (or at least a contractual obligation to assign) of invention rights that don’t exist at the time of the assignment (aka “future invention rights”). Should (as the Federal Circuit held) Roche (or more appropriately its predecessor, Cetus) by using the language “I will assign and do hereby assign” (aka the “Cetus Assignment Clause”) trump what may have been an earlier obligation by a Stanford University researcher (Mark Holodniy) to assign invention rights to Stanford University (aka the “Stanford University Assignment Obligation”)? I would argue, as did Justice Sotomayor’s concurring opinion and Justice Breyer’s dissenting opinion (joined by Justice Ginsburg) that a “yes” answer to that question defies logic, reason, and prior case precedent (other than the Federal Circuit’s 1991 case of FilmTec Corp. v. Allied Signal, Inc. whose logic, reasoning, and adherence to prior case precedent was challenged by both Justice Sotomayor’s concurring opinion, as well as Justice Breyer’s dissenting opinion).

At issue in the case, essentially, was whether the extraordinarily successful Bayh-Dole legislation (enacted in 1980) automatically vested ownership of patent rights in Universities when the underlying research was federally funded. In a blow to the convention wisdom of Supreme Court patent-watchers, the Supreme Court actually affirmed the United States Court of Appeals for the Federal Circuit. Unlike some recent decisions where the result of the Federal Circuit was affirmed but a wholly new test announced, the Supreme Court simply concluded: “The judgment of the Court of Appeals for the Federal Circuit is affirmed.” Perhaps even more surprising, the Supreme Court seems to have objectively reached the correct conclusion.