Posts Tagged: "Drug"

Every once and a while we get a clear example of the gulf between those battling over important public policy issues and can understand why the public and policy makers are confused by resulting charges and counter charges. The Tuft’s study estimates that the costs of drug development have doubled from $802 million in their 2001 study to $2.6 billion today… After summarizing the Tuft’s findings, the Post invited longtime critic Jamie Love to comment. Love, who unsuccessfully petitioned the National Institutes of Health to regulate prices for any drug developed from federal funding said: “First impression: the study, which is part of a public relations campaign by the drug companies to justify high prices, is long on propaganda, and short of details.”

Our survey of the patents recently issued by the USPTO to Merck showed us a great deal of innovation in the field of metabolic disorders and conditions, especially obesity-related diabetes. But one particular patent issued to Merck now protects a pharmaceutical compound inhibiting the activity of gamma secretase and other enzymes involved in the production of amyloid beta. It’s believed that reductions in amyloid protein can treat or even prevent Alzheimer’s disease, making it a very important area of medical research.

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 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.

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.

What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. Supreme Court Denies Teva’s Request for an Injunction Relating to Generic Copaxone® — Actavis Announces Celebrex® Patent Challenge Settlement — Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014.

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.

Gardner proposes to make it patent misuse to charge much more in the United States for the same drug than in the rest of the G7. According to Gardner, “it would be presumptive patent misuse to charge more than 125% of the average price in the other 6 countries in the G7 and it would be conclusive patent misuse to charge more than 150%.” This innovative change would be a simple change in the U.S. patent laws and would be very impactful. Said Gardner, “If the patent is being ‘misused’ in this way, the patent would be invalidated and/or unenforceable, opening up competition for generics. So the owner of a drug patent would have a strong interest in avoiding losing the protection of the patent and would hold down U.S. prices and/or drive up prices around the world. Either way, we (the U.S. consumers) would over time end up paying the real price of patented medicines, not the exaggerated price which includes a subsidy for foreigner consumers.”

The government is funding basic research at universities, not drug development. Bayh-Dole allows schools to own resulting inventions and license them for commercialization. These discoveries are more like ideas than products. The expense and risk of development falls on the private sector. A study in Nature Biotechnology on drugs commercialized from federally-funded inventions finds: “the private sector spends 100-fold or more to bring the product to market than the PSRI (public-sector research institution) spends in research directly leading to the invention.” Here’s why: for every 10,000 compounds about 250 make it to preclinical testing, 5 go to clinical trials, and one enters the marketplace. Of these just 20% turn a profit– and they must pay for all those which died in the pipeline.

The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a case (Alice Corp.) on patent eligibility of system and computer-implemented method claims; on April 21, in a case (POM Wonderful) on claims under Section 43 of the Lanham Act challenging labels regulated by the Food and Drug Administration; on April 22, in a case (Aereo) on whether a provider of broadcast television programming over the Internet violates a copyright owner’s public performance right; on April 28, in a case (Nautilus) on the proper standard for finding indefiniteness invalidity for patents; and on April 30, in a case (Limelight) on joint liability for method claim infringement where all of the claimed steps are performed but not by a single entity.

Newly implemented policies, compulsory licensing practices, and recent court decisions have heightened concern about IPR in India. Congressmen Erik Paulsen and John Larson expressed their worries with India’s intellectual property violations in a letter written to President Obama. Over 170 members of Congress, consisting of a bi-partisan support, signed the letter. During their speeches at the GIPC, the Congressmen emphasized that this bi-partisan support demonstrates the grave concern of IPR in India and the importance of persuading India to comply with global practices. The Congressmen sent the letter just prior to a visit to India by Secretary of State, John Kerry.

This newly approved, updated prescribing information for ISENTERSS now includes 240-week results from the STARTMRK study, the double-blind Phase III study that evaluated integrase inhibitor in previously untreated adult patients with HIV-1 infection. The results show that the regimen containing ISENTRESS in combination therapy demonstrated long-term viral suppression and a greater immunologic response than conventional treatment regimens, as well as a proven, long-term safety and tolerability profile through 240 weeks in previously untreated adult HIV-1 infected patients. ISENTRESS had sales of $243,636,000 during Q1 of 2013, and has experienced growth quarter over quarter, which means that ISENTRESS is flirting with the $1 billion per year in sales that would make it a blockbuster drug.

After years of debate and controversy, the US Supreme Court ruled that drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal. The decision largely vindicates the position held by the Federal Trade Commission, which argued the deals are anti-competitive because generic drugmakers are given incentive to file lawsuits against brand-name rivals and then settle for a quick profit, rather than challenge a patent in court. The FTC calculated the reverse settlments, as some call them, cost consumers $3.5 billion annually.