Posts Tagged: "pharmaceuticals"

Traditionally, “small molecule” drugs are patent protected for a twenty-year term. Biologic medicines, however, are more difficult to comprehensively protect with patents due to their size, complexity, and numerous similar effective variants. This comprehensive protection is critical given the investment and risk associated with biologics. Estimates are that the pre-approval cost of developing a biologic approaches $1.2 billion and that the time needed to recover the pre-approval R&D costs be between 12.9 and 16.2 years. In the United States, the Biologics Price Competition and Innovation Act of 2009 (“Biologics Act”) provides for 12 years of exclusivity for the drugs. Through this, Congress endeavored to fill the void left by patents and trade secrets in the protection of biologics.

As many following India IP issues are well-aware, in 2012 India issued the 1st compulsory license (CL) to Natco for Bayer’s anti-cancer drug Nexavar. The granting of this CL was further upheld by the Intellectual Property Appellate Board in Spring 2013, leading to great concern and condemnation in the international IP community, especially by those in the Pharma field. Also in Spring 2013, BDR Pharmaceuticals, Ltd. filed the 2nd Indian application for a CL (still pending) for Dasatinib, Bristol Meyers Squibb’s blockbuster anti-cancer drug. Thus it appears to be the beginning of a trend for Indian pharma companies to request CLs, and I believe that this trend will continue and likely increase.

In a recent article in the New England Journal of Medicine, Amy Kapczynski argues that the Supreme Court of India’s strict interpretation of the country’s new patent law provides a model to be followed by other countries. Kapczynski applauds this “Patent Law 2.0” and argues that it will enhance access to medicines and may improve pharmaceutical innovation. Unfortunately she is wrong on both counts. Section 3(d) of the Indian Patent Act forbids the patenting of new forms of known drugs unless the new form significantly enhances efficacy and yields therapeutic benefits. Accordingly, much of the incremental innovation that is done on existing treatments will no longer be patentable under the so-called Patent Law 2.0. These are not issues considered by Kapczynski. Astonishingly, she interprets the impact of this law as follows, “Provisions like Section 3(d) can help reverse this effect [prioritizing incremental innovation over breakthrough drug discovery] and encourage companies to undertake the riskier and more expensive research that is required to generate breakthrough drugs.” Her analysis is strikingly naïve. It is laughable to think that weaker intellectual property rights (IPR) protection will incentivize innovative pharmaceutical firms to expend more resources and take on greater risk.

The summer may be in full swing, but the torrent pace of news and interesting developments has not subsided at all. Hot days simply yield hot stories. Unarguably, the most sensational item over the past few weeks has been the GlaxoSmithKline bribery scandal unfolding in China. As of mid-July, four Glaxo executives, all of whom are Chinese nationals, were detained and authorities hinted that other drugmakers may be examined as they review records held by travel agencies implicated in the drama.

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.

Critics argue that pharmaceutical patents are a barrier to wide-reaching access to medicines, especially for vulnerable populations in the developing world. They cast their argument in the phrase, “Patents Kill” and advocate against intellectual property (IP) protection for medical innovation and the trade agreements that incorporate them… Not surprisingly, barriers to access are more prevalent in less developed nations and access to medicine is a function of the level of economic development. Not surprisingly, higher-income nations benefit from greater access to medicines.

“Reverse payment” cases are an outgrowth of a key feature I noted in my first article on the basics of Paragraph IV Certifications: the filing of an Abbreviated New Drug Application (ANDA) by the generic drug maker with a Paragraph IV Certification is treated as a technical act of patent infringement.[2] After receiving notice of the Paragraph IV Certification, the patent owner/NDA holder has 45 days to bring suit, otherwise the FDA can move forward on approving the ANDA.[3] Conversely, if the patent owner/NDA holder does bring an infringement suit within the prescribed 45 day period, the FDA cannot approve that ANDA for 30 months, unless the patent(s) that are the subject of the Paragraph IV Certification are earlier deemed invalid or not infringed in that suit.[4]

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

Senator Ron Wyden (D- OR) is a man with an idea for lowering health care costs. Unfortunately, it’s an idea which proved disastrous the last time it was forced on the National Institutes of Health. But that hasn’t dissuaded the Senator from trotting it out again. He seems sincere in his concern with the ever escalating costs of medicine. Unfortunately, his proposed solution empowering the government bureaucracy to second guess industry drug pricing decisions simply because they worked with NIH would make things worse. We could see fewer new drugs at any price.

In response to the scandal over a fungal meningitis outbreak, the FDA has begun a crackdown on compounding pharmacies and targeting about 30 ‘high risk’ operations in nearly a dozen states. San Francisco officials approved a referendum that will allow residents to decide whether to require city officials to hold talks with drug makers about pricing for ‘essential medicines.’ A federal appeals court upheld the conviction of a former biotech chief executive, who argued that federal prosecutors violated his First Amendment and commercial speech rights. The Federal Trade Commission filed a brief siding with generic drug makers in dispute with brand-name drug makers. At issue is whether a brand-name drug maker should be required to sell samples of its medicine to an aspiring generic rival when its medicine was approved with a Risk Evaluation and Mitigation Strategy.

Among other claims, the generic firms allege that Actelion’s conduct violates the federal antitrust laws. Actelion seeks a broad declaration that it is under “no duty or obligation” to sell its products to potential competitors. Although Actelion contends that its distribution restrictions are required by the FDA, it argues that its right to refuse to sell to the generic firms is nearly absolute and would apply even without any FDA mandate. The FTC’s amicus brief explains that Actelion’s legal position, if adopted by the court, could pose a significant threat to competition in the pharmaceutical industry.

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.

Not surprisingly, 2013 began with a predictable rush of interesting news. So here are some of the most recent highlights, from court rulings and medical study findings to FDA doings and steps taken to developed new parameters for prescribing and clinical trials in various places. The Obama administration again missed a deadline for releasing much-anticipated Sunshine guidelines for industry transparency. The year also began with the usual anticipation surrounding the annual JP Morgan Healthcare conference. Meanwhile, a research letter in JAMA Internal Medicine caused a stir after finding that 43 percent of doctors in practice more than 30 years acknowledged they sometimes or often acquiesce to patients who pester them for – or even demand – brand-name drugs.

Litigation always factors into the pharmaceutical world, but the US Supreme Court commanded a special place in recent days. The high court figured in no fewer than four contentious issues that, not surprisingly, play a vital role in how drug makers can and will operate. Let’s start with a case that is not yet before the court, but many predict will be headed there thanks to one of its earlier rulings. Earlier this month, a three-judge panel of the US Court of Appeals for the Second Circuit overturned the conviction of a former sales representative, who argued that prosecuting him for remarks made about off-label use violated his free speech rights.

Several public interest groups recently filed a march in petition under the Bayh-Dole Act asking NIH to force Abbott Laboratories to license its competitors for the production of Ritonavir, a drug used to treat AIDS.  Drug developers face a daunting task. For every 5,000 drugs tested, about five proceed to clinical trials. Perhaps one is eventually approved.  That one must not only pay for itself, but for all the company’s other drugs that died along the way. This grim math eludes the petitioners.