Posts Tagged: "FDA"

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.

A variety of electronic cigarettes have hit the market in recent months, and lately it seems that I am seeing a lot of electronic cigarette commercials on TV. Last week ICAP Patent Brokerage announced that it would be selling a patent portfolio of heatless and smokeless cigarette technology that exclusively advances electronic cigarette science. The patent portfolio includes U.S. Patent No. 6,769,436 and related patents that are still pending. According to ICAP, the ‘436 patent has already been challenged in court and prevailed as valid. And if you look at the claims in the patent you can’t help but notice that they seem exceptionally broad.

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.

We have made significant strides over the past 30 years through laws like the Bayh-Dole Act, the Federal Technology Transfer Act, and supporting Executive Orders leading to the creation of 9,000 new companies around university inventions, the development of 153 new drugs from federal funding now protecting public health world-wide, the leadership of the U.S. biotechnology industry, the addition of $836 billion to our gross domestic product supporting 3 million good jobs from university patent licensing between 1996-2012, etc. Still as far as we have come, it’s clear that we could be doing even more to reward the hard earned taxpayer dollars spent on public R&D.

Once again, a plethora of interesting events has occurred since the last time we stopped by. What was the biggest headline? That decision may be up for grabs, but certainly, the $500 million penalty paid by Ranbaxy Laboratories is high on the list. In other news, yet another Johnson & Johnson manufacturing scandal has erupted, this time in South Korea, where the authorities plan to bring criminal charges against its Janssen unit and ban production of five products – notably, a type of Children’s Tylenol. A non-profit group put Bayer on notice that a lawsuit will be filed charging the drugmaker with making “unsubstantiated and illegal claims” about the ability of its One-A-Day vitamin to prevent various disease, such as breast cancer, bolster physical energy and improve immunity, among other things.

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.

“Carve outs” essentially involve a situation where there is an FDA approved drug for which the generic drug maker seeks to market that drug, again through an Abbreviated New Drug Application (ANDA), but instead for an FDA approved use, where also that FDA approved use is unpatented. While these “carve outs” also involve the filing of a Paragraph IV Certification, there is a slight but important twist in that Certification: inclusion of what is called a “section viii statement” that the generic drug maker “is not seeking approval for a method of use that is claimed in the patent.” When submitting the “section viii statement,” the generic drug maker must also provide a proposed label that removes or “carves out” the claimed method of use.

In a moment of extreme weakness, I agreed to Gene’s request to doing a primer on Paragraph IV Certifications under the Drug Price Competition and Patent Term Restoration Act, commonly referred to as Hatch-Waxman. I don’t know if you would call me an expert, but I’ve studied many, many cases involving Paragraph IV Certifications under Hatch-Waxman. The courts have found Hatch-Waxman to be a hydra-like monster with a labyrinth of sections that are frequently confusing (or worse yet, conflicting). Paragraph IV Certifications are a particular trouble spot in Hatch-Waxman. So if you’re up to diving into the “belly of this beast,” let’s examine the characteristics of this most infamous of the Hatch-Waxman monsters. To understand Paragraph IV Certifications, you must first address what an Abbreviated New Drug Application (ANDA) is. ANDAs are how generic drug manufactures expedite the approval of their generic drugs.

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.

The FDA decided not to pursue a re-hearing before a federal appeals court that recently ruled the federal government could not prosecute a sales rep who promoted off-label uses of a medicine because his speech was not false and misleading. Meanwhile, Congress delayed Medicare price restraints on a group of medications that will benefit Amgen while costing taxpayers up to $500 million over two years. Still further, after a federal court judge decided that the Bristol-Myers patent on the Baraclude hepatitis B treatment was invalid, some analysts are saying the ruling may prompt greater scrutiny of so-called composition of matter patents.

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.

Not only is the FTC arguing that product changes to patented drugs violate U.S. antitrust laws, but the FTC and Department of Justice (DOJ) are going to look into whether patent enforcement activities that seek redress for infringement violate U.S. antitrust laws. See FTC, DOJ to Hold Workshop on Patent Assertion Entities. This does not bode well for a second Obama term, and I have to wonder whether those in the patent community that decided to vote for President Obama due to his perceived friendliness to patents and smooth running of the Patent Office are going to start to have regrets, particularly now that David Kappos is leaving the USPTO.

While the Supreme Court may have expanded the reach of the Hatch-Waxman “safe harbor,” the Medtronic and Merck cases only involved pre-marketing FDA approval activity. But the recent split Federal Circuit panel decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. has now (alarmingly in my view) further widened the applicability of this “safe harbor” beyond such pre-marketing FDA approval activity. In Momenta Pharmaceuticals, Judge Moore (writing for the majority joined by Judge Dyk) ruled that this “safe harbor” could also apply to post-FDA approval activity, even if that activity was at least arguably commercial in nature.

Americans cannot be expect to either personally or through their health insurance bear the burden associated with solely providing the return on investment required by investors to prompt pharmaceutical companies into the marketplace. Whether Americans pay through exorbitant prices out of pocket, or they pay through high priced health insurance premiums, there is no doubt that Americans subsidize individuals all around the world who pay far less than we pay in the United States. This is not a patent problem, but rather it is a government problem. Rather than seize control of the U.S. health care industry government should have tackled the underlying drivers of the cost, and a great place to start would have been in the staggeringly disparate cost of drugs between the U.S. and virtually every other country around the world.

It will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase FDA’s access to external expertise to improve the drug review process. FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core Agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective drugs available to the American public in a timely manner.