Posts Tagged: "Pharma & Chemical"

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.

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.

A few trends were readily apparent in 2012. First, pharmaceutical patent holders in litigation fared well – in a series of cases, the Federal Circuit rejected obviousness attacks in pharmaceutical patent challenges on appeal from the district courts. Second, patent holders appealing decisions from the Board of Patent Appeals and Interferences (whether it be an original application, a reexamination, or a reissue) fared poorly – the Federal Circuit affirmed several Board decisions finding chemical patent claims obvious. While these trends are not surprising, a third more subtle trend suggests chemical patents in district court litigation may be less susceptible to invalidation for obviousness post-KSR. In 2012, when the Federal Circuit reversed the obviousness decision below on a chemical patent, those reversals favored non-obviousness three to one.

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.

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.

The Federal Trade Commission will require Watson Pharmaceuticals, Inc. and Actavis Inc. to sell the rights and assets to 18 drugs to Sandoz International GmbH and Par Pharmaceuticals, Inc, and relinquish the manufacturing and marketing rights to three others, to settle charges that Watson’s proposed $5.9 billion acquisition of Actavis would otherwise be anticompetitive.

Last week the Federal Circuit decided the case of Santarus, Inc. v. Par Pharmaceutical, Inc., which dealt with whether a drug covered by an Abbreviated New Drug Application (ANDA) infringed the patents owned by that patent owner relative to the proton pump inhibitors (PPI) product omeprazole. The big issue in the case is what might at first glance seem to be a rather innocuous statement relative to the support necessary in a patent specification for a negative claim limitation. But after reading the Newman dissent (which joins in the other aspects of the Court’s decision) it starts to become clear that this could be a much larger issue of significant consequence.

Patents for Humanity in the news was also the perfect excuse to chat with Erik. I always enjoy our conversations. We touch base regularly and talk about industry matters, and I always leave those conversations wanting to write about something. Unfortunately, I have had the hardest time getting my head around what seems to be very counterintuitive — namely the use of patented technology for humanitarian purposes. I can confidently now say that I get it. I am happy to share this interview and hope that it can shed light on what might seem like an otherwise purely altruistic endeavor without much likelihood of success. There is great work being done in this space and it is indeed a “win-win” for everyone.

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.

One of the most complex issues in antitrust and patent law today involves agreements by which brand-name drug companies pay generics to delay entering the market. In the past decade, with the Supreme Court showing no interest in wading into the area, the Federal, Second, and Eleventh Circuits have upheld these agreements. And, with each court relying on its sister court, a momentum had developed that made it nearly impossible to discern a role for antitrust scrutiny. The Third Circuit just found that a reverse payment was “prima facie evidence of an unreasonable restraint of trade.”

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.

Last week, on Friday, June 15, 2012, Merck (NYSE: MRK) announced the U.S. District Court for the District of New Jersey (Judge Peter G. Sheridan) ruled against the company on the issue of patent infringement in its suit against Apotex Inc. According to Merck, global sales of Nasonex® in 2010 topped $1.2 billion. See Merck News. A variety of Internet sources place the Nasonex® market share of the inhaled steroid market at 47%. Therefore, this patent loss some 6 years before the Nasonex® patent expires is a big deal.