Every once and a while you get a reminder that lives are literally at stake in some R&D partnerships. Last Wednesday was one of those days. I was privileged to moderate a panel for the Congressional Technology Transfer Caucus on innovative partnerships fostered by the National Center for Advancing Translational Sciences (NCATS) the newest center/institute at the National Institutes of Health. It was anything but a run of the mill tech transfer session.
We often hear that $2 billion to $5 billion are required to commercialize a new drug, with 14 years or more required for development and a 95% chance of failure. Less well known is that for thousands of serious diseases plaguing humanity only about 500 have FDA approved treatments available. Stark as that seems it’s downright cheery compared to rare or neglected diseases. Of more than 6,500 such ailments only 250 have treatments. While these may be “rare” diseases for many of us, to millions of our friends, families and neighbors each morning brings another day of suffering desperately hoping that someone, somewhere is working on a cure.
Earlier today the United States Supreme Court issued another of the many intellectual property related decisions the Court took during the October 2013 term. In this case, POM Wonderful LLC v. The Coca-Cola Company, the Supreme Court reversed a decision from the Ninth Circuit that held that within the realm of labeling for food and beverages, a Lanham Act claim asserting that the label is deceptive and misleading is precluded by the Federal Food, Drug, and Cosmetic Act (FDCA). The Supreme Court ruled that a claim brought pursuant to the Lanham Act, which makes deceptive and misleading advertising actionable under 15 U.S.C. § 1125(a), is not precluded by the FDCA, which forbids the misbranding of food, including by means of false or misleading labeling.
This case arose relating to the belief of POM that claims made by the Coca-Cola Company were misleading with respect to a juice blend sold by Coca-Cola’s Minute Maid division. The juice sold by Coca-Cola prominently displays the words “pomegranate blueberry,” but in truth the product contains only .3% pomegranate juice and only .2% blueberry juice.
In a unanimous ruling delivered by Justice Kennedy (minus Justice Breyer who took no part in the decision) explained that there is no text within the statutes that would support the contention that the FDCA precludes Lanham Act claims. Indeed, the Supreme Court specifically found the FDCA and the Lanham Act to complement each other.
Mylan Inc. (NASDAQ: MYL) recently prevailed in the United States District Court for the Northern District of West Virginia in a patent dispute involving Perforomist® (formoterol fumarate) Inhalation Solution, which has as the active ingredient a bronchodialating compound. The district court confirmed the validity of all patents asserted by Mylan. At issue were U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645, which cover Perforomist through June 2021.
Mylan previously sued Teva alleging that Teva’s Abbreviated New Drug Application (ANDA) for this product infringed four Mylan patents covering Perforomist. After a full trial, the Court entered a judgment finding infringement of the patents-in-suit, rejecting Teva’s defenses, and enjoining Teva from making, using, offering to sell, selling or importing the inhalation product described in Teva’s ANDA. The Court’s decision also prevents Teva’s ANDA, which has yet to receive a tentative approval from the U.S. Food and Drug Administration (FDA), from receiving final approval prior to expiration of the patents in suit.
The oral argument schedule for the Supreme Court over the next few months is heavy on intellectual property cases.
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.
What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of January 2014. Please also see Protecting IP is NOT ‘Satanic Genocide’, written by Dr. Kristina Lybecker.
All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C Genotype 1
On January 31, 2014, AbbVie (NYSE: ABBV) announced the completion of its phase III clinical program and released results of four additional studies designed to assess AbbVie’s investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. These results described below confirm previously reported AbbVie data and further demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients. Even in difficult-to-treat patients (cirrhotic patients) achieved 92-96 percent SVR(12) rates.
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
Summer is always a busy time for me. Between crisscrossing the country teaching the PLI patent bar review course, I also fit in a week teaching a class at John Marshall Law School. Between keeping up with the Federal Circuit, the inevitable end of term patent decisions from the Supreme Court and whatever nonsense Congress is thinking up (this year relating to patent trolls) I manage to stay pretty busy. What that means is a number of items typically fly under my radar screen until sometime toward the end of July. With this in mind I thought I would do a rundown of some of the more interesting items that perhaps didn’t support an entire article worth of attention.
1. Reed Tech takes over USPTO Contract from Google
Many are probably familiar the fact that the USPTO has wholeheartedly embraced the President’s Open Government Initiative (OGI) to provide increased transparency of government operations and information by making bulk data available directly to the public for no charge. To that end, the USPTO entered into a no-cost contract with Google a number of years ago. Under this no-cost contract Google scraped information from the USPTO servers, transferring the many image files into searchable text documents, which were then released to the public. But all good things must come to an end.
Once again, it is time to catch up on the news from the pharmaceutical industry. And so, here is the latest monthly compendium in which we attempt to highlight some of the more noteworthy and fascinating news with a focus on the Food and Drug Administration (FDA), preemption and the Supreme Court.
1. FDA to Allow Generic Drugmakers to Update Labeling
The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval.
The moves comes in response to a US Supreme Court ruling two years ago that generic drugmakers are not required to strengthen product labeling, even when alerted to side effects, so long as the same change has not been made to the labeling for the branded medicine. The decision sparked an outcry that product labeling would be insufficient to warn patients about the risks associated with numerous medications.
On July 1, 2013, Merck (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets. The primary purpose of the FDA labeling requirements and regulations is to give healthcare professionals the information they need to prescribe drugs appropriately. See An Introduction to the Improved FDA Prescription Drug Labeling.
ISENTRESS is Merck’s integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination Human Immunodeficiency Virus (HIV) therapy. It is the first and only integrase inhibitor approved by the FDA. 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. See Isentress Sales Data. The FDA approving new labeling seems likely to guarantee that during FY 2013 ISENTRESS will achieve blockbuster status.
The Food and Drug Administration (FDA), originally approved ISENTRESS on October 12, 2007, granting accelerated approval for raltegravir tablets (400 mg) for treatment of HIV-1 infection in combination with other antiretroviral agents. ISENTRESS received a priority review by the FDA, with the review and approval of the New Drug Application being completed within six months. At the time of the initial approval the FDA explained that when ISENTRESS is used with other anti-HIV medicines, it “may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight other infections.”