Posts Tagged: "generic"

The FTC brief explains that the no-authorized-generic (no-AG) commitment at issue raises the same antitrust concern that the Supreme Court identified in Actavis. A no-authorized-generic commitment means that the brand-name drug firm, as part of a patent settlement, agrees that it will not launch its own authorized-generic alternative when the first generic company begins to compete. An FTC empirical study of the competitive effects of authorized generics found that when a brand company does not launch an authorized generic during the exclusivity period reserved for the first-filing generic under the Hatch-Waxman Act, it substantially increases the first generic company’s revenues, and consumers pay higher prices for the generic product.

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.

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.

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. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.

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.

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.

One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond? The Cipro case presents an ideal vehicle for Supreme Court review. It involves a simple, undisputed payment from brand to generic to delay entering the market.

The Apple application for “APP STORE” is currently in opposition proceedings at the Trademark Trial and Appeal Board. Here’s the skinny in 4th grade prose. Back in ’08, Apple opened up its first app store. Shortly thereafter, it filed a trademark application for “APP STORE” in the United States Patent and Trademark Office (“USPTO”). The Examiner said “No way! That mark is descriptive!” Apple said “Nu-uh!” Examiner said “Yes huh!” Apple said, “Nu-uh!!!”, and appealed. Examiner said “OK, fine” and published the application for opposition. Then Microsoft said, “No way! That mark is descriptive!”