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Posts Tagged: "brand name drugs"

Why should we encourage generics to challenge pharma patents?

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same insidious thought process underlying Hatch-Waxman seen underlying the justification for post grant challenges of all patents at the USPTO. How absurd is it that those who question the need for incentive to innovate are so eager to provide incentive to challenge patents?

The Abuse of Orange Book Listings by Branded Pharmaceutical Companies

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, the FTC would have none of it. The agency filed suit against AbbVie in the Eastern District of Pennsylvania in 2014, accusing the company of illegal monopolization under the antitrust laws. The gravamen of the FTC’s complaint was that AbbVie wrongfully filed objectively-baseless sham litigations, to block generic competition.

Patent settlement between AbbVie and Amgen delays Humira generic until 2023

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023… Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues.

Winning the Drug Development Debate

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole. No one is going to spend billions of dollars and more than a decade of effort turning early stage inventions into new drugs or fund a life science startup company without strong patent protection. Yet the patent system and Bayh-Dole are precisely what the critics seek to undermine.

A Simple Way to Lower Drug Prices

Consumers suffer the scourge of high drug prices. Brand-name drug companies reap monopoly profits. But generic drugs, which promise lower prices, are often nowhere to be found. One reason is that brand firms have engaged in an array of conduct to block generics. In short: A sample is crucial. Without it, there is no generic.

Third Circuit Lamictal Ruling: ‘Payment’ Broader than Cash

On June 26, the Third Circuit held that payment includes more than just cash transfers. Judge Scirica, in a unanimous decision, wrote that Glaxo’s promise to Teva not to introduce an authorized generic version of epilepsy-and-bipolar-disorder-treating Lamictal was an “unusual, unexplained reverse transfer of considerable value.” And the court held that this transfer could “give rise to the inference that it is a payment to eliminate the risk of competition.”

Supremes Say Reverse Payments May Be Antitrust Violation

On Monday, June 17, 2013, the United States Supreme Court issued its much-anticipated decision on so-called “reverse payments.” This decision will impact how brand name drug companies and generics enter into patent settlements to resolve pending patent litigation. In a nutshell, speaking for the majority, Justice Breyer wrote that there is no valid reason for the FTC to be denied the opportunity to pursue reverse payments as an antitrust violation. Breyer, who was joined by Justices Kennedy, Ginsberg, Kagan, and Sotomayor, determined that reviewing courts should apply the rule of reason when determining whether reverse payments violate antitrust law.