Posts Tagged: "generic drugs"

95 percent of WHO’s essential medicines are off-patent

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). As of 2013, 95 percent of the 375 pharmaceutical compounds on that year’s MLEM were off-patent, indicating a high likelihood that generic equivalents of treatments are available. Going back to the early 2000s, the percentage of essential medicine on WHO’s MLEM which are off-patent has consistently been between 90 to 95 percent. Thus, it seems clear that the patent system has served its intended purpose: To incentivize the creation of important, innovative, even live saving products that society can reap the benefits from long after the exclusivity of the patent has expired.

Are Patents the Reason Poor Countries Lack Healthcare?

A consistent charge against the patent system is that it denies the poor access to critical medicines. This belief led the UN Secretary General to launch his High Level Panel on Access to Medicines that is supported by groups like Universities Allied for Essential Medicines (UAEM)… As to UN Secretary General’s claim of a “policy incoherence” between IP rights and access to medicines, without the patent system there will be a lot fewer drugs to access here or abroad. That’s a thought he might ponder.

Reverse Payment Settlements and Holdup Under PTAB

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow legal authority. Further, while there is a statute requiring agreements between Hatch-Waxman firms to be submitted to the Federal Trade Commission (FTC) for antitrust review, the parties may attempt to evade it. The statute requires submission of agreements that relate to the manufacture or sale of either firm’s drug. The parties might therefore feel justified (rightly or wrongly) in not submitting a consent decree stating that the patent is valid and would be infringed by the proposed generic, since this does not expressly address manufacture or sales. Alternatively, it could be that the parties submit a district court consent decree (which includes no reverse payment), but not the PTAB settlement (which could include a reverse payment). After all, a PTAB settlement simply says that the parties agree to terminate the IPR – it need not declare the patent valid – and this arguably does not relate to manufacture or sales.

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.

Eli Lilly prevails in divided infringement Alimta® patent case

The United States District Court for the Southern District of Indiana ruled in favor of Eli Lilly (NASDAQ: LLY), issuing a final judgment in the Hatch-Waxman infringement litigation relating to U.S. Patent No. 7,772,209. This matter arose as the result of the defendants’ filing of Abbreviated New Drug Applications (ANDAs) with the Food and Drug Administration (FDA). The ‘209 patent, covering a method of use, protects the co-administration of pemetrexed disodium with two nutrients – folic acid and vitamin B12, which protects against the side effects of the drug Alimta®. The district court found direct infringement by administering physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b).

The Sticking Point that Shouldn’t Be: The Role of Pharmaceutical Patents in the TPP Negotiations

The controversy swirling around the Trans-Pacific Partnership (TPP) Trade Agreement sheds light on two critically important but divisive issues: international trade and intellectual property protection for pharmaceuticals. One of the most significant sticking points in the negotiations is the issue of intellectual property protection for pharmaceuticals, specifically data exclusivity. Data exclusivity is a means of correcting a free-riding market failure, providing the innovative firms with a limited period of time in which data from clinical trials and other required testing cannot be used by competing firms to secure market access.

BIO, PhRMA lobby for IPR fix to insulate their patents from challenge

Greenwood and Castellani will have two major problems as they seek relief. First, the IPR provisions do not include a standing requirement, which means that anyone can bring an IPR for any reason. The second problem is potentially more challenging. An IPR fix would create a so-called scoring problem with the Congressional Budget Office (CBO). What this means is that if this relief were provided for the biotech and pharmaceutical industries, as desired by Goodlatte and Castellani, it will cost the federal government money and increase the deficit unless it is offset.

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.”

Uncle Sam the Patent Troll Sues to Stop Generic HIV Drug

HHS is suing a defendant that merely wants to market a generic version of a drug that is used to treat patients with human immunodeficiency virus (HIV). Not only is the United States government a patent troll, but the government is also trying to deprive patients who need live saving HIV drugs an affordable generic version. Egad!

FTC Files Amicus in 3rd Circuit Over Reverse Payments

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.

Pharma Update: News for April 2014

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.

Patents, Drugs and the Moral High Ground

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.

Pharma Update July 2013: FDA, Preemption & SCOTUS

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.

Pharma Law and Business Roundup: June 2013

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.

Myriad: Positive Implications for Genetic Research, but Some Questions Remain Unanswered

Widely divergent views have formed in the wake of the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip. op. (U.S. Jun. 13, 2013). Some commentators have reacted with dire predictions for the biotech industry, suggesting that the Court’s holding has unduly narrowed patent protection traditionally granted to DNA technology and has disincentivized researchers in the field, particularly those from small start-ups. Other commentators suggest that the Supreme Court’s decision in Myriad will actually benefit genetic research, particularly researchers at the start-up level. The authors of this post tend to agree with this latter view.