Posts Tagged: "pharmaceuticals"

The ‘156 patent discloses methods of treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin, e.g., renal disease, metabolic acidosis, congestive heart failure. Defendants alleged that the asserted claims are patent ineligible because the claims recite a natural law. Plaintiffs argued claims of the ’156 patent are directed towards methods of treating the targeted patient population with metabolic diseases using non-naturally existing DPP-IV inhibitors, which alter the natural state of the body in a new and useful way, and hence do not fall within the natural phenomena exception… Superficially, this decision may appear to be consistent with Mayo – methods of treatment claims that manipulate natural biological processes are considered to be directed to patent ineligible subject matter under § 101. However… it is not perfectly clear that the treatment claims of the patent-at-issue are directed to a law of nature or an abstract idea. Claim 1 is directed to an active practical application of a compound for treatment… The decision also appears at odds with the USPTO Subject Matter Eligibility Examples.

On January 5, 2017, the District of Delaware issued its long-awaited decision in the patent dispute pending between Amgen and Regeneron wherein the Court granted Amgen’s request for a permanent injunction against Regeneron’s new PCSK9-inhibitor cholesterol drug. Both Amgen and Regeneron each independently spent billions of dollars over the past decade-plus developing a new class of cholesterol drug. The drug itself comprises an antibody that binds to PCSK9 proteins… Whereas Regeneron managed to be the first to market, Amgen succeeded in getting to the Patent Office first. Amgen originally sued Regeneron, along with Sanofi, its European partner, in October 2014. Amgen asserted three patents directed to antibodies that bind to PCSK9. Over the next month, Amgen commenced additional lawsuits as new patents issued from the Patent Office. The cases were eventually consolidated, but Amgen eventually went to trial against Regeneron on only two of the originally asserted patents.

On Thursday, December 15th, a subsidiary of Kenilworth, NJ-based pharmaceutical developer Merck & Co. (NYSE:MRK) was awarded $2.54 in royalty damages in a case involving one of the most popular available treatments for combating the hepatitis C virus (HCV). A federal jury decided that Gilead Sciences Inc. (NASDAQ:GILD), an American biotech firm headquartered in Foster City, CA, owed these royalties as a result of its infringement of patents for HCV treatments held by Merck’s Cambridge, MA-based subsidiary Idenix Pharmaceuticals. According to coverage of the verdict by Bloomberg, this $2.54 billion royalties award is the largest verdict for patent infringement in the history of the United States. The case was decided by jury in the U.S. District Court for the District of Delaware (D. Del.).

While those in the military are often thanked for their service, let’s also thank researchers like Dr. Rosenberg and his colleagues who spend their lives trying to alleviate human suffering. But that can only happen when their discoveries are commercialized– otherwise they are merely generating interesting research papers. Rather than deserved accolades, NCI and Kite Pharma got a pie in the face from the NY Times.

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

If the UN Secretary General and the members of his “High Level Panel on Access to Medicines” thought the State Department was bluffing when it warned against their attempt to make intellectual property the fall guy for the lack of health care in poor countries, they were rudely awakened Friday afternoon. Disdaining diplomatic niceties, less than two days after the UN report issued, State bluntly replied in a statement titled “U.S. Disappointed Over Fundamentally Flawed Report of the UN Secretary-General’s High-Level Panel on Access to Medicines.” Compounding the pain, the same day five prominent university associations issued a joint paper taking the report apart. Being directly and publicly rebuked in this manner is a new experience for the Secretary General and his minions– but one they richly deserve.

Delayed for months beyond its expected issue date the Secretary General’s High Level Panel on Access to Medicine’s report emerged yesterday. Apparently the panelists scrambled to better disguise their predetermined agenda behind reams of soothing rhetoric. While lip service is given to the unimagined advances in medicine under the current industry led drug development system, that’s quickly discarded under the pretext of providing better access to health care for the world’s poorest citizens through a system run by international bureaucracy. These recommendations are largely directed at the US life science industry. Luckily, one panel member provides an effective rebuttal to this approach but unless his message is repeated many public officials, media outlets and the general public could come to accept that a government run system would be “more fair.”

Nome, Alaska and San Juan, Puerto Rico are both home to a federal courthouse where, ostensibly, under the recent Acorda Therapeutics holding and subsequent court decisions, a generic pharmaceutical company will be subject to personal jurisdiction if they file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA). In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), the Federal Circuit held that an ANDA filer opens themselves up to nationwide personal jurisdiction merely by virtue of filing an ANDA application. This is a broad holding that, in effect, subjects a generic company to personal jurisdiction in any forum that has a district court.

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.

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more fundamental than advocates acknowledge. The long-term price of exercising these exceptional prerogatives could include creating a crisis in confidence over use of federally funded research discoveries, dried-up private investments where basic research has federally funded fingerprints, hesitation to commercialize university research, and a corresponding drop in start-ups, new products, economic development and technological advancements. March-in could effectively repeal Bayh-Dole.

How will our patent system treat this wonderful new discovery? How long will it take before its curative benefits can be deployed ? We can only hope that DC’s meddlers in our innovation ecosystem read the Ms. Sun’s article. Because however fervently the medical and scientific communities respond to this growing superbug crisis, IP’s DC government legal eagles are either unaware or unconcerned. The USPTO is regularly rejecting microbial patent applications in blind servitude to Alice-Mayo’s confusing eligibility formula. We can hope, but cannot be assured, the Federal Circuit will make sense some day of Alice-Mayo’s two-step test. But when? Worse, it appears that SCOTUS is infected by the anti-patent poison infesting our Capitol. How refreshing it would be to have our Congress and the nation’s highest Court be as concerned with superbugs as they seem to be with PR-created patent trolls.

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal Circuit concluded that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. 794 F.3d 1347 (Fed. Cir. 2015). Where an aBLA filer elects to forego the patent dance by failing to provide the aBLA and the biosimilar manufacturing information to the RPS, the only remedy available to the RPS lies in a declaratory judgment action for patent infringement, as expressly contemplated by § 262(1)(9)(C). In addition, the court concluded that an aBLA filer who did not engage in the patent dance was required to provide a notice of commercial marketing and that such notice could be effectively given only after the FDA had approved the aBLA. The court’s ruling left open the question whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. This decision is on appeal to the Supreme Court, which has yet to decide whether it will hear the issue.

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

Given the devastating impact of counterfeit medicines on patients and the importance of intellectual property protection in combating pharmaceutical counterfeiting, it is troubling that the UN High Level Panel seems poised to prevent a series of recommendations that will undermine public health under the guise of enhancing access. Without the assurance of quality medicines, access is meaningless. Moreover, while falsely presenting intellectual property rights as the primary obstacle to global health care, the High Level Panel downplays a host of other factors that prevent developing country patients from getting the drugs they need: inadequate medical infrastructure, insufficient political will, a shortage of clinical trials in nations where neglected diseases are endemic, poverty, and insufficient market incentives.

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.