Posts Tagged: "eli lilly"

The U.S. Court of Appeals for the Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (PTAB’s) decision upholding the patentability of Eli Lilly & Co.’s patent claims directed to reducing toxicity of a chemotherapy agent. In so holding, the Federal Circuit cited the Food and Drug Administration’s (FDA’s) skepticism of the efficacy of the methods as evidence supporting non-obviousness. See Neptune Generics, LLC v. Eli Lilly & Co., Nos. 2018-1288, 2018-1290, 2019 U.S. App. LEXIS 12492 (Fed. Cir. Apr. 26, 2019) (Before Moore, Wallach, and Hughes, J.) (Opinion for the Court, Moore, J.) Neptune Generics, LLC, Fresenius Kabi USA, LLC, and Mylan Laboratories Ltd. (collectively, the Petitioners) filed three petitions for inter partes review (IPR) against claims 1-22 of U.S. Patent No. 7,772,209 (the ?209 patent) owned by Eli Lilly & Co. The ?209 patent generally relates to methods of administering folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, to reduce the toxic effects of pemetrexed. The Board found that the ?209 patent was not unpatentable as obvious because it was not known in the art to pretreat pemetrexed with vitamin B12 along with folic acid and the skepticism of others, specifically the FDA, supported a conclusion of non-obviousness. The Federal Circuit found that substantial evidence supported the PTAB’s findings and affirmed.

During the week of October 8, 2018,  there were five cases involving patents that were decided without an opinion as a result of Rule 36 affirmances at the United States Court of Appeals for the Federal Circuit. Three of those cases were issued by panels including Chief Judge Sharon Prost. In two cases, the Federal Circuit upheld district court invalidations of asserted patents whereas another two affirmed rejections of applicants claims by the U.S. Patent and Trademark Office. The last case was a summary affirmance of a victory by German drugmaker Erfindergemeinschaft UroPep over Eli Lilly in the Eastern District of Texas.

Drug manufactures spend billions of dollars in R&D and it takes years to get FDA approvals and patent protection. It is vital that these companies keep a vibrant and thriving product pipeline to offset costs of failed drugs, which do not work as intended or do not get FDA approval. Yet, all the money spent can yield tremendous dividends when a drug reaches “blockbuster” status. To attain this label, a drug must be so popular that it generates at least $1 billion in annual sales. Often treating the most common chronic and long-term ailments such as diabetes, high cholesterol and blood pressure, for example… In 2015, Pfizer spent $7.7 billion on R&D costs and Eli Lilly spent $4.5 billion. The forecast for Pfizer and Lilly in 2022 is expected to grow to $7.8 billion and $5 billion respectively. This is on trend with the worldwide pharmaceutical numbers at an expected growth of 2.8% to $182 billion in 2022. Both companies are targeting the largest therapy areas with sales which include oncology leading the group followed by anti-diabetics and anti-rheumatics.

Each year, millions of men rely on pharmaceuticals like Viagra and Cialis for their erectile dysfunction (ED), but they may not be the only ones facing dysfunctionalities. As the patents on these lucrative lifestyle drugs come to an end, price tags and bottom lines are expected to plummet… The lifestyle drug market is extremely lucrative. These medications can be used by all age groups worldwide and increased individual awareness of health and beauty has created a demand for physical fitness and improved performance of all our body parts. People are living longer, have higher disposable income, and the demand only grows more when a drug touts the high quality and safety of their formulations after it passes the stringent requirements for FDA approval… The real question, however, is whether U.S. patent law and policy will continue to give pharmaceutical companies the incentives necessary to innovate lifesaving medicines, or whether we will continue to see more and more blockbuster lifestyle drugs moving into the future.

LAB sued Eli Lilly & Company, alleging marketing of the drug Cialis induced infringement of LAB’s patent. Eli Lilly subsequently requested that the Board conduct inter partes review of the patent. The Board agreed to do so and ultimately found the patent to be obvious in light of three prior art references… The Court then found the Board’s construction of certain claim terms to be overly broad, stating the Board’s construction “would make the patent claims applicable to individuals with erectile dysfunction not caused by penile fibrosis.”

The Federal Circuit’s decision in Akamai V broadened the circumstances in which the actions of others may be attributed to a single actor to support liability for direct infringement. Here, a patent that claims a method of administering treatment can be directly infringed if a physician performs some of the claimed steps and the patient performs the other steps under the physician’s direction and control. The infringement is induced by the drug manufacturer when it unambiguously encourages the performance of the infringing steps, as in its labeling for the drug.

Rather than use the word ‘conflate’ to describe the mongrel mixture of patentability requirements the Supreme Court undertook in Mayo, the Eli Lilly brief characterizes the analysis employed by the Supreme Court as including a separate, implicit ‘threshold test’ for patentability that is applied even before consideration of the statutory patentability requirements. Eli Lilly hypothesizes that this ‘implicit exception was imposed to assure that patents cannot validly protect—or preempt access to—laws of nature, natural phenomena, or abstract ideas.’

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to lights, smells or sounds which characterize a migraine attack. Not much is known about the brain chemistry that directly causes a migraine, although it’s generally understood that hormonal fluctuations or environmental stimuli can act as triggers. News of successful mid-stage trials for a migraine treatment developed by Alder Biopharmaceuticals Inc. has been greeted with a warm welcome from news media. The results of the trial show that an injectable treatment known as ALD403 administered four times over the course of a year reduced patient suffering from chronic migraines.

While Justice Scalia served on the Supreme Court for nearly three decades, his contributions to the area of intellectual property law were quite limited. Scalia did famously refer to patents as “gobbledegook” during the KSR v. Teleflex oral arguments. Scalia was the only Justice not to sign onto an opinion in Bilski v. Kappos that would have recognized that at least some software is patent eligible. But Justice Scalia did not author any of the major patent decisions considered by the Court during his tenure. The passing of Justice Scalia does not seem likely have much of an impact on intellectual property cases, particularly patent cases. Having said this, I could see legislative history becoming more relevant than anyone would have anticipated just a week ago when the Supreme Court considers Cuozzo Speed Technologies v. Lee.

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 early months of 2015 have been interesting ones for the pharmaceutical industry, an incredibly valuable industry sector that comes under our focus from time to time here at IPWatchdog. The first quarter of this calendar year has seen a number of mergers and acquisitions which are showing us that the patent market for pharmaceuticals is quite active right now.…