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Back in 1993 when I was looking for an industrial job, I came across an ad for a research scientist at a Philadelphia-based biopharmaceutical company called Neose. Unlike most other biotechnology companies at the time, the company was focused on identifying and discovering drugs against carbohydrate-based targets—a novel idea at the time. Because I had spent the previous seven years working on carbohydrate biochemistry, I applied for the job and I was invited to interview for the position. At the time, Neose was a small, marginally-funded biotech company that was started in 1993 by a cell biologist from the University of Pennsylvania. 

I was very impressed with the company and thought that my background was consistent with the company’s long-term goals. Unfortunately, they never made me an offer and I went to work for one of Neose’s main competitors, a small, start-up company called Transcell Technologies. Plagued by poor management and a weak technology platform, Transcell Technologies was sold and liquidated in 1999.

Neose ultimately went public and had to reinvent itself several times over the past 14 years. At one point, it had developed a novel carbohydrate-based PEGylation technology for recombinant therapeutic proteins and monoclonal antibodies, which appeared to be gaining traction in the biogenerics market space. Unfortunately, it was “too little, too late” and like most other companies focused on carbohydrate drug discovery, Neose couldn’t sustain itself. Consequently, Neose recently inked separate deals with Novo Nordisk and BiogeneriX to liquidate most of its assets for cash deals worth only $43 million. Both companies had been collaborating separately with Neose on it clinical development programs.

Neose reported that it would retain certain intellectual property rights including those related to producing glycolipids. Like Pharmacopeia, another biopharmaceutical pioneer that recently sold its assets, Neose had a solid 15 year run—something that most biotechnology companies can only dream about!

Until next time…

Good Luck and Good Job Hunting!!!!

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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties. 

According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug.  Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.

Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it.  As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”

Brand name drug manufacturers contend that generic drug makers routinely attack their patents by accusing them of inequitable conduct, whether they are guilty or not. Further, they claim that unwarranted and endless patent litigation impinges on their ability to discover and bring new drugs to market. Consequently, brand name drug markers argue that the inequitable conduct doctrine should be eliminated from US patent law. Not surprisingly, this would seriously hinder or curtail the ability of generic drug manufacturers to bring their products to market—something that brand name drug makers desperately want to protect their multibillion dollars drug franchises from generic encroachment.

The number of patent applications submitted to the USPTO has doubled in the past 10 years and more than tripled since 1987. According to Jon Dudas, the current undersecretary of commerce for intellectual property “We are getting more and more unpatentable ideas and worse and worse quality applications”. Historically, the annual number of patents that are allowed (approved) ranges from 62 to 72%. After reaching a high of 72% in 2000, it dropped to 43% in the first quarter of 2008. These data suggest that, the probability of getting new patents allowed is diminishing. This is making brand name drug companies anxious and extremely competitive when it comes to patent applications. And, when competition increases, it is not uncommon for companies and individual to resort to unorthodox (and sometimes overtly unethical or illegal methods) to insure success. In my opinion, the doctrine of inequitable conduct and the penalties associated with it are what keep illegal and unethical behaviors in check. With this in mind, I think it would be extremely unwise for Congress to eliminate or severely curtail the penalties for inequitable conduct.

Based on the small number of inequitable conduct cases that have reached the Federal Circuit, it appears that the current system is working the way it was designed to function. This begs the question: “Why fix something that isn’t broken? “ Oh wait, this debate isn’t really about ethics or legality–it is about making money–silly me!

Until next time….

Good Luck and Good Job Hunting (try intellectual property law)!!!!!!!!

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Danish drugmaker Novo Nordisk announced today that it will expand its New Jersey-based North American headquarters. This is welcome news for the state. New Jersey has lost about 10,300 jobs so far this year. And that comes after it added 3,700 jobs last year, its worst performance since 2003. 

I would say things can’t get much worse but …..

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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The Danish drug maker Novo Nordisk announced today that it was halting further clinical development of its inhalable insulin product called AERx. AERx was in Phase 3 clinical testing as a short-term diabetes treatment. In a press release the company stated that it was halting development of its inhaled insulin compound because the drug was "unlikely to offer significant clinical or convenience benefits" versus current diabetes treatments.” AERx joins Exubera (Nektar Therapeutics/ Pfizer) on the inhalable insulin scrap heap. This leavesEli Lilly and Alkermes’ IR insulin system as the only inhalable short-acting diabetes treatment in Phase 3 clinical development.

Interestingly, Novo didn't say that it was giving up on developing inhalable insulins— only that it was halting its current late-stage AERx program. The company did announce that it plans to pursue a Glucagon_Like Protein (GLP-1) inhalable diabetes treatment which is similar to a product being developed by California-based MannKind. Its product in Phase 1 clinical testing. Unlike Nektar, which partnered with Pfizer to develop Exubera, MannKind, a small startup, is developing its inhalable insulin product alone. Novo also disclosed plans to develop a longer-acting injectable form of insulin which would eliminate the need for daily injections by patients with diabetes.

In theory, inhalable insulins make sense—many people hate daily injections. That said, inhalable insulins may create other problems that obviate their usefulness as alternatives to daily insulin injections-just ask Pfizer and Nektar about that!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!

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