Alternate Careers: Patent Agents and Intellectual Property Attorneys

Posted in Career Advice

Times are tough for many in the legal profession these days. However, the demand for patent experts including attorneys and patent agents is skyrocketing. Openings for patent attorneys account for more than 15 percent of law firm job openings while only 3 percent of lawyers in the US specialize in this area. The bottom line: it is a great time to be a patent attorney or agent in today’s tough economy.

Not surprisingly, many patent attorneys (and agents) usually have a background in science or engineering. And, because of the scarcity of qualified applicants many law firms are doubling their recruiting spending to meet the growing demand for specialists in intellectual property (IP) and patents.

One of the reasons for the growing demand is passage of the America Invents Act, the largest overhaul in theUSpatent system in the past 60 years. The legislation which changes how patents are reviewed and process is spurring competition between firms to higher IP specialist to ease the transition pain. At present, there are over 230 IP openings among more than 1400 lawyer positions nationwide. Many of the openings have been unfilled for over 90 days and more are added daily.

Currently, there are about 40,000 patent attorneys and agents registered with the US Patent and Trademark Office (USPTO). In order to register with the USPTO agents and lawyers are required to pass the patent bar examination. While registered patent agents have taken and passed the exam, they are not lawyers who are required to pass state bar examinations to become licensed attorneys. For those of you who may not know, you don’t have to go to law school to take the patent bar exam nor is a law degree required to take individual state bar exams (however, person who are not law school graduate are likely not to pass the state tests). Patent agents can prepare patents and prosecute cases with the USPTO but cannot litigate in court or draw up contracts. There are roughly 1.2 million licensed patent attorneys in theUSaccording to the American bar association.

The greatest demand for IP attorneys and agents is in information and computing technology and the life sciences. Persons with PhD degrees in the life sciences can sometimes find work at IP and patent law firms. Also, you may be able to find work at a patent examiner with the USPTO! PhD degree holders who have passed the patent bar are even more desirable. However a law degree plus a PhD degree will almost certainly guarantee you employment at most IP firms. That said, before you decide to go to law school, I high recommend that you talk with IP professionals or read a few dozen patent applications (they can all be found at www.uspto.org) in your spare time. If you find the reading interesting or manage to stay awake after reading the fifth application than patent law may be a good choice for you. If not, I suggest that you consider other alternate career options.

Until next time…

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

 

Patents, Genes and the Future of Biotech

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The decision yesterday rendered by Federal District Court Judge Robert W. Sweet that invalidated the patents issued to Myriad Genetics for the breast cancer marker genes BRCA1 and BRCA2 is analogous to the “shot heard round the world” that kicked off the American Revolution in 1775. While it isn’t clear whether or not the decision will stand (Myriad has appealed the ruling), it does have the potential to change the way in which life sciences companies may operate in the future.

Patents are the lifeblood of the biotechnology industry. Because of this, scientists, university technology transfer offices and many would be entrepreneurs have sought to patent any and all ideas, inventions and potential products that may serve as the basis for a life sciences community. This has resulted in the issuance of a surfeit of composition of matter patents for many human and non-human DNA sequences that encode potential industrial and therapeutic proteins.

Prior to the sequencing of the human genome, many scientists and entrepreneurs had compelling and legitimate arguments to patent newly discovered DNA sequences. While these sequences existed in nature prior to their discovery, their commercial potential could not be fully realized until the genes and their products were isolated and fully characterized which generally required many years of scientific study. In contrast, however, the advent of whole genome sequencing allows scientists, to easily identify genes and their products that are likely to have future commercial potential and value. Because this renders inventions that make use of the genes or proteins themselves obvious, composition of matter patents are no longer feasible or warranted. Also, while composition of matter patents may have been lucrative in the past, it is usually secondary process patents that extend the commercial lifecycle of protein-based drugs. For example, the composition of matter patent for recombinant erythropoietin (held by Amgen) expired in 2004. However, Amgen has recombinant erythropoietin process and production patents that preclude competition in the US until 2017.

While composition of matter patents may be important for therapeutic proteins, the same isn’t true for diagnostic products. In fact, composition of matter patents in this case (like Myriad Genetics patents for BRAC1 and BRACA2) tend to stifle innovation and create monopolies for the companies that own them. The elimination of composition of matter patents for DNA sequences will give scientists the requisite freedom to operate and necessary creativity to develop new tests and uses for novel genes and their products.

To that end, the diagnostic industry would be well served if it adopted the open source business model pioneered by the software industry. This has resulted in the creation and development of new products, commercial applications and business opportunities that have exceeded the expectations of the companies that developed the original code. I see no reason why the same approach couldn’t be used in the diagnostic and personalized medicine industries as they continue to mature.  After all, the human genome is the ultimate source code and allowing free and unfettered access to its contents will undoubtedly result in many innovative, useful and previously unimagined commercial scientific and healthcare advances in the future.

Until next time…

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

 

Bugs, Drugs and Patents

Posted in Career Advice

I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time…

Good Luck and Live and Learn!!!!

 

Pharmaceutical Industry is Losing its Reputation As an Ethical Industry

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According to a recent analysis conducted by Covalence a Geneva Switzerland-based organization that tracks the ethical reputation of multinationals, the pharmaceutical industry’s ethical reputation dropped from first to third on Covalence’s all-time EthicalQuote ranking that monitors 10 industries. Further, over the past year, pharma has only managed to achieve an overall ranking of 8th on the list.

The reasons given for the ongoing decline are increased attention on product risk and decreasing media coverage of donations and philanthropy of pharmaceutical companies. The recent high profile coverage of the safety risks associated GlaxoSmithKline’s Paxil and Merck’s Vioxx are good examples of why the ethical image of pharma continues on its downward spiral.

To improve their image, ethicists recommend that drug companies showcase innovative drugs in poor countries, reduce prices to increase access to drugs and loosen intellectual property rights so that there is global access to potentially life-saving drugs. While several companies like Merck and Roche have gone down this path, it may be too little too late.

Until next time…

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

 

Life Sciences Patent Factoid

Posted in Career Advice

According to a survey of 1,800 American professors in the life sciences conducted by economists at the University of Wisconsin-Madison, 90% of life sicentiest hold only one or no patents.  This means that  remaining 10% hold more than one (and are probably weathier than the other guys). 

The results of the study led its authors to surmise that despite the recent explosion in patenting in the life sciences, a majority of academics still do research the "old-fashioned way"–by winning federal research grants, publishing in scientific journals and training PhD and postdoctoral students.  Yeah right–I bet many of the old-fashioned folks wish they had patents and were able to start biotechnology companies!!!!

Until next time….

Good Luck and Good Patenting!!!!!!!

Big Pharma and Biotech Assail US Patent Laws

Posted in Career Advice

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.”

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