The book “Best Practices in Biotechnology Business Development” is a guidebook for those seeking to understand how to practice the business of biotechnology in order to become empowered to better manage their operations.

This is not a typical page 1 to end (page 186) storyline with a nice plot and happy ending.  Instead, this is a series of 11 missives covering a variety of topics having to do with the business of biotech.  From how to communicate with investors to managing intellectual property to getting a grip on cash flow, the various segments guide you through individual useful segments.

You can get your money’s worth just in the section on the Top Five Mistakes by Entrepreneurs by Carlos Velez of the Erie Hudson Group.  In my experience, these are right on as the type of hard news struggling start-ups need to hear.  For example:

Mistake #2 - Taking the Wrong First Step

What this means is that newly set forth entrepreneurs often think that the first step is to run out and get some money (via VCs, angels, etc.).  In fact, these companies struggle precisely because they are unwilling to take the necessary personal risk and invest themselves.  They want others to take on all the risk.

But, who wants to invest in a company if the founders/management are not personally (and severely) at risk themselves?  Investors want to know that those involved are going to be sufficiently motivated to move quickly, decisively and (more importantly) prudently.  Nothing propels one to get things right like fear of total devastation.

I see a lot of entrepreneurs start companies but fail to quit their day jobs.  These companies with great promise eventually founder after years of fits and starts because they are not sufficiently invested.  More often than not, these are people with secure jobs (like tenured faculty members) who like living in a nice environment free from risk and it’s just too difficult to leave that behind for the wild ride of a business start-up.

Best Practices in Biotechnology Business Development is edited by Yali Friedman, author of Building Biotechnology a coursebook for biotechnology.  His other projects include the Biotech Blog and Drug Patent Watch.

You can get the book here: Best Practices in Biotechnology Business Development: Valuation, Licensing, Cash Flow, Pharmacoeconomics, Market Selection, Communication, and Intellectual Property

Posted June 30th, 2008 by Stephen Albainy-Jenei in Book Reviews
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The book “Patent Appeals: The Elements of Effective Advocacy in the Federal Circuit” by Mark Simon Davies (Oxford University Press, USA) provides detailed guidance for IP lawyers on the requirements for an appellate brief set out in the Federal Rules of Appellate Procedure 28(a).  The book inherently focuses on the U.S. Court of Appeals for the Federal Circuit but other appellate courts are also covered (e.g., the Ninth Circuit and Second Circuit).

Not being an appellate lawyer, I was hesitant to review a book on such a specialized topic. Patent prosecution and transactional lawyers tend to steer clear of arcane rules regarding what size font to use in a brief and debating whether it would be better to use serif or sans serif. But I gave it a read after deciding that all patent work is about obtaining patent protection that is ultimately found to be both infringed and valid. In the end, that means getting past any final review at the Fed Circuit.

Like it sounds, the book covers the nitty-gritty regarding the organizational requirements for an appellate brief. However, along the way the author provides some insight on the informal expectations and special challenges presented by a patent appeal. Each chapter contains general advice on how to prepare a certain section of the brief — from Statement of the Facts to Summary of the Argument — along with samples and some inside tips. The book also covers post-briefing issues, petitions for panel rehearing and rehearing en banc as well as advice on hiring appellate co-counsel.

What’s important is that the author sets out the new dynamic of patent law where the Federal Circuit is under intense scrutiny by the Supreme Court. Between 1998 and 2005, the Supreme Court took up ten cases (10 of 502 or double the historic average) and reversed in 9 of 10 of these cases. The take-home message is that everything has to be geared as though addressed to the Supreme Court and the author urges avoiding reliance on any kind of Federal Circuit test. From eBay v. Mercexchange to KSR Int’l Co. v. Teleflex Inc., the Supreme Court has shown time and again that it just doesn’t think much of the Fed Circuits cute little tests. In KSR, the justices show their disdain in a protracted exchange:

Chief Justice Roberts: “It adds a layer of Federal Circuit jargon that lawyers can then bandy back and forth, but if it’s — particularly if it’s nonexclusive, you can say you can meet our teaching, suggestion, or motivation test or you can show that it’s nonobvious, it seems to me that it’s worse than meaningless because it complicates the inquiry rather than focusing on the statute.”

Goldstein: “Mr. Chief Justice, the reason that the Federal Circuit disagrees and over 30 years this special court has elaborated this problem - is that we need a guidance, we need guidance for the lower courts. We need to focus them on the right question, and for patent examiners and patent practitioners, and the right question is not is — was someone merely capable of putting the two together. The right question is is there any reason to believe that it would have been apparent at the time of the invention to create this invention whether it’s through a teaching, a suggestion, a motivation.”

Justice Scalia: “I agree with the Chief Justice. It is misleading to say that the whole world is embraced within these three nouns, teaching, suggestion, or motivation, and then you define teaching, suggestion, or motivation to mean anything that renders it nonobvious. This is gobbledygook. It really is, it’s irrational.”

Practice tip: avoid reference to any test.

Mark Simon Davies is a counsel in O’Melveny & Myers LLP’s Washington, D.C. office. He has argued more than twenty-five cases, including Festo Corp. v. SMC, Corp., Fed. Cir. No. 95-1066 (en banc), and Southco Inc. v. Kanebridge Corp., 3d Cir. 02-1243 (en banc).

Patent Appeals: The Elements of Effective Advocacy in the Federal Circuit

Posted May 19th, 2008 by Stephen Albainy-Jenei in Book Reviews
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I usually try to keep up with various to-do’s but one item that I’ve been behind on lately is reviewing some books on my shelf. One book that I’ve recently perused is “Patents for Business: The Manager’s Guide to Scope, Strategy, and Due Diligence” by attorney M. Henry Heines (Praeger Publishers, Westport, CT (2007)).

Patents for Business is just like it sounds. Written for the corporate manager responsible for patentable inventions. From “What is a patent?” to patent strategies, the book is a very readable and informative introduction to intellectual property issues. While not a Grisham novel, it is written in a very approachable style that makes the best of a topic that can often be dry and tedious in its details.

Heines provides complete coverage of the issues, methods, and art of managing patents including ways of identifying prior art, understanding the differences between novelty and obviousness, and the critical inquiries of whether or not a company will have the ability to conduct its business, or have freedom to operate — all based on the author’s real-world experiences.

One subject that I see critically lacking in manager’s is a full understanding of global patenting, especially the differences in allowable subject matter.  Heines provides a good overview of the various national and regional patent systems around the world.  This is a topic that will only continue to gain importance in corporate mission statements.

This type of book should be required reading for those tasked with the burden of building and maintaining a patent portfolio. Of course, if it were, we wouldn’t get to bill so many hours.

Patents for Business: The Manager’s Guide to Scope, Strategy, and Due Diligence is available on amazon.com.

Posted April 21st, 2008 by Stephen Albainy-Jenei in Book Reviews
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As many of us have discovered, who you know is often more important than what you know. So important that networking is nearly a full-time job on its own, according to the book, “Never Eat Alone: And Other Secrets to Success, One Relationship at a Time,” by Keith Ferrazzi. Yes, it’s filled with much wisdom and he reveals his “secrets to success“! Below is my review of the book:

First, Ferrazzi was the son of a working class dad (like mine) only his dad (unlike mine) went to the CEO of the steel company he worked for and asked the CEO to please help his son. The CEO, on the board of the local private school, immediately got Ferrazzi into a prestigious school where all the wealthy kids were driven in chauffeured limos. This school got him into Yale, which got him into Harvard Business School. When he needed to get connected to anyone, say in DC, his teachers at the private school would get him connected to other alum (like the Asst. Secretary of Commerce) who then would seemingly do anything for him. Yes, he went to a prestigious school and he repeats this over and over again from beginning to end.

When Ferrazzi took his first job at Deloitte, he sucked so bad at his job that, instead of firing him, his boss gave him a $150,000 budget to just go around and schmooze and market Deloitte services without (apparently) having to do any actual work.

Everywhere Ferrazzi went, no matter who he met — e.g., Michael Milken, Phil Knight, various other CEO’s, politicians, movie studio big-wigs, etc. — that person would immediately take him under their wing and show him the ropes. Apparently, name-dropping is one of the keys to success. I don’t think Ferrazzi ever met a name he hasn’t dropped from Rob Reiner, Howard Dean, Arnold Palmer and William F. Buckley to Michael Ovitz, Hillary Clinton, and Jack Valenti.

The other important lesson, it seems, is to never actually do your present job. While Ferrazzi was a Chief Marketing Officer, he spent all his time getting a CEO position at an internet start-up. While a CEO, he spent all of his time trying to get a better position. For example, while CEO, any time Michael Milken would fly anywhere for a cancer cause or business, he would fly along “just to watch him and learn” — all the while (we assume) on the clock at the company he was supposed to be running?

Basically, no matter what job he held, he had an almost endless supply of time, money and resources to do nothing but non-stop marketing of himself. Never, at any time, did he hold a position that he actually had to be accountable for his work, say, by billing 1800+ hours a year. The main point that struck me is that Ferrazzi apparently has no family obligations whatsoever (no spousal commitments, no attending school functions or children’s sporting events, no parents to visit or take care of) and he behaves as if every other person is in the same care-free state of living as he. He defends his way of living by saying that being balanced is B.S. — I guess it is if you don’t have a life.

Among the many useful tips for professionals include “always learn” where he recommends that you attend 3-5 conferences per year and “stay healthy” where he details how he takes a weeks vacation every other month plus takes a one day “spirituality retreat” at least once every month.

You also need to spend lots and lots of time at fancy events (including the Democratic National Convention, the Yale CEO convention, the Vanity Fair party at the old Russian Embassy, and White House dinners) and belong to lots of foundations and exclusive clubs. You also need to host at least 3 to 10 political fundraisers at your house each year for regional and national candidates. This is all besides the weekly dinner parties you throw for all the celebrities you don’t even know but whom attend because your dinner parties are just so fabulous. Oh, and you need to golf. Again, actual work is not important here.

Lots of good tips here. I can’t wait to put them into action — just as soon as my Dad can get me into that prestigious grade school.

Never Eat Alone: And Other Secrets to Success, One Relationship at a Time is available at Amazon.

Posted October 14th, 2005 by Stephen Albainy-Jenei in Book Reviews
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