Patent Baristas

Joseph Scott, President of Patent Buddy, contacted me about their site.  Listed as “Where IP Professionals meet to gather & exchange information,” it is a new service that provides data (obtained from the U.S. Patent & Trademark Office) on registered patent attorneys and their employment histories since 2001.

It claims to have data on 39,259 attorneys from 13,081 organizations. You can search by name, registration #, organization, and geographic location.

If you join as a member, Patent Buddy enables you to create a professional profile in which you can list your qualifications and list patents that you have successfully prosecuted. You can even link directly to the patents so that prospective clients or other law firms can review your work.

The Opportunities feature enables you to stay on top of actual and possible patent job openings in your area. For example, Patent Buddy notifies you when a patent lawyer leaves a firm. By acting quickly, you could apply for that vacated position before the firm begins seeking a replacement.

If you’re a patent attorney voyeur, you can receive weekly updates on attorneys and agents joining and leaving organizations in your area.  You can use a similar feature to keep track of the activity of competing firms — who they hire, which patents they file, etc.  Apparently, you can receive email notices from Patent Buddy showing when and how frequently people have accessed your profile.

The site ranks each organization by growth and experience (little stars).  One interesting feature is a tab that lists previous employees and see where they are up to.  Patent Buddy also provides a career news blog and job posting board. You can search for jobs by location, specialization, education, experience, and job type.

One note of caution, the information isn’t necessarily up-to-date or accurate (as noted by others, too).  In looking at my firms’ listing, I noted that:

• it listed an attorney who left the firm years ago;
• it did not list some attorneys and agents
• it did not list many of our previous employees; and
• it had mistakes in my profile.

You can join for free, but you must have a USPTO registration number. Learn more about Patent Buddy.  Use at your own risk.

In their book iProperty: Protecting Ideas in an Age of Global Innovation, the authors ask that we move past our old views of protecting ideas and look at what is necessary for companies to thrive in the new intense global competition today.

They call this new vision the world of iProperty.  The “i” in iProperty does not stand for internet as one might imagine but for a whole thesaurus full of i-words: intellectual, imagination, ideation, insight, innovation, international, intangible and integration.

iProperty is about competing in the future where innovative companies must use intellectual property to protect their valuable ideas. This is a world where stock purchases are not based on factories and inventories but on the innovation and technology embedded within the company’s patent portfolio.

iProperty is defined as:

It is the spirit of outside-the-box thinking that includes intellectual property concepts and a host of other ideas as well.  iProperty is best thought of as a set of visionary concepts, strategies, and tactics used by companies for establishing ownage of their ideas in a manner that undergirds and prolongs their competitive success in the global economy.

Thankfully, the book in not totally filled with business-speak.  Once in to the meat of the book, you connect the ideas that innovation is happening everywhere.  While scaring the bejeebers out of you with the fact that highly skilled innovators are now creating new technologies in thousands of locations around the world, it lays down practical advice as to how business managers can suck it up and start putting the protection and enforcement of ideas into this global context.

Self-described as answering the question, “If I’m serious about strategically deploying intellectual property in a way that benefits my bottom line, what should I do on Monday morning to make that happen?”  iProperty tries to set out the concrete details involved in actual implementation and provides executives, managers and attorneys with practical advice for developing and executing a strategic intellectual property plan that will yield a measurable return on investment.

The book also points out that patent attorneys — as gifted as they are — may not always be the best trained to integrate the company’s business strategy with its iProperty strategy.  In order to be successful, all of the key players from legal to management, must understand (and buy-in) the iProperty strategy.  This means that everyone needs to have input into the development of the strategy as well as a stake in the game.  Think about whether your company actually rewards outside-the-box innovative thinking or if it just talks a big game.

As the authors state it, “iProperty is above all things about people.”  Companies that run on innovation require cultures that understand and value iProperty — and the people that make it happen.

“iProperty: Protecting Ideas in an Age of Global Innovation” by William Barrett, Chris Price, and Tom Hunt (John Wiley & Sons, Inc.) is available at Amazon.

About the Authors

William Barrett is a patent attorney and author with a passion for developing novel approaches to managing intellectual property.  He is Vice President, Intellectual Property for Advanced Liquid Logic, Inc., in Research Triangle Park, North Carolina.  He publishes the weblog gPatents.

Christopher Price is CEO of LAAM Science, Inc., in Research Triangle Park, North Carolina.  A serial entrepreneur, Chris has served as CEO for several companies based on a variety of technologies and is an inventor on more than 30 U.S. patents and patent applications.

Thomas Hunt is Director of Intellectual Property at Markem Corporation in Keene, NH.  A patented inventor and co-Founder of ipCapital Group, Inc., a premier IP Strategy Consulting firm, Tom has developed and refined intellectual asset management methodologies and processes that have been used in over 350 companies.

Please join the Kentucky BioAlliance for their Annual Meeting and Reception as they explore the Life Cycle of Life Sciences.  Roger Griggs, founder of the Drug Enhancement Company of America, will talk to Kentucky BioAlliance members and guests about his experience in growing five successful life science companies in Kentucky.

Following the presentation, the Kentucky BioAlliance will host a cocktail reception. This is your chance to network with industry leaders, entrepreneurs, service providers, and research institutions from the region.

When:  4:00 – 6:00 PM on Wednesday, December 10, 2008

Where:  Lexington Convention Center, 430 W. Vine St, Lexington, KY

RSVP:    By December 5 to Ben@KentuckyBioAlliance.org

Cost:      $25 Members/$40 Non-Members

Roger D. Griggs is an entrepreneur and businessman.  In 1990, Mr. Griggs founded Richwood Pharmaceuticals and rapidly grew the company until it merged with Shire Pharmaceutical Group plc, of Andover, England in 1997.  In February of 1998, Mr. Griggs resigned his position as President of Shire US and has since founded numerous businesses including Union Springs LLC, Integrity Pharmaceuticals, Xanodyne Pharmaceuticals, PediaMed Pharmaceuticals, and DECA.

The Kentucky BioAlliance promotes, connects and develops the life science assets of the Commonwealth’s thriving bioscience industry. As a catalyst for sharing ideas and exchanging knowledge, they are a community where industry leaders, entrepreneurs, investors, and educational institutions collaborate to turn science into success.

For both startups and well-established businesses, intellectual property is a core asset that drives both innovation and brand development. As a result, it is crucial to preemptively protective one’s resources from potential challenges by outside firms whose sole business practice is instigating litigation against operating companies.

These “patent trolls” seek to buy up intellectual property through a variety of means – from buying assets of liquidating companies to working with smaller firms with niche patents – in order to seek damage claims in court. Without broad reform of the nation’s intellectual property regulations, these companies have successfully issued legal challenges against major companies ranging such as Blackberry (see BBC News), despite having no operating businesses outside of patent holdings.

Many companies face growing IP challenges from these companies as a result of friendly District Courts, as well as contingency fee structures for challenging attorneys, which limits the downside risk of filings. In order to protect your business from patent trolls and future defensive litigation, there are several steps you can take:

•  Actively monitor  patent filings to see if they apply to your business

There are a number of prominent services which provide businesses with an update list of patents that could potentially be applicable to a particular field of operations. Generally released on a quarterly basis, by reviewing these new filings for potential risk factors, companies can stay ahead of the curve by ensuring that its products are on solid legal footing. In particular, companies can generate ideas which will allow them to apply for more direct patents, modify existing designs to ensure full compliance with IP law or to preemptively negotiate a license from a company.

•    Invest in patent infringement insurance to hedge your risk

Specialty corporate insurers offer risk-adjusted premiums to protect a company’s major products against patent infringement challenges.  Although premiums are generally high, as there is no standard, accepted actuarial structure and a limited market at this point, companies can protect themselves against excessive legal costs that can emerge from challenging intellectual property lawsuits. Although the offerings are limited, it’s best to review premiums and coverage from a number of specialty insurers before deciding on an investment in patent insurance.

•    Work with an intellectual property law firm to preemptively build a case for your major patents

If a company’s flagship product appears to be particularly vulnerable to 3rd party legal challenges, it may be beneficial to build up a legal case for the uniqueness of the product design and function in advance of any potential filing – this will ensure that a company’s operations can continue in earnest by directly challenging any potential lawsuits in court (as Blackberry did in advance of its settlement).  This case can form the basis for a potential out of court, early settlement, a design around process that circumvents the filing through modifying the existing product or an opposition proceeding, where companies can challenge the validity of a contested patent.

•    Join an industry protection group, such as the Allied Security Trust

A number of collaborative, industry groups have emerged to provide shared litigation support and intellectual property rights across companies. By joining an IP protection group, a company can pool resources to protect its IP assets.

Today’s article was submitted by Guest Barista Maya Richard, who writes about high speed internet.

If you are a small business and are interested in obtaining early-stage financing to support your cancer research and technology development, you may be in luck.

The National Cancer Institute (NCI) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs are offering funding opportunities to eligible small businesses and research institutions for the development and commercialization of novel technologies and products to prevent, diagnose, and treat cancer.

The NCI SBIR & STTR Programs currently have several grant opportunities with December 5, 2008 receipt dates. Funding is available in a range of topic areas. The topics below represent some of NCI’s highest priorities for technology development and commercialization. These topics include:

Why Apply for NCI SBIR & STTR Funding?

Small businesses and research institutions play an important role in advancing cancer research, prevention, diagnosis, and treatment. In addition, the NCI SBIR & STTR Programs can benefit small businesses in many ways. Small businesses can receive seed capital to push promising technologies through development and commercialization without diluting company stock or shares in any way. Businesses maintain intellectual property rights to technologies.

These funding opportunities are awards, not loans, and no repayment is required. In addition, SBIR & STTR funding can be a leveraging tool to help attract additional funding from other third-party investors.

Additional NCI SBIR & STTR Funding Opportunities

For a complete listing of all funding opportunities from the NCI SBIR & STTR Programs, including the new NCI SBIR Phase II Bridge Award, please visit here. The NCI Bridge Award is a new innovative funding opportunity designed to address the funding gap known as the “Valley of death” between the end of a NIH SBIR Phase II award and the commercialization stage. Budgets up to $1 million in total costs per year for up to three years may be requested from the NCI as part of the Bridge Initiative. The next funding deadline is February 27, 2009.

Learn About How to Apply

View presentations and videos from the NCI SBIR & STTR Programs Forum to learn more about the application process and get tips from prior awardees on how to prepare a successful proposal. These videos also provide information and resources about how the NCI SBIR & STTR Programs can help your company develop its business.

Contact

If you are interested in discussing your organization’s project with NCI Development Center staff to explore how it aligns with NCI’s priorities, please contact a Program Director here.

The SBIR & STTR Programs are government set-aside programs for domestic small businesses to engage in research and development that has the potential for commercialization and public benefit.

Sign up here to receive updates about SBIR & STTR funding opportunities.

“Who do you think was the country’s biggest supplier of prescription drugs in 2007?  Was it Pfizer or Merck or Bristol-Meyers-Squib or Novartis?   No. It was Teva Pharmaceuticals, a generic manufacturer.”

   ~ Martin Voet, The Generic Challenge:  Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (Second Edition).

The Generic Challenge is about providing the necessary information to pharmaceutical executives, managers, regulatory, legal and business development professionals, those involved in strategic marketing and in research and development, among others in the pharmaceutical field, to deal with the increasingly aggressive tactics of generic companies designed to legally copy innovative drug products.

I think we can agree that generic drugs are a reality and brand name drug companies that do not accept the challenge will do so at their own peril.  In the last 20 years since the Hatch-Waxman Act fostered the generics industry, the generics industry has grown steadily so that now it accounts for well over 50% of the drugs sold in America. As Voet puts it, the generic drug companies will not stop and we can expect them to attack virtually all new drug patents at the earliest possible time.

The purpose of this book is not to provide the complete review and study of pharmaceutical law and regulation.  It is a quick overview to familiarize the reader with both the strategic and tactical aspects of the interaction of patents, FDA regulations, the Hatch-Waxman Act and product improvements on pharmaceutical product life cycles.  This is a must read for pharmaceutical managers and executives who want to succeed in their jobs by becoming knowledgeable in these matters quickly so that they can plan for the successful development and long term success of their company’s pharmaceutical products.

While not intended to replace competent legal counsel, this concise little guide is intended for the busy executive to learn these subjects in understandable language so that you will be able to ask the right questions and understand the answers you receive. Broad in coverage, the book covers patent enforcement and infringement, pharmaceutical product life-cycle management, regulatory matters, and legislation related to pharmaceuticals with Take Home Messages at the end of each chapter summarizing the main points.

Martin A. Voet is a Senior Vice President and Chief Intellectual Property Counsel for Allergan.

The Generic Challenge:  Understanding Patents, FDA & Pharmaceutical Life-Cycle Management (Second Edition) is available at Amazon.

Therapies for Ignored Diseases

Last week, the Bill and Melinda Gates Foundation gave Collaborative Drug Discovery (CDD) a $1.9 million grant to help tuberculosis scientists to collaborate to discover new cures for TB, a disease that is resurgent in the 3rd world.   The company provides web-based software that organizes preclinical research data to enable scientists to collaborate worldwide to advance new drug candidates more effectively. The humanitarian side of our mission is helping labs in universities and foundations to find therapies for ignored diseases such as malaria, schistosomiasis, African sleeping sickness, etc.

Obama Transition Team Member Is No Fan of the U.S. Patent System

Peter Zura at the 271 Patent Blog comments on the report by Condé Nast Portfolio that President elect Barack Obama is setting up agency review teams responsible for reviewing all the major U.S. government departments.  One of the team members is Reed Hundt, who was Bill Clinton’s FCC Chair from 1993 through 1997. Hundt is apparently not fond of patents saying:

America’s patent system is a mess . . . The U.S. ought to chuck this 18th-century relic and start all over again. Here’s what the ideal system would look like.

First, we should slash the number of patents granted each year by 90%. In 2004 the U.S. Patent &Trademark Office issued 165,000 patents. Sixteen thousand is more like an optimal number. This should be easy to accomplish because most technology should not be patentable.

Huh? And don’t even get me started on his idea of a $500,000 application fee to buy a guarantee that your patent application will be reviewed and accepted or rejected within one year.

Biotech Bankruptcies Looming?

Ed Silverman Pharmalot discusses the fate of biotechs as the global economic crisis has cut funding to the lowest level in a decade, triggering bankruptcies and threatening development of drugs.  In the past month, at least five biotechs filed for bankruptcy. The amount raised this year by biotechs fell by $9.7 billion through September, or 54 percent, compared with the same period in 2007, according to Burrill & Company, a life sciences investment bank. According to a Bloomberg report, “This all will play out in the next six to nine months.”  The upside?  Investors will likely return to biotech once the economy stabilizes because the industry still promises attractive returns.

And Joe the Plumber Thought He Was Picked On

Matt Buchanan at Promote the Progress mulls over the US Patent Office Final Rule, which levies a ‘practitioner maintenance fee’ on attorneys and agents recognized to practice before it in patent cases.  The new rule requires all registered patent practitioners to pay an annual fee to maintain their professional association with the agency.  The fee is to be used “to enable the Office to maintain a roster of registered practitioners and, consequently, better protect the public from unqualified practitioners.

Under “Rule Making Considerations,” the Deputy General Counsel for General Law, United States Patent and Trademark Office, declared that this is all OK since apparently patent practitioners make a good salary.  Thus, this fee does not have a significant economic impact.

So, why did it take five years to take this rule from draft (published on December 12, 2003) to final (published November 17, 2008)?  I’m guessing someone at the USPTO said “Holt Crap!  We’re all &^$*#@’d come January 20th!  We’d better get all our initiatives through now!“

As Congress is considering possible legislation to create an abbreviated pathway for the FDA to approve generic biologic therapies (“biogeneric,” “biosimilar” and “follow-on biologics”), differences in the R&D expense and product cost, and the potential for both new therapies post-approval and second-generation innovations have raised questions about how to achieve the proper balance between innovation and competition.

One important policy for Congress to establish will be the number of years of data exclusivity awarded to the innovator drug. Data exclusivity rules control the amount of time after an approved drug enters the market that a biogeneric drug, relying on the innovator’s data on drug safety and efficacy, must wait before entering the market. In the case of chemical drugs, that period is generally five years.

Recent legislative proposals vary along several dimensions, including differing durations of data exclusivity. Representatives Jay Inslee, Gene Green and Tammy Baldwin introduced H.R. 1956 and Senators Gregg, Burr and Coburn introduced S. 1505, which proposes 14 years of data exclusivity. S. 1695, sponsored by Senators Kennedy, Enzi, Clinton and Hatch, would allow for 12 years of data exclusivity. H.R. 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional two years for a new indication and six months for pediatric exclusivity. In contrast, recent legislation introduced by Representative Henry Waxman would provide no data exclusivity for new biologics.

Now, former House Ways and Means Committee Chief Economist Alex Brill has released a paper arguing that 7 years ought to be a sufficient number of data exclusivity years to grant brand biologics before biogenerics can enter the market.  This paper by re-examines and improves upon the model developed previously by Duke University professor Henry Grabowski.

In his paper “Proper Duration of Data Exclusivity for Generic Biologics: A Critique,” Brill makes the case for the shorter duration for data exclusivity and critiques the recent work by Duke economist Henry Grabowski on this subject (Grabowski 2008). Grabowski estimates the number of years required for an average portfolio of biologic drug investments to recoup all development and fixed production costs and to also reward the investors their expected (double-digit) rate of return (a period of time economists refer to as a break-even point for the investment).  Grabowski estimates break-even to be between 12.9 and 16.2 years for a portfolio of biologics

Brill examines this result and its implication for data exclusivity. First, using an alternative set of assumptions to the Grabowski model that he considers to be more plausible, we find that the break-even point drops to slightly less than nine years. Second, the break-even point is not the period for sufficient data exclusivity in this industry.

Data exclusivity less than the break-even point is valid under any assumption in the Grabowski model as long as some economic profits continue to be earned by the innovator drug post-exclusivity; this is reasonable, given expectations for the effect of biogeneric competition on prices. Given our preferred model specifications, we show by example that seven years of data exclusivity would be sufficient in maintaining strong incentives to innovate while fostering a competitive marketplace.

This paper assumes that the break-even point should be interpreted as an extreme upper bound for data exclusivity and not as an estimate of optimal duration of data exclusivity. In the case of the biologic drug industry, because innovator drugs can be expected to continue to earn economic profits in a market open to biogeneric competition, Brill contends that the optimal data exclusivity will always be less than the break-even point.

While nearly two dozen biologic drugs have lost their patent protection in the last few years and over 70 biologics will lose their patent protection soon, the Food and Drug Administration (FDA) currently does not have an established, abbreviated framework for permitting biogeneric drugs to enter the marketplace.

With global sales of biologics at approximately $75 billion in 2007 (IMS Health 2008), expect to see more vigorous discussion on this topic.  The Federal Trade Commission (FTC) is holding a roundtable on competition provided by developing an abbreviated regulatory approval pathway for follow-on biologic drugs on Thursday, November 21, 2008.

Alex Brill is CEO of Matrix Global Advisors, LLC, and a research fellow at the American Enterprise Institute.  Note that financial support for this white paper was provided by Teva Pharmaceuticals.

See the entire report here.

See also:

Biologicsland: Which of These is Not Like the Others?
Red or Blue: We’ll Likely to See Biosimilars Either Way
Does Congress Need A Lesson On Biotechnology or Economics?