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.

Posted November 24th, 2008 by Stephen Albainy-Jenei in Ventures, Bioventures
| | No Comments Yet »

“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.

Posted November 24th, 2008 by Stephen Albainy-Jenei in Generic drugs, Book Reviews
| | No Comments Yet »

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!“

Posted November 21st, 2008 by Stephen Albainy-Jenei in Friday Round-Up
| | No Comments Yet »

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?

Posted November 20th, 2008 by Stephen Albainy-Jenei in Biogenerics, Biotech
| | No Comments Yet »

In another blow against late claiming, the Court of Appeals for the Federal Circuit denied an appeal from a re-examination because the patent applicants “could have filed the present claims” earlier in the application.  Although I suspect the court was just ticked off because the applicants appeared to be gaming the system – the reexamination involved a patent that claimed priority through various continuations dating back to 1954 – it sure makes for awfully murky law.

Basell Poliolefine Italia, S.P.A. appealed decisions of the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences stemming from a Director-ordered reexamination of U.S. Patent 6,365,687 (Reexamination No. 90/006,297).  In Re Basell Poliolefine Italia S.P.A. (07-1450)

The Board affirmed the rejections of all the claims of the ’687 patent as unpatentable under 35 U.S.C. §§ 102(b) and 103(a) and the doctrine of obviousness-type double patenting.  The patent, entitled “Process for the Polymerization and Copolymerization of Certain Unsaturated Hydrocarbons,” was issued on April 2, 2002 and claimed priority from Italian Application No. 25,109, filed July 27, 1954 (almost 48 years later).

The invention relates to “a process for copolymerizing unsaturated hydrocarbons of the formula CH2═CHR in which R is a saturated aliphatic radical with two or more carbon atoms or a cycloaliphatic radical, in the presence of a catalyst comprising a catalytic aluminum alkyl compound and a catalytic titanium halide compound.”

The reexamination was for all claims, which were rejected on double patenting in view of various expired patents The Board affirmed the double patenting rejections but first had to determine whether the patentees were entitled to a one-way or two-way test for double patenting.

The Board found that a two-way test for double patenting didn’t apply since the patentees “significantly controlled the rate of prosecution throughout the chain of ancestor applications,” and thus the one-way test applied.

The judicially created doctrine of obviousness-type double patenting “prohibit[s] a party from obtaining an extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent.”

In determining double patenting, a one-way test is normally applied, in which “the examiner asks whether the application claims are obvious over the patent claims.”  In unusual circumstances, where an applicant has been unable to issue its first-filed application, a two-way test may apply, in which “the examiner also asks whether the patent claims are obvious over the application claims.”  See In re Berg.

In the present case, the court wouldn’t go for the two-way test:

As a preliminary matter, we are unpersuaded by Basell’s assertion that the Board erred by failing to apply a two-way test for double patenting.  The two-way test is “a narrow exception to the general rule of the one-way test.”  Id.  The test arose out of the concern “to prevent rejections for obviousness-type double patenting when the applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing, rejecting the basic application although it would have been allowed if the applications had been decided in the order of their filing.”  Id.  Thus, the two-way test may be appropriate “in the unusual circumstance that the PTO is solely responsible for the delay in causing [a] second-filed application to issue prior to [a] first.”  Id. at 1437.

Those circumstances, however, are not present here.  The record shows that the patentees did not present any claim resembling the claims at issue until 1964, nine years after Natta filed the first U.S. application in the chain of priority and well after Natta filed the application that resulted in the ’987 patent.  Moreover, those claims appear to have been filed for interference purposes only.  In addition, the Board found that since 1954, the patentees repeatedly submitted claims directed to claims covering other inventions, urged the examiner to declare interferences for unrelated inventions, and repeatedly filed continuing applications without appeal.  During the critical co-pendent period of the applications for the ’687 patent and the ’987 patent, Natta could have filed the present claims.  Natta’s actions, or inactions, had a direct effect on the prosecution and thus were responsible for any delay in prosecution.

Left unanswered:   Was it presenting the claims nine years after first filing that got them?  What if they filed in eight years?  Would seven be OK?  Or, was it the repeated interferences that did them in?  If so, how many interferences are too many?  How do we know what to do in future cases?

Posted November 19th, 2008 by Stephen Albainy-Jenei in IP Litigation
| | No Comments Yet »

As mentioned in the AmLaw Daily, Dennis Crouch’s Patently-O blog reported on a newly published patent application by Halliburton Energy Services.  The patent application has claims to what can only be described as a method of doing business when your business is patent trolling, i.e., getting rights to a patent and asserting it against infringers.

Presumably, the part that makes one a troll versus non-troll is whether or not the person/entity asserting the patent rights actually makes their own products.  Here, the key is asserting a patent as a non-inventor.

This application appears to be an attempt to make a social commentary (or flat out joke) about so-called patent trolls.  The application is for “patent acquisition and assertion by a (non-inventor) first party against a second party.” It was amended to include an element about a “secret aspect” — whatever that means — which may be a nod to In re Bilski (that is, adding in a hardware requirement).

It claims:

1. (Amended) A method for a non-inventor first party to acquire and assert a patent property against a second party, the method including the first party performing the following acts:

obtaining an equity interest in the patent property;
writing a claim within the scope of the patent property, the claim being written to cover a product of the second party, where the product includes a secret aspect, the secret aspect including an unobservable aspect, where writing the claim includes performing research using a computer to convert the unobservable aspect to an observable aspect;
filing the claim with a patent office;
offering a license of the patent property to the second party after the patent property issues as a patent with the claim; and
attempting to obtain a monetary settlement from the second party based on the assertion of infringement of the claim.

AmLaw Daily called Halliburton to ask about the application and received a response stating:

It is important to note that Halliburton has no intention of applying the technique offensively. Rather, Halliburton intends to use any patent that may issue from this application defensively to discourage entities that engage in such tactics.

The filing may be an honest attempt to keep from being forced into making payments to patent holders but nothing in this claim appears to be outside what everyone has a legal right to do within the patent system.  Every citizen is allowed to (a) acquire patent rights, (b) amend their claims, and (c) offer licenses.  I struggle to find what could possibly be novel.

Gene Quinn of IPWatchdog believes that re-examination may be the better solution to a non-inventor first party asserting a patent property against a second party.  Statistics show that ex partes reexamination is granted 92% of the time, with all claims being canceled in 10% of cases and at least some claims being changed in 64% of cases.  Inter partes reexamination is granted 95% of the time, with all claims being canceled in 78% of cases and at least some claims being changes in 15% of cases.  Thus, quality reexamination representation would seem a far better route.

Whether this filing is just a form of protest or commentary on the present state of patent litigation or an honest attempt to stop (perceived)  patent litigation abuse, I can’t help but wonder if these kinds of filings don’t make the Patent Office even more hardened against allowing applications.

I struggle daily to get applications allowed over rejections that there is some lack of written description regarding the structural characteristics of the claimed genus, despite years of research data. Will I get even more responses of “Applicant’s arguments have been carefully considered but are found not persuasive“?

Send me a note and tell me what you think.

(Note to Dick Cheney:  Everything contained in this post is satire.  And thanks for the invite to go duck hunting.)

Posted November 19th, 2008 by Stephen Albainy-Jenei in Prosecution, USPTO
| | No Comments Yet »

Now that it appears that we are in a recession — and there’s no good way to nuance that anymore — what does is mean for the legal profession? The legal area was once considered recession-proof with some areas even going up as companies focus on competitors.  Now, the demand for legal services is certainly going to change.

Bruce MacEwan, over at Adam Smith, Esq., compares the current legal business to Motown’s Big Three.  Citing reader Brent Jeffcoat, of McGuire Woods’ Charlotte office, he questions if law firms need a bailout:

After all, think of all the people we affect: our young associates marry and live in condominiums in urban centers.  We probably support Starbucks.  Allen Edmonds is toast. … Think of all those poor guys in Scotland who will not be able to sell their single malt whiskeys.  It would be a global crisis of unimaginable proportions if one or two of the AmLaw 100 were to fail.

Now, the ABA Journal is surveying lawyers about the job market and the current state of the economy.  Specifically, they want to know how you think the recession will affect the legal profession.

Please click below to take the two-minute survey. The survey results will be published in the January issue of the ABA Journal. Your answers will be kept confidential, and used only in combination with all other responses received.

Take the quick survey here.

Note to non-lawyers:  No, entering law school is not a smart way to deal with the terrible job market, as you and the other 100,000 students graduate en masse in three years creating a glut of new associates in the market.

Posted November 18th, 2008 by Stephen Albainy-Jenei in Legal Business, Current Affairs
| | No Comments Yet »

cul·ture (n.) the set of shared attitudes, values, goals, and practices that characterizes an institution or organization (Merriam-Webster’s Dictionary Online).

The book “Intellectual Property Culture: Strategies to Foster Successful Patent and Trade Secret Practices in Everyday Business” by Eric Dobrusin and Ronald Krasnow is much better than its bland title or cover would belie. This is a book that weaves together deeper ideas on what principles should guide a company with specific details useful in day-to-day practice.

It is not just about the management of intellectual property assets, it is about creating a culture within an organization that recognizes that intellectual property is essential to the very livelihood of the business and knowing how to proactively protect IP assets.

Over the course of its 392 pages, Intellectual Property Culture delivers an excellent guide for any organization that deals in knowledge and technology.  The guiding principal is that any organization that wishes to survive in the knowledge economy must develop an IP culture:

To thrive in the knowledge economy, organizations must cultivate attitudes and behaviors that recognize IP, respect IP, and trade upon the value of IP.  This needs to be done organically, within each individual organization, and to meet the specific needs and characteristics of each such organization.

The trick, of course, is to develop a “healthy IP culture.”

The book is also stocked with practice tips valuable for businesses of all sizes.  In discussing confidential information and effective corporate trade secret programs, the authors note:

While many organizations spend a great deal of time seeking to Protect against intentional taking of confidential information by third parties, often the greater risk lies in the accidental disclosure of confidential information by its own personnel.

Filled with illuminating examples and anecdotes from the authors’ real-world experiences, the book contains valuable practical advice along with sample agreements, notice letters, employee training materials, patent status reports, IP policies, questionnaires, timelines, and other resources. Even the Appendices add niceties such as sample laboratory notebook usage guidelines and a policy and form for review and approval of information prior to disclosure.

I highly recommend this book for anyone set on creating a culture that both manages and respects IP.

About the Authors

Eric M. Dobrusin is a founder and shareholder in the law firm of Dobrusin & Thennisch, where he has concentrated his practice in patent counseling and strategic patent prosecution.

Ronald A. Krasnow is the Senior Vice President of intellectual property and Chief Patent Counsel at Relypsa, Inc., in Santa Clara, California, where he is responsible for all legal functions, including corporate, contract, and intellectual property.

“Intellectual Property Culture: Strategies to Foster Successful Patent and Trade Secret Practices in Everyday Business”
Oxford University Press, USA, is available on Amazon.

Posted November 17th, 2008 by Stephen Albainy-Jenei in Book Reviews
| | No Comments Yet »