Patent Baristas

This week Patent Baristas talked with John LeGuyader, Director of TC 1600 at the U.S. Patent and Trademark Office, about the regarding the biotech section’s take on alternate claiming strategies and restrictions:

So, first I thought it might be helpful just to go over what your role is as a Director in the USPTO and how long have you been in this position.

I oversee several areas in Technology Center 1600.  We have a new director on board as of roughly May, and previous to that I was overseeing one of our organic chemistry/pharmaceutical areas and also our immunology area, as well as what we call our Quality Shop.

We have managers that are referred to as “Quality Assurance Specialists.”  They help TC manage with quality training and also special laws cases like petitions, reissues, reexams to the extent that we still have some in the Technology Centers that are not being processed through the Central Re-Exam Unit.

I am still overseeing the immunology area, and I’m still overseeing the “Quality Shop” of the Technology Center.  And so, I’m responsible for, at a higher level, the performance of my managers.  My managers oversee art units.  They directly oversee examiners.  So, I hope to mentor and direct my managers both in the workgroup, for examination purposes, but then as part of the Quality Shop, I look at a higher level across the TC.  We look to see what our overall quality is like, where we need to do training, so forth and so on.

I have been in my current position, for about 2 ½ years now.  Before that, I was the Executive Assistant to John Doll who was and is the Commissioner of Patents. Prior to that I was a Supervisory Primary Examiner in the molecular biology area. And prior to that I was an Examiner in the molecular biology area, and I’ve been with the Office since December of 1990.

I thought I would start with what you see as the impetus or what prompted the proposed rulemaking on “Examination of Patent Applications That Include Claims Containing Alternative Language,” 72 Fed. Reg. 44992 [Docket No.: PTO-P-2006-0004].

Well, if you look historically at Markush practice, which really began back around the 1920s, it was a way for applicants to generically claim their invention when there was no true generic language to use to claim their invention, right?  For example, fruit is a generic term that covers a whole variety of individual species of fruit.  In chemistry, there is oftentimes no true generic language in which to broadly claim their invention.  And so, Markush practice came about where generic chemical formulas with variable constituents were used in order to generically claim the inventions, because there was no generic language to refer to the genre and the species of a chemical formula that would fall under a more generic chemical formula that had variable groups.

That process has been evolving ever since the ’20s where we’re really not allowed a lot of checks and balances for practitioners on the outside with regard to how broadly they can actually claim their invention via Markush practice or via alternative language.  We have some examples, and there are also practitioners on the outside that would argue similarly to what I’m arguing that sometimes these Markush claims are huge.  They can contain billions of species, and if you do the math in certain situations, they claim more molecules than there are atoms in the universe.  Now that happens to be some of the extreme examples.  I mean, not all Markush claims are outrageous.

If you go back and you look at the case law and you look at law articles throughout history until the present day, in the ’80s, there were three different court decisions: In re Harnish, In re Weber, and In re Haas (referred to as Haas II).  The Court of Customs and Patent Appeals invited the Office to deal with emerging problems in Markush practice and to do it via rule making.

At one point, in the ’70s or so, the Office was rejecting what they referred to as improper Markush grouping.  The issue percolated up to what is now the Federal Circuit and the Court told us “We’re sorry, the statute for restriction purposes [that’s 121] doesn’t permit you to reject improper Markush groups.”  Those decisions told the Office:  “Please stop doing that!”  But they explicitly said, however, that we could rule make our way out of the problem and invited the Office to rule make so that we could get a grip on the extreme Markush groupings.  And for whatever reason the Office really hasn’t seriously taken up the issue.

I think part of the reason why we’re doing it now is the extremes are beginning to become more extreme.  I think if you ask practitioners about how they feel about some of the Markush groups that are being issued, they would say that it provides a certain kind of uncertainty in the market, because the groupings can be so large, you don’t really know what the invention covers in terms of scope.  And for the outside, that can be very problematic as well.  And I can tell you I have personally attended, over the last couple of years, several meetings where practitioners themselves have gotten up and spoken about the uncertainty in the market deemed to those that have Markush claims.  Sometimes these Markush groupings are very difficult to search.

Our restriction practice allows us to limit examination in applications to an individual invention, is discretionary by the examiner, and it so happens we have no rules for limiting the examination within the Markush or within a claim of which the alternative — we don’t have the rules to allow examiners to restrict those to a single invention.  And oftentimes, I wouldn’t say how often, it does occur that Markush groupings are so large, or so broad in scope, that they can cover multiple inventions.

And so what our rule is proposing to do is in those situations where Markush groupings can be identified to embrace more than one invention, we are proposing to allow examiners to restrict within a claim, or to restrict among the alternatives, so we can limit the examination from individual invention in any situation.

As you know, there’ve been a lot of issues about how the Patent Office has problems with dealing with the patent backlog.  Are Markush claims a particular problem in the Office?  Are chemical and/or nucleic acid claims mostly at issue?

They can be.  We’ve seen more Markush groups and alternative language within claims to claim their inventions, primarily in the pharmaceutical area, within the organic chemistry area, because that is where it evolved from.  It has been generally creeping in to the biotech area, particularly as you noted for the claims with sequences.  But it is also creeping in to other technologies across the Office.

My next question is that others are saying that it doesn’t make sense to single out Markush Groups for new rules, that’s just a generic claim, whether it was a Markush or not.  Say you just claim “fruit” and leave it at that.  Then the argument is “Well, there are a lot of fruits in the world.”  How do you respond that it seems unfair to pick on Markush?

I think your original question was “arbitrary.”

Well, that’s the way it has been criticized.

My first reaction when I saw that is that the description process in and of itself would be kind of arbitrary.  I mean, we are allowing examiners — again, at their discretion — to limit examination from individual inventions via restriction process.  And so, for someone to say that:  “Well, why are you doing it on Markush or why are you per se picking on Markush or alternative-type claims?” I think they are being a big disingenuous about restriction practice in general.

Perhaps they should be criticizing restriction practice as a whole, rather than just criticizing the Office for trying to rule make and deal with the problem that the Court indicted for us to rule make on, recognizing that the Office has limited resources.  Restriction practice is one way in which we can properly limit the examination and limit it to a single invention. Really, all we’re proposing to do is to bring Markush alternative claims in line with standard restriction practice.

Now, that doesn’t mean that we are going to be able to restrict.  I mean, if these rules actually go final — and I can’t tell you whether or not that is going to occur — but if they were to go final, the practice would not abolish our standard species practice, nor would it permit examiners in every instance to restrict within the claims where Markush and alternatives are being recited.  It would only be in those instances where the Markush covers more than one invention.

I don’t’ want too far sidetracked but, in parallel with this, I don’t think it would be any surprise there’s been a lot of concern or criticism about restriction practice in and of itself has gotten out of hand, that everything is restricted and then if you try to traverse, you’ll get nowhere.  You just get a standard “We didn’t find that persuasive.”  How do you address that?

Well, I can tell you, certainly in my technology, over the last two years, that was one of the first things that I wanted to rein in and to make sure that the examiners were being consistent.  And so over the last two years, we’ve been getting a whole series of pieces of training on various parts of the restriction process, in an effort to get examiners to be consistent.

To our examiners’ credit, a really small fraction actually ends up being petitioned.  And in those instances where an examiner has done it wrong, well, we support the applicant.  We know that there are a number of  petitions I have signed in the applicant’s favor.  You know that the reverse is true too.  Sometimes what an applicant is alleging isn’t necessarily correct either.  Did we get it wrong sometimes?  Yes!  You know, but it goes both ways too.  I think sometimes the applicant is unreasonably claiming very broadly.

I’m not in a position to be able to tell applicants how they should be claiming. The things that applicants can look at, to try to see if they’re reasonably claiming their invention, and what is the predictability like in their art — and try to draft their claims accordingly or what one would recognize as being predictable in the art.  The question is, when is it and is it not reasonable?

In that regard, have there been, or will there be any, you know, guideline issues to help clarify?  Because I find that it can be somewhat subjective.

I think restriction is part logic, part procedure and part art form.  Restriction is steeped in procedure and that is part of what I think makes it difficult for both the examiners and the outside.  What we’ve tried to do in the last couple of years for our examiners is to give training and give guidelines about how to do it.

It’s a point well taken.  We have been criticized.  The Office, in general, has been criticized this year for going a bit a field in restriction process.  I think the Office recognizes that.  I think certainly 1600 does and we’re trying very hard.  Sometimes, however, it could be a judgment call.

Okay, how does the increase in technology, computer searching capabilities, and that sort of thing, counterbalance the need for restrictions or the new Markush Rules?

Yeah.  My first comment about that is that I think that with searching per se, technology has made searching very fast, but the amount of information that is now available is growing exponentially, particularly in the sequences that can be claimed.  And so while computational searching is very fast — examiners, particularly for our own counts get results back within 24-48 hours — the amount of output they actually have to look at to verify whether or not there is applicable [subject matter] is also growing exponentially.  So, it’s not so much the search itself, as it is going in and doing the analysis on the results that you get.

Have there ever been discussions of having an increased fee for Markush claims such as with multiple dependent claims?

I think that’s been kicked around quite good.  We issued a green paper a couple of years ago — I think it was in 2004 and that is available on our website — where we look at the possibility of raising fees to deal with restriction problems.  The Office determined that it wasn’t totally viable for a number of resource issues.  The other thing that you have to remember to is we don’t necessarily have direct control over our fee structure.  We have some regulatory fees, which we must cost account for and charge our applicants what it cost our business.  So that is actually a small number of fees, in comparison to all the other statutory fees that we have and those statutory fees normally set by Congress.

While you may want to lobby Congress for the ability to have fees that would parallel the kind of examination you want, I think you also have to be very careful about what you ask for.  Because, once it goes through Congress, it may not look like anything that you first envisioned.  So, we’re a bit hampered by the fact that many of our fees are statutory, and if I’m not mistaken, fees associated with restriction would also be statutory.  We would have to have Congress to change that and, like I said, you have to be careful what you ask for, because you never know ultimately what you are going to end up, once you go through that process, because there are so many interested parties. Congress wants to hear from all the interested parties and then come somewhere in the middle, right?

Okay, here’s a last one.  In a situation where the Examiner finds an elected species to be allowable but deems the claims not enabled or lacking an adequate written description over their entire scope, another provision of the proposed rule would permit the Examiner to require restriction of the claims to the elected species.  Why not allow the patentee to reduce the scope of the genus?

No, that is not exactly true.  What are currently in genus/species practice that you would use for Markush Grouping, the examiners tend to limit the initial search and examination from an individual species and they don’t have to extend examination of that claim if the broad claim is rejectable under art or under any other acceptable statutes

If the species has the same structure and function they stay together.  If the species has a different structure function, that would be a reason to split them apart and say “Okay, there’s a different invention.”  So, our proposed rule has an objective part by which you would be able to identify when you have more than one invention among a set of alternatives, or within a Markush.  That’s basically what our proposed rule says.  In no way in those situations would we restrict.  Otherwise, standard species practice as it currently exists in the USPTO is what would be applied, if the examiner wanted to restrict.  And again, remember restriction is discretionary on the part of the examiner.

The other thing that I wanted to point out , which I really didn’t get to say, is about the concern of applicants not being able to get the full scope of their invention examined.  But I would compose rules, just like in a standard restriction process, applicant could file a divisional on what would be restricted out, via our proposed rules.  So we could pursue the full scope of their invention or inventions in divisional applications.  I assure you that when you say that is potentially problematic for the applicant, because of all of the other fees associated with the additional filing.

I think people would rather have a surcharge than end up with a number of issue and maintenance fees that go on over the next 20 years.

I don’t’ disagree with you.  I think there are a number of issues.  I think practitioners on the outside are willing to pay additionally for different levels of examination.  I think you’re right.

Okay.  I’d like to know if you have any recommendations on, you know, in Markush claims.  As they currently exist, what’s your No. 1 recommendation for applicants?

If applicants come up with true generic languages, that’s the best thing they can do.  But if that’s not available, if there’s no true generic language available to claim an invention, another option is to seriously think about the breadth or scope with which they want patent protection to cover them.  And they should look to things like predictability in the arts to determine really how appropriately that breadth of scope should be claimed. Applicant should try to reasonably limit the Markush on their own.

Well, if I can ask one bonus question.

Sure, go ahead.

If you had your wish list, what would be at the top of your list for changes at the PTO?

Gosh!  I don’t have one top one.  Without giving it some careful thought, I’m going to decline to answer that at the moment. There is a whole number of things.  You know in patent practice, I can tell you that you are almost never bored because it is continually evolving.

Okay.  Well, thank you very much for your time.  I really appreciate that.

Sure.  Happy to help.

[This is part of a series of interviews where Patent Baristas gets to spend some time with thought leaders in the industry.]

Well,  we ended up having some iPod Shuffles left over from the BIO2008 International Convention, in San Diego, Calif.  After running the Patent Baristas’ iBarista contest, it turned out to be harder than expected to just “bump into” someone in a crowd of 20,000.

So, I thought I’d give everyone a shot at picking up one of the iBarista iPods from Editor-in-Chief Barista, Stephen Jenei.  There are now two (2) all new chances to win and it can’t be easier.  I can’t wait to give these away.

Chance 1.

For everyone to have an equal chance, I will randomly select a winner of an Apple iPod shuffle 1 GB from everyone who submits a new  comment on the PatentBaristas.com website in the month of July ’08.  One entry per person — multiple comments will not increase your chances.  Comment spammers will be disqualified.

Chance 2.

For a chance to win another Apple iPod shuffle 1 GB, all you need to do is post a new link to the PatentBaristas.com website on your website.  I will randomly select a winner from everyone who posts a new link to the PatentBaristas.com website in the month of July ’08.  One entry per person — multiple links will not increase your chances.  Link spammers will be disqualified.

There are a few, uh, provisos. Ah, a couple of quid pro quo. 

We reserve the right to disqualify any entry that looks like it isn’t legitimate. The winner will be contacted at the email address entered or available on their website. Failure to respond within 5 days will result in the prize being given to someone else. If a winner lives somewhere that we can’t ship to directly using standard shipping, a cash (e.g., PayPalâ„¢) value prize may be substituted.

Otherwise, all of the previous iBarista iPod Giveaway Terms and Conditions still apply.

That’s it.

Good luck.

In Corliss O. Burandt v. Jon W. Dudas, Director, United States Patent and Trademark Office (07-1504), the U.S. Court of Appeals for the Federal Circuit showed no mercy for a patentee that tried to reinstate his patent for failure to pay the maintenance fee a decade later.

Burandt designed internal combustion engines for Investment Rarities, Inc., and entered into an assignment agreement with IRI providing that IRI would fund Burandt’s research and get rights to any patent application or patent resulting from that research.  Burandt was entitled to receive a percentage of the profits derived from the patents and to repurchase the patents from IRI in the event IRI ceased funding Burandt’s research.

Burandt filed a patent application that issued as U.S. Patent 4,961,406 with IRI as the assignee.  Burandt tried to exercise his repurchase rights before the patent issued and claims that he gained equitable title to the patent.   IRI, as the legal title holder, was required to pay maintenance fees.

As you could guess, IRI failed to pay the first maintenance fee by the end of the six-month grace period, and the patent expired on October 9, 1994.  Then, according to Burandt, he became mentally disabled at some point before 1992.  Burandt submitted a declaration from his psychiatrist stating that Burandt had been suffering from an anxiety disorder.

Burandt learned of the expiration of the ’406 patent seven years after the patent had expired, when he contacted the PTO about his patent after reading an article about Honda’s introduction of a variable valve engine.  Burandt admits that he did not inquire about the ’406 patent at any point before then – over a decade of time.

Burandt filed a petition in the PTO under 37 C.F.R. § 1.378(b) for acceptance of a delayed maintenance fee payment, asserting that the failure to pay the maintenance fee was unavoidable arguing that he should not be bound by IRI’s actions because he held equitable title in the patent and he was excusably unable to pay the fee.  Burandt urged the PTO to consider the reasons for his inaction in deciding whether the delay in the payment of the maintenance fee was unavoidable.  The PTO said no.

Burandt brought an action against the Director under the Administrative Procedure Act and the district court granted summary judgment in favor of the Director.  The court determined that IRI was the party responsible for making payment here and that Burandt failed to proffer any evidence showing that IRI exercised due care in paying the maintenance fee.

On appeal, Burandt raises four primary arguments.  First, Burandt argues that the district court erred by giving deferential review to the PTO’s determination regarding unavoidable delay.  Second, Burandt asserts that the court erred by focusing on the actions of IRI as the legal title holder in determining whether there was unavoidable delay rather than focusing on the actions of Burandt as the equitable owner.  Third, Burandt contends that the court erred by failing to find that Burandt’s delay in paying the maintenance fee was literally unavoidable.  Lastly, Burandt argues that the court erred in sustaining the denial of the Rule 183 Petition.

The CAFC sided with the PTO:

We agree with the Director.  The Patent Act governs whether a patent that has expired due to nonpayment of maintenance fees can be reinstated.  Pursuant to 35 U.S.C. § 41(b), maintenance fees are to be paid at three different intervals during the life of a patent.  35 U.S.C. § 41(b).  In the event payment of a maintenance fee is not received in the PTO by the due date or within a six-month grace period, “the patent will expire as of the end of such grace period.”  Id.  The statute further provides that:

(c)(1) The Director may accept the payment of any maintenance fee required by subsection (b) of this section which is made within twenty-four months after the six-month grace period if the delay is shown to the satisfaction of the Director to have been unintentional, or at any time after the six-month grace period if the delay is shown to the satisfaction of the Director to have been unavoidable.

35 U.S.C. § 41(c)(1) (emphases added).  Thus, the statute provides the Director with the discretion to accept a late maintenance fee any time after the close of the grace period if the delay is shown to the satisfaction of the Director to have been unavoidable.

Here, IRI, as the legal title holder of the patent, was the party responsible for paying the maintenance fee and IRI allowed the ’406 patent to expire, as it had deliberately allowed three others of Burandt’s patents to expire.  See Ray, 55 F.3d at 609.

Burandt also cited Futures Technology, Ltd. v. Quigg, 684 F. Supp. 430, 431 (E.D. Va. 1988) that the relevant inquiry should have been whether Burandt, as the equitable owner, intentionally abandoned the patent but that also fell on unsympathetic ears

Here, unlike the plaintiff in Futures, the record shows that Burandt did not make repeated inquiries about the status of his patent.  Burandt conceded that he did not inquire about the ’406 patent at any point during the time period between when the patent issued in 1990 and when he read the Honda article in 2001—over a decade later.  Moreover, there is no evidence in the record that IRI made misrepresentations to Burandt about the status of the ’406 patent as the company had done in Futures.  Significantly, Burandt conceded that he was aware that IRI had previously allowed three of his other patents to expire; yet he continued to rely on IRI to make the maintenance fee payments.  Burandt’s reliance on Futures is therefore misplaced.

The lesson here is that if you have an interest in keeping a patent alive, don’t wait a decade to check on how things are going.  Unless you can get Congressional relief.  But, if it cost the Medicines Company $65,000,000 for just one day, imagine what it would cost for a decade.

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

25 Shocking Facts

Laura Milligan uncovered 25 of the most shocking facts about the pharmaceutical industry.  While some aren’t really shocking — like the price of drugs is increasing faster than anything else a patient pays for — some are not widely known — like pharmaceutical companies spend more on marketing than research.  The reasons for these realities and whether or not they’re justified is another matter but I’ll leave that to others.

Trademark Valuations

James Berger and Diana Tadzijeva write about Marketing Perspectives on Brand Valuation when dealing with trademark infringement litigation.  The key to trying to make that determination is the ability to calculate what the brand or trademark is worth from a marketing perspective.  The marketing valuation is far different from the accounting valuation and the authors review some of the most popular techniques for determining the marketing value of the brand or trademark.

All Things Genomic

The Genomics Directory is a tremendous new resource center for bioentrepreneurs, scientists, and students in the field of biotechnology.  It provides a wide variety of resources useful during design, implementation, and running of a biotechnology project. I haven’t had the time to wade through all of the resources but looks like it offers a good one-stop shop for information.

Patent Quality Reports

The PatentCafe offers Patent Quality Reports in its free CAFC Library. The new Patent Factor Index (PFi) Reports, available for public downloading without cost, statistically score more than 2 dozen indicators of patent quality, many of the indices correlating directly to how the CAFC has decided on cases involving these patents.

Espresso, Anyone?

Emerjent, which offers web applications that track emerging technologies, is now offering Espressoâ„¢, an emerging technology information search engine. According to Emerjent, Espressoâ„¢ delivers a single site for up-to-date and in-depth information on the most promising technologies, people and companies that make up today’s knowledge-based economy. You can either take it for a test run without registering, or complete the free registration and use the more full-featured version.

After vigorous debate, H.R. 6344 passed in the U.S. House of Representatives to amend 35 U.S.C. 156, the statute governing patent term extensions based on regulatory review delay.

This has been bounced around for several years now, and is intended (very specifically) to help Massachusetts-based The Medicines Company, which submitted its PTE application for U.S. Pat. No. 5,196,404 for ANGIOMAX (bivalirudin) 61 days after FDA approved its New Drug Application (NDA) .  In case you haven’t already guessed, the patent term extension law requires the submission within 60-days of the date of NDA approval.

Known as the “Dog Ate My Homework Act”, Section 4 of the bill involves a grant of authority to the Director or the United States Patent and Trademark Office (USPTO) to excuse specific late filings—this time, in connection with unintentional human error.  Section 4 would provide the USPTO with the authority to accept an application for patent term restoration under the Hatch-Waxman Act if that application is filed within three business days after the expiration of the 60-day period provided in subsection (d)(1) if the applicant files a petition, not later than five business days after the expiration of that 60-day period, showing, to the satisfaction of the Director, that the delay in filing the application was unintentional.

What’s most amazing is that the Act requires a payoff in order to effect a patent term extension — the patent holder must pay a fee to the United States Treasury equal to:

(i) $65,000,000 with respect to any original application for a patent term extension, filed with the United States Patent and Trademark Office before the date of the enactment of this Act, for a drug intended for use in humans that is in the anticoagulant class of drugs; or

(ii) the amount estimated under subparagraph (B) with respect to any other original application for a patent term extension.

Subparagraph (B) says the Director will estimate the amount required as the amount equal to the sum of:

(i) any net increase in direct spending arising from the extension of the patent term (including direct spending of the United States Patent and Trademark Office and any other department or agency of the Federal Government); (ii) any net decrease in revenues arising from such patent term extension; and (iii) any indirect reduction in revenues associated with payment of the fee under this subsection.

I supposed that $65M is not a bad deal for getting a patent extension depending on the patent.  The Medicines Co. wants its patent to be extended 1,773 days, giving it exclusive rights to the drug until Dec. 15, 2014.  Medicines expects Angiomax to generate more than $500 million in sales in the United States by 2010.

What a Diff’rence a Day Makes!

Elizabeth Edwards is a woman on a mission and her mission is healthcare.  Mrs. Edwards wants us to know that we are facing a crisis in healthcare.  Ours is a system that is the best in the world but that is too expensive for many.

Last week at the BIO 2008 conference, Amgen hosted a media event to discuss the importance of innovation in medicine and the support needed to achieve success.  The keynote speaker was Elizabeth Edwards, who shares her husband’s (former Sen. John Edwards) commitment to improving healthcare.

She sees the cause in a nation with a fast-food mentality.   We’re a nation that wants what it wants and wants it now.  But we don’t save, invest or plan for the future.  She wants us to adopt a long-term planning strategy as a nation and this will require collaboration of all the players in the system if it is to produce a win.  And a win requires winners at all levels although acknowledging that to win, all players will need to give up something along the way.

While not all problems with heathcare can be solved with collaboration, it is a necessary first step with a nation that won’t even wait for french fries.

What is holding us back?  There is little will to analyze the efficiencies of our system.  Collaboration is viewed suspiciously at all levels.  There is a lack of common goals.  Mrs. Edwards believes that to achieve our goals, we need to have long-range planning, an ability to take risks and a system that is patient-centered.

So, what would a win look like?

A Win for Citizens

A win for citizens/patients would be healthcare made available at an obtainable cost with assured access to (reasonable) choices.  Our government needs to understand this.

Mrs. Edwards said “The disease holds all the cards and the researchers and doctors are the ones that get to play.  I don’t get to know most of the rules.  But I am not only willing to play, I need to play.”

A Win for Healthcare Providers

A win for healthcare providers would be healthcare with a manageable caseload — for a reduction of errors — and at a reasonable compensation.  “This depends on a universality of paying patients,” said Mrs. Edwards.

Right now, our system shifts the cost from the uninsured to the insured.  This is generally ignored in discussions of healthcare as though universal healthcare would mean millions of people suddenly getting care they wouldn’t have otherwise.

A Win for Government

A win for the government would be healthcare that is not cost prohibitive for patients or the government.  Joking that not even her husband John Edwards will touch it, Mrs. Edwards points out that no one is even discussing the looming crisis of long-term care for an aging population.

A Win for the Industry

A win for the pharma industry would be getting buy-in from the public (trust) with increased transparency.

So, how do we get all this?

Mrs. Edwards believes that we need a greater role by the federal government to make this happen.

First, we need increased funding of research by the NCI and NIH to get more innovation.  However, the funds need to be doled out in a different manner.  Under the current system, research grants typically to research proposals where the results are largely assumed (the established researchers).  Mrs. Edwards noted that “If you look at the past, it is when people went in new directions that there are successes.”

Second, we need to improve reporting capabilities.  The current system at the FDA relies on flawed (her words) system of self-reporting of effects.  She also points to increased user fees that put stress on the FDA to earn those dollars.  She wants to see more user fees used for reporting.  She also wants to see more efforts at pursuing treatments that don’t just favor the more profitable ones.

In closing, Mrs. Edwards tells that her breast cancer has now metastasized to her bones.  But she still feels lucky.  Noting that “cancer does not care if you have insurance,” she points out that because she can afford better insurance and is near quality research facilities, she received the best in care.  In many poor and rural areas, this would not be the case and she doesn’t see that as fair.

Everyone should hold out such hope.

BIO2008 conference attendee Ben Keeton, of the Kentucky BioAlliance, won a Patent Baristas iPod this week.  Ben was the first person to find me at the 2008 BIO International Convention in San Diego and ask for the Patent Baristas’ iBarista iPod.

Ben picked up a nice teal-colored iPod shuffle after asking for it Thursday.  Ben was attending BIO and coordinating the Commonwealth of Kentucky Reception for Gov. Steven L. Beshear, which was quite an affair atop the Marriott.

Admittedly, Ben had a bit of an advantage since we’d met a couple of times in the past so he recognized me immediately — as anyone on the convention floor knows, reading the tiny print on the name badges of strangers as people flood by is not too easy.

While several bloggers in attendance recognized me at the conference, they declined to accept an iPod saying they wanted to let them go to the nonbloggers.  Now, I have some iPods left over so I’ll be looking for suggestions on how to give them away.