The Big Red Biotech Blog

Prometheus Decision Sparks Usual Post-Ruling Debate

Nothing like a good patent cat-fight. 

You have to love Supreme Court patent decisions as they make one side so clearly euphoric and the other completely disgusted.  The recent Mayo Collaborative Sciences v. Prometheus Laboratories happily is no exception to this principle.

In brief, the case involves a method of determining the proper drug dosage for administering 6-thioguanine to treat patients for Crohn's disease.  In this instance, the high court ruled the method as patent ineligible largely for running afoul of the "laws of nature" test and "machine or transformation" test.

Now the fun begins.  In his blog, Derek Lowe, hails the decision by the Court as the best thing since sliced bread and can barely contain his glee -- in fact the post is entitled - "The Supreme Court Makes Me Smile."  His comments on Prometheus trying to "patent the practice of medicine" are quite amusing and you shoud read for yourself.  He concludes that he hopes we don't see any more of this "nonsense" -- refering to the Prometheus patents. 

In Xconomy this afternoon, Robert Sachs (IP attorney) takes the Court to task for handing down a ruling that will likely kill innovation in the diagnostic testing field, will hurt all of life sciences and biotechnology and will have far-reaching unintended consequences for untold industries. Basically, the patent world will spin off its axis. My favorite quote, "the Court spliced together a legal virus that will undoubtedly be used to challenge and ultimately invalidate patents in a wide range of technologies....the law of unintended consequences will be tested -- and confirmed -- once again." 

The Patent Doc blog does its usual fine job of just summarizing the Court's decision and reasoning ... though it is evident throught that presentation in spots that the writer (Kevin Noonan) doesn't agree with the reasoning and that is further clarified in the blog's comments sections.  Normal practice will be for Kevin to discuss and analyze the Court's reasoning while supplying his assessment of its merits or lack thereof in an upcoming post -- likely to appear at a Patent Doc blog page near you.

My take thus far is that patent attorneys are disdainful of the Court's ruling as a matter of law (and legal reasoning) and are also put off that the Court did nothing to clarify the standard for patent eligibility of these life science type inventions.  "Common sense" commentators seem to embrace the ruling as keeping another stupid patent off the books that would allow an obvious process to be patented, and one that would encumber further development in the field.

Let the games begin.

Posted by Bruce Lehr Mar 22nd 2012.  

 

Dendreon Shareholder Uprising (or Not) and 'Mammoth Potential'

Is there a shareholder uprising at Dendreon brewing?  Or not? According to a story from Xconomy, there is one afoot led by a disgruntled Kansas investor who'd like to see the Dendreon Board add one or too new memebers to represent the retail investor's point of view. 

To hear, Seeking Alpha's Saul Kerpelman tell it.  It would be great if Dendreon or perhaps most public companies added Board members to represent the little guy - but to say Dendreon is experiencing or about to experience a stockholder revolt is -- well -- Balderdash!

And two more articles from writers at Seeking Alpha aimed at propping up Dendreon's potential and hopefully stock price going forward - one claiming that Dendreon gives the rest of pharma "pipeline envy" as Provenge according to it can be a pipeline in and of itself through the various stages of prostate cancer -- not to mention that Neuvenge is following hot on its heels for various cancers including: kidney, colon, cervical, lung and breast.

The second SA article proclaims Dendreon to have "mammoth potential" from its impending Provenge sales over the next few years and states that concensus analyst estimates put the target value of the stock in the $55 range which would represent a 47% premium over where it is today. 

So who is an investor to believe?   Read and do your due diligence I always say.  Buy low, sell high, borrow early and pay late.

Posted by Bruce Lehr April 4th 2011.

KV's 'outlandish' price for prenatal drug stirs hornet's nest

KV's pricing decision on its hormone therapy, Makena, has done it now.  Most of you are undoubtedly aware that the company successfully introduced an FDA approved version of the drug earlier this month under the Orphan Drug Act.  With its FDA approval and seven years market exclusivity provided by the act, KV promptly raised the list price to $1500 per dose from the prevailing rate of $20-30 that was being delivered from in-house compounding pharmacies.  The next sound you could hear was the hornet's buzzing!

Backlash builds over KV's 'outlandish' price for prenatal drug.

KV now has members of the US Senate, the FTC, the March of Dimes, the NEJM, the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics in hot pursuit and calling for them to roll back their "outlandish" price.  The FTC, at the Senate's request, will investigate whether the company is engaging in "potential anticompetitive conduct".  Most of the above groups have contacted KV directly to lobby it to reduce its price - even its former allies, like the March of Dimes, has expressed shock and outrage at the pricing decision.

For its part, KV seems to have figured out that it made a serious error in judgment but may not have figured out what to do about it.  It does seem to know that it will be unlikely to get past third party payers at this point and all the other anti-constituencies that it has united.  KV issued a statement in its latest 10Q filing with the SEC acknowledging the risk it now faces with its pricing.  It noted the following issues it needs to deal with for its pricing of Makena:

• Ability to maintain certain net pricing
• Degree of success in obtaining 3rd party reimbursement - including government, privae health insurers, HMOs, insurance companies, and Medicaid
• Convincing medical practitioners to prescribe
• Degree to which compounding pharmacies continue to produce unlicensed alternatives

"The success of the Company is largely dependent upon these efforts and appropriately responding to both the media and governmental concerns regarding the pricing of Makena."

As noted by several commentators, the whole circumstance appears to have been created by KV receiving Orphan status and exclusivity for a product it did not discover, didn't fund clinical trial work on, and don't even manufacture.  Then it MADE an egregious pricing decision for which it is deservedly being criticized.  However, one must question why Orphan status was even a possibility on a drug that had been around for 50 years, was previously shown to work in this application.  KV added some benefit in producing it under GMPs but certainly did NOT create any clinical value to the patient or provider along the lines of a $20 to $1500 per dose increase.  That's just plain greedy. 

This type of action I hope will be considered by the Congress in lookng at the Orphan Drug Act.  The Act has been good generally but is clearly intended as a carrot for companies to produce novel treatments for diseases/markets that would otherwise be unattractive for their revenues -- unless conferred with exclusivity.  However, it was not intended to allow a company to take an old treatment - gain approval - and then exploit a pricing position under a regulatory monopoly.  With the law written as it is, there is nothing to prevent another company from doing the same in the future.  It wouldn't surprise me if someone was working on new (old) projects right now. 

 
Posted by Bruce Lehr March 26th 2011.

How are Pharma CEO's like the Ostrich?

Can you guess from this photo?  Here's the rest of the story from PharmaManufacturing.com.

Posted by Bruce Lehr feb 3rd 2011.  

Sir Chris Decries Woeful State of UK VC Climate - No Bravehearts Here

Fierce Biotech published comments from Sir Chris Evans, one of the original investors in BioVex in the UK, decrying the state of VC investment their. BioVex pulled up stakes as a result to raise millions in Cambridge (sounds like it is in UK) in the US before it sold out to Amgen for $1 B in cash and milestones last week.

"BioVex were never going to raise the millions they needed in the UK. They were better off in the States where they raised 60 M pounds.  We don't put enough money into these firms in the long term.  There is too much pressure that they will pull off sensational results quickly." said Sir Chris.  

He added that this type of weak investment environment is hitting home in places like Scotland.  All the more reason for President Obama and the Congress to get behind calls to feature the biotechnology industry for more investment in the US to further push our leadership position.

Meanwhile with regard to Sir Chris' quest, he likely can keep talking till he's blue in the face.........

 

 

 

Posted by Bruce Lehr Jan 31st 2011.

 

BIO Publishes Survey to Support Its Position on Gene Patents

According to the Patent Doc blog, BIO commissioned a survey who's results [surprise, surprise] support its position on gene patents.  The survey was conducted by Public Opinion Strategies of 400 "elite" voters - that is voters with a college degree, a household income of >$75,000 and "who closely follow such matters".

The Survey says:

• 89% of respondents believe patents provide the protection, time and funding that researchers need to provide major technological breakthroughs and are thus a "good thing" (with a thanks to Martha Stewart)
• 51% (overwhelming Yes?) had reservations about DNA-based patents but could support them anyway for the good of the biotech's working on disease cures
• The term "gene patents" or "human gene patents" produce a negative response = "bad"
• The terms "genome sequence patents", "DNA-based patents" or "DNA patents" = "good"

So expect BIO to use the latter terms in its subsequent rounds of press releases.

 

 

Posted by Bruce Lehr Jan 13th 2011.

EMA Head Rips Pharma R&D Waste vs. Big Pharma Fears Increasing Regulatory Hurdles

Last week, departing EMA chief Thomas Lonngren took the opportunity to question Big Pharma's R&D spending - saying, in effect, that $60 B of $85 B spent annually was being wasted.  He reasoned that only 7-9 drugs were making it to market that were worth maybe $20 B and where did the rest of the $85 B in value go?  He also took Big Pharma to task in relation to which therapeutic areas it chose to pursue - sopecifically he criticized cutbacks in CNS therapies and in antibiotic research. He finished his mini-rant with conviction that drug regulators around the world would unite to cooperate more in the coming years, saying "The evolutionary momentum of this is unstoppable." See Fierce Biotech report.

Yesterday, I read this article in the WSJ regarding Big Pharma's (and its investors) fears of how regulatory scrutiny is rising in unpredictable ways -- from Big Pharma's viewpoint.  The poster child in this particular case was AstraZeneca's Brilinta receiving a delay in regulatory approval from the FDA - despite having already been approved by EMA earlier this month. AstraZeneca feels it can negotiate the regulatory hurdle but at what cost?  Investors reacted by causing a significant drop in AZ's share price - reflecting a possible worst case scenario that the drug will never be approved in the US.  Are drug developers and regulators working at odds here?

The fact is that success rates for new chemical compounds have fallen from about 12% a decade ago to less than 8% today and the trend is still going down. Clinical trials must be up to twice as large and costs of development are rising.  Is this anyway to run an industry? It is high time that both developers and regulators work on changing the model to better optimize use of precious R&D and regulatory resources to get more successful launches of needed drugs to the market. This would seem to be more productive than hand wringing by either side.

 

 

 

Posted by Bruce Lehr December 21st 2010.

 

Blogger View: Memo to Congress: Hands off FDA

Eric Greb, in The PharmTech Talk blog, discusses the possible consequences when the US House of Representatives passes hands to the GOP in January 2011.  With their stated cost-cutting agenda, every government department involved with domestic spending is at potential risk of cuts -- including the FDA.

PharmTech Talk » Memo to Congress: Hands off FDA.

However, the FDA is already straining under increasing levels of responsibility, e.g regulation of tobacco.  Moreover, a recent GAO report criticized the FDA's lack of oversight of foreign pharma manufacturing plants, the majority of which have never been inspected. 

The post questions the wisdom of cutting this department's budget if we want to keep the public health and safety secure. I would second the writer's opinion that there must be other areas where cuts can be better directed. 

The agency still stands as the last line of defense for the safety of the pharmaceuticals we take -- and there have been ample examples in the past several years of problems with raw materials in the supply chain and drug manufacturing sites where we need all the help that we can get.

 

 

Posted by Bruce Lehr November 15th 2010.

Analysis of Market-Exclusivity Incentives to Promote Pharma Innovation

Here's a nice article from the New England Journal of Medicine (NEJM) looking at legislation that conferred market-exclusivity incentives to pharma manufacturers to promote innovation.  The article discusses the pros and cons that ensued.  Many tmes the legislation did drive the effects it was seeking but usually got some significant unintended consequences -- which in many cases may have outweighed the value. 

Five pieces of legislation were examined in brief.  These included:

• Patent and Trademark Act amendments (Bayh-Dole)
• The Orphan Drug Act
• Drug Price Competition and Patent Restoration Act (Waxman-Hatch)
• The Prescription Drug User Fee Act
• FDA Modernization Act Section 111 (pediatric exclusivity extension)

The following slide neatly summarizes the intentions of the sponsors and congress in introducing each piece of legislation.  It also points out the flaws discovered on implementation that critics frequently point to for each. 

Download NEJMFigure01[1]

The author, Aaron S Kesselheim, MD, JD, MPH, conlcudes that use of market-exclusivity incentives to promote innovation has potential as good public policy.  But, and this is a significant but, future legislatin of this type should be linked to a demonstration of positive public outcomes.  Without linkage as a countermeasure, the results of incentives may be more damaging to the public health than they are worth as policy instruments.

Posted by Bruce Lehr November 6th 2010.

FDA Mulls Tighter Standards on Generics?

According to a Bloomberg story quoting Janet Woodcock, director of the FDA's CDER, the agency is considering tighter standards for generics.  Why this is the case is not exactly clear to me.  In the article, Woodcock refers somewhat cryptically to alleged comments purportedly from patients and unnamed employees of generic manufacturers that say some generics "don't work as well as the originals".

Hmmm.  The employees are unnamed.  The companies they work for are unnamed.  The drugs in question are unnamed.  The basis for "don't work as well" claim is unsupported with data or specifics.  There seemed to be some innuendo aimed at anti-seizure drugs though. 

Woodcock made her statements at a meeting of the Generic Pharmaceutical Association. I speculate she was delivering a message to someone - certainly Miles and Sandoz sat up and took notice. Maybe they are supposed to help police some of their members?  PhRMA of course also took notice and the opportunity to state the FDA must keep us safe by ensuring generics are safe.

David Rosen, an attorney at Foley & Lardner LLP in Washington who served as a top-level generic official at FDA between 1980 to 1989, said questions have long been raised about generic compounds’ effectiveness based on anecdotal evidence. He wondered what is different now.

Nothing.  Just more sabre rattling by FDA. 

Woodcock said she didn’t know when the agency would come to any conclusions about generic standards of equivalence. The standards assure the generic is absorbed at the same rate and extent as the brand-name version.

The absorption problems aren’t necessarily harmful, Woodcock said. FDA permits generic drugs to absorb at a 25 percent different rate and extent than the originals they copy.  Australia, Canada, the European Union, Japan and South Africa have stricter bioequivalence standards for critical dose drugs. Woodcock also urged generic-drug makers to put more emphasis on “product presentation.” 

“Manufacturers need to think beyond therapeutic equivalence,” Woodcock said.  Why, if that is what the regulations emphasize?  If you want different emphasis, add to or emend the regs - preferably in public forum with commentary. 

Sounds like a case for SuperRegulator. 

 

 

 

 

 

 

 

 

 

 

Truth, Justice and the American Way!

 Posted by Bruce Lehr October 24th 2010

If Left to Republican 4 Pay-To-Delay Will Stay They Say

Four Senate Republican have written to party leadership informing them of their intent to block a recent Senate spending bill that contained a provision to ban pay for delay deals. The Department of Justice (DOJ) and the Federal Trade Commision (FTC) are against pay for delay deals - calling them anti-competitive and a bad deal for consumers.

But, pay for delay is OK in these 4 Senators' books.  They say the bill wil give "excessive power" to the FTC which in this case is bad. Excessive power belongs only in the hands of 4 Senators of course.

Senate Republicans Hate The Pay-To-Delay Ban // Pharmalot.

The Congressional Budget Office (CBO) on the other has estimated pay for delay deals will cost the federal government (i.e. tax payers) $2.6 B over the next 10 years.  You know the drill - a billion here and a billion there and pretty soon you're talking real money.

Posted by Bruce Lehr September 21st 2010.

 

Senate Panel: We're from Gov't. We're here to help Stem Cells!

As covered in ScienceInsider blog, the Senate has convened a panel to discuss its response to Judge Lambeth's ruling last month that government funds cannot be used at all for human embryonic stem cell research as this would be in violation of the Dickey-Wicker Amendment.

Senate Panel Weighs In on Threat to Stem Cell Research - ScienceInsider.

Democratic Senate heavy-weights like Tom Harkin (IA) and Arlen Specter (PA), proponents of the research, indicate they are looking at introducing laws that would permanently reverse the effect of the Judge's ruling and restore certainty to the field (in terms of funding anyway).

Senator Arlen Specter (D–PA), a longtime champion of stem cell research who introduced a bill to make hESC research legal on Monday, warned that the outcome of the legal process "is very, very uncertain." He added that Congress "had better get busy."

Posted by Bruce Lehr September 19th 2010.

Please, Sir. May I have some more? Fabrazyme

According to WSJ just now, Genzyme expects to stop rationing its Fabrazyme during the 1st half of next year - which could still be up to 9 months from now by my calendar.

For the patients who are waiting on their meds to return to normal, I hope it is sooner rather than later.

The timing may be a little curious for this announcement since its not really effective until 2011 at the earliest.  Would this have anything to do with positive PR at a time when the company is under acquisition rumors?  Perhaps, a few kudos for current management?

Posted by Bruce Lehr September 15th 2010.  

DOJ Singles in Appeal: Stem Cell Ban 1 Stem Cell Funding 1 in 2nd

The WSJ reports that the Department of Justice has convinced an appeals court that the ban on funding human embryonic stem cell research is stayed pending the next round of deliberations - which could be as short as 10 days.

The US Court of Appeals  for the DC circuit has issued a stay of Judge Lamberth's ruling from last month which determined that the Obama administrations funding of embryonic stem cell research violated a 1996 law (previously violated by extension since its passage by both the Bush and Clinton administrations).

The latest ruling - in what only can be expected to be a vigorous back n' forth - gives both sides a chance to file written arguments prior to September 20th.  Then it is possible that the ban may go back into effect if the DOJ loses that inning.

Posted by Bruce Lehr September 9th 2010

 

ARVO Opposes Stem Cell Injunction - Backs F. Collins Vision

The Association for Research in Vision and Ophthamology (ARVO), the world's largest international association of eye and vision scientists, released as statement opposing the Federal Court injunction on embryonic stem cell work.

Sight-saving research halted by stem cell ruling.

The statement disputes Judge Lamberth's contention that his ruling would "not seriously harm hESC researchers because the injunction would simply preserve the status quo..."  ARVO members state that their research has already been disrupted as they have been forced to separate infrastructure, equipment and personnel funded by Federal Agencies from those funded by private sources.  The NIH announced earlier this week that it was shutting down all its intramural hESC projects.  Sounds like an effect, does it not?

ARVO states that liberal stem cell policies work in the favor of its members in Australia, Belgium, China, India, Israel, Japan, South Korea, Sweden and the United Kingdom. Members in the United States, Austria, Germany, Ireland, Italy, Norway, and Poland labor under more restrictive policies.

ARVO generally supports Francis Collins, NIH Director, statement that the US will be put at a scientific disadvantage under the injunction that threatens to stop all progress in the field and its future promise.

Posted by Bruce Lehr September 2nd 2010.

Shirley&Deisher - 1 NIH Stem Cell Funding - 0 after 1st inning

The WSJ gives a more in depth profile of the two researchers who brought suit against government funding policies for embryonic stem cell research. Neither knew each other and each was recruited by legal groups seeking to challenge the funding policy.  In reading the article, both seem to be sincere in their opposition but also have activist pasts - so not strangers to controversy.

Both would appear to have a bit of an axe to grind as they work in adult stem cell areas.  The feel that they get short shrift when it comes to government funding, as from their perspective embryonic stem cell work gets favored treatment from government programs.  Having said that, Deisher has never applied for Federal funding and that would seem to weaken any argument that she is passed over or disadvantaged in some way.

Looks like the case will now be picked up by the Obama adminstration on appeal with thoughts of achieving at least a stay until a more permanent ruling is reached.  The political sphere will now also become more involved with members of Congress who oppose the ruling, perhaps looking to pass a law that will effectively nullify Judge Royce Lamberth's ruling.  Drs. Sherley and Deisher will also start their tour of Capitol Hill to garner support for their position.

This is only the beginning of this ballgame I'm sure. Lawyers and law makers are up in the bullpen.

 

 

 

Posted by Bruce Lehr September 2nd 2010.

Will the Stem Cell Ruling Affect Venture Capital Investing?

Here's a piece from Brad Webb, partner at Claremont Creek Ventures, published in Xonomy today. He opines that the recent anti-stem cell ruling (currently being appealed by Obama administration) will have a negative effect on venture capital flowing into stem cell biotechs.

Will the Stem Cell Ruling Affect Venture Capital Investing?.

Yesterday, even the NIH shut down its stem cell funding for internal programs while this situation is being sorted out legally.  This type of political/regulatory back and forth results in strong investor uncertainty. This is not a good thing for continued investment.  It can't help but have a dampening effect.

Posted by Bruce Lehr September 1st 2010.

Lamberth Stem Cell Ruling Stems Research Pending Appeal

Judge Royce Lamberth's ruling that federally funded human embryonic stem cell research violates the Dickey-Wicker Law has thrown stem cell research in the USA into temporary (though immediate) disarray. According to stem cell researchers, Lamberth's temporary injunction has halted research at dozens of labs. The University of Wisconsin alone has 34 approved stem cell projects -- 21 of which are federally funded and affected by the ruling.

The ruling calls into question not only research done with 75 new stem cell lines approved by the Obama administration since 2009, but even research with previous cell lines considered to be acceptable by the Clinton and Bush administrations could be at risk under this ruling.

The NIH announced that researchers who are currently working on $131 M worth of grants in 2010 can continue their work.  However, the NIH has suspended all review of new grant applications.  There is currently up to $74 M in new funding requests in 50 grant applications before the NIH - $54 M in renewed funding requests and $20 M in completely new research.  All of this is suspended.

Francis Collins, director of the NIH, expressed concern that the suspension of stem cell funding could do great harm to research in the US - "It has the potential to do serious damage just at a time when we were gaining momentum."  Tim Kamp says, director of the University of Wisconsin Stem Cell and Regenerative Medicine Center, the ruling "will put us at a huge competitive disadvantage to other countries" including programs in Japan, the UK, Australia and China.

The Justice Department stated on Tuesday that it would appeal the ruling. It has asked the district court to put its ruling on hold while the appeals court considers the case.  Beyond that, Democratic Leaders in the Congress are deciding whether to pursue additional legislation to restore stem cell research or to remove Dickey-Wicker from this year's spending bill.  Leaders are exploring legal and political ramifications.

Seeking Alpha reports that a basket of stem cell stocks that they follow were down 5.5% in Tuesday's trading following the ruling. Ironically, several of the companies affected do not work with embryonic stem cells and have programs centered on use of adult stem cells from autologous adipose tissue or bone marrow.  Cytori Therapeutics, Aastrom Biosciences, StemCell Inc, and International Stem Cell Corp are 4 companies who saw their stock drop more than 5% but DO NOT work with embryonic stem cells. Geron IS a company that works with embryonic stem cells that saw its stock drop.  Osiris Therapeutics is a company that works with adult stem cells that actually saw its stock rise. 

Read here for more gory details:  WSJ Health blog, WSJ, Fierce Biotech, Seeking Alpha, and Seeking Alpha (Zacks).

Posted by Bruce Lehr August 25th 2010.

 

 

US DoJ Probes Big Pharma Misbehavior in World Markets

Here's the latest news on the Department of Justice (DoJ) probe into Big Pharma companies possible corruption in world markets. The investigation is looking into behaviors like improper payments for hospitality, consultants, physician recruitment, licensing agreements and charitable donations (i.e. inducements or bribes). There is a particular emphasis on payments that may have influenced the reliability or integrity of data in foreign clinical trials.

http://pharmagossip.blogspot.com/2010/08/ftcom-us-probes-corruption-in-big.html.

GSK, Pfizer, BMS, Lilly, AZ, Merck and SciClone have acknowledged contact from both the DoJ and SEC in respect to this investigation.

Under the Foreign Corrupt Practices Act, a US anti-bribery law, companies may not offer items of value to foreign government officials for profit. Medical personnel associated with state-run medical institutions in foreign countries are considered "government officials" under the law.

Posted by Bruce Lehr August 13th 2010.

Dendreon Gets FDA Letter Friday After Close

This from the Biohealth Investor blog states that Dendreon received a letter from the FDA on Friday after closing asking it to stop certain promotional materials with Provenge.  The materials were said to be "false or misleading" with regards to statements of risk. The materials are also said to overstate the effectiveness of the drug.

Posted by Bruce Lehr August 7th 2010.

Gotta Love Derek on Open Source Discovery in Pharma

Derek Lowe writes the very very good and very highly read In the Pipeline blog.  Derek has a way of getting right to the point with a nice blend of bluntness and sardonic humor without being mean spirited.  Sometimes his posts just make me smile.  Here's one such post from today on the topic of Open Source discovery.

I'm actually a backer of the concept and think that companies really should try to explore its potential  -- by testing and operationalizing it. However, Derek makes a good point in his blog.  Too often proponents on the topic - provide a lot of talk but don't seem to be able to deliver the concrete actions or proof of concepts. 

Maybe this post hit home a bit more as I received the following note from a colleague commenting on a current discussion on "open innovation" in one of the innovation groups that I participate in. My colleague wrote:

To me it's unbelievable how little capability to analyze things have most of the people who are posting comments on that discussion group!!! They got "stuck" into that Soft skills topics they can read in books of Change management, Leadership, etc, but when it comes to Hard skills and concrete innovation they do bla-bla-bla...

Presumably it is hard to articulate the "hard innovation ideas" as they are hidden in the ball of fuzz that Derek refers to in his post.  Maybe we need to contact Rush to help us find the answer as he seems to know a lot about Fuzzballs.

Posted by  Bruce Lehr July 29th 2010.

Why Give FDA Monopoly on New Drug Approvals?

As reported in Fierce Biotech, a think tank known as the Pacific Research Institute (PRI) has recommended that the US FDA should also accept drug approvals from the EU's EMA.  The group notes that the EU and FDA have approved a combined 39 drugs in the past two years.  However, the 11 of these are exclusively approved in the EU, and the EU is averaging more than 3 months faster than its US counterpart in spitting out approvals.

The PRI says the FDA's monopoly regulatory position for US approvals is creating inefficiency and is blocking access to new drugs for Americans. Like most conservative groups, they'd prefer (or so they say) to see some healthy regulatory competition to speed the process - which they claim would likely save lives as well.

What that says about safety and efficacy criteria, I'm not sure, but I wouldn't hold my breath for lawmakers or the FDA to relinguish any regulatory control anytime soon.

 

Posted by Bruce Lehr July 28th 2010.

Lilly CEO "innovation crisis in America's life-sciences sector"

Is America facing an innovation crisis?  Lilly CEO John Lechleiter says "YES!" in a speech delivered before the Detroit Economic Club. He cited a study by Information Technology and the Innovation Foundation. In the study, the US was ranked 6th out of 40 in innovate-based competitiveness but a shocking 40th (or last) in taking steps to maintain its innovative edge in the future.

Lechleiter called for 4 main US government policy changes to combat this perceived issue:

• Broad improvement in science and math education
• Immigration laws that permit top foreign scientists to work in the US
• A well-funded basic research infrastructure in academic and government labs
• Tax policy that fosters innovation

See PharmTech Talk blog for more.

Some commentators, notably Derek Lowe in his In the Pipeline blog, noted a certain inconsistency between Mr. Lechleiter's comments and Eli Lilly company actions.  Lilly has been very aggressive in outsourcing R&D jobs/projects to India and China. Wouldn't this be counter to 4 point plan above?

Regardless of the whether this is right cure, there does seem to be a problem (unlikely of Lilly's making with or without its outsourcing policies).  The innovation gap appears real.  But is it due to people working on new innovations, or is it caused by the fact that the disease targets that Big Pharma is now chasing are much harder to address?  Diseases like cancer (really a spectrum of diseases) and Alzheimer's.  Interestingly, several Big Pharma companies just announced that they would be sharing results of their failures with Alzheimer's drugs in hopes that they will help each other better understand the disease (I think this is the type of innovation we need - OPEN innovation).

Fierce Biotech's coverage of Megan McCardle's analysis in the Atlantic poses deceptively simple question, Are fewer drug approvals a result of R&D being harder field to work in now? The low hanging targets are gone.  New therapies must be an improvement on existing therapies versus enterng virgin territory with the first therapy. Plus, being the nth drug in class, means that the safety hurdles are higher since safe existing therapies are already approved.

This line of reasoning might argue that innovation gaps aren't the result of lack of quality scientists as implied by Lechleiter's reasoning, but may be a result of the bar being raised on technical difficulty of finding new cures in complex areas and increased regulatory hurdles - environment versus people causation. She also throws in the little kicker that the genome project hasn't really accelerated new discoveries at this point - at least in terms of new therapies on the market. This is at least an alternative hypothesis.

I think the innovation gap will much more likely be solved by intelligent people and companies working together.  The drugmakers, NIH, FDA and Science foundation coalition (alluded to above)that has joined forces to look at Alzheimer's by sharing patient data on over 4000 patients -- will go a lot further toward promoting innovative treatments in my view than the changes in government policdy requested above - although some of those suggestions (math & science education, & immigration reform) might be good ideas to implement as well.

Like the FDA's Joshua Sharfstein says, "I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease." Amen.

Posted by Bruce Lehr June 18th 2010.

Reprise of Commentary on Sweet/Myriad BRCA 1&2 Ruling

Previously, I've written posts (no. 1 & no. 2) regarding Judge Sweet's ruling in the Myriad gene patent case for BRCA 1&2.  Myriad and its backers need to file their appeal by June 18th - 60 days after the decision - which they will do.

Today the Kevin Noonan, in his Patent Docs blog, did an excellent job of reviewing the popular and not so popular opinion coming from all walks of life following the decision.  I couldn't begin to duplicate this post - so I won't try. I've just passed it on for your reading pleasure.

The blog provides an extensive list of references if you care to read in even more depth.

Posted by Bruce Lehr June 9th 2010.

Everyone's Gene into the Pool!

This week I read a post in Patent Doc blog critical of an editorial that appeared in Nature Biotech regarding the state of patent law with respect to patenting genes. The editorial (spurred by the recent Myriad decision by Judge Sweet) took the position that allowing gene patents was a effectively a license to block innovation. Society, according to the editorial, was worse off as a result.  The editorial opined that patent pools or clearinghouses might serve the public's interest in breaking through patent thickets, but that it would likely take government legal coercion to implement these remedies in the biotech arena. 

The Patent Doc post argued that the Nature editorial writers were confusing the role of patents in preventing infringement relative to commercial activity, with perceived blocks by these same patents on basic research.  The latter activity hasn't been impeded by patent enforcement actions relative to patents like the BRAC gene patents. This - according to Patent Doc's - is where the innovation is occuring unencumbered. This post also criticizes the Nature Biotech writers for not understanding the "balance of rights" that the patent bargain actually strikes relative to protecting both incremental improvements and the groundbreaking ones. Finally, the Nature writers are called to task for asserting that patent pools will require government coercion to be enacted in biotech -- in conflict with actual recommendations given by the US Health and Human Services Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) report.

See report here Download SACGHS Patents Report Approved 2-5-20010 and page 92 for patent pool recommendation.

Patent Pools are an interesting concept, and not new, for resolving the gene patenting issue.  A patent pool as defined in Wikipedia is a consortium of two companies agreeing to cross-license patents relating to a particular technology. Follow link for more history.

Patent pools date back to 1850's and have been used to break up logjams of overlapping patents, referred to as patent thickets, in industries as diverse as sewing machine manufacturers, aircraft manufacturers, digital broadcast signals, DVDs and RFID technology.  Now, will they work for biotechnology and specifically for gene patent issues?

In 2000, the US PTO issued a white paper, Patent Pools:A Solution to the Problem of Access in Biotechnology Patents?  The paper does a great job of summarizing history of patent pools, requirments/characteristics of a pool to be legal (interaction with anti-trust law), discusses their plusses and minuses, and finally discusses potential benefits to their application in biotechnology.

The major benefits in terms of biotechnology (according to this report):

1. Elimination of problems caused by "blocking" patents or "stacking" licenses
2. Significantly reduce several aspects of licensing transaction costs
3. Distribution of risk across all members of the pool can spur more innovation due to effects of sharing risk
4. Pools often lead to systematic, more open exchange of technical information (not covered by patents) among pool members, i.e. sharing trade secrets for advancement of all

There can be negatives too, primarily pools can inflate costs of competitively priced goods, can shield invalid patents (thrown illegally into the pool), can encourage collusion and price fixing among pool members.  The US PTO concluded that there were enough existing guidelines, regulations, and laws to prevent this type of behaviour. Their conclusion?  Patent pools are win-win for biotech.

In a similar paper, published in The Journal of Philosophy, Science & Law, the author, David Resnick, Prof. of Medical Humanities, Brody Sch. of Medicine, ECU, similarly concluded that "companies, universities, and other interested parties should form a biotechnology patent pool" to prevent problems related to licensing from undermining scientific research and technical innovation. The key is to convince potential members of the pool that it is in their long term best economic interests to be in the pool. If members perceive that they have individual patents that are more valuable than those in pool, there is an incentive to "go rogue" as Sarah might say.

The jury is still out - both for the appeal of the Sweet verdict and for the viability of patent pools in biotechnology.

Other references

Verbeure, B., van Zimmeren, E. et al. Patent pools and diagnostic testing. Trends in Biotechnology 24(3): 115-120.

Patent Docs blog, Debating Gene Patents - Round four

Posted by Bruce Lehr June 3rd 2010.