The Big Red Biotech Blog

Biosimilars Not Only Threat Facing Biopharma

As this piece from BioProcess Blog points out, biosimilar competition is only one hazard faced by biopharma producers of the world's top bio drugs. In addition to increased price competition, there are the unscrupulous drug counterfeiters (see recent Avastin issues).  There is also the possibility of compulsory licenses being invoked in places like India (see recent Nexavar case). 

Biosimilar Competition is Only One of Several Threats Facing Biopharma Blockbuster Drugs.

These type of developments led PhRMA President and CEO John Castellani recently to comment, "If countries begin to routinely use complusory licenses, we could see a 'race to the bottom' in which governments in the developing world walk awayfrom their responsibility to support research and innovation in public health. In the absence of investment made by our members, and the resulting research and development, there would be no generic medicines for the world's patients."

As we say in Oz, "Biosimilars, Counterfeits and Compulsory Licenses, Oh My!"

 

Posted by Bruce Lehr May 8th 2012.

Bayer Challenges Compulsory License In India

To no one's surprise Bayer has gone back to court to challenge the India Patents Office decision to award a compulsory license to the generic manufacturer Natco to make Bayer's patented anti cancer drug Nexavar.  The IPO invoked compulsory license rules citing Bayer's high selling price ($5500 per patient/month) as preventing most India patients from using the drug. Natco will sell its version for $175 or a 97% decrease.

Bayer Challenges Compulsory License In India // Pharmalot.

“We will rigorously continue to defend our intellectual property rights which are a prerequisite for bringing innovative medicines to patients,” a Bayer spokesman writes us. “The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India’s essential drug list are not patented.  Rather, the order of the Patent Controller of India damages the international patent system and endangers pharmaceutical research."

“This is the trivial argument Big Pharma has been making for years to cover the impact of its monopoly pricing policies,” writes Brook Baker, a professor in the Program on Human Rights and the Global Economy at the Northeastern University School of Law, and a member of Health Gap, Global Access Project. “Of course, there are other barriers to access, but does Bayer want to seriously argue that medicine priced 60 times more than the newly announced Cipla price doesn’t adversely impact access?"

Bayer unmoved, appears ready for an all out legal fight, you could say "they are going to the Madras" on this one.

 

Posted by Bruce Lehr May 7th 2012

More on Abbott Anti-Biosimilar Petition to FDA

I posted a few days ago on Abbott's letter to the FDA urging it to reconsider its policy on reviewing biosimilars.  Abbott argues that to approve any biosimilar that is challenging a reference product filed prior to the law's enactment in March 2010 will necessarily cause the FDA to use innovator company trade secrets in their analysis -- and thereby violate provisions in the 5th amendment.  Provocative, yes?

If Abbott's argument is correct or at least has good chance of being found so in the federal courts, this would seem to completely undermine the intent in geting biosimilars approved, and certainly would hamer any positive healthcare budgetary effects (i.e. saving drug costs) that Congress may have been seeking in passing this legislation.

Read more here in today's Pharmalot blog.

Posted by Bruce Lehr May 1st 2012.

Supreme Court Sets AMP v. USPTO (Myriad) Schedule

According to the Patent Docs blog, the Supreme court has asked the all participants in "Myriad case" to submit  briefs addressing "the applicability of the Court's recent decision in Mayo" to Myriad's isolated DNA claims. If you are so inclined, the Court also invited the submission of amici briefs by June 15th.

Oral arguments will then follow on July 20th for those who want to have their hot popcorn ready in front row seats.

Posted by Bruce Lehr Apr 30th 2012.

Abbott Moves to Block Many Biosimilar Applications

The Biologics Price Competition and Innovation Act (BPCIA) was signed into law on March 23, 2010.  It is the basis for establishing an approval pathway for biosimilars.  In early April this year, Abbott petitioned the FDA to disallow any biosimilar applications that cited a reference drug's BLA that was submitted prior to the March 23rd date.  Abbott's legal representatives contend that the FDA's consideration of such materials would violate the Fifth Amendment. See Patent Docs blog.

It seems the Fifth Amendment, in addition to protecting one's right against self-incrimination, also "prohibits the taking of private property for public use without just compensation."  Abbott says the FDA would be dong just that if they use data from a BLA (filed before March 23, 2010) to allow a biosimilar drug on the market.  Prior to March 23rd, Abbott contends that it and other similar BLA filers had the expectation that the information in their filing would remain guarded as a trade secret, and the FDA is now about to reverse that policy.  Abbott specifically mentions BLA 125057 for Humira® (adalimumab) as one BLA to be protected in its FDA petition.  The drug is a known target of biosimilar "producers to be".  Even as I type, it is earning its way to becoming the TOP SELLING drug in the world in 2012 with more than $9.3 B in projected revenues.

Abbott's argument in a nutshell. 

Reference product sponsors invested massively in bringing products to market, taking great risk to develop, test, and seek a license to market the reference product.   Abbott argues that an innovator's  license application typically reflects more than a decade of research and contains analytical, preclinical, and clinical data, as well as detailed manufacturing information, most of which qualifies as trade secrets.  It further contends that these trade secrets are the private property of the reference product sponsor and are therefore protected by the Fifth Amendment to the U.S. Constitution.  And [the coup de grace] according to Abbott's Petition, when the FDA approves a biosimilar biological product on the grounds that the reference product has been shown safe, pure, and potent, it uses these trade secrets. Abbott says only biosimilar applications citing data filed after March 23, 2010 should be allowed.

Abbott finishes its Petition by requesting that the FDA interpret the BPCIA as applying only to post-enactment reference products, thereby avoiding both significant constitutional questions and significant governmental liability. 

 Abbott even cited a Supreme Court case -- Ruckelshaus v. Monsanto Co.  (1984) -- involving a somewhat analogous situation where Monsanto submitted a trade secret to the EPA in support of a pesticide license application.  The Supreme court did rule in this instance that trade secrets were protected under the 5th amendment and that Monsanto had an expectation that the goverment would not use the information to benefit a competitor in their license application -- instead their data "would remain inviolate."

Wow...this completely undermines the intent of the biosimilars legislation does it not?  Sounds eerily similar to me. I think it would be bad public policy to block biosimilars but I think Abbott's argument is ingenious to say the least.  Right now, this is just a petition to the FDA to influence how it chooses to set policy, now we'll have to wait anxiously to hear the agency response. You can see this argument potentially going to some court however.

Posted by Bruce Lehr Apr 24th 2012.

 

 

Myriad Will Return To Supreme Court

As expected, the Supreme Court remanded the Myriad case back to the lower Circuit Court to review its previous finding in lieu of the new ruling in the very recent Prometheus case.  As explained in the blog post, the Supreme Court would like to make sure the lower court vets all the issues. 

Myriad Will Return To Supreme Court: Rod Explains // Pharmalot.

This case as you may remember essentially is deciding whether gene sequences (genes) are patentable.  Most of the biotech industry and the BIO organization have certainly backed Myriad claiming that a denial of these patents would chill innovation and investment in the industry.  

Opponents see patenting genes as goign against the patent doctrine prohibiting patents "on the underlying laws of nature."  Prometheus was cited as being in violation of this concept as its patent was thrown out last week. Opponents also see the Myriad BRCA patents as potentially limiting access to potentially life-saving genetic tests if it is deemed to be the only provider.

Many observers expect the Circuit Court to reaffirm its original ruling (in Myriad's favor) and then we'll end back up at the Supreme Court anyway. The drama unfolds.

Posted by Bruce Lehr Apr 2nd 2012.

Supremes Remand Myriad to Federal Circuit Court

As expected, the Supreme Court remanded the Myriad case back to the Federal Circuit Court for further consideration in light of the Mayo Collaborative Services v. Prometheus Laboratories case.

Supremes Remand Ruling On Cancer Genes & Patents // Pharmalot.

Patent lawyers observing the proceedings think that Myriad has cause to be worried as to the decision the Federal Circuit may make. 

"Myriad must have increased concerns about the validity of its DNA fragment claims, as the Federal Circuit could find support in Mayo to invalidate them under the theory that the fragments are products of nature and that the technique to isolate them is common and conventional."

The Federal Circuit, which ruled in Myriad's favor the first time around, can issue a decision with the same or a different outcome. We will anxiously await its decision. See the Patent Docs blog for more background and analysis on these issues.

Posted by Bruce Lehr Mar 26th 2012.

Supremes' Prometheus Ruling: Death Sentence for Personalized Medicine?

There's no doubt where the writer of the IN VIVO blog stand on the wisdom of the Supreme Court's ruling against the Prometheus' patent.  The logical extension of the ruling (according to the writer) would be the denial of patent rights to a myriad (get it) of personalized diagnostic tests. 

The IN VIVO Blog: Supremes' Prometheus Ruling Has Dire Consequences for Personalized Medicine.

Not only would the analysis of small differences in gene sequences (as embodied by the Myriad case) potentially be covered by this ruling, but any tests that attempt to figure out why certain individuals respond better to one drug over another and how much drug should be administered should be covered. At least, if the logic exhibited in Prometheus were extended to other cases.

But then again, who ever accused the Supreme Court or most of the legal system to actually be bound by logic? Until another case comes along that will allow a reversal, I guess we're left with hanging chad in the biotech industry.

Posted by Bruce Lehr Mar 26th 2012.

 

Supreme Court Screwing Up 30 Years of Patent Law

According to Kevin Noonan, writer of the Patent Docs blog, the Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories 'ignore(s) thirty years of Federal Circuit precedent in favor of its [own] decisions from thirty, sixty or over a hundred years ago." 

Noonan continues that the court is creating a problem for American innovation as it is making the granting of patents in the life sciences area uncertain -- which hurts patent holders and dissuades investors. Most observers have understood for some time the danger of "imposing horse-and-buggy thinking about technology to the 21st Century" -- everyone except the supreme Court apparently.

The Court seems to have taken more of a "we'll know it is a patent-eligible subject matter" when we see it approach.  This has the danger of being both arbitrary and unpredictable -- neither of which is good for the funding environment in an industry and its ultimate success if funding is a key factor - which certainly is the case for biotechnology.

So if there weren't enough assaults on the industry's health from a regulatory perspective, we've now added legal/IP uncertainty as well to make doubly sure investors think twice before plunking their money down.

By the way, from my practical point of view, it seems to be good that Prometheus was rejected.  But in reading various attorney's take on the matter, it seems the Court is not paying attention to precedent in a predictable way in the patent arena.  We're going to have to watch closely where this goes and how the patent attorney's respond to the Court's less than clear meanderings on "what is patentable".

Posted by Bruce Lehr Mar 23rd 2012.  

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.  

 

Ireland Hitting Patent Cliff Too

We hear a lot about various companies in the pharma industry who are nearing their own patent cliff -- where some of their highest selling drugs are reachign the end of their patent life and where they don't have a lot new in their pipeline to replace the revenue that will be lost.  That's a theme that's been discussed ad nauseum for several year now.

But have you ever thought of a country having a patent cliff?  That's something that Ireland may be facing as 5 of the top drugs manufactured in the country are coming off patent altogether or losing protection in the US.  See PharmaGossip.

The drugs in question include (drum roll):

• Pfizer's Lipitor & Enbrel
• Takeda's Actos
• Merck's Singulair
• Lilly's Zyprexa

All are about to experience big revenue drops -- CLUNK!

Posted by Bruce Lehr Feb 27th 2012

 

 

Shhh! My Bioproduction Processes are Secret

Mass High Tech today picked up on a theme that is being increasingly bandied about now that biosimilars are becoming a reality in the US -- that being companies may eschew patents in favor of keeping intellectual property information as 'trade secrets'.

The concept is that biosimlars rely much more on production processes as a critical feature to produce the reference molecule -- which a biosimilar maker would like to be able to match or certainly know about in detail.   Patents on processes typically can require disclosure of detailed information that would make "copying" the process or more to the point designing around its patent claims more easily accomplished.  

Trade secrets on the other hand -- are well -- secret.  There is no public disclosure and if you keep your mouth shut (your company's collective mouth shut), you can keep the secret for an eternity in theory.  Patents of course have a finite lifespan of 20 years.

The upshot is that many innovator (or biobetter) companies may now be concluding that to protect themsleves from the expected biosimilar onslaught, they should simply stay quiet on their processes. The "don't ask don't tell" version of the biosimilar world.

Posted by Bruce Lehr Feb 16th 2012.

More on Relative Value of Patents for Bio Drugs in a Biosimilar World

More from the Patent Doc blog on why biologic drug producers in the future will stay away from patents and rely more on trade secrets to protect their interests. The Biologics Price Competition and Innovation Act of 2009 (particularly the litigation provisions) contains incentives for biologic drug innovators not to rely on patents to protect these drugs and the return on investment.  A recent analysis also showed that patent protection provides (on average) about one additional year (~327 days) of exclusivity past the end of the 12-year exclusivity provided by the BPCIA. So statutory protection is about equivalent with patent protection and the former can be accomplished through much less information disclosure on one's biological drug.

The blog post below talks about using trade secret approach more in late stages of development for process related steps like cell line optmization -- that generally doesn't benefit from patent protection.  This would make it harder on a follower to try to copy a bio-drug.

...the expected de-emphasis on patent protection for later-stage development (including regulatory approval) can be expected to change the relative importance of patents in the two stages.  Such de-emphasis will also change where the valuation in biologic drugs may lie, because there will be a relatively greater advantage in optimizing cell lines and other process parameters (which even today rarely benefit from patenting) than in patents on the biologic drugs per se. 

So less emphasis on composition of matter and more emphasis on the process. The author further concludes that "the future will be different than the past regarding biologic drug development and efforts to obtain the benefits of biologic drug development at a reduced price."

Posted by Bruce Lehr Dec 26th 2011.

Bio-drug Innovators Eschew Patents in Future to Block Biosimilars?

Here's interesting post from the Patent Doc Blog that argues that there are incentives for producers of innovator drugs to NOT file patents to block information access to biosimilars producers in the future.

The writer argues that instead of filing patents innovator drug producers could file the bare minimum information with the FDA to get their drug approved.  Because biologic drugs are so complex, this degree of stealth would prevent knowledge flow to biosimilar producers who wanted to copy their drug. Thus, the innovator would not disclose the cell used to produce the drug, or any optimization of that cell line.

The bloggist argues that this would produce obstacles for the biosimilar follower and would also avoid litigation under the biosimilars statute. The innovator could thus avoid protracted biosimilar patent infringement lawsuits. 

It is an interesting post.  But if non-filing is this easy, why doesn't someone do it now? It would save time and money.  It may protect from a biosimilar follower but does it protect from a fellow innovator?

Posted by Bruce Lehr Dec 20th 2011.

Continued Intrigue in AMP v USPTO with Certiorari Petition

The Patent Doc blog reports that the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PubPat) have filed a certiorari petition with the Supreme Court in connection with two issues connected to the AMP v USPTO (Myriad) case.

The two issues at question? 

1. Are human genes patentable?
2. Did the court of appeals err in ruling that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights still lack standing to challenge those patents if  they haven't been personally and directly threatened with an infringement action?

The Patent blog writers say that "it is clear that plaintiffs (ACLU and PubPat) are interested in not only reducing the scope of patent eligibility (no genes) but in expanding the scope of declaratory judgment jurisdiction, so that members of the public affected by a patent but not threatened by suit would have standing." 

The authors continue, "In many ways, this argument is much more threatening to an effective patent regime in this country, since garnering Supreme Court agreement would make the recent spate of patent litigation look benign.  For example, if every consumer who purchases a patented product had standing to challenge the patent."

I'll be following this thorugh the Patent Doc blog and suggest you do the same if interested in this case and its implications.

 

 

Posted by Bruce Lehr Dec 12th 2011. 

 

 

Irreconcilable Differences: Lilly & Amylin Divorce

Breaking up is hard to do.

Irreconcilable Differences: Lilly & Amylin Divorce // Pharmalot.

In this case, apparently not as Lilly and Amylin part ways in their diabetes efforts with the drugs Bydureon and Byetta -- which Amylin will take control of after giving Lilly some cash. Amlylin will pay Lilly $250 million now and a 15 percent royalty on global sales until a $1.2 billion note has been repaid to Lilly.

The split ends a long partnership that unravelled after Lilly signed a deal with Boehringer Ingelheim to jointly develop and sell several diabetes compounds that are in mid- and late-stage development -- and compete with Amylin's drugs. 

What do they say about fury and a partner scorned?

Posted by Bruce Lehr Nov 11, 2011.  

Novartis, A Gleevec Patent & India

In follow up to the previous post, the Pharmalot blog published an interview with Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northwestern University School of Law, and a member of Health Gap, Global Access Project. Dr. Baker explains sequence of events in the case and why advocates on both sides have latched onto it.

Novartis, A Gleevec Patent & India: Baker Explains // Pharmalot.

The Indian Supreme Court postponed its hearing this week. The case will establish patentability for changes to existing drugs, define "enhanced efficacy", set rules for evergreening and will likely have important implications to generic manufacturers and drug availability and pricing in India.

That's all.

Posted by Bruce Lehr Sep 7th 2011.

 

Novartis Patent Dispute In India Heats Up

Pharmagossip and Pharmalot below both provide coverage of an avidly watched patent case playing out before India's Supreme Court. Novartis is challenging an Indian patent office ruling that its new crystalline salt form of the cancer drug Gleevec is not patent eligible as it provides "little enhanced efficacy". 

Novartis Patent Dispute In India Heats Up // Pharmalot.

The case is important to the innovator Pharma industry, Generic producers, patient advocates and Indian health policy makers as it is effectively establishing the rules for "evergreening" by setting the standard for "enhanced efficacy". 

Novartis argues that by not granting a patent for this improvment, it (and other innovators) lose any incentive to create "new" drugs.  Patient advocates fear that allowing small changes to result in increased patent protection "up to 20 years", i.e. evergreening, will drive up medicines to unaffordable rates for the poor and gut the generics industry. Novartis' drug is a cancer drug but this same concept might be applied to AIDs medicines for example.

Thus, the case is heavily in the spotlight.  For the moment, we'll have to wait on the ruling as one of the Justices recused himself and the hearing schedule for this week was postponed.

 

 

 

 

 

Posted by Bruce Lehr Sep 7th 2011.

In AMP v. USPTO - Looks Like What We Got Here Is A Failure to Adjudicate

The Patent Doc blog related that Wake Forest Law Professor Simone Rose charges [in The Huffington Post]  that the Federal Circuit court failed in its duty as "keeper of the Constitution" in rendering its decision in AMP v. USPTO. Specifically, Professor Rose takes issue with the Court allowing the BRCA gene sequences (or any gene sequences) to be patentable subject matter instead of "patent-ineligible products of nature". 

Dr. Rose argues the court erred in its analysis by allowing chemical differences between native genes and isolated DNA sequences to be the primary criterion versus looking at the more important biological identity function of the gene sequences.

Going further, Professor Rose also argues that the Court erred in failing to balance the effects of exclusive rights granted under a patent with providing broader rights of accesss to basic knowledge as required under the Patent Clause in the Constitution.  She claims that granting patent rights to genes prevents access to these basic research tools during the term of the patent and blocks progress in direct violation of the clause.

Finally, Professor Rose believes that had the Court properly invalidated the BRCA patents then the Congress would have been highly motivated to look at the proper legislative framework to govern the matter of gene patenting or not. And hopes that then, the environment would be set for "an appropriate legislative dialogue" to balance access and innovation. 

 

 

Posted by Bruce Lehr Aug 23rd 2011.

India "Floodgates" Poised on Compulsory Licenses

The third Indian generic drug maker in the past year has filed for a compulsory license to make a patented drug in India.  This time it is Natco that wants to make Bayer's cancer therapeutic Nexavar.  Natco had approached Bayer for a license in December and was turned down.

Compulsory Licenses are controversial.  They come into play in developing countries that argue the cost of many life-saving medications for diseases like AIDs and cancers are way too expensive for most patients in these countries (e.g. India, Thailand, Brazil, S. Africa).  The generic producer says they can offer the medicines at a fraction of the cost if they had the license.  Of course they can as they did not pay any of the discovery and development costs for these medicines. Innovator (brand name) drug producers are, needless to say, very mus opposed to compulsory licenses and say their imposition will remove financial incentives to find these innovative medicines.  

The Natco case will be closely watched.  If it is granted a compulsory license, then many Indian generic producers may also be encouraged to apply as well openign the floodgates potentially in India.  That won't do much for the marketing of innovative drugs in India in my view, nor will it be much help to multi-nationals who may be seeking to develop more business in countries like India to help cover revenue losses they may be experiencing in other parts of their portfolios due to patent expirations.  So much perhaps for developing markets serving as new growth engines. See Pharmalot.

 

 

 

Posted by Bruce Lehr Aug 4th 2011.

 

Myriad Prevails Over "Magic Microscope" in AMP v. USPTO

Here's more detailed analysis of the Federal Circuit decision from Firday in the Association for Molecular Pathology v. US Patent and Trademark Office (the Myriad case) from the Patent Doc blog. As usual, read the actual  blog post for all the nitty-gritty details and insightful analysis, I will recoount only the essence.

The majority opinion reminded parties in the case that the Supreme Court had established a test for product of nature and a human-made invention:

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition's identity compared with what exists in nature.  Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given "markedly different," or "distinctive," characteristics.

In its opinion, the court concluded that isolated DNA molecules meet the definition of human invention under this test, and based its conclusion on the chemistry of isolated DNA:

It is undisputed that Myriad's claimed isolated DNAs exist in a distinctive chemical form -- as distinctive chemical molecules -- from DNAs in the human body, i.e., native DNA.  Native DNA exists in the body as one of forty-six large, contiguous DNA molecules.  Each DNA molecule is itself an integral part of a larger structural complex, a chromosome.  In each chromosome, the DNA molecule is packaged around histone proteins into a structure called chromatin, which in turn is packaged into the chromosomal structure.

Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene.  Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule....Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA

In rendering the opinion, the Court also rejected the "product of nature" argument and the government's "magic microscope" argument.  The Court said the District Court erred when it did not consider "the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit." 

The 'magic microscope" is out because "it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities."  The ability to visualize a DNA molecule through a microscope when it is bonded to other genetic material is "worlds apart from possessing an isolated DNA molecule that is in hand in usable. It's the difference between knowledge of nature and reducing a portion of nature to concrete form."  The latter being patent eligible.

Finally, the Court said the patents have been granted to isolated DNA sequences for 30 years and the invention community needs to be able to rely on these expectations. Congress needs to put further exceptions or limitations in place to include DNA sequences under "products of nature", if that is what it wants, and not the Courts.

 
Posted by Bruce Lehr Aug 2nd 2011.

 

 

Stem Cell Suit Effects May be Felt for Years

Here's an interesting post/commentary from Nature News on the aftermath of the suit that sought to prevent the NIH from funding embryonic stem cell work.  Even though for now, the court seems to have made it very clear that NIH can fund embryonic stem cells science -- the damage may have been done. The temporary injunction and resulting legal turmoil caused some scientists to leave the field permanently.

"Things have changed permanently. It's not just going to go back to the way it was — not immediately," says Meri Firpo, who researches stem-cell therapies at the University of Minnesota Stem Cell Institute in Minneapolis. 

Candace Kerr, a stem-cell scientist at the Institute for Cell Engineering at Johns Hopkins University had NIH funding for human embryonic stem-cell work at the time of the shutdown, but has since moved entirely to work with induced pluripotent stem cells. She has no plans for future studies on human embryonic stem cells. "The shock of what happened last year, coming out of nowhere, makes us really sceptical about moving forward," says Kerr.

Scepticism appears to be a rational response. Three presidential administrations had interpreted the Dickey-Wicker amendment to permit funding for research on lines of human embryonic stem cells, but not for the creation of such lines, which requires destruction of embryos. In 2001, President Bush restricted the funding to research involving a small number of existing lines. President Obama, lifted this restriction in 2009, prompting the approval of dozens of new stem-cell lines.  Then the suit by opponents of the research which resulted in a temporary stoppage of work pending resolution of the legal issues.

Last week, constrained by the appeals-court decision, the orignal trial Judge Lamberth rejected the plaintiff's lawsuit. His written opinion attacked all of the plaintiffs' key arguments, finding that the Dickey–Wicker amendment's wording is "ambiguous" and that the NIH's interpretation that it allows funding of human embryonic stem-cell research is "reasonable". 

Nonetheless, human embryonic stem-cell research remains vulnerable. The current US Congress is so politically divided it is unlikely to enact a law either explicitly permitting or explicitly prohibiting government funding for the research. And, nothing in this decision and nothing in the Dickey–Wicker amendment stops a new president from quashing research simply by refusing to fund it.

There you have it: a victory for proponents of embryonic stem cell research.  Or is it?  With the continued environment of uncertainty, will enough researchers commit to developing the field's potential — or will they be put off by the lawsuit's lingering shadow?  That's the lingering question.

Posted by Bruce Lehr Aug 2nd 2011.

Court Rules on AMP vs USPTO (i.e. Myriad) Case

The Federal Court has spoken on AMP vs USPTO.

In an extensive and thorough opinion by Judge Lourie, the Court affirmed the District Court's decision on standing, reversed the decision regarding isolated DNA claims (i.e. allows patenting of isolated DNA sequences), and affirmed the decision of unpatentability for method claims reciting merely "comparison" steps, on the grounds that these claims failed the machine or transformation test from Bilski.

Judge Moore wrote a separate concurring opinion, explaining her decision to join Judge Lourie (with regard to the isolated genomic DNA claims) on the grounds that, at this late date it is up to Congress, not the courts, to extend the "laws of nature" exception to isolated DNA.

From my reading of the various legal opinions on this case, this is the result that has been expected since the very moment Judge Sweet made his original ruling in the case. See the Patent Docs blog.

Posed by Bruce Lehr July 29th 2011.

Stem Cell Suit Over -- For Now

The U.S. District Court for the District of Columbia Chief Judge Royce Lamberth agreed with the with the appeals court’s finding that NIH can interpret Dickey-Wicker to allow funding for research on human embryonic stem cells but not on their derivation because the definition of “research” in the law is ambiguous.

So for now, the suit contesting NIH funding of embryonic stem cell research is out.

PharmTech Talk » Stem Cell Suit Tossed.

Stem cell researchers, their supporters in and out of the science community, and patient advocacy groups are all letting out a sigh of relief. Stephanie Sutter, Assistant to the President and Deputy Senior Advisor, posted yesterday in her blog “For too long, patients and families have suffered from debilitating, incurable diseases and we know that stem cell research offers hope to millions of Americans across the country. President Obama is committed to supporting responsible stem cell research and today’s ruling was another step in the right direction.”

This does not prevent another appeal by plaintiffs.  Ain't the legal system grand?  We may not have heard the end of this for awhile.  Of course, if we do not pass a Federal budget, the NIH may not be funding anything.

Posted by Bruce Lehr July 29th 2011.

J&J at Odds with Hep C Partners?

Fierce Biotech reported yesterday that J&J's partner, Medivir, on a late stage hep C therapy, called TMC435, is upset with J&J's promotion of Vertex Pharmaceutical's newly approved hep C therapy - Incivek.  It seems J&J's sales force woudl be representing both products to the same use community of prescribing physicians.  Medivir CEO Ron Long says he can't see how this won't result in conflicts of interest.

"They have to resolve that issue," Long said, "You can't use best eforts if you are prioritizing one drug over the other.  I think their positon is unsustainable and I've told them so."

This seems freakishly similar to the back and forth we've been seeing between Lilly and Amylin over Lilly's plans to promote both Amylin's and Boehringer's diabetes treatments to the same user base.  That one has resulted in Amylin's filing suit against Lilly.  I wonder how common these type of issues are going to become with Big Pharma buying up molecules from biotech's -- apparently from the same therapeutic areas. 

 

 

Posted by Bruce Lehr July 14th 2011.