The Big Red Biotech Blog

Latest Myriad Case Commentary

I like to keep info flowing on the Myriad ("gene patent") case as it percolates through the Supreme's toward a final decision.  This from Patent Docs blog yesterday summarizes some findings in a recent Nature Biotechnology paper as to the impact on existing patents -- and this effect is expected to be less impactful than it might have been 30 years ago.

Frankly, one wonders why this case is even going to court now.  Many of the diagnostic techniques being challenged are effectively obsolete (or soon will be) due to the fruits of the genome project and sequencing.  But there is some level of trepidation that a sweeping ruling with regard to "products of nature" by the Court could actually damage other fields of biotechnology.  That might cause harm to economic incentives for commercializing genetic technology, which in turn could lead to inhibited disclosure of knowledge to the detriment of progress in the industry.

And more to the point, any ruling in Myriad at this juncture is unlikely to alter the current access to diagnostic testing that the case was purportedly about.

Posted by Bruce Lehr May 16th 2013.

 

Related articles

The Myriad Case and "Gene" Patents: Much Ado about Nothing?

Myriad BRCA Test Cost is In-Line

This post from Patent Docs blog is self-explanatory.  Suffice it to say that any hoo-haw over the exhorbitant price of a BRCA diagnostic test at $3000 is -- shall we say overblown.  Assertions of this sort couldn't be more wrong-headed.  If you want to blame somebody on this front, it is likely more apt to blame a particular insurer for NOT covering the test cost. 

Posed by Bruce Lehr May 3rd 2013

 

Supremes Hear Oral Arguments in Myriad v. AMP? Or do they?

I've written about this before, but wouldn't it be nice if the arguments presented before the Supreme court in a potentially pivotal patent eligibility definition case like Myriad, actually contained discussions of science to illustrate the Law? 

We're trying to discern whether isolated DNA should be patent eligible or not.  OK.  Then why do we have to resort to analogies like if the DNA were a tree, sap from a tree, chocolate chip cookie, baseball bat, or a liver or kidney? Huh?  Why can't we discuss isolating and replicating a DNA sequence from say .... DNA?

I know we are science challenged as a Nation at least across the population as a whole -- but you'd think we'd have the ability to discuss the science and that Supreme Court justices could have access to ANY experts that they wished to explain basics to nuances of what was being presented.  I'm not arguing that arcane jargon should be the basis of oral arguments but can we do a bit better than comparisons to baseball bats and chocolate chip cookies?  See Patent Doc blog.

Posted by Bruce Lehr Apr 19th 2013.

PBS Newshour Covers Myriad v. AMP Oral Arguments with The Supremes

Here's video of from the PBS Newshour discussing the oral arguments presented before the Supreme court yesterday in the Myriad v. AMP "gene patent" case.  The link to the newshour comes courtesy of the Patent Doc blog -- authored by Kevin Noonan -- who also appeared in the Newshour segment. 

Posted by Bruce Lehr Apr 16th 2013.

 

Good Gene Patent Discussion

I'm a regular reader of the Patent Docs blog written by patent attorneys Kevin Noonan and Donald Zuhn. In a series of blogs this week, there was a good discussion of an article from the recent issue of Genome Medicine.  The thrust of the article was that patents were being allowed for genetic sequences that were so common in the whole genome, that the patent's broad claims could cover huge percentages of total genes (84%-100%).  This was deemed to have a potentially chilling effect on future research being blocked by potential patent infringement by the paper's authors.

You can read the series of posts discussing this topic here, here, here and here. 

Key comments that came out of the discussion from Patent Docs authors were that non-lawyers are frequently misinterpreting patent claims, i.e. misunderstanding what is actually claimed.  Also, commentators frequently give more credence than is due to a patent application versus an actual patent.  The latter being enforceable while the former is not. On the other hand, Patent Doc authors conceed that some claims are written to broadly in the attempt to extend clients' rights as far a permissible.  Unfortunately, many are so broad as to really run afoul of prior art and would never be allowed.  So author's agree that better claim construction would also help the situation.

Posted by Bruce Lehr Apr 12th 2013

Biosimilar State Legislation Score Card

The Pharmalot blog is doing a good job keeping us up to date on the legislative efforts of various States to put forth regulations on the interchangeability of biosimilars --- assuming any ever get approved by FDA in our lifetime. 

Maryland is the latest State to reject a law that would make substitution of a biosimilar harder, or allow a physician to prescribe and specifically prevent substitution. AZ, MI and WA states have also voted down such legislation. 

States that have accepted limits on biosimilar substitution include ND, VA and UT.  But Virginia and Utah have sunset provisions in their laws that would require them to pass updated legislation when FDA sets their final guidelines. 

Arkansas has a bill in committee. And nine other States have legislation that is expected to be considered by their lawmakers.  These include CA, CO, FL, IL, IN, MA, OR, PA and TX. 

Backers of these types of limitation bills include the Alliance for Safe Biologic Medicines, Amgen and Genentech who would like to protect their innovator franchises.  Opponents include generic manufacturer trade groups like the GPA -- who obviously would like to make and sell biosimilars as easily as possible.

I still tend to believe the economic incentives for health payers and governments favors allowing substitution and would expect this to eventually occur when we actually get some drugs on the market.  I think legislators ought to consider other types of tax incentives and credits for innovators to keep them doing their good work toward creating new products for the rest of us.

Posted by Bruce Lehr Apr 11th 2013.

April Fool - No Patent for Gleevec in India

Fierce Biotech also reports today that the Indian Supreme Court rejected Novartis' bid for a patent on its cancer drug Gleevec.  The court said the extended release form of Gleevec, which has never had an Indian patent, failed to meet a hurdle as a new subsance with increased efficacy. Effectively they ruled this represented an instance of "evergreening" by Novartis and rejected its application under section 3(d) of Indian Patent code.

Consumer advocates and biosimilar producers hailed the ruling as a victory to make this drug more available to the Indian populace.  Novartis said it the ruling provided heavy disincentives for it to invest in any more R&D work in India and implied it would think twice before marketing anything in India without patent protection secure in hand.

If this became a more generalized phenomenon experienced by other multi-national companies in India, will they as a group choose not to market some of their newer products there?  If so, does that mean India will be increasingly relegated to using older (and cheaper) versions of drugs that have had their IP expire effectively.  I'm not sure.  One could argue this would have a long term negative effect on what is offered for sale in India.  On the other hand, people can't use a drug they can't afford to buy in the first place, now can they?  This will be worth watching.

In the Fierce Biotech piece, it was also noted that the UK had passed some new tax provisions that will favor R&D investment in the UK -- effectively reducing tax rates on profits from patented products.  There is also an above the line tax credit of 10%.  The new provisions called the Patent Box were hailed by the BioIndustry Association (BIA) as being a new spur for R&D investment in the UK -- instead of a place like say India.

Investment may well swing back toward the UK, at India's expense for example.  But something like this to me is less likely to sway India R&D investment decisions, than the aforementioned patent ruling -- which in itself is less likely to effect R&D investment I think than it is to affect decisions on what products to actually introduce and market in India. That's just me.

Posted by Bruce Lehr Apr 1st 2013.

 

 

IPO Files Amicus Brief in Support of Myriad Genetics

The Patent Doc blog outlines the arguments in the Intellectual Property Owners (IPO) Association's recent brief filed in support of Myriad Genetics.  The brief asks the Supreme Court to affirm that isolated human DNA are patent-eligible. 

The brief very pointedly calls out that we are not debating "human gene patenting" but whether an "specific sequence of isolated human DNA" is patent-eligible. Quite simply, IPO argues that it is as it passes the "hand of man" test established by the Court under Chakrabarty.  Clearly, it is argued, the isolated DNA sequence is a product of human ingenuity, "having a distinctive name, character and use."

The brief also points out that despite claims to the contrary by those in opposition, there is no evidence that this patent has had any effect in slowing down the science aroudn the subject matter, brac1 and brac2 sequences.  In fact, there are at least 10,652 references in the scientific literature to publications around these sequences. Moreover, the number of new publications is growing each year and have done so even after the patent issued.

You should read the whole discussion yourself which covers other aspects as well in rebuttal to Petitioners arguments.  At the end of the blog post, it is revealed that one of the amicus brief's authors is Kevin Noonan of the Patent Docs blog.  I must say the amicus brief is written a lot more coherently than the one submitted by Myriad's lawyers in the case.

Posted by Bruce Lehr Mar 22nd 2013.

Pre-Emptive Strike by Biotechs Over Biosimilars Substitution

Biotech innovators score this time by backng a new law in Virginia that dictates rules for allowing interchangeability of biosimlars for the original biologic drug.  The legislatins requires tha FDA must have specifically deemed the biosimilar to be interchangeable with the prescribed biologic for the indication in question. Physicians will also have the authority to specify "Do not substitute."  FDA, of course, has not even approved ONE biosimilar yet.

Biotechs Get First State Victory Over Biosimilars // Pharmalot.

"The legislation properly preserves the physician-patient relationship, protects patients, maintains incentives for innovation, and promotes a competitive market for biologic therapies.  Furthermore, it is a model for legislation necessary in all 50 states to address vital drug safety measures that accompany this cutting-edge technology," in BIO issued statement.

BIO certainly is reflecting the opinion of its members.  This pre-emptive law will make substitution harder.  No doubt it will help protect member revenues.  It may protect patients (but not their wallets).  It won't make any 3rd party payers happy.  And it is all too reminiscent of the battles that went on when generics were first introduced.  Nobody thinks twice about substitution with generics now.

Posted by Bruce Lehr Mar 22nd 2013.

Myriad Flubs "Its Day in Court" with the Supremes

They did if you concur with the opinion of Kevin Noonan, author of the Patent Docs Blog.  According to him, their response in AMP v. Myriad Genetics will not stir the Supremes passions. 

He opines that Myriad should have made a point of "Emphasizing the negative consequences on progress and innovation of a decision in the ACLU's favor would have provided the Court with greater motivation to pause before taking a broad, sweeping and unnecessary position on where the balance should be struck on patenting isolated human DNA.  Myriad's brief gives the Court no basis for doing so."

And their lukewarm brief is likely to go down in defeat. The consequences may not be so good for those pursuing (or holding) gene patents.

Posted by Bruce Lehe Mar 12th 2013.

 

 

AbbVie Sues EMA Over Trial Data

If you had any doubt that Abbott, now Abbvie, was quite serious about legally protecting its trade secrets.  Think again.  AbbVie is suing the EMA to prevent possible sharing of its trial data in support of Humira.  Competitors, specifically UCB and InterMune, are seeking the data through a Freedom of Information filing.

Transparency? AbbVie Sues EMA Over Trial Data // Pharmalot.

The previous blog post similarly discusses Abbvie's Citizen Petition to the FDA over the same issue.  In that letter, AbbVie highlights that it believes that an FDA revelation of its Humira data would represent a breach under the Takings Clause of the Fifth Amendment.  If AbbVie is suing EMA above, it most certainly would pursue similar action if the FDA were to move toward sharing of its trade secrets with potential biosimilar filers. 

This is shaping up to be quite an interesting set of legal challenges.  I don't know if there is a good negotiated legal solution to be had here or not.  Presumably it would be very expensive as AbbVie is trying to protect its $9 B per year franchise in Humira.  That's a healthy compensatory amount at minimum for FTO permision.  See Fierce Biotech for more.

Posted by Bruce Lehr Mar 11th 2013.

WLF Backs Abbott's Citizen Petition to FDA on Biosimilars

Here's an update from the Patent Doc blog.  It details the Washington Legal Foundation (WLF) comments on Abbott's Citizen Petition to FDA regarding its policy on approval of biosimilars. Regular readers of this blog will have seen previously that Abbott asked the FDA to not share any of its BLA filing information on Humira or any other manufacturers filing on their drugs that were submitted to the agency prior to March 23, 2010 when looking to approve a biosimilar.  The March date being when BPCIA was enacted into law.

Abbott's argument is that to share the information with a competitor would constitute the government taking its valuable trade secrets, which Abbott had every right to expect would be held confidential when filed, without just compensation to Abbott.  This would constitute an infringment by the goverment of Abbott's rights under the Takings Clause in the Fifth Amendment.

In short, WLF agrees with Abbott. WLF says while the government has the right to enact biosimilar legislation in part to help reduce the costs of biological drugs which in turn might decrease the profits of innovators ...it doesn't have the right to do so by taking private property (e.g. taking information from a BLA filed before the biosimilar law existed).   On balance, WLF argues that such appropriation of private proprty is more harmful than any benefits one might see in having biosimilars on te market from such an action. Some companies should not bear a disproportionate burden of costs to benefit the public which should be borne by the public as a whole.

So far other groups have weighed in against Abbott as well. These include the Generic Pharmaceutical Association (GPhA), Therapeutic Proteins International LLC (biosimilar's manufacturer), and Zuckerman Spaeder LLP (litigation firm). 

We haven't heard the last of this.  I expect to see this in the Supreme Court someday.

Posted by Bruce Lehr Mar 8th 2013.

India Rejects Bayer Appeal On Compulsory License

India's Intellectual Property Appellate board rejected Bayer's appeal fighting a compulsory license to its drug Nexavar.  The license was granted last year to the generic manufacturer Natco when authorities determined that Nexavar cost to much for Indian consumers -- patents or no stinkin' patents.

India Rejects Bayer Appeal On Compulsory License // Pharmalot.

Needless to say, Bayer was not impressed.   “The order of the Intellectual Property Appellate Board weakens the international patent system and endangers pharmaceutical research,” the Bayer (BAY) spokesman writes.

Consumer advocates on the other hand were dancing in the streets.  “The decision confirms that the Indian patent office is able to use all the means legally at its disposal to check the abuse of patents and open up access to affordable versions of patented medicines,” says Leena Menghaney, the access to medicines campaign manager in India for Medicins Sans Frontierers, also known as Doctors Without Borders. “Most importantly, the decision means that the way has been paved for compulsory licenses to be issued on other drugs now patented in India and priced out of affordable reach.”

This can't be good news for multi-national pharma companies in India if the decision stands -- not unless they want to drop prices by 90%.  Ouch!  Certainly, there appear to be disincentives developing for Western companies to introduce new drugs to India if their patents are not to be respected. 

Posted by Bruce Lehr Mar 4th 2013.

India May Drop Compulsory Licenses Based On Price

Does it really matter?  It appears that India will no longer issue compulsory licenses to generic or biosimilar manufacturers to make a patented drug based solely on whether that patented drug's price is perceived to be too high.  Good news for the multi-nationals right?  They seem to think so.

India May Drop Compulsory Licenses Based On Price // Pharmalot.

Instead India has set up a new Committee to set pricing for patented drugs by comparing to prices negotiated between manufacturers and governments in US, Canada, France, Australia and New Zealand.  The thought seems to be this comparison will lead to higher prices than what consumer advocates in India would like to see but less than what pharma companies would charge on their own, but woud still be acceptable to these same companies.

But....the Committee would take per capita gross national income (GNI) and purchasing power parity in these countries into account.  The ratio of GNI in comparison country/GNI in Indiawould be calculated and used to adjust the price of the medicine for India from that of the comparison country.  This adjusted price would also serve potentially as the starting point for future reductions.

Ok. No compulsory licensing. Yes to a Pricing Committee.  What if they price products lower that what pharma is expecting?  Are we back where we were?

Posted by Bruce Lehr Mar 1st 2013.

Should Myriad Drop Its Gene Patent Challenge?

Nice article by the Patent Doc blog again.

The author, Kevin Noonan, argues (persuasivley for my money) that Myriad should drop its challenge before the Supreme Court as to whether genes should be patentable or not -- for the good of biotech generally.  The crux of the argument is as follows:

• The original gene patents are about 30 years old and were meant to protect therapeutic molecules like tPa or EPO.  These type of patents are fading fast.

Most new patent applications for genes were filed in or aroudn 2000 as a result of the Human Genome Project and these are limited in several important ways. 

• The applicant had to provide a utlity for the genes on the filing date to be patent eligible, not just file on the sequence
• Second, much of the HG sequence was published very soon after its discovery thereby akng it part of the prior art landscape
• Since most of these were filed in the 2000 time frame, they only have life until about 2020. Thus it is a self-liquidating problem if it indeed is a problem to begin with.

Noonan argues that Myriad shoudl drop its case before the Supreme Court.  They have other patents to protect their business.  Even if they didn't, they have 15 years of business experience and a proprietary database that is more valuable to them than the patents and ensures their market position fo rthis tye of diagnostic testing.  Plus, modern methods don't rely on isolation and sequencing of a gene anyway so aren't important. The Myriad gene patent doens't block anyone from doing research in the area either.

Bottom line: there is no compelling legal reason that we need this ruling.  And Myriad doesn't have any compelling business reason either.  Their other patent suite protects them.  So, Noonan argues that Myriad grant the plaintiff, Harry Ostrer a convenant not to sue. This renders the case moot and the Supremes will not hear nor rule on the issue. No ruling on the patent eligibility of isolated DNA from other species (which may have importance in fields like agriculture or biofuels) or other "products of nature" that may provide the basis for biologic and other types of drugs will be protected.

The only reason that Myriad would proceed now woudl be to gratify its own ego.  That could cause more damage than its worth.  Food for thought.

Posted by Bruce Lehr Jan 25th 2013.

 

 

 

 

States Are Crafting Biosimilar Laws

This is an intersting post from Pharmalot.  As we know, FDA has not approved any biosimilars yet and have not determined whether a biosimilar could be interchanged or substituted for the original biological.

Never Mind FDA, States Are Crafting Biosimilar Laws // Pharmalot.

Don't let that be a deterrent.  Six States so far -- including Illinois, Pennsylvania and Virginia -- are already crafting bills that would allow substitution or interchangeability (if FDA says OK).  Can't be left waiting in the gate can we?  This is what makes America great!

Posted by Bruce Lehr Jan 18th 2013.

WIPO Report says China Takes Lead in New Patent Apps

The Patent Doc blog summarized a new report from the World Intellectual Property Organization (WIPO) that shows world patent filings grew by 7.8% in 2011, and China reached the top as judged by number of patent applications filed.  Yes.  China's State Intellectual Property Office (SIPO) became the world's largest by new applications with 526,412, followed by USPTO with 503,582 and JPO (Japan) with 342,610. 

In the past 100 years, only 3 patent offices have ever led in the number of new applications -- those being US, Japan and Germany's Deutsches Patent and Marktnamt (DPMA).  In 2011, 2.14 M applications were filed worldwide and this is the first time the 2 million mark has been breached.

Finally, with respect to country of origin, residents of Japan filed the largest number of applications worldwide (472,417), followed by Chinese residents and then US residents. Digital communications apps grew fastast at 8.1%, and biotech apps grew by 3%, while pharma actually dropped by 1.6%.  So much for pharma R&D productivity! Japan also had the highest number of granted patents with 238,323 and was followed closely by the US with 224,505. Look for the Chinese to catch up here too in the near future.

Posted by Bruce Lehr Jan 17th 2013.

India's Government Targets Cancer Drugs

India's government has been rattling sabres for some time with regard to high priced drugs and compulsory licenses.  Now they will go after three more cancer drugs and their makers to force licenses.  The drugs are Roche's Herceptin (breast cancer), BMS' Ixabepilone chemotherapeutic agent, and Dasatinib for leukemia. 

Last year, the government forced Bayer to give a compulsory license for its Nexaver (kidney and liver disease).  The drug's price dropped by a whopping 95% in country after the generic maker Natco Pharma took a license.

This is all about the price Western companies charge in India for cancer meds.  Herceptin is priced at $1400 per month, Ixabepilone is similarly priced and Dasatinib is priced at $300 per month.  These are out of the reach of India's common man.

One enthusiastic oncologist was quoted , "It's a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European countries."

Said another patient advocate from the group Knowledge Ecology International, "Companies like Roche have cut prices of Herceptin in the past but the price cust has been a joke."

So there continues to be a strong backlash against western style pricing in emerging markets like India. This will no doubt result in companies having to re-evalute their competitive strategies in these markets -- and certainly will affect the profits they can expect.  The so-called pharmerging markets are fighting back more frequently now and may not be the panacea once supposed for Big Pharma struggling to gain new profits to make up for those that have gone over the "patent cliff".  India, for sure, is not cooperating so far. See Pharmalot.

Posted by Bruce Lehr Jan 15th 2013.

Maybe It's Just Me

When looking at all the fines that Big Pharma is absorbing -- primarily for violations of selling and marketing regulations around the world -- did you ever find yourself saying "ho-hum" business as usual.  Especially when the fines involved are much less than $1 B!  I do.

Just this week Pharmalot reported fines for Lilly ($29 M), Sanofi ($109 M) and Amgen ($762 M).  The Amgen is big enough for me to take more notice but the others -- "ho-hum".  That's kind of sad.

These pale next to some of the multi-billion dollar settlements we've seen in the past two years as well.

Posted by Bruce Lehr Dec 20th 2012.

Supreme Court to Review Myriad Case on "Gene Patent Eligibility"

Are human genes patentable?  That is the BIG question.

The US Supreme Court granted certiorari to petitioners to hear arguments in answer to this question, ostensibly by examing issues in the Myriad case.  There are many many (one could say myriad) petitioners from the ACLU, PubPat, and amici including academics, patients, doctors, and other advocacy groups opposed to gene patenting.

Myriad (the company) filed in opposition to the plaintiff's certiorari petition -- supporting patenting -- but obviously didn't prevent the case being heard.

US Supreme Court To Review Gene Patent Ruling // Pharmalot.

Myriad did however get its arguments on the record as to why the Supremes should not prevent genes being patented, and why the petitioners arguments are factually incorrect. For a really good discussion of the Myriad opposition filing see The Patent Docs blog. 

In addition to its many scientific, technical and legal arguments, Myriad also pointed out that "despite 30 years of isolated DNA patents, this case is the first and still only appellate decision to address the patent-eligibility of such compositions."  Always got to be a first time.  But, they further correctly state that many biotechnology companies have relied on precedent of standing DNA patents as important intellectual property protection that their investors rely upon to induce their financial participation in these companies.

Myriad argues the Court should not switch the rules of the game now, and that if a policy switch is to occur, it should emanate from the legislative policy-making process not by legal fiat. The Patent Doc blog author further advises that anyone with "skin in this game who sits on the sidelines should be ashamed."

Posted by Bruce Lehr Dec 3rd 2012.

New US PTO Performance Stats Report Out

Hey, I've got something for you Stat Junkies who like to review performance stats from various goverment agenices --  a new report from the Patents Doc Blog  -- that outlines the 2012 US PTO performance in processing patent applications. Wow!  Are you excited or what?

In a nutshell, the US PTO processed more patent applications in shorter times than their goals for 2012 called for and they improved across the board in all categories (see link above).  Some highlights include:

• Average first action pendency (21.9 months versus target of 22.6 months)
• Average total pendency (32.4 months versus target of 34.7 months)
• Patent applications filed electronically (97.1% versus target of 96.0%)
• Number of applications filed increased from 537,171 in FY 2011 to 565,566 in FY 2012 (5.3% increase in both years)
• Number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (4th consecutive year drop)
• Total number of pending applications also decreased, dropping from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.

For the next few years though, the sledding gets much tougher with respect to first action and total pendency.  For first action pendency, the annual performance target drops from 22.6 months for FY 2012 to 18.0 months for FY 2013 and 15.8 months for FY 2014, and for total pendency, the annual performance target drops from 34.7 months in FY 2012 to 30.1 months in FY 2013 and 26.1 months in FY 2014.

Mush PTO. Mush.

Posted by Bruce Lehr Nov 29th 2012.

Gang of 31 AG's Takes Pay-to-Delay to Supremes

Thirty-one State AG's have filed an amicus brief with the US Supreme Court in favor of ending pay-for-delay delas between pharma innovators and generic producers.  The AG's are backing the US Federal Trade Commission position that says these deals cost States and consumers dearly in increased healthcare costs. The FTC estimates the increased cost at approximately $3.5 B per year. The AMA has also come aroudn to support the FTC position.

31 States Urge Supremes To End Pay-To-Delay // Pharmalot.

Drug manufacturers say the deals are legal and that they actually get generic drugs to market faster than might be possible otherwise. In fact the GMA (generics trade group), says the deals have never stopped a drug getting to market beyond a product's patent expiration date -- and in many cases months or years sooner.

Opponents counter that the deals prevent patent challenges and thereby weaken the patent system by allowing marginal patents to stand.  This in turn allows holders of those patents to maintain a monopoly position witha drug longer than they might otherwise -- and this is anticompetitive.

So far, lower courts have sided both ways.  The 3rd, 6th and DC Circuits have generally ruled to make pay-for-delay harder, and the 2nd, 11th and Federal Circuits have made rulings more likely to allow pay-for-delay. Normally, the USD prefers to have law that is a bit more consistent across the land, so the Supreme court is being asked to review the issue. But will they hear the case and break the ties?  Hard to say.

Posted by Bruce Lehr Nov 15th 2012.

 

India: "Roche, Let Me Have that Patent Back!"

India continues it adminsitrative attack on drug makers' IP.  The Intellectual Property Appellate Board revoked the patent on Roche's Pegasys hepatitis C treatment.  Maybe they don't like flying horses? In fact, they didn't like Roche's patent extension from pegylating the drug and said it didn't enhance efficacy compared to existing treatments. This will open the door to cheaper generic alternatives in India.

India Revokes Patent On Roche Hepatitis C Drug // Pharmalot.

This is India's second override of a big pharma company's patent. Earlier this year, Bayer was forced to grant a compulsory license to Natco for Bayer's Nexavar cancer med.  In both cases, one of the main issues seems to be the perceived high price of the innovator medicine compared to what generics competitors would offer in the market.  This is a big deal to movers and shakers responsible for India's healthcare policy.

"This victory will facilitate early entry of generics which is likely to lower prices.  If this happens, millions suffering from hepatitis C, both in India and globally will benefit," said Anand Grover, senior counsel and director of Lawyers Collective HIV/AIDS Unit (a patient advocacy group).

Not only are we targeting lower prices in India but apparently for the World too!  A Roche spokesman retorted that the company remained "concerned that a policy of neglect for patent rules would inhibit research into future treatments." No Drugs for You, India.

Posted by Bruce Lehr Nov 6th 2012 - Get the Vote Out

 

Trade Secrets: A Biosimilars' Complication?

I saw a couple articles this week on the topic of how the FDA will handle review of biosimilars applications without revealing either the innovator's or the biosimilars applicant's trade secrets.  I don't suppose anyone considered this complex issue during passage of the Biologics Price Competition and Innovation Act (BPCIA).  How could they have? It probably took months to come up with the Act's name.

The possible revelation of trade secrets apears to be a real issue now that the hard work of implementing the Act is underway.  There seem to be a real prospect that the FDA will indeed overtly or inadvertently get drawn into the act of divulging company secrets -- in many instances through no fault of its own.

The prospects are most likely in revealing trade secrets around manufacturing processes.  The liklihood is enhanced as the FDA almost certainly must review these processes as a key part of determining the similarity of a an applicant to a reference drug.  In fact, many biosimilar applicants try to determine these processes so they can mimic them and hopefully enhance their chances of matching the original licensed product.

The FDA reveiw process might reveal trades secrets of either the originator or the applicant in several ways:

1. The BLA package is public and contains key documents from the originator drug.  There is even a prospect that other elements (like manufacturing processes) could be made public thorugh FOIA filings.
2. The FDA reviewers might inadvertently disclose innovator information to a biosimilar applicant during the review process.
3. Biosimilar applicants must provide a copy of their application to the innovator within 20 days of notification of acceptance by the FDA possbily putting the former's trade secrets at risk.
4. Biosimilar applicants mus explain why they do not infringe the innovator's patents or why their patents are invalid.  They may have to use their trade information to effectively make their case.

Thus, this new process has some possible bugs to be worked out. It remains to be seen whether the above issues will transpire or not. See Fierce Biotech.

Layer on top of this, Abbot's specific Citizen Petition filed with the FDA on the subject of biosimilars and trade secrets.  Abbott has asked the agency to acknowledge that it will NOT make information from Abbott's Humira BLA available to any biosimilar applicant and in fact will not make information from any BLA filed prior to the  BPCIA's paasage on March 23, 2010 available.

Their argument?  That by revealing its trade secrets, the FDA would violate the takings clause in the Fifth Amendment that requires just compensation -- and of course this information could be considered worth millions to billions.

On October 1st, the FDA responded to Abbott's citizen petition in writing (complying with the law to respond within 180 days of its receipt).  The FDA said the agency "has been unable to reach a decision on Abbott's petition because it raises complex issues requiring extensive review and analysis by Agency officials."  The FDA further stated it would respond to the petition as soon as it reaches a decision. 

In other words, "We're caught between a rock and hard place and we don't know what the hell to do or say.  Maybe if we don't say anything it will all go away like a bad dream." See Patent Doc blog.

Posted by Bruce Lehr Oct 25th 2012.

 

Indian Drugmakers Fight No Brand-Name Rule

Earlier this week, I described the India drug controller's, GN Singh, plan to prohibit the use of brand names in selling drugs.  This is an effort to promote generics' use to reach a greater portion of the population and to save money for the government.  I had the impression that it was aimed at the multi-nationals operating in India.

Indian Drugmakers To Fight Brand-Name Rule // Pharmalot.

However, the local Indian Drugs Manufacturer Association is the first to voice a vehement dissenting response to this concept.  They contend the controller has NO jurisdiction on the use of brand names and pledge to fight this legally if necessary.

"Just as you cannot tell a carmaker or a chocolate maker to stop branding their products, you cannot ask pharma companies to do away with branding their products," said Vinay Pinto, managing director of Wallace Pharma. 

Ironically, the trade association that represents foreign multi-nationals is taking more of a wait and see approach.  The government has indicated a desire to get comment on this proposal and the MNCs want to participate in that exercise first. This story has more to come.

Posted by Bruce Lehr Oct 19th 2012.