Facts, Perhaps the Antidote to the Anti-gene Patenting Plague

    By Kevin E. Noonan --

It is apparent that the facts are often at risk or ignored by opponents of gene patenting.  Indeed, the various forms of fact-twisting or outright falsehood ("corporations own your genes") suggests that it isn't facts that are at issue but opinions, and how the public's opinion on gene patenting is to be best manipulated to oppose the practice.

One example (of the very many) of this phenomenon came to us in a reader comment to our post, "Huffington Post Provides Latest Ant-gene Patenting Soapbox" last week.  Our commenter writes:

While the errors throughout her "editorial" are too numerous to recount, her discussion of African sleeping sickness deserves special recognition.  She writes "In 1990 Sanofi-Aventis developed the drug Ornidyl (eflornithine) which is safe and effective against trypanosomiasis but it was withdrawn from the market in 1995 because few poor subSaharan sufferers could afford it.  Ornidyl can no longer be bought for love or money but Aventis, and later, Bristol-Myers Squibb, began to market eflornithine to the West as Vaniqa, a prescription-only facial depilatory."

First, Orindyl for sleeping sickness she mentions above is eflornithine via intravenous injection, while the eflornithine currently marketed as Vaniqua is formulated as a topical creme.  This is a major difference she conveniently overlooks.  And much more importantly, her claim that the drug is unavailable is completely false.  "In 2001, Aventis (now Sanofi-Aventis) and the WHO formed a five-year partnership, during which more than 320,000 vials of pentamidine, over 420,000 vials of melarsoprol, and over 200,000 bottles of eflornithine were produced by Sanofi-Aventis, to be given to the WHO and distributed by the association Médecins sans Frontières (also known as Doctors Without Borders) in countries where the sleeping sickness is endemic ... From 2001 (when production was restarted) through 2006, 14 million diagnoses were made.  This greatly contributed to stemming the spread of sleeping sickness, and to saving nearly 110,000 lives.  This changed the epidemiological profile of the disease, meaning that eliminating it altogether can now be envisaged.[9]  . . .  The positive results of the 2001-2006 partnership between Sanofi-Aventis and the WHO in the fight against sleeping sickness motivated and justified the decision taken by the Sanofi-Aventis Group's senior management to continue supporting the WHO at the same level for another five years, 2006-2011," citing "IFPMA Health Initiatives: Sleeping Sickness."

I guess I must concede that Ms. Washington's point may actually have been accurate, as eflornithine really is not avialable for "love or money" since Sanofi, WHO and MSF have collaborated to make it available for free.  All this information is available at Wikipedia or the Sanofi website http://en.sanofi-aventis.com/binaries/brochure_aam_en_tcm28-18133.pdf.

(Quoted citations from Wikipedia, see, http://en.wikipedia.org/wiki/Eflornithine).

In addition, our commenter states Ms. Washington "is wrong that there is only [one] drug for HCV, with a 20% cure rate (she is off on both points)."  Again quoting from Wikipedia (with references to supporting scientific journal articles; http://en.wikipedia.org/wiki/Hepatitis_C#Treatment):

Current treatment is a combination of Pegylated interferon-alpha-2a or Pegylated interferon-alpha-2b (brand names Pegasys or PEG-Intron) and the antiviral drug ribavirin for a period of 24 or 48 weeks, depending on hepatitis C virus genotype.

Pegylated interferon-alpha-2a plus ribavirin may increase sustained virological response among patients with chronic hepatitis C as compared to pegylated interferon-alpha-2b plus ribavirin according to a systematic review of randomized controlled trials.  (Awad et al., (2009). "Peginterferon alpha-2a is associated with higher sustained virological response than peginterferon alfa-2b in chronic hepatitis C: Systematic review of randomized trials.".  Hepatology (Baltimore, Md.) 51 (4): 1176–84. doi:20187106. PMID 20187106).  The relative benefit increase was 14.6%.  For patients at similar risk to those in this study (41.0% had sustained virological response when not treated with pegylated interferon alpha 2a plus ribavirin), this leads to an absolute benefit increase of 6%. 16.7 patients must be treated for one to benefit ( number needed to treat = 16.7. click here to adjust these results for patients at higher or lower risk of sustained virological response).  However, this study's results may be biased due to uncertain temporality of association, selective dose response.

Treatment is generally recommended for patients with proven hepatitis C virus infection and persistently abnormal liver function tests.

Treatment during the acute infection phase has much higher success rates (greater than 90%) with a shorter duration of treatment; however, this must be balanced against the 15-40% chance of spontaneous clearance without treatment (see Acute Hepatitis C section above).

Those with low initial viral loads respond much better to treatment than those with higher viral loads (greater than 400,000 IU/mL).  Current combination therapy is usually supervised by physicians in the fields of gastroenterology, hepatology or infectious disease.

The treatment may be physically demanding, particularly for those with a prior history of drug or alcohol abuse.  It can qualify for temporary disability in some cases.  A substantial proportion of patients will experience a panoply of side effects ranging from a 'flu-like' syndrome (the most common, experienced for a few days after the weekly injection of interferon) to severe adverse events including anemia, cardiovascular events and psychiatric problems such as suicide or suicidal ideation.  The latter are exacerbated by the general physiological stress experienced by the patient.

Responses can vary by genotype.  (Approximately 80% of hepatitis C patients in the United States have genotype 1.  Genotype 4 is more common in the Middle East and Africa.)

Early virological response is typically not tested in non-genotype 1 patients, as the chances of attaining it are greater than 90%.  The mechanism of cure is not entirely clear, because even patients who appear to have a sustained virological response still have actively replicating virus in their liver and peripheral blood mononuclear cells.  (Castillo et al., (2006). "Hepatitis C virus replicates in the liver of patients who have a sustained response to antiviral treatment". Clin Infect Dis 43 (10): 1277–83. doi:10.1086/508198. PMID 17051492)

In the face of such consistent disinformation, it can be difficult to decide the most effective course for combating it.  However, some suggestions come to mine:

First, don't challenge the morality issue component, since it is generally hard if not impossible to change deeply-held moral beliefs (no matter how out of touch with reality).

Second, however, do challenge the flawed logic.  For example, using claims made in Ms. Washington's article, just because the National Health Service in Britain or a private insurance company in the U.S. won't pay for a test or a treatment doesn't mean the test is too expensive.  It means the payor has decided it can wait until the cost of the test goes down when the patent expires, and the patients denied the test be damned -- the bottom line is more important.

Third, while not necessarily convincing those whose minds are closed to information (aka, the facts), it is also good to use actual data, such as the limited numbers of patents granted to U.S. universities before enactment of the Bayh-Dole Act and the veritable flood of university patents thereafter.  The point is that the amount of basic research isn't what's different (after all, President Nixon started the "War on Cancer" in 1971 with increased funding for the NIH and NCI), but that universities now have ways to prevent predation from private businesses that would otherwise turn publicly-funded research into private investment without many of the advantages of the Bayh-Dole Act, including preference for U.S.-based licensees (i.e., jobs); royalty revenue to the universities to be used for teaching and further research; "march-in" rights in a case of a private licensee enacting a public harm by failing to commercialize an important invention (such as a cure or treatment of a disease, something that has never happened in the 30 years since the Act was passed); and the many milestones and other positive incentives on the patent right incorporated into licenses from universities because of the university's unique public service mission.  These facts turn the anti-corporate argument on its head, since by being able to protect its intellectual property, universities have real leverage for deciding how and by whom their technology is commercialize.  Coupled with the fact that, prior to Bayh-Dole, many of the predating companies were overseas or large international conglomerates, and that such technology piracy cost American jobs, there is a good argument that university patenting is good for society.

Finally, it is good to paint the picture of what would happen if these inventions could not be protected.  As has been argued here in the past, the patent system promotes disclosure and the advancement of the useful arts, i.e., technology.  Patents require disclosure to a degree not required by scientific journal articles and other sources, with "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention."  35 U.S.C. §112, first paragraph.  Since patents expire, this information can be used by anyone thereafter, and importantly, can be used as information even during the lifetime of the patent.  Thus, arguments that basic (as opposed to clinical for profit) genetic research is impeded by patenting is wrong, since the information (whether of a genetic sequence or the existence of a mutation) is not patented.  The public availability of this information, and the requirements as to its completeness, fulfill the Constitutional mandate that patenting "promote the progress" of the useful arts.

The alternative would be the antithesis of this reality, where there would be significant incentive not to disclose genetic and other information.  In situations where an invention is easy to "reverse engineer" (as for many mechanical inventions), this would not be a fruitful path to protect intellectual property.  For something as complicated as human genetics, the possibilities for being able to "hide" basic discoveries are greater and the consequences much more dire.  Ironically, universities would be the victims of this alternative, since the university's mission would not permit it to use trade secrets and other forms of undisclosed intellectual property protection.  The predictable result of this alternative would be to inhibit if not destroy the university-company partnership that has promoted the biotechnology industry for a generation, to society's benefit.  Perhaps new diagnostics and treatments would arise "eventually" under such an alternative reality, but not as rapidly as in the past.  Thus, the counter-argument for the "anti" groups is that they are (in philosophy or as a consequence of their vision of morality) anti-science, anti-progress, anti-better diagnostics, and anti-treatment.  If this argument is effectively made, it's hard to see how the public would prefer the "eventually" world their position would produce.

Comments

[EG]

Kevin,

Facts are definitely the antidote, provided the "Kook-Aid" drinking as evidenced by Ms. Washington's article stops. Also, let's not forget the other important point I made on the other thread as what will happen if patenting becomes too difficult on biotech: making it more difficult for American biotech/pharma to grow/invest capital which means loss of (or failure to create) American jobs. American job loss/failure to create jobs is the important economic reality here, and is one even the politicians understand (and SCOTUS unfortunately is clueless about). The jobs issue is also one I've yet to see those so anti-gene patent respond to and especially factually address how not protecting biotech will foster/avoid loss of jobs. May be the answer is they can't.

[Geoff Karny]

I hope this person also posted this comment on the Huffington Post. Same for everyone else who took issue with the many factual errors/outright misrepresentations in the article, including you Kevin. We patent professionals need to get our views on gene patenting out to the general public and counter the errors when and where they are first made.

[6]

"the patent system promotes disclosure and the advancement of the useful arts, i.e., technology."

See Kev, I think you're going to have problems at this point. Most people wouldn't consider a string of DNA from their body sans junk to really be "technology".

I'm still curious about your personal role in the chilling effect that gene patenting has promoted.

Overall though, a great article about how the lady may have been off on her facts by a bit.

"Finally, it is good to paint the picture of what would happen if these inventions could not be protected."

Companies might be compelled to come up with the best actual technology based on these "inventions"? I'm not really sure where you think you're going with this.

"Patents require disclosure to a degree not required by scientific journal articles and other sources,"

Indeed, in my art I all too often come up against NPL references that are on simplified embodiments that demonstrate a certain concept that is meant to be applied to a somewhat more complex embodiment that couldn't (or simply wasn't bothered with, or there was some other reason to simplify the demonstration, like testing etc) be made in their humble laboratory. It is helpful when they explicitly say "oh and btw, you should totally use this in the more complex embodiment, I'm telling you this because you're not one of ordinary skill and it wasn't apparent to you why I did this experiment in the first place".

"The alternative would be the antithesis of this reality, where there would be significant incentive not to disclose genetic and other information."

Hmmm, kind of like in Myriad's case where a competing research group published one week after Myriad filed? Sure Kev. You're totally convincing on that point.

[6]

Facts, also, is facts. Two students just bested the multi-billion dollar bio industry. How did they do this? They engaged in a bit of that useful arts tomfoolery that the bio industry is loath to do and turned a salad spinner into a centrifuge. Which, to be honest, I had kind of thought had already been done, but apparently hadn't.

http://shine.yahoo.com/channel/health/salad-spinner-centrifuge-a-cheap-ingenious-health-care-tool-2019637/

To be 100% honest, I see plenty of opportunity in the bio industry for straight up useful arts rather than trying to patent abstractions.

[Skeptical]

6,

Would that be the "new" useful arts as described by the majority in Bilski, or the 18th century useful arts as described by the minority in Bilski?

[6]

"Would that be the "new" useful arts as described by the majority in Bilski, or the 18th century useful arts as described by the minority in Bilski?"

I think you mean the "new" useful arts as described by a 4 person minority in Bilski opposing the 18th century useful arts as described by another 4 person minority in Bilski. Scalia just couldn't seem to make up his mind on that issue.