Public Health is a Mess Because Governments are Obstructing Innovation in Nutrition

By Urvashi Bhagat
October 11, 2019

Nutrition businesses need major innovation that can only come with realignment of financial incentives, such as limited exclusivity granted by patents, but governments around the world are obstructing innovation in nutrition.

nutrition - istock photoExperts agree that public health issues in the United States are not being solved despite an abundance of highly trained personnel, remarkable facilities, and access to the newest drugs and technologies. Instead, health care costs keep rising as the technology advances. Experts also agree that “improving American nutrition would make the biggest impact on our health care.” A significant part of the problem is that governments are more likely to grant patents to drugs, devices, and treatments over nutrition innovations, making treatments more financially rewarding than prevention and increasing the disease burden and health care costs.

Though there is no restriction against nutritional inventions in most patent laws, in practice the patent system favors drugs, devices, and treatments over nutritional solutions.  Further, when nutritional patents are granted, they are severely restricted, such as to a narrow formulation or to fortification of foods with certain nutrients for certain use.

Innovation Obstruction in Nutrition Causes Chaos

The U.S. and European patent offices each have developed their own methods of obstructing innovation in nutrition. The presumption is that nutritional solutions are already inherent in nutrition. However, under the doctrine of inherency, the prior art must necessarily function as claimed and there must not be opposite teachings in the art for the claimed solution to be considered obvious. Therefore, when other objections cannot be applied to significant nutritional innovation, the U.S. Patent and Trademark Office resorts to the “patent-ineligibility” objection under Section 101 of the U.S. patent law, whereas the European Patent Office resorts to the “added matter” objection. In reality, these objections are applied to force applicants into a restricted position. The holdings of these two offices are copied by other patent offices around the world.  In effect, governments around the world in collusion are obstructing innovation in nutrition.

This is creating chaos in the field of nutrition. Unlike drug companies, which rely upon high margins for success, afforded by the clear exclusivity of patents, food businesses rely upon volume for success because the restricted patents or sales rarely give them sufficient margins.

In order to drive volume, food businesses put out thousands of food products with their own spin on why their products are healthy, bombarding citizens with contradicting marketing messages and making it more difficult for them to practice good nutrition.

As it is, nutrition is exceptionally complex.  It involves an infinite number of interacting nutrients that affect our bodies in an infinite number of ways, including which genes are expressed and which ones are silenced.  Further, some nutrients are potent in micrograms and extremely difficult to monitor.  Furthermore, nutrients in food sources are highly unpredictable, based on geography, cultivation, and storage.  The problem is not so much the amount of food consumed, but the components of food and how it is prepared, which influences cravings and how much is consumed.  Above all that, nutrition has a delayed effect, in that it can take a decade or more for cause and effect to be known.

For example, take lipids, fatty acids like omega-6 and omega-3, and certain vitamins and phytochemicals. Scientists have taken decades to understand lipids and have gone back and forth on their guidance on lipids, and businesses have peddled thousands of lipid supplements, thoroughly confusing consumers. How do we expect consumers to understand and follow? The general public cannot self-configure nutrition and governments and food businesses make it harder for them, which reflects in the diet-related incidence of disease.

Tailored Nutritional Solutions are Needed

The solution is in tailoring nutrition for the public by age, gender, diet-type, and medical disposition; it is not in randomly fortifying products or selling thousands of “healthy” products, which create excesses and imbalances. Responsible businesses are needed to carry this out.

Tailored lipids alone are an inexpensive innovative solution to a large part of the problem, since imbalanced lipid intake is associated with almost all chronic diseases and hormonal issues.  Ninety million Americans are affected by diabetes and pre-diabetes, 1.6 million by annual cancer diagnoses, 54.4 million by arthritis, 26 million by asthma, and 80% of women suffer from hormonal imbalances; each of which can be abated with tailored lipids.

But tailoring nutrition requires immense capital.  For example, food businesses that typically employ an unskilled workforce will have to hire a highly skilled workforce despite thin margins, and these specialized food tailoring businesses will not be able to rely upon volume for viability.  It is difficult to attract investment in such a scenario.

The misalignment of financial incentives has created a bizarre system where the workforce for the foundation of health, i.e. nutrition, is highly unskilled but the healthcare workforce for correcting ill effects of bad nutrition is highly skilled.

Patents Nurture Innovation

The patent system has a vital role in this because the limited exclusivity provided by a patent can provide a higher price point (which will still be a fraction of drug prices), which would allow the specialized nutritional product platform employing a skilled workforce to be developed and implemented. These products can be subsidized for lower income groups in partnership with the governments. The most valuable asset of a nation is the health of its citizens,  incentivizing citizens’ health using patents is a good public policy.

Therefore, the foundation of health, i.e. nutrition needs innovation, and governments around the world must support it by creating a sufficiently protective legal environment to nurture such innovation.  The result: suffering from diseases and health care spending will decrease; productivity, per capita income, and tax income to the government will increase.  And we all win!

Image Source: istock.com 

The Author

Urvashi Bhagat

Urvashi Bhagat is the Founder, Chief Executive Officer, and Chairwoman of the Board of Asha Nutrition Sciences, Inc. Ms. Bhagat made groundbreaking discoveries in lipid metabolism and the role of lipids and other nutrients on the manifestation of infectious and chronic diseases and acute events. Since the foundation of Asha Nutrition Sciences in 2008. Prior to founding Asha Nutrition Sciences, Ms. Bhagat was the Founder and President of Health Care Solutions, a consulting firm that assisted companies with strategy and business development.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 27 Comments comments. Join the discussion.

  1. Pro Say October 11, 2019 11:56 am

    Thank you Urvashi for shining a bright light on a major health problem that most — including me until now — had little or no knowledge of or appreciation for.

    This battle for protection is a worthy one.

  2. Manjit Sandhu October 11, 2019 1:40 pm

    An eye opener.

  3. Urvashi Bhagat October 11, 2019 3:25 pm

    Indeed, it is a very serious problem. We hope that governments will take steps to properly support innovation in nutrition. We are doing our utmost to call their attention.

  4. Anon October 11, 2019 3:55 pm

    Under the rubrics of the Supreme Court, none of this is patent eligible as ALL ongoings are nothing more than the “natural law” of the body processing whatever it is that is being given to it. ALL utility, therefore, is “not by the hand of man,” but quite literally, is by the body of man (and therein, lacking the cognition that patent law requires to be in place for patent protection to be deserving.

    …. and while I — personally — am saying this with more than a little ‘tongue in cheek,’ it IS possible to have this view traced to a (admittedly) wooden interpretation of the Supreme Court 101 jurisprudence.

  5. Urvashi Bhagat October 11, 2019 4:48 pm

    Supreme Court may not understand all the issues. That’s why we have to call their attention to the issues.

  6. Anon October 11, 2019 6:17 pm

    Miss Bhagat,

    To the contrary, my point (a view that some would advance as sanctioned by the Supreme Court), would make false your foundation of:

    Though there is no restriction against nutritional inventions in most patent laws, in practice the patent system favors drugs, devices, and treatments over nutritional solutions.

    If – for argument’s sake – that view of Supreme Court jurisprudence is true, then your whole argument (vis a vis patents as a mechanism) crumbles to dust — with the ensuing point that you will simply be ignored (and “justifiably so” by those holding that view). Your message — no more how noble at End — won’t get off ‘ground zero’ for your aimed at Means.

    Note that q

  7. Anon October 11, 2019 6:26 pm

    — entered too quickly…

    Note that quite distinct from this view of “what patents are for,” I espouse a wide view (as mirroring the intent of Congress, as opposed to the intent of the Court) of patents for ANYTHING that pass two extremely low bars:

    The innovation can be expressed (by the innovator, not the Court) as at least fitting into one of the Statutory categories; and

    The innovation as claimed provides utility within the (US Sovereign’s wider choice than the Rest Of the World’s choice) Useful Arts.

    Clearly, health and nutrition fall within the Useful Arts.

    So while I may agree with your views (and agree APART from any desired Ends), there ARE those (and some, including me) that posit that the Court won’t listen otherwise (and even though it would make more sense both pragmatically and ‘politically’ for the Court to wield its own ‘Kavanaugh Scissors,’ it does appear that the only viable path in the near term is through Congress).

  8. Urvashi Bhagat October 11, 2019 6:55 pm

    Thank you for your helpful input. These articles are not the right place for legal arguments. Our legal position involves much more. Here we simply note that the way the patent system is working, or not working, it is causing problems in nutrition and making public dependent on drugs and devices.

  9. Benny October 14, 2019 10:29 am

    Does the author advocate patents like US8609158 ? I would struggle to find sufficient novelty in any natural food based nutrition plan to obtain a patent.

  10. Urvashi Bhagat October 14, 2019 11:39 am

    Whether or not something is patentable depends on the claims and requires reading through case history. Issues have been called to attention and links for reading are provided. With regard to novelty in natural food based plan, here’s a patented case https://patentimages.storage.googleapis.com/81/0e/e7/fba066447bb5c4/US10292958.pdf.

    We should read before we comment. Armchair lawyering is inappropriate. Also it is not always desirable to make legal arguments on such posts. Author does not wish to engage in legal arguments here.

  11. Benny October 14, 2019 12:14 pm

    Urvashi,
    I am in no position to engage in a legal argument, but I noticed that the original application for the patent you directed me to was the subject of much contention, the argument being that the claimed invention was a natural product (i. e, olive oil). Without passing judgement on the examiner’s position, it does highlight the problems of obtaining and enforcing patents of this kind.

  12. Urvashi Bhagat October 14, 2019 1:15 pm

    Benny,

    That is exactly the problem. Bright people like you don’t read. Read my letter to the US Congress, the link is in the article and I give it here again https://asha-nutrition.com/wp-content/uploads/2019/09/190811LetterToCongress_w_Annexes-compressed.pdf.

    Claimed invention is NOT a natural product. Moreover 55 claims were rejected under the pretense of natural product. Not only that Claim 102, 107 and 119 were rejected despite admitting that no natural product contains the claimed ratios.

    This is obstruction of innovation in nutrition by US government and unimaginable travesty of justice in the most advanced country in the world. Not to mention harming public health.

    There is no issue in obtaining and enforcing patents of this kind. The government HAS granted such patents before. See US Patent 7759507. The issue in our case is that claims are broad, but that is EXACTLY my point. The breadth is necessary to remove the chaos in nutrition. I said in my article above, restricted patents cause chaos and do not provide for financial incentives necessary to nurture major innovation in nutrition. USPTO forces restriction because they want to, not because they need to per law.

    Again I don’t want to hold a law class here. It is too time consuming to teach all the details.

  13. B October 15, 2019 1:54 am

    FYI, Ms. Bhagat’s 101 decision came out 1 day after the Berkheimer en banc denial, and conflicts with Berkheimer. Also, the PTAB and CAFC explicitly stated that they ignored several limitations.

    @ anon “Your message — no more how noble at End — won’t get off ‘ground zero’ for your aimed at Means.”

    I’ve looked at every single argument sent to the SCOTUS to address a 101 Alice/Mayo challenge. The Supreme Court didn’t care enough in any of them, BUT on petition for rehearing Ms. Bhagat uses the same question as Berkheimer. Also, because it is the only cert petition where the PTAB and CAFC FULLY ADMIT that they deliberately discounted several limitations, there is something different to consider.

    I’m crossing my fingers, but like you I don’t think the importance of the issue is important to the SCOTUS in the slightest.

  14. Urvashi Bhagat October 15, 2019 10:03 am

    “Importance of the issue” is SUPPOSED to be important to the SCOTUS. See Rule 11.

  15. B October 15, 2019 12:37 pm

    “Importance of the issue” is SUPPOSED to be important to the SCOTUS. See Rule 11.

    The Supreme Court’s decisions to take cert. must typically have political importance.

    For example, if a guy cut his girlfriend’s throat in an Arkansas trailer park, then converted to Islam while in prison in order to grow a beard and the prison system won’t let him — well, that’s a politically important enough topic. NOT KIDDING.

    Contrast due process rights for honest Americans at appellate courts – not important. In fact, the Supreme Court has refused to force a single appellate court to comply with 5th or 14th Amendment due process despite the last two decades of constant cert. petitions. Enemy combatants taken off the battlefield have more due process rights than a person before the Federal Circuit. Judges Hughes and Dyk violated the due process rights to American Axle by gathering their own evidence and making decisions based on issues not before them and that no one briefed. AA is screwed.

    This is not to make less of what the courts did to you. Just an explanation.

    The Supreme Court isn’t taking cert from anyone.

  16. Urvashi Bhagat October 15, 2019 1:57 pm

    THEN SUPREME COURT IS FAILING TO DO FOR AMERICANS WHAT IT HAS BEEN PUT IN PLACE TO DO.

    117 million people suffering from chronic diseases and 1+ million dying each year from the same, and 80% of women suffering from hormonal imbalances is NOT IMPORTANT enough for the Supreme Court, then what is the Supreme Court doing?

  17. anon October 15, 2019 2:05 pm

    B,

    To “piggy back” on the notion that the Supreme Court won’t take cert — when it is not in their interests, I will again take the tangent opportunity to advocate that we (the proverbially Royal We of Congress) should employ the Constitutional power provided to Congress of stripping the non-original jurisdiction of patent appeals from the Supreme Court, take the time to establish a new Article III specialty court (to stay in accord with Marbury, and have this court staffed with those judges interested in advancing innovation (and NOT having been trained as simians in a cage with a fire hose held by the Supreme Court).

  18. Urvashi Bhagat October 15, 2019 2:08 pm

    Supreme Court, Rule 11 states “A petition for a writ of certiorari to review a case… will be granted only upon a showing that the case is of such imperative public importance”. It does NOT say of “political importance.”

    SCOTUS has made itself into a political court, compromising itself.

  19. Benny October 15, 2019 2:11 pm

    Never mind the courts, the patent office is falling down on the job. On the other hand, nutritional advice, unlike synthetic drugs, are not really a matter for patent protection. You can’t really expect to sue doctors who provide nutritional advice for intellectual property theft on the basis of research which validates the advice. Also, I would think that most, if not all, doctors, would ignore the limitation of “ambient temperature” in the authors claims.

  20. Urvashi Bhagat October 15, 2019 2:47 pm

    Benny, you don’t appear to know how patents work. I recommend that you pick up a book on the subject. It is not possible to teach fundamentals on this platform.

    As I said before what matters is totality of the claim(s). Nutrition is patentable and protectable depending on what is in the claims. Also claims are written in alternatives, to protect broad and narrow coverage.

    You have missed the whole point, the less we make nutrition patentable, the more dependent on drugs we will be and the sicker we will be.

  21. Benny October 15, 2019 2:58 pm

    Urvashi,
    On the basis of your reply, I would draw the conclusion that the examiner of your original application also doesn’t appear to know how patents work, hence the persistent rejection. Which brings me back to my original point – the problems with the patent system are at the source, the USPTO, and not the courts.

  22. Urvashi Bhagat October 15, 2019 4:00 pm

    Benny,

    The answer is VERY complex.

    The Examiners apply rejections for many reasons, including that the patent office is a business. The longer they prosecute patent applications and the more patents they issue they more fees they collect. And the Examiners also get paid more if they get you to divide applications into more applications.

    So there are many reasons for them to give you fake rejections aside from genuine examination, the purpose of which is to ensure that there is a genuine innovation.

    The problems with the patent system are both at the USPTO and the courts. A very significant part of the problem is that they don’t understand that the way they are going about it, they are creating more problems for public health than solving.

  23. Anon October 15, 2019 5:10 pm

    Benny,

    Your statement of “On the other hand, nutritional advice, unlike synthetic drugs, are not really a matter for patent protection.” has no actual grounding in US law.

    You quickly look at :who to sue” and that is the wrong path to take. The correct path is the one that Congress laid out:
    1) Can the innovator put the innovation in terms of at least one of the statutory categories; and
    2) Does the innovation provide utility within the Useful Arts.

    Further, I can only imagine that you have been living in a cave for a very long time if you truly believe your statement of:

    brings me back to my original point – the problems with the patent system are at the source, the USPTO, and not the courts.

  24. Benny October 15, 2019 11:58 pm

    Anon,
    In the real world, the first questio an inventor asks is, can I recoup financial reward from my IP, and in the case of the patent under discussion, my guess would be… no. II could make money writing a book on nutrotion incorporating the non-copyrightable patent , though.

  25. Urvashi Bhagat October 16, 2019 4:18 am

    Benny,

    “can I recoup financial reward from my IP, and in the case of the patent under discussion, my guess would be… no.” You don’t know what you are talking about.

    We have also copyrighted the content of the patent separately from the patent.

  26. Anon October 16, 2019 8:15 am

    Benny,

    As usual, your writing shows a lack of appreciation of what patents are, what they are meant to protect, and instead merely (and meekly) accept the score from a broken scoreboard.

    I would posit that conversation along the lines that you provide is very much part of the problem rather than any part of a solution to that problem.

  27. Urvashi Bhagat October 18, 2019 10:23 am

    CALL UPON US PATENT LAWYERS FOR ACTION

    If governments get away with wrongdoing, then weakness is in the people. If American people wake up and say, “No you cannot make us dependent on drugs and devices like this. Innovate the foundation of our nutrition,” then there is no way that USPTO or the Federal Circuit or the Supreme Court can get in the way.

    For example, if 40,000 US patent lawyers (https://www.nytimes.com/2011/10/10/business/new-law-creates-demand-for-patent-specialists.html) descend upon the capitol in support of innovation in nutrition, then nothing can stand in the way.

    My company will pledge to donate 50% or more of the company’s profits to public service including subsidized nutrition for low-income groups for such support.

    Write to us at admin@asha-nutrition.

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