Denying Patents on Applications of Discoveries Puts Public Health at Risk

By Urvashi Bhagat
October 4, 2018

https://depositphotos.com/138905600/stock-photo-public-health-text-on-pocket.htmlIn the 90s my mother was handed a death sentence at 61, a diagnosis of Progressive Supranuclear Palsy. It debilitates motor functions, like walking, speaking, swallowing, and progresses fast.  Life expectancy after diagnosis is 7 years. Over the next few years she struggled to do simple tasks such as eating and passed away at 67.  We were shocked as there was no incidence of neural disease in our family.

In hindsight I can trace mother’s earliest symptoms, extremely sensitive teeth, breathing difficulty, and loss of balance to when she was in her 50s.  The prevalent dietary advice for prevention of chronic health diseases in 80s and 90s was low-fat, low omega-6 fatty acids, and high monounsaturated fatty acids and primarily olive oil intake.  Mother had adopted this advice because one of her brothers had died of heart disease at 48.

Troubled by mother’s case, I began researching lipids (fats, certain vitamins and phytochemicals) in early 2000s.  I was skilled in the field having majored in biology and chemistry.  Scientific and mainstream literature then overwhelmingly taught reduction in omega-6 and increase in omega-3 to achieve omega-6 to omega-3 ratio of 2:1 or less.  It isn’t just that they taught against excessive omega-6 but they taught extremely low omega-6 intake (e.g., less than 0.5% of calories or less than 1.11g/day for 2000 calories/day; see Landsin collaboration with US National Institutes of Health, Ann. N.Y. Acad. Sci. 2005;1055).  Such teachings are still prevalent.

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I made an important discovery in my own experiments: low dosage of omega-6 (e.g. less than 6 g/day for women) produced adverse health effects in live subjects, and when the dosage was increased at first the symptoms got worse, but after adjustment over few weeks at higher dosage of omega-6 (e.g. 11g/day for women) better health was achieved.  Applying this principle, I was able to ameliorate and sometimes reverse adverse symptoms of chronic disease (e.g., high cholesterol, diabetes, ALS, ADHD, asthma) in live subjects at higher dosage of omega-6 (e.g., greater than 5% of calories).

In my findings, omega-6 was the most important fatty acid for health; its dosage was critical, and omega-6 to omega-3 ratios higher than 4:1 were found effective in general, particularly for high antioxidants and phytochemicals consumers.  Current scientific research confirms my discoveries. It was now clear that my mother’s neural disease was associated with extreme deficiency of certain lipids including omega-6 due to erroneous the teachings in 80s and 90s

In fact, most chronic diseases are associated with imbalanced lipid intake, and 117 million Americans suffer from these diseases.  About $3 trillion annually is spent in US on treating those diseases.  Despite the criticality of lipids, clear solutions are not provided to the public.  Rather there is confusion and misinformation.

Education about lipids alone is not enough, because healthy dosages of the various lipids vary for different members of the family and are hard to obtain.  Lipid-rich foods such as oils and butters are unpredictable in lipid content. For example, omega-6 can be 6-80% in safflower oil and 2-20% in olive oil.  Even olives from same tree vary seasonally in lipid content.  Moreover, certain lipids are potent in micrograms, particularly from oils, because in concentrated state they are absorbed differently.

The problem has to be solved innovatively by providing pre-formulated tailored lipid dosages to the public.  This innovation will not only reduce the disease burden and healthcare costs but will also make further contributions by affecting downstream actions of others.  So, I founded Asha Nutrition Sciences in 2008 with the main product offering of packaged tailored lipid dosages using different lipid sources to control the lipid content, and filed for patents, because without patents we could not fund the effort. Patents are the lifeblood of innovation; without a patent there is simply no way to obtain the funding necessary to implement this complex innovation.

To be clear there is no statutory prohibition on nutrition patents.  The US statute of “patent eligibility” 35 USC § 101 simply states, “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

However, in practice the patent system severally restricts nutrition patents, such as to my innovation.

Because of such patent practice, lipid delivery fundamental to public health have not materially advanced since the invention of food oils approximately 6000 years ago.  Periodically, certain fatty acids (e.g., omega-3) or oils or low-fat teachings have been hailed, only to reverse a few years later.  To date random oils are randomly added to foods; no guidance is given that different batches of the oils can have significantly different lipid composition and that minor lipids components present in oils can be potent.  Oil making has advanced but delivery of oil for ingestion by subjects is still archaic.

Instead, the patent approval process favors patent grant to drugs, devices, and structurally altered molecules. Under the circumstances it is to be expected that prevention would not receive attention from medical practitioners. Additionally, structurally altered molecules (e.g. hydrogenated fats) favored by the patent practice have previously caused worldwide diseases for over 100 years.  Because the patent practice refuses to grant patents that solve the problem head-on, divergent mini-solutions are developed, which make things worse.

After nine years of costly legal proceedings the United States Patent Office denied the patent by misapplying the law.  The Court of Appeals for the Federal Circuit rubberstamped the Patent Office and issued an evasive non-precedential opinion—meaning this ruling does not apply to other cases.  The case is now appealed to the Supreme Court of the United States.

While I am frustrated with the Patent Office, and the Federal Circuit, the real problem is that the U.S. Supreme Court has given conflicting guidance on patent eligibility despite the clear and unambiguous terms of § 101. Thus, unless and until Congress steps in – and they should – innovators like me have no choice but to throw myself on the mercy of the Supreme Court and ask them to consider the magnitude of the harm their rulings have created.

During the nine years the patent application has been pending, 13.6 million Americans have died of associated chronic diseases.  While the Government denies any responsibility, I beg to differ. Advancement in the art must be the overriding constitutional standard, and where there would be a positive effect on society a patent must not be denied. Denying patents on such significant advances, which will not take place without patent protection, goes against everything the patent system is supposed to promote.

I trust that the Supreme Court will reverse the prior decisions and restore confidence that our legal system does indeed work!

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 11 Comments comments. Join the discussion.

  1. LazyCubicleMonkey October 7, 2018 3:24 pm

    “…without a patent there is simply no way to obtain the funding necessary to implement this complex innovation.”

    Is this referring to funding from investors? What about funding from non-profits?

  2. Enlightened October 7, 2018 5:49 pm

    Do you know of non-profits that would be willing to fund this? Do tell whom to contact?

  3. CW October 11, 2018 11:26 am

    “…without a patent there is simply no way to obtain the funding necessary to implement this complex innovation.”

    I hear this a lot in my practice. In addition to my 25 years practicing, I picked up an MS in Tech. Commercialization from UT a little bit ago.

    Often, inventors believe they need a patent to attract investors. This might be true in a few cases, but more than not, investors aren’t looking to a single patent. Some might not see it at first, but the most critical aspect of any venture is the Team, including a star CEO. One of the first things most VC’s I’ve met will do, is seek to replace the CEO almost immediately. Rob Adams gets to this in his book “A Good Hard Kick in the A$$”

    The main issue is creation of a sustainable competitive advantage, and often this comes in these types of arts from trade secrets associated with processes for making the products. Having advantageous supply chain agreements helps, and appropriate partnerships with other players. We consider also the level of barriers to entry for other competitors. Patents might help in some instances, but given the stats from the PTAB in the IPR proceedings, the question becomes one of how quickly can we generate revenue at a rate to pay everybody, including the drawn out legal reviews which are likely to occur.

    On the other hand, it is wise to choose one’s competition wisely, if what one is doing is small enough, it might not invite any legal resistance. Downside is, if it is small, you don’t make much money. Even the inventor of the water balloon filling invention who visits this site is aware, resistance can be expected even in small markets.

    A while back I patented a new molecule useful in skin care, the patent describes it fully, but, the trick was in the processing. Using conventional methods, low yields are afforded. Using an obscure catalyst X, doubled the yield. Perfect trade secret material !! That is, as long as nobody else figures it out….

    There was a time when obtaining a patent was a bit of a holy graile for new businesses, and it still is, in some cases. But in many cases also, a patent is of less value than many perceive, and might even be considered a liability inasmuch as its defense can be a money pit.

    With the right team and the remaining essential considerations, the importance of a patent in the grand scheme of a business is diminished. The bottom line is generating revenue, and for that to happen, sales must occur. I always recommend to my clients, “get out there and sell, sell, sell”. Commercial success can obviate 103’s sometimes but more importantly, money can get you momentum. The clients I’ve seen who’s ventures fail, are the ones who tell me they don’t want to sell product until after they have a patent granted. Looking back, I think that mindset was a mistake. Funding comes more often from sales, than from patent grants. Adams’ book is a good short read loaded with practical advice for anyone starting a venture.

  4. Enlightened October 12, 2018 1:47 pm

    @CW

    Yours is precisely the kind of thinking that has reduced the value of patents. Willingness to use and participate in patent system just to make money is root of the problem. Think deeply. Purpose of patents is not to make money, purpose of patents is to solve problems more than anything. The purpose is also to teach, but teaching without public benefit does not get a patent. For example, a method of creating public disorder is not patent eligible. § 103 has provisions for patent grant to critical unsolved problems, because solving problem, positive effect on society is the overriding constitutional standard, although parties lose sight of this.

    Further comments will not be responded to for scarcity of time.

  5. cw October 12, 2018 2:26 pm

    But, wait !! What ? I never wrote that the patent system is “just to make money”, did I ? The purpose of patents all of our’ great grandparents, even going back centuries !! The purpose of patents is well-known in the Legal Arts !! My understanding is that the patent statutes in the USA were enacted for the purpose of promoting advances in the useful arts. But…. patents are not necessary for promoting advances in the arts !! I can just go tell someone all about my special catalyst X, and if it is good enough, others will use it because it is an advance, otherwise, they won’t use it.

    Issues might arise when people try to mis-use a tool, such as a patent, or a screwdriver. Indeed, I can turn a phillips head screw using a flat head screwdriver if I am careful, but it doesn’t always work !

    I’ve had rotten luck snapping my fingers and having folks jump to my tune, and unfortunately my name isn’t Morgan or Rockefeller, and at some point, money becomes a consideration. I found if I couldn’t make any money, sometimes I’d resort to begging for it. I tried standing by the road with a sign, that wasn’t very good. I played my guitar on the street and did a little better. So, its all maybe an entertainment act, and choosing the correct audience might be key. The effectiveness of the begging process using a patent, or the prospect of maybe obtaining one, involves more considerations than the street singer.

    I was only sharing what I’ve learned over the years, and it is entirely possible I am wrong, and ignoring me comes cheap !. Or does it ?

    Rob Adams is an extremely successful VC, and a great teacher, he’s made a ton of money and advanced a lot of arts !! Most other VC’s and Angel investors know him, or of him and many have adopted what he has taught. He advanced the art of venture capitalism, without a patent !! He told me personally once that he whinces at inventors who try to be CEO’s and their first step is to get a new CEO, or they walk from any deal and move on to another. The fact is, new ideas and good ideas are a dime a dozen !! The key to success is in the Team. I”m not making this up !!

    Thank you for sharing your thoughts, I suggest to pick up Adams’ book !! It is ok if you don’t respond, I’m sure you’re very busy 🙂 take care, and good luck !!

  6. Enlightened October 13, 2018 11:15 am

    @CW

    At enormous opportunity cost (time wise) to me I respond…

    “But…. patents are not necessary for promoting advances in the arts !!”
    All problems are not equal, patents are necessary to solve some problems!!!

    “at some point, money becomes a consideration.”
    Yes to advance some arts resources and protected environment are required. Just like a corrugated tree guard is used to nurse a small tree plant. Patents help attract capital not necessarily from VCs but in strategic alliances from corporations, special interest groups etc. Consider that some advances may require extensive teaching, rising above the noise level… Without protected environment it does not make sense to put capital into the venture, like it does not make sense to plant a baby tree in the path of a herd of cattle.

    Not all reservations are about who is the CEO; you appear to be overly focused on that.

    “Success” is in the mind of the beholder. Rob Adams may well be admirable, but I have read many and admire many others.

  7. cw October 13, 2018 11:51 am

    Thanks. I don’t see how patents solve problems. In my experience, the solution to a particular problem might be rewardable via a patent, but I can’t think of a single problem a patent in and of iteself has ever solved, except for excluding unauthorized parties from making, using, selling what is claimed.

    As I alluded , the inventor has to be an entertainer if they are going to be commercially successful, and they have many audiences. Sales at the consumer level are admission tickets, and sales of IP rights is more akin to buying an interest in the artist or the venue itself. Before you sell the IP rights, it helps to have sold some admission tickets, since no investor wants to buy rights to an empty show. I have the IP on a few songs, that haven’t made it to the radio yet, hence its difficult for me to sell the IP to the songs, since potential investors have not been convinced anybody would pay to hear them. Against the backdrop of this, there are also a million other artists out there.

    Lots of analogies there.

    I don’t see where patents are necessary to solve problems, all the inventors I’ve seen, typically solve a problem prior to filing for a patent and in the spec they describe the problem and how it was solved by the invention.

    As re CEO’s, one has to be practical, superman and wonderwoman are fictional, in real life it is extremely rare for an inventor to also be a successful CEO, I’m not suggesting the absolute statement that it never happens, only that statistically it is almost extremely rare. One has to be practical about these things. Looking back, I’d say off the top of my head, maybe 3-5% of inventors would make a decent CEO. Rob Adams isn’t the sole source of this nugget, I only mentioned him b/c he doesn’t jerk around, is focused and gets straight to the nuts and bolts. He’s got a good book, and its relatively inexpensive.

    Health related inventions are difficult, you’ve got to typically deal with GAU 1600, and they’re not an easy unit. On top of that there are potential drug claims which FDA will come crashing in on the party with C&D letters. I obviously can’t comment on matters close to me but in the past I’ve observed some extremely intelligent inventors crash and burn, incinerating literally several millions of $$ by not heeding certain advice they were presented early on. I’ve also observed that having a patent, or even five patents does not guarantee one will attract investors
    , basis the other considerations I hinted at exists. One of them is the CEO aspect b/c in a presentation, an inventor/CEO tends to focus on things which isn’t relevant for commercial purposes, and the inventor types typically pause a silence when some very pertinent questions are asked by the investors, which instantly ends the show in the mind of the investor.

    I’d be careful with the corporations, the “not invented here” syndrome applies, and the fact that the officers are already guaranteed a paycheck next Friday means there’s no motivation for them to help anyone. Moreover, these companies have a tech pipeline and their R&D money is already spent for 3-5 years out. Even with an immediate “drop in” new technology, it can take quite some time for it to be adopted, those big ships by their nature are slow to make changes at the rudder.

    There’s a lot of good ideas and opportunity in these health / dietary supplement areas, but it takes a special team to pull it off, otherwise we’d see more of it. One example might be my bone health formula which stops osteopenia and restores bone density as measured by a DEXA scan to that of a teenager in about a year’s time. Given what I now know, I wouldn’t in a million years attempt to advance this art using that formula given the current regulatory climate.

    As always, I recommend sell, sell, sell. (after protections are in place or pending). Sell tickets to your show, the more you pack the stadium, the greater will be your chance to sell the IP to the script and performance. Trying to sell the IP to the script and performance before any audience has bought tickets is a little bit on the tough side, although in theory nothing is impossible.

    I wouldn’t plant a sapling without first having some idea of the soil qualities, pH, mineral content etc. or having seen other saplings of the same species growing in the same area. There will always be cattle, and many other unexpected surprises, that’s what makes this sooooo much fun !!!!!!

  8. Enlightened October 13, 2018 12:12 pm

    @CW

    Your statement “I obviously can’t comment on matters close to me” is appropriate, just leave it at that. Everything else you say does not apply in this case.

    Good Bye!

  9. Enlightened October 15, 2018 12:34 pm

    Objective of patents in addition to solving problems is positive effect on society.

    “The authority of Congress is exercised in the hope that ‘[t]he productive effort thereby fostered will have a positive effect on society through the introduction of new products and processes of manufacture into the economy, and the emanations by way of increased employment and better lives for our citizens.”
    Diamond v. Chakrabarty, 447 U.S. 303, 307 (1980)

    One way patents bring positive effect on the society is by evening out the playing field with large corporations and investors who tend to invest in companies of their “types,” by giving owners of intellectual property (in exchange for sharing the applications of their discoveries) a limited period within which only they can practice the invention. That is an important point of “intellectual property,” that intellect has value, not just “might” as in “might is right,” and therefore employees of a corporation can benefit not just the heads of corporations and entrepreneurs having profiles different than the “types” a VC may prefer can benefit.

    Then to say that patents have no value, VCs invest in whom they want to, and that is how it is, is resignation to the wrong.

    In part value of patents is low because of the way patent office approves patents. For example,
    — Nutrition patents are severely restricted.
    — Prevention patents are disfavored.
    — Examiners are given points for generating more divisional applications, leading to backlog of applications and obstruction in implementation of innovation.

    The point of this article is that mini-patents don’t solve any problem. They create more chaos, and that the way patent practice disfavors patent grant to prevention, it is increasing the disease burden rather than reducing it. Some of the comments took off on tangents from the main points the attention was called to.

  10. Bud October 19, 2018 7:47 pm

    Urvashi,

    “35 USC § 101 simply states, ‘Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.’”

    Yes, and the CAFC wrote out “manufacture” and “composition of matter,” and replaced these terms with a vague standard of “invention” and “transformation.”

    You have my hopes and prayers, and I’ve been proud to support you before the Supreme Court.

    Bud

  11. Urvashi Bhagat October 20, 2018 12:10 pm

    Thank you Bud, your support restores my faith in humanity.

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