A rare point of consensus following the midterm elections is that Americans are adamant about lowering drug prices. Bipartisan pledges to seek common ground on this vexing issue suggest we might finally see action to make medicines more affordable.

What should this new common ground look like? Beyond important proposals like allowing drug importation or Medicare negotiation, policymakers should take a hard look at one of the key factors affecting market competition, transparency, and affordability: patents.

Patent abuse by drug makers is one of the most influential drivers of our pricing problem. U.S. law provides 20 years of patent exclusivity for inventions such as a new medicine — meaning two decades that a drug maker has monopoly power to develop a medicine and set prices however they wish. Even if it takes eight years to develop a medicine, that leaves 12 years for the drug to have market exclusivity.

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While rewarding invention is important, under the U.S. patent system those rewards have become inflated and unmerited as drug makers have developed defensive strategies that include overly broad patent claims and filing large numbers of follow-on or secondary patents to extend their monopolies. Patients are paying the price.

Diabetes provides a good snapshot of the problem. Approximately 7 million Americans rely on insulin to live. Surging insulin prices have gotten so out of hand that 1 in 4 Americans are rationing their own treatment, putting their lives in jeopardy and, in some cases, dying.

Without insurance, one five-pen carton of Lantus Solostar costs $280 at all major pharmacies in the U.S. The exact same branded — not generic — package costs about $50 in a leading diabetes clinic in Mexico.

Lantus, made by Sanofi, is the leading drug for people with type 1 diabetes. The company makes $15 million every day selling this type of insulin.

As shown in a new report from I-MAK, the organization I help direct, the price of Lantus jumped 18 percent each year from 2012-2016. During that time, U.S. taxpayers bought more than $22 billion worth of Lantus through Medicare and Medicaid. In fact, Lantus ranked number two for total overall expenditure in 2016 for both Medicare and Medicaid.

Lantus is also highly overpatented. Though Sanofi’s primary patents on Lantus expired in 2015, the company has filed 70 secondary patent applications in the U.S. — 95 percent of its total — since the drug was first approved and put on the market in 2000. If granted, these additional patents would give Sanofi monopoly protection for up to 37 more years — almost double the duration provided under U.S. law.

Why would a pharmaceutical company file so many patents after a drug is already on the market? Quite simply to preserve and extend its ability to keep competition at bay while hiking prices.

The company — which along with Eli Lilly and Novo Nordisk control nearly the entire U.S. insulin market — has further prevented insulin competition in America by pursuing litigation against two companies that want to offer cheaper biosimilars. (Biosimilars are the generic-like equivalents for complex molecules such as insulin and other biologic drugs.) Like overpatenting, this tactic works against the millions of Americans who must take insulin.

Putting two or more generics on the market has been shown to drastically reduce drug prices. In Europe and Japan, fewer patent applications and more friendly biosimilar regulatory requirements have led to multiple biosimilar competitors of Lantus, helping drive down prices and improve access to treatment.

Gestures like Sanofi’s recently expanded patient assistance programs offer savings to struggling patients. But Americans in need of treatment should not have to jump through hoops for medicine that ought to be affordable in the first place. Put another way, “I shouldn’t have to go beg for my insulin. It should be affordable to me,” Myranda Pierce, a graduate student at Boston University School of Medicine who has type 1 diabetes, told STAT.

Unfortunately, the mix of patent thickets, prolonged exclusivity, delayed competition, and jacked-up prices is typical of America’s best-selling medications. Overpatenting is so pervasive that a new report from the bipartisan Congressional Diabetes Caucus calls for outlawing “evergreening,” and also proposes other patent reforms because such practices block competition and prevent affordable generics from reaching Americans.

To get patent reform right, policymakers should not only stop evergreening and pay-for-delay agreements that keep generic alternatives off the market. They must also remember what’s at the core of a patent: invention. To deserve the title “patent” — and the reward of exclusivity that comes with it — a discovery must be truly inventive, not just an incremental improvement.

Unfortunately, the current patent system too often forgets the inventive part of patent law and hands out 20-year monopolies for “improvements” based on routinely practiced science — whether that’s putting three pills into one pill to improve adherence or making a slight adjustment to the dosage formulation, as Sanofi claimed in one of its later patents on Lantus. To provide real incentives to help companies usher in the next medical breakthroughs, we need to raise the bar for what is deemed inventive under patent law. If we don’t, we should no longer call it a patent system but a monopoly-handout-in-return-for-an-investment system.

As cited in the I-MAK report on Lantus, Erin Little, an entrepreneur in Kansas City, Mo., told T1International, “No one I know can afford this drug without assistance, and patient assistance programs, if you even qualify, eventually run out. I had to pay $1,000 for a month’s supply of Lantus before I found a way to get the same version in Mexico for just $100. It’s not right. Drug companies are squeezing us for every possible penny. It’s forcing people to ration drugs and putting lives at risk.”

Americans deserve better. That’s why Minnesota’s attorney general recently sued the big three insulin makers for price gouging the U.S., why the American Medical Association has called for federal interventions on insulin pricing, and why there’s a lot riding on the next Congress to rein in rising drug costs.

As part of the solution, patent reform can help boost competition and transparency and stop companies from dictating sticker-shock prices. There are too many stories of agonized patients struggling to afford treatment, forced to ration their medicine, and left to absorb the cost of high drug prices with their very own bodies.

Tahir Amin is the co-founder and co-executive director of I-MAK.org, a global nonprofit organization that works to lower drug prices.

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  • Overpriced? I just looked at prices on GoodRx on 18 Aug 2019. I calculated the average cash price for Lantus versus Basaglar, Tresiba and Levemir (the latter three on CVS Caremark formulary; 100 u/mL products only). I then calculated the per-unit cost of each: Tresiba: $0.35; Levemir: $0.32; Lantus: $0.19; Basaglar: $0.17. Based on these findings: Tresiba costs 84.2% more than Lantus; Levemir costs 68.4% more than Lantus; and Basaglar costs 10.52% less than Lantus (two cents less per unit).

    So, I’m not sure I understand why you are beating up on Sanofi for its pricing, when there are much more expensive insulins.

    Lantus has been on the market since the year 2000, so approaching twenty years, and is SAFE, especially when compared with some of the newer oral meds. It is so effective that it is used as the gold standard in FDA testing of novel insulin analogs.

    Go to GoodRx and read what patients are saying about Lantus versus its main U.S. competitor, Basaglar (the only other glargine). The average rating was 7.6 for Lantus and 2.4 for Basaglar, taking into account effectiveness and side effects. Major complaints about Basaglar among those who had been forcibly switched from Lantus were: higher fasting morning blood sugars; higher A1C tests; more unpleasant side effects; and unpredictable drug delivery system, with injector pen dosing too high/too low. (Hint: If a product costs 10 percent less, but is 30 percent less effective, how much will your final cost be? Do the math.)

    A 2009 law passed along with Obamacare allowed fast track approval of Basaglar via an abbreviated pathway. Prior to receiving FDA approval, Basaglar was tested in 369 Type 2 diabetics for only 24 weeks, of which only 205 were in the U.S. and its territories, and less than a third of that number were women (estimated to be about 66 U.S. women). This, despite diabetes drug testing guidelines saying that 1300-1500 and 500 patients should be exposed to a novel insulin analog for >= 12 months and >= 18 months, respectively.

    Eli Lilly’s own words state that Basaglar is a “completely novel insulin molecule (i.e., a new analog)”; it is NOT identical to Lantus.

    The medical literature has, since about 2012, been warning of allergic reactions to biosimilars (or “follow-ons,” as they are called in the U.S.), based on the fact that they are not identical to the innovator drug (see above sentence). According to a report of a severe hypersensitivity reaction to Basaglar in a patient who had previously taken Lantus (see PubMed Central archive), Eli Lilly’s initial testing showed a statistically significant number of detectable antibodies in the subgroup of patients who had previously been using Lantus (29 versus 11; P=0.006). However, by using testing loopholes (LOCF, etc.), it was able to ignore this, and use Sanofi’s Lantus test results. My worry is that there is a theoretical chance some patients could develop allergy to insulin glargine in general, leaving only the less effective, more expensive insulins available to them.

    Push Lantus out of the market, and we will be left with more expensive, less effective, potentially more dangerous alternatives.

    And if we punish companies like Sanofi by making them go bankrupt (after providing the world with safe, effective, LIFE-SAVING medication for the last twenty years), then only disreputable companies interested in making low quality products will fill the void. Be careful what you wish for. There has been a recent explosion of biosimilars in Asia, where testing is even less stringent than in the U.S. and Europe.

  • Enjoyed reading facts not fake reporting. I and so MANY MORE just Quit Participating, Listening, or Feeding into Fake Journalism.
    Hopefully we will start getting news that is unbiased accurate and Journalism gets back the “Good accurate” Name it once was Proud to represent.
    Money cannot buy Morals!

  • These articles defending Sanofi overpricing Lantus is BS. Sanofi is not an American company It’s world headquarters is in francs. It has a “US headquarters “ in the US and gets a patient to keep its drug price outrageous. When a new company creates a competitor version they merge with the original or the original buys out the new company thus allowing them to keep viciously overcharging for the product. Wonder what Lantus sells for in France?? Why should the US citizens pay the price for the world to research and develop drugs??

  • Criminal charges should be filed against the drug companies, their executives and the politicians who refuse to take action to protect the people they are supposed to represent. Token relief to citizrns that have to rekey on these medications to live is unacceptable

  • We can’t wait we need help right now. Not in 1, 2, or maybe 3 years while Congress drag their feet and do nothing like they are so famous for. Why should they care. They aren’t rationing and sick from lack of money for those thieving bastards drug companies. What’s the difference with them and some drug dealer on the street selling heroin. Drug companies can operate with the help of the Wealthy Republicans who have the money and power and heartlessness to steal from honest Americans BECAUSE THEY CAN and get away with it legally. They are killing the working class and all we can do is wait for these assholes from hell and go broke or die.

  • Suzann, you bring up a good point but it is a different issue. The fact remains that the original article is inaccurate in its claim that Sanofi has “extended” its IP protection on the original Lantus product through follow-on patents. The market is currently open to bioequivalents and in fact, one is already on the market. This is just one of several misleading claims in the article. If we want to advance progress toward lower drug prices we need to stop with misleading claims and work together based on facts.

  • Randall…”more government involvement with research & development”??? The same government that brought us FEMA, VA, TSA, etc. One of the major challenges companies face as they grow is size slows down the R&D process and hinders risk taking. Involving the bureaucracy of the Federal Government in R&D will destroy innovation.

  • These additional patents would give Sanofi monopoly protection for up to 37 more years.

    You seem to overlook that Sanofi in fact has lost its monopoly. Eli Lilly launched a copy of Lantus shortly after the expiration of the compound patent. Why omit such critical information from your article?

    • Lilly’s copy of Lantus costs as much as Lantus does (between $230 – $300 retail for 5 pens). So although Lilly has launched competition for Lantus, it has not helped the consumer at all.

  • If granted, these additional patents would give Sanofi monopoly protection for up to 37 more years — almost double the duration provided under U.S. law.

    No, it wouldn’t. Since the patent term was extended from 17 years to 20 years, the term begins from the date of filing. No patent that has currently been filed will still be in force more than 20 years from now. This article is full of baloney. There is no such thing as “overpatenting”. There are only valid patents and invalid patents. Sure, the patent office should deny all patents for stuff which is not new or useful. But let’s say I invent a new polymorph of insulin that doesn’t require refrigeration, should I not be allowed to get a patent on that? Or, a new dosage form of insulin that can be taken orally? I should be able to get patents on either of those and charge whatever I want. If you want to keep using the old stuff for which the patents have run out, that’s fine. But if I can’t get a patent on the new stuff, there won’t be any new stuff.

    • Mark,
      “Charge whatever I want”. Really Mark? Your philosophy is why we need more regulation on drug prices and more government involvement with research and development, so drug companies can’t hold advancements and therefore patients, hostage to their greed!

  • Drug pricing is a real issue which must be solved as patients should NEVER go without their medicines. However, misleading articles like this one do not lead to viable solutions. The article includes many misleading statements. There are many but I’ll mention just a couple here. 1) The article states “Even if it takes eight years to develop a medicine, that leaves 12 years for the drug to have market exclusivity.” In reality most drugs (Oncology excluded) take significantly more time to make it to the market (and billions of dollars of investments), leaving significantly less than 12 years to recover research costs and provide a reasonable return on investment, and 2) the article leads readers to believe that follow-on patents block the entry of generics, when in fact, they only protect the follow-on innovation and not the original product. Generics are able to enter the market immediately following the original patent expiry.

    Drug costs are too high. However, if we want to reduce prices while continuing to encourage innovation, we need to have a serious discussion on why those prices are so high. Solutions must be developed that lead to a) reduced discovery and development costs and b) a system to ensure research costs are recovered (with a reasonable return) at a more reasonable price point. Simply reducing the exclusivity period will lead to a) even higher prices (albeit over a shorter period) or a reduction in innovation.

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