ICYMI: Three Things You Should Be Reading Today In The Push For Patent Reform & Lower Drug Price for Patients

IN CASE YOU MISSED IT: This week, the chorus of evidence and support for patent reform has grown even larger with three important news items that demonstrate both the extent of Big Pharma’s patent abuse and the much-needed relief that substantive patent reform will bring American patients.

  • Axios published the below article yesterday keying off a must-read Fortune piece that pulls back the curtain on how Big Pharma is abusing the patent system to prevent competition, maintain its drug monopolies and continue raising the cost of life saving medication, all at the expense of American patients.  Key Graph: “Hundreds of millions go to marketing and legal-fortress building, while innovation and scientific discovery — ostensibly the beating heart of the biopharmaceutical industry — is often imported from the outside.”
  • Today, Politico Pro shared the below analysis from the Congressional Budget Office that points to the widespread benefits of patent reform. Key Graph: U.S. Senators Richard Blumenthal (D-CT) and John Cornyn’s (R-TX) legislation to end product hopping and patent thickets “would lower federal spending by $507 million over 10 years.”
  • STAT News also published the following op-ed from the dean of the University of Missouri School of Law and breast cancer survivor, Professor Lyrissa Lidsky. Professor Lidsky’s piece notes the need for substantive patent reform to help ensure that women with breast cancer can afford the treatment they desperately need. Key Graph: “Fortunately, many members of Congress are putting forward ideas on how to lower drug prices and institute patent reform to prevent drug companies from strategically deploying patent lawsuits to block competition. I applaud these efforts, including those by Senator John Cornyn from my home state of Texas and Senator Josh Hawley from my adopted state of Missouri.”

These articles echo what CAPA has told lawmakers, and underscore the importance and urgency of reforming the patent system and preventing Big Pharma’s continued abuse of American patients.

“Big Pharma’s rampant abuse of the patent system is a primary cause of rising drug prices nationwide. With American patients paying more than citizens of other developed nations for the same prescription drugs, it is time for Congress to pass legislation that ends Big Pharma’s blatant and underhanded manipulation of our nation’s patent system.” CAPA’s Executive Director Matthew Lane

Below are links and the full text of the articles:

Vitals: 1 Big Thing: How Big Pharma works

Axios, July 22, 2019

By Sam Baker

Humira is the world’s most profitable drug, but it’s also a prime example of Big Pharma’s business model, as Sy Mukherjee lays out well in a big Fortune story.

The big picture: “These companies became like great big record labels: reliant on talent spotters going out and finding new artists,” SVB Leerink analyst Geoffrey Porges tells Fortune.

Details: AbbVie, which now sells Humira, did not invent the drug. It bought the smaller biotech that did.

  • Once it owned Humira, AbbVie protected it with a thicket of patents — roughly 136 of them, and it has aggressively sued to protect those patents. It has also raised its list prices every year and spent big on marketing.
  • And now, with Humira competition inevitably approaching, AbbVie is buying Allergan, where it will benefit from the lucrative market for Botox and other cosmetic products.

This is increasingly how the industry works.

  • Small biotechs patented two-thirds of the novel drugs the FDA approved last year; Big Pharma companies only developed one-quarter of them.
  • Most Big Pharma companies are expected to reduce their research and development budgets.

The bottom line, per Mukherjee: “Hundreds of millions go to marketing and legal-fortress building, while innovation and scientific discovery — ostensibly the beating heart of the biopharmaceutical industry — is often imported from the outside.”

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CBO: Cornyn Patent Bill Saves $500m

Politico Pro, July 23, 2019

By Sarah Owermohle

The measure to limit certain patent tactics by drugmakers would lower federal spending by $507 million over 10 years, the Congressional Budget Office estimated on Friday. With numbers like those, sponsor Sen. John Cornyn (R-Tex.) said, “there’s no reason” the Senate shouldn’t support the bill, S. 1416 (116).

… But while it passed the Judiciary committee unanimously, the legislation has also been dogged by criticism that Cornyn softened the section aimed at curbing patent thickets — stacking tens and even hundreds of patents up around a drug — under industry pressure. Another measure, to limit product hopping, a practice in which drugmakers push patients onto similar new therapies just as old products are running off patent, has been championed by co-sponsor Sen. Richard Blumenthal (D-Conn.) and was largely unchanged. CBO didn’t break down how much each section would feed savings, but said boosted generic and biosimilar competition would account for most of them.

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Patent Reform Is Needed To Protect Patients’ Access To Lifesaving Drugs

STAT News, July 23, 2019

By Lyrissa Lidsky

It’s no secret that the cost of prescription drugs is too high for many Americans to afford. Across the country, patients are struggling to access medicines they desperately need. In fact, we are charged, on average, significantly more than residents of other high-income countries for the same prescription drugs. These high prices are due in no small part to the ability of pharmaceutical companies to protect sometimes decades-long monopolies on their products. It’s past time for patent reform.

The painful reality that so many Americans experience was brought home to me this year by my own bout with breast cancer. I was diagnosed with Her2-positive breast cancer seven months ago. This type of cancer is aggressive, and was once among the most deadly forms of breast cancer. Now, thanks to groundbreaking biologic medicines like Herceptin, Her2-positive breast cancer, particularly in its early stages, is one of the more treatable forms of breast cancer. Herceptin, when combined with chemotherapy, has significantly increased the survival rate for women like me.

I’m incredibly fortunate to have had access to Herceptin and other lifesaving drugs and treatments. I have excellent insurance and access to top-notch medical care at the Siteman Cancer Center at Washington University in St. Louis. I am also blessed to have had an incredible network of support at the University of Missouri, where I now serve as dean of the law school. This powerful network helped me get through treatment and I am grateful to report I am now cancer free.

I want every woman with Her2-positive breast cancer to be as fortunate as I have been. But the high cost of biologic drugs like Herceptin, which is made by Genentech (a unit of Roche), is a significant hurdle for many. Herceptin costs about $9,600 per vial, and patients like me take it every three weeks for a year — that’s more than $150,000. And that doesn’t even count the costs of the other drugs or treatments we require.

Herceptin has been on the market since 1998. The many patents on it are set to expire this year. On June 13, the FDA hit a milestone by approving its 20th biosimilar — drugs that are akin to generic versions of biologic medications — for a Herceptin competitor. That makes five biosimilars for Herceptin (the generic name of all of these drugs is trastuzumab); the first of these was approved in 2017. That should be good news, but none of these biosimilars has been able to go to market because of ongoing litigation with Genentech about patents.

Herceptin is protected by numerous patents covering all aspects of its production, and Genentech has used them to sue competitors like Celltrion, alleging that its biosimilar infringes as many as 40 of Genentech’s patents. The effect of such litigation has been to help preserve Herceptin’s market dominance for more than 20 years — arguably going beyond the period necessary to reward Genentech’s undisputed innovation.

The good news is that some of the companies have settled their patent litigation and biosimilars might enter the market before the end of this year.

The entry of generics into the small-molecule market creates competition that can drastically reduce the prices of their reference products. An FDA study found that, on average, competition from generics reduce prices to just one-fifth of their monopoly price.

Competition from biosimilars should also reduce prices, though not as much as generic competition does because biosimilars are more expensive to develop than generics. Nonetheless, biosimilars should soon give more women with Her2-positive breast cancer more affordable access to this vital medication.

The entry into the market of biosimilar competitors to Herceptin should not have taken so long. Fortunately, many members of Congress are putting forward ideas on how to lower drug prices and institute patent reform to prevent drug companies from strategically deploying patent lawsuits to block competition. I applaud these efforts, including those by Senator John Cornyn from my home state of Texas and Senator Josh Hawley from my adopted state of Missouri.

I’m grateful that pharmaceutical companies continue to make discoveries like the one that saved my life. But Congress should pursue patent reform that puts patients first. Our lives are worth it.

Lyrissa Lidsky, J.D., is the dean of the University of Missouri School of Law.

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