Patent reform is needed to protect patients’ access to lifesaving drugs

By: Lyrissa Lidsky

From: statnews.com

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.