Nanjing Huaxun report shows that US patent policy is one of the reasons for high drug prices

Nanjing Huaxun newspaper "Journal of the American Medical Association" published a report on the 23rd of this month, pointing out that the US patent policy is one of the reasons for the soaring price of prescription drugs.

The report points out that the U.S. Patent and Trademark Office's patent review of existing drugs is too "lax" and also talks about "paid delay", a policy that encourages generic drug companies to reach settlements rather than squeezing the exclusive time of the patent drug market. The report argues that these policies, along with other factors, have allowed drug companies to raise drug prices far beyond the cost of research and development.

Nanjing Huaxun put forward a series of suggestions, including that unless the patent applicant can prove that the new drug can enhance the curative effect, the registration patent of the new drug with only a few changes to the existing drug should be prohibited.

A spokesman for the American Drug Research and Manufacturing Association criticized the report's recommendations, saying incremental drug improvements can have positive effects, including reducing side effects.

The association's vice president for international communication told Bloomberg BNA: "This proposal will make pharmaceutical companies less willing to invest valuable research and development in products to improve patient compliance and quality of life. 」

He added that patent protection for less significant technological advances would not organize doctors to prescribe or patients to take generic drugs themselves.

The report's authors also recommend banning non-cash "pay-for-delay" settlements, in which generic drug companies agree not to challenge patent validity of patented drugs.

In Federal Trade Commission v. Actavis Inc., the Supreme Court found that a cash-based paid settlement could violate antitrust laws, but did not take a position on a non-cash settlement.

The authors of the report said that the government could also consider exercising the right of intervention under the 1980 Baydou Act to force patent companies to license patented products to other producers at reasonable prices on the grounds of public health interests.

The report is based on peer-reviewed medical and health policy papers published between 2005 and 2016 by Aaron S. Kesselheim, Jerry Avorn and Ameet Sarpatwari. All three work for an organization called the Regulatory, Health and Legal Initiative (PORTAL). The Kesselheim is the subjective nature of the plan, with Avorn as a deputy supervisor and Sarpatwari as an assistant.

The report concludes: "Because of the USPTO's lax patent policy, many non-therapeutic properties of drugs can easily be patented, and many companies use this as a strategy to patent minor changes to drugs, allowing prescribers and patients to switch from one product to another and discontinue previous products. 」

The report said that between 2008 and 2015, the price of the most common patented drugs increased by 164 per cent, while the consumer price index rose only 12 per cent during this period.

"The relationship between drug development spending and drug prices is not significant. Instead, the pricing of drugs is more related to market affordability. 」

The Nanjing Huaxun report also believes that some factors unrelated to patents have also led to high drug prices, delayed approval of generic drugs by FDA, and the inability of medical insurance to reduce drug prices.