The Pitfall of American Patents
The willingness of the pharmaceutical industry to abuse the American patent system is having severe consequences on the patients. The cost of healthcare and prescription medications in America is much higher than in other countries. This is a direct result of big pharma abusing the American patent system. If Biosimilars and generic drugs were more readily available, the costs of healthcare would significantly decrease. Biosimilars are exactly the same as the drug with the brand name but another company distributes them once the patent has expired.
The issues are the tactics being used by big pharma to eliminate any competition. Patents are being accumulated by the big pharmaceutical companies to prevent patients from being able to purchase less expensive drugs. Generic drugs are constantly being delayed so they are not available on the market. The majority of the patents are being strategically used to ensure big pharma regains the monopoly for their discovery. Once the competition has been eliminated, Americans are forced to pay exorbitant prices for brand name drugs. All competition ceases to exist.
Big Pharma and Patent Abuse
Forest Laboratories is a good example because they produce a drug called Namenda. This drug treats the confusion linked to Alzheimer’s disease. In 2015, the company was facing competition from generics. The company did not agree to fair competition. Instead, they changed Namenda from a pill taken two times each day to a formulation changing the dosage to once a day. This enabled Forest Laboratories to get another patent that will not expire until 2029. This is a clear case of abusing the patent system.
The state of New York sued the company for its efforts to prevent patients from accessing a generic version. New York won and the company abandoned its efforts. The time for regulation is now because Americans can no longer trust big pharma. Big pharma is using the patent system to ensure its monopolies remain secure. They are creating new patents to replace the old ones. This enables them to capture the market. Since there is no competition, the price of drugs continues to rise. The average price increase in the United States for top-selling drugs since 2012 is 68 percent.
Targeting Increasing Drug Prices
The bad news is that big pharma has spent hundreds of millions on donations and lobbying. The good news is President Trump has targeted the increasing prices for drugs. Bipartisan legislation has been passed unanimously by the Judiciary Committee. The sponsors of the legislation were Senator Richard Blumenthal from Connecticut and Senator John Cornyn from Texas. They are trying to find a solution for the ways big pharma is abusing the American patent system to make even more money. This is the first step in preventing big pharma from circumventing the laws regarding patents.
The issues are the ways patent thickets are being used by the pharmaceutical companies to prevent both generic substitutions and competition. One of the most important aspects of the United States patent system is the (IPR) Inter Partes Review. The Appeal and Patent Trial Boards conduct this procedure within the United States Patent and Trademark Office. This tool is effective in locating invalid patents. The patent office has authority from the IPR to look at any questionable patents so they can be removed. They also remove patents that should never have been issued.
In many instances, overly broad patents are being granted to big pharma because the examiners did not have enough time to thoroughly review the application for a patent. The IPR helps make certain all patents in the market are valid. The only possible solution to the issue of increasing prices for prescription drugs in the United States is patent reform. The IPR and the patent process must be streamlined to challenge bad patents, encourage innovative patents and ensure generic medications are available for the patients.
Basic Research is Being Funded by American Taxpayers
Creating and marketing new drugs requires billions of dollars from taxpayers. According to the Los Angeles Times, the (NIH) National Institutes of Health has made investments in the biotechnology and pharmaceutical industries of nearly $90017 billion for applied and basic research since the 1930s. In spite of the investment of the taxpayers, the price of drugs in the United States is consistently increasing. A study was conducted in 2018 regarding the NIH.
The contributions they made for new drugs covered all of the 210 new drugs receiving approval from the FDA from 2010 through 2016. The NIH funded in excess of $100 billion for research indirectly or directly contributing to the approval of the 210 drugs for a period of six years. The most common grant for funding the science behind the new drugs was the (RO1) NIH Research Project Grant. Almost 118,00020 RO1 grants were provided for these drugs between 2010 and 2016.
Big Pharma and Federal Perks
Big pharma is benefiting from development and research tax credits. In 1981, the federal R&D tax credit was introduced. This encouraged investments in pioneering research by the private sector. The tax credit is for companies trying to technologically advanced, improve or develop new trade processes or advanced products. The Tax Hikes Act23 was signed into law by Barack Obama to protect Americans. The law not only ensured the tax credits became permanent but it also extended them to startup companies and small businesses.
A tax deduction is also received by big pharma for marketing and advertising expenses. The American Medical Association Journal published a report stating there was a substantial expansion in medical marketing from 1997 through 2016. Spending jumped from $17.7 to $29.9 billion. The most rapid growth was for advertising to consumers for health services and prescription drugs. The report additionally stated from 1997 through 2016 there was an increase in the number of ads from 79,000 in 1997 to 4.6 million by 2016. This included television commercials.
The Bottom Line
The abuse of patents by big pharma must be stopped. There are already too many individuals unable to afford their prescription medications. One of the worst culprits is insulin. Type 1 diabetics require insulin or they will die. The only answer is to prevent big pharma from blocking generic drugs on the market.