Drug patents have sprung a debate around how effective the patent system is in the United States. Drug makers want drug patent life to be extended while generic drug manufacturers want to reduce the lifespan of pharmaceutical drug patents. This article will cover how long drug patents last in the U.S, as well as other countries, such as Canada, the UK, and Australia. We will also cover the importance of drug patents.
Every year the pharmaceutical drug market gets rattled by the expiration of patents on blockbuster drugs and medications. When brand name drugs expire, this opens the door for generic substitutes to enter the market. That said, just because a patent on a brand name drug expires does not mean that a generic substitute will be immediately available, drug manufacturers use several methods to block generics from entering the market for as long as possible.
Before we dive in, let’s take a look at how long drug patents last in the U.S.
How Long Do Drug Patents Last For?
In the United States, attorneys often throw out the 20 year patent term without adding more detail. That said, Drug patents last for 20 years from your earliest patent filing date. For patents filed before June 8, 1995, the patent will last 20 years from the filing date or 17 years after the patent was issued, whichever is later. Source
This means that the 20 year term for drug patents does not start from the date the drug was brought to market, but rather from the date that the drug was invented and the drug patent application was filed.
Drug patents can easily take 8 to 10 years to be issued because of all the testing that the FDA (Food and Drug Administration) requires from the person or company filing for the drug patent.
Why do Drug Patents Take so Long in the United States?
Drug patents take so long because the FDA requires drug makers to conduct tests and experiments on human beings to test the drug’s efficacy and side effects. The more data the FDA requires, the longer the patent will take to be granted. While the drug is undergoing all of these trials and testing the 20 year patent clock is running.
Because pharmaceutical drugs take so long to be issued by the USPTO (United States Patent and Trademark Office), pharmaceutical companies are always looking for ways to extent the patent life of their top-selling drugs.
So, you might be asking yourself, why is it so important for pharmaceutical makers to extend the life of their patents? It’s important because they are business to make money and extending the patent term (patent life) of their top-selling medications means that they can make more money for a longer period of time.
Some criticize the U.S patent system for rewarding pharmaceutical manufacturers by granting them market exclusivity for long periods of time that enables them to recoup their research and development (R&D) expenses along with hefty profits.
That said, it may be easy to blame the U.S Government and the pharmaceutical makers’ lawyers for creating such a system, but the length of market exclusivity in the United States is what encourages so many companies to develop new, helpful drugs in the first place. Also, it’s what encourages them to introduce their treatments first in the United States. This is why drugs generally reach the U.S market more quickly than any other place on earth. So, is market exclusivity really a bad thing? That’s up to you to decide.
How Long do Drug Patents Last in Canada?
The law in Canada provides 20 years of drug patent protection that starts on the day a company files its drug patent application. The actual length of market exclusivity is between 8 to 10 years in Canada because of the extensive testing and regulatory hurdles that drug makers have to go through before bringing their pharmaceuticals to market. Source
In Canada, the government requires new drugs to undergo certain procedures that reduce the patent life of drugs. Such procedures include clinical trials, new drug reviews, and listing requirements with the Federal Canadian Government as well as Provincial Authorities.
Some argue that Canada may lose out on the next wave of lucrative pharmaceutical investments unless it develops a patent system that is on par with the U.S Patent System. Some suggest “restoring patent life” to offset the regulator delays that occur when introducing new pharmaceutical drugs to market. But, this view has been met with some criticism claiming that adding to the patent life of brand names drugs has the potential to raise generic drug prices for consumers and insurers alike.
That said, if Canada wants to encourage multinational drug companies to do business there, improving its intellectual property protections will definitely bring in more companies willing to invest their money and time in Canada.
How Long do Drug Patents Last in the UK?
UK Drug patents last for 20 years from the date of filing the patent application. To obtain a patent in the UK, you need to file your patent application at the UK Intellectual Property Office. Source
The UK Intellectual Property Office offers similar patent protection to inventors as is afforded by the United States Patent and Trademark Office.
How Long do Drug Patents Last in Australia?
In Australia, pharmaceutical drug patents last up to 25 years from the filing date of your application. The Australian Intellectual Property Office requires inventions to be new, non-obvious, and different from existing technology. Depending on the circumstances surrounding your invention and the protection you are seeking, examination of your patent may take between six months to several years. Source
Why is Drug Patent Life Important?
Drug patent life is important because the longer a patent on a specific drug, the longer time a manufacturer has market exclusivity. What this means is that a drug maker can sell the brand name drug for as long as possible to recoup its investment and profit from selling the drug.
If drug manufactures don’t have a long enough drug patent term, they will have spent enormous sums of money developing and testing their drug to get it approved and by the time they get to market, they wouldn’t have enough time to recoup their investment and profit from the hard work it took them to develop the drug.
Drugs makes a lot of money once they hit the market and millions of people depend on them. When the patent life on a brand name drug expires, generic manufacturers step in, engineer a new drug with a similar chemical composition and sell it at a much reduced cost. Once this happens, most people stop purchasing the brand name drug and opt to purchase the cheaper, generic alternative.
Although some may disagree with this statement, but protecting brand name drugs is important because it encourages large companies to invest their time and money in developing new drugs to treat the ever-growing number of ailments that we suffer from. Without decent patent protection, drug makers won’t be incentivised to invest their time and money in coming up with new cures.
When a company owns a patent for a drug, the drug is sold under a brand name. While the patent is in effect, doctors prescribe the brand name drug. This gives the brand name drug company a monopoly over the drug until the patent period ends. The long brand name drug companies have patents over the brand name drug, the longer before other companies can make generic versions to make them more affordable.
Some argue that the current patent term stifles lowering drug prices and making them more accessible to the masses, we disagree because if the brand name drug company wouldn’t have had to reason to develop and market the new drug, there wouldn’t be a cure at all. If you disagree, please feel free to leave us a comment on why you disagree.
Examples of Brand Name Drug Patents that Have Recently Expired
Here are some blockbuster brand name drugs that have patents that expired in the past year:
- Lyrica. In December of 2018 the patent on Lyrica was set to expire. Lyrica was developed by Pfizer to treat to for nerve and muscle pain. The drug made Pfizer $3.45 billion dollars in sales. Last time we checked, Pfizer was working on extending the patent and in November of 2018, it was able to extend the patent’s life to June 30th, 2019.
- Cialis. Cialis was approved in 2003 to treat erectile dysfunction. Cialis has been a major seller for Eli Lilly since its approval, however Cialis entered into a settlement with generic drug manufacturers to have its patent expire in September of 2018.
- Xolair. Novartis and Roche developed Xolair to treat allergic asthma and chronic idiopathic urtcarial. Their patent expired in 2018 but only after raking in hefty sales.
- Neulasta. Amgen developed Neulasta, which helps the body make more white blood cells after receiving cancer medication. The drug brought in $4 billion in sales for Amgen in 2014. Neulasta’s drug patent expired in 2015.
- Zytiga. Johnson & Johnson lost its patent on Zytiga it’s profitable prostate cancer therapy medication in 2018, opening the door for viable generics to compete.
What Factors Reduce Drug Patent Life?
The main factor that reduces drug patent life is that the 20 year patent clock starts ticking as soon as drug is invented and a patent application is filed with the USPTO. This means that pharma manufacturers lose time while they are seeking FDA approval for their drug while not being able to sell it for 7 to 10 years until they get approval.
This means that 10 out of they 20 years are lost while the FDA approves the drug, leaving 10 years for the drug makers to profit from their product. Some have considered legislation which would give drug makers 15 years to sell their drug from the date the drug becomes available in the market. That said, this is quite complicated and a lot of policy considerations have to be taken into account.
Currently, drug companies do whatever they can to extend the patent life of their drug to maximize their profits. Lets explore whether patent term restoration addresses this problem.
Drug Patent Term Restoration
To address the patent life that is lost while the FDA approves human drugs, Congress allowed patent term restoration. PTR (Patent Term Restoration) seeks to compensate drug makers for the time lost while the FDA approves their medication.
PTR allows drug makers to extend their drug’s life for a maximum of 5 years regardless of how many years the company lost while waiting for FDA approval. There is a second restriction on patent term restoration which limits the patent life of a drug to 14 years from the date that the FDA approves the drug.
Although some limitations apply to patent term restoration, the added patent life can make some pharmaceutical manufacturers billions of dollars, especially if they are the only ones with a treatment for a specific illness or disease.
We will cover more ways that are used by brand name drug makers to extend the patent life of their blockbuster drugs below.
How do Brand Name Drug Companies Extend the Life of their Drug Patents?
- Pediatric Exclusivity. Many brand name drug manufacturers are extending the terms of their patents by claiming pediatric exclusivity. They do so by seeking to test a drug on children and by doing so, the USPTO grants them an additional 6 months of patent life. Companies can do this two times using the same drug. Now, you’re probably saying to yourself that six months is too short, but in some cases, this could literally help a drug maker make tens if not hundreds of millions of dollars, depending on the popularity of the drug.
- Different Versions. A trick that many drug makers use to extend the term life of their patent is by combining medical components in a different way. For example, Adderall XR was reformulated from the already patented Adderall by creating an extended release version that extends the drug’s period of effectiveness. Other manufactures have sough administering the drug in a different way. For example, Limitrex a well-known migraine drug originally sold in tablet form was reformulated for intranasal delivery, this extended the patent life of the drug.
- New Use Rule. The FDA allows patent extensions of three years if a drug manufacturer finds a “new use” for its drug. What this basically means is that if a manufacturer discover that its drug can treat a different illness or achieve a different remedy, they can increase the patent for an additional three years on the basis of the drug’s new purpose.
- Chemical Adjustment. Drug makers often make adjustments to the amount of isomers in a medication. By doing this, they are essentially changing the drug and they can patent the the drug as a completely “new drug,” thereby extending its patent life. This situation occurs when an isomer doesn’t make a drug more effective, allowing manufacturers to remove it and “purify” the drug, making it something that’s completely new and therefore patent-able.
- Combining Medications. Some pharmaceutical makers have been successful in extending the patent life of some medication by combining two drugs into one. At times, they have found the new combination to be more effective than the original drug. These fusing of two drugs is common and the newly formed drug gets a new patent to extend its life. One example of this is when Pfizer combined its patented drugs Norvasc and Lipitor into a new medication and had a patent issued for the new combination called “Caduet.”
- Rare Disease Drugs. The FDA offers a 7 year extension of patent life for drugs that treat rare diseases. The FDA defines rare disease as those affecting fewer than 200,000 people in the United States. The FDA offers this extension to encourage drug companies to develop treatments for these diseases. Without extending the patent life, companies would be discouraged from spending their time and money to develop a medication that won’t be used by many people, so to make up for that, the FDA gives them an additional 7 years of patent life.
Drug Patent Length vs Market Exclusivity
Now that we’ve covered the lengths of drug patents and how some manufacturers extend them, lets explore market exclusivity. If you’re not part of the pharmaceutical industry, then you’ve probably never heard of market exclusivity, so lets explore what is market exclusivity for drugs?
Explaining the difference between patents and market exclusivity will help you understand market exclusivity.
By now, you should know that patents are granted by the USPTO and protect the chemical makeup and claims of a drug. Exclusivity is a right granted by the FDA once a drug is approved and this right grants the drug maker market exclusivity which blocks the approval of any generic drugs until the brand name manufacturers exclusivity clock runs out. Source
The FDA established market exclusivity to rewards new drug innovation and to curb generic drug makers from profiting off the success of those who contributed their time and money to develop a new drug.
Another major difference between patents and market exclusivity is that a drug patent can expire before the FDA approves a drug whereas market exclusivity is granted upon the approval of a drug by the FDA.
How Long Does a Patent Last?
This article dove deep into how long do patents last and how drug manufacturers increase the length of their patents. We also covered how long drug patents last in the U.S and other countries such as Canada, UK, and Australia. We also discussed the importance of drug patents as well as how drug manufacturers increase the life of their patents. If you have any questions or comments please feel free to leave them in the comments section below.