On November 8, 2012, the Supreme Court of Canada invalidated Pfizer’s patent for blockbuster erectile dysfunction (ED) drug Viagra.
Pfizer’s patent for Viagra is history in Canada.The court ruled that in its patent, Pfizer failed to specifically state that the compound Sildenafil was the substance that created the therapeutic effect. The patent narrowed down a list of 260 quintillion compounds, but never explicitly stated that of those, Sildenafil, was the one that the patent was all about. The ruling was unanimous, and the plaintiff challenging Pfizer’s patent, Teva Canada (the Canadian arm of Israeli generic drug manufacturer Teva Ltd.) lost no time getting the product to market.
On the same day as the ruling, Teva Canada updated its website to introduce its product, known as Novo-Sildenafil. A spokeswoman for Teva Canada confirmed Nov. 8 that “We launched today,” and the website noted that the product “is available via prescription.” A pop-up window on Teva Canada’s home page states in large lettering, “Sorry Viagra … No hard feelings?” and notes that Pfizer lowered prices in Canada to match that of Novo-Sildenafil. The price for four, 100mg tablets of Viagra dropped from $49 to $37.
Launching Generic Drugs in the U.S.
The Canadian ruling won’t change things for U.S. consumers, however. While U.S. Customs and Border Protection (CBP) tends to look the other way when U.S. citizens travel to Canada and bring back small amounts of prescription drugs they purchased at cheaper prices, technically, it’s illegal. It is especially dangerous to purchase medications online from Canadian Pharmacies that ship non FDA-approved medications. It’s also illegal to order prescription drugs for import from other countries. While Customs cannot catch all of these imports, U.S. consumers do run the risk of having a shipment intercepted and having to answer to CBP.
Currently, Pfizer’s U.S. patent on Viagra is scheduled to end in April, 2020. As that time approaches, generic manufacturers will be working diligently to have their medications approved under the Drug Price Competition and Patent Term Restoration Act of 1974, more commonly known as the Hatch-Waxman Act. This law spells out the process for generic drug manufacturers in getting their products to market.
The FDA has specific procedures for makers of generic drugs in getting their products on pharmacy shelves.The first step for these manufacturers is the filing of an Abbreviated New Drug Application, or ANDA. To have an ANDA approved by the Food and Drug Administration, the applicant must fulfill four conditions:
1. The drug that is the subject of the ANDA has not been patented in the U.S.
2. The patent for the original name-brand drug has expired.
3. The generic will not be sold until the name-brand patent has expired.
4. The patent for the original drug either has not been infringed by the generic, or is proven in court to be invalid.
If the generic manufacturer has these ducks in a row before the patent expires, it can move very quickly when the expiration date for the original drug patent arrives.
180-Day Exclusivity in the U.S.
While the ANDA process sounds straightforward, when it comes to major industries like pharmaceuticals, complications are to be expected. Additionally, under the Hatch-Waxman Act, the first company to submit an ANDA for approval has the right to 180 days of generic market exclusivity, during which it can price its product closer to that of the name brand drug. Once this exclusivity period is over and more generics enter the market, however, prices can drop significantly and quickly.
When multiple generics reach the market, consumer prices for these drugs can drop significantly.How Brand Name Drug Manufacturers Hold Off Generic Competition
Major pharmaceutical companies like Pfizer try to protect their huge investment in blockbuster drugs like Viagra, and there are several ways to hold off generic competition. Pfizer has been successful in essentially extending its original patent for Viagra, which was set to expire in 2012. In a 2012 court ruling in the U.S., the court sided with Pfizer, who argued that a second patent — one which specifically indicated the use of its product for treating ED — should keep generics off the shelves until it expires, in 2019. The original patent for Viagra was for the compound itself, which was originally studied as a treatment for heart failure and hypertension.
Major pharmaceutical brands have also used various incentives to keep generic manufacturers from selling their products, including paying them large sums of money. The Federal Trade Commission does not like this practice, and has argued in various court cases that these payoffs harm the public and keep drug prices inflated. Court rulings on the matter have been mixed, so big pharmaceutical companies have to weigh the risk involved with such payments against potential profits.
The FTC does not like name-brand pharmaceutical companies enticing generic makers to hold back their products.The Case of Generic Lipitor
A generic version of cholesterol drug Liptor (the world’s best selling prescription drug) was ready to go to market in early 2010, but Pfizer, maker of Lipitor, made an agreement with Ranbaxy Laboratories, a generic manufacturer from India, to hold off until November 2011. In announcing the agreement, Pfizer specifically said that no part of the deal with Ranbaxy would go afoul of the FTC, indicating that there were no direct payments to Ranbaxy.
What Ranbaxy got from the deal was the right to sell generic Lipitor in seven countries, and Pfizer dropped its court challenges to Ranbaxy’s sales of generic Lipitor in four other countries. The end result? Liptior’s market exclusivity in the U.S. was extended by 20 months. The Lipitor scenario shows how getting generics onto the market in the U.S. can be complicated and drawn out.
The effects of Canada’s Supreme Court ruling were swift.
Due to the huge popularity of Viagra, you can expect generic manufacturers to seek ANDA approval so that the day Pfizer’s U.S. patent expires, they’ll be ready to start shipping generics to pharmacies. The first patent for ED drug Cialis expires in 2016, and Levitra, currently the third most popular ED drug, loses patent protection in the U.S. in 2018. These are the earliest dates generics could appear, and it’s possible the manufacturers will attempt to prolong brand exclusivity using various means.
Right now, U.S. consumers’ safe, convenient options are limited to shopping around to find these name-brand medications at competitive prices. eDrugstore.com, a U.S.-based online medical facilitator, has facilitated thousands of orders for Viagra, Cialis, and Levitra dispensed by U.S.-licensed pharmacists since 1998. eDrugstore.com offers competitive prices, convenience, privacy, and secure, discreet shipping so that men can safely obtain these products while saving money.
Photo Credits: TevaCanada.com, Trec_Lit, Michael C. Burgess, MD, Images of Money, John Taylor
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