Nov 26, 2012
By Trevor Shewfelt, Pharmacist at the Dauphin Clinic Pharmacy
Trevor let the cat out of the bag. My wife Doris says that about me when I say something Im not supposed to. Thankfully Doris isnt an officer in the Royal Navy. Back in the days of sailing ships, letting the cat out of the bag had a more sinister meaning. In the Royal Navy, the British Naval Officers had a hard core instrument of discipline. It was called a Cat o Nine Tails which was a nine tailed whip. The Cat o Nine Tails came out of its bag when someone spoke out of turn or said something they shouldnt have.
Now Im really going to let the cat out of the bag. I hear there is cheap generic Viagra at the Dauphin Clinic Pharmacy. No this information didnt come from spam email. And I hear the pharmaceutical industry is driving over a Patent Cliff. Actually generic Viagra is an excellent example of the Patent Cliff.
Viagra was one of the most profitable drugs in the world when it was launched by the company Pfizer. The drug to treat erectile dysfunction had the patent number 2,163,446 and the patent was granted in 1998. Some would argue that the word erectile dysfunction was invented by the marketers of Viagra. Viagras patent was set to expire in Canada in 2014. The generic drug manufacturer Teva has been fighting the patent for a few years. On November 8, 2012 Teva convinced the Supreme Court of Canada that Pfizers original Viagra patent was invalid. That means Teva can now sell a less expensive, generic sildenafil which will have the same active ingredient as Viagra.
Cheaper medications are good for everyone, right? Mostly, yes. Medications are one of the most expensive and fastest growing segments of health care. But the research companies, like Pfizer arent happy with inexpensive generics and that might hurt us in the long run. Pfizer is one of the research drug companies that discover and market new medications like Viagra. If you want a new drug for your diabetes, heart disease, or cancer it will probably be a company like Pfizer that will do at least some of the research necessary to bring it to market.
It is expensive to bring a drug to market. The numbers Ive read vary widely, but quotes range from $800 million to $1.7 billion. It is so expensive in part because you have to research somewhere between 5,000 to 10,000 different chemicals to come up with one candidate for a new drug. Then you have to put that potential drug through expensive clinical trials before the FDA and Health Canada will approve them for sale. It may take 10-20 years between drug discovery and getting a drug to market. So companies like Pfizer argue they need to charge high prices for their successful drugs like Viagra to pay for all that research. To encourage them to make new drugs, the Canadian government gives companies like Pfizer a patent that says only they can sell Viagra for a long time to make their money back.
It hurts Pfizer when a blockbuster drug like Viagra goes off patent and a get made by generic companies like Teva. But patients who take sildenafil are happy with the price reduction. What if a whole bunch of patents expired for Pfizer and companies like it all at the same time? That is exactly what is happening right now. That is the Patent Cliff. Recently in Canada, Pfizer has lost the patent on Lipitor, Norvasc and now Viagra. The cholesterol pill Lipitor was the best-selling medication in the world.
Amongst all the research drug companies, not just Pfizer, patents on drugs worth $12 billion expired by the end of 2011, and in 2012 that figure is expected to increase to more than $30 billion in annual sales. It is estimated that generic competition will have eroded $67 billion from top drug companies annual sales in the United States between 2007 and 2012. This is because more than three dozen drugs lost patent protection during this time. That figure represents approximately 50% of the companies combined U.S. sales in 2007.
So should we be happy that we can buy Viagra more cheaply today? Or should we be scared that companies like Pfizer are going over the Patent Cliff and will be less able to sell us miraculous new cures tomorrow? Like most things in pharmacy, we need to weigh the risks and benefits. The federal government gave companies like Pfizer patent protection so they could recoup the huge amounts of money it takes to develop a new drug. But the patent protections arent forever. When the patents expire, generic companies are allowed to make Health Canada approved generic versions off previously exclusive, brand named products. Generic drugs mean Canadians have to spend less money on their medications. This keeps medications costs lower and is supposed to encourage companies like Pfizer to develop new medications and get a new patent protections. Why havent companies like Pfizer developed new medications and avoided the Patent Cliff? I dont know. But, because Pfizer is one of the most powerful companies in the world, I hope they dont pull out their nine tailed whip for me letting the Patent Cliff out of the bag.
We now have this and most other articles published in the Parkland Shopper on our Website. Please visit us at www.dcp.ca
The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.
Mylan Canadas Choosing Generics www.choosinggenerics.ca
Pfizers news release -Viagra price - www.pfizer.ca/en/media_centre/news_releases/article?year=2012&article=418
Tevas news release about its sildenafil - www.tevacanada.com/Pdfs/SildenafilPressReleaseEnglish.aspx
CMAJ article on Drug Development costs - www.ncbi.nlm.nih.gov/pmc/articles/PMC2630351/pdf/20090203s00009p279.pdf
Forbes Article on costs of New Drugs - www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/
US Pharmacist article on the Patent Cliff - www.uspharmacist.com/content/s/216/c/35249/