In last week’s issue of BioWorld Insight, our esteemed Washington editor Mari Serebrov wrote an article titled, “Shorter Exclusivity Could Carry a Hefty Price Tag.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity for innovator biologics to seven years, as the president and a number of lawmakers have proposed, would be bad news for patients, payers and drug makers.
In the article, Mary Webster, a patent attorney with Nixon Peabody, said: “If you can’t corner your market and recoup your costs, are you going to do it?”
And suddenly I had a flashback to negotiating with my three-year-old:
Me: “No you can’t have a cookie for dinner.”
Toddler: [crossing arms and stamping foot] “Fine, then I’m not going to eat anything for dinner.”
This scene has replayed itself in my head several times recently as I’ve written about biotech news – i.e. when gene patents are questioned, or reimbursement policies are debated, or drug importation gains traction, or the FDA shifts its stance on something. Each time, the industry’s response is to threaten that these moves will result in a “chilling effect on innovation” (translation: mess with us and we’ll stop making drugs).
Don’t get me wrong, I think the biotechnology industry deserves every advantage. But if biologics end up with seven years of exclusivity, do we really think companies will stop making them? Really? When biologics account for many of the top-selling drugs, each raking in multi-billions of dollars annually?
I worry that biopharma firms aren’t winning any points in the court of public opinion by stamping their feet and threatening to stop innovating every time something they don’t like gets put on the table. This approach certainly hasn’t worked for my toddler: When he threatens that he’s not going to eat dinner, I say, “fine, don’t eat” – and within minutes he’s seated at the table, munching away on his veggies.
You know what did work, though? When he said, “What if I eat a good dinner? Then can I have a cookie?” Negotiation is a fact of life – everybody has to give and take. My three-year old figured it out. Maybe it’s time for the industry to follow suit.
2 Comments
Mary Webster’s comment was made in the context of attracting investors. If a company can’t recoup its costs, it’s not profitable. While altruism may play a role in drug development, the bottom line is what investors look at. Losing the most profitable years of exclusivity could break a small biotech.
The funny thing about the 7 vs 12 argument is that it’s just a backup plan. I took a random sampling of biologics (4 or 5) and they all had at least 12 years of patent protection when they were approved.
If toddlers would put away their toys in a timely manor, their parents would bug them to clean their room.