12 years? seems like a long time....

Caught up in all the health care reform battles is the war to establish patent protection for biologics produced by biotech and pharma companies. The premise is simple: the manufacturers want 12 years protection from biosimilars (the biologics version of generics), some democrats (including President Obama and Senator Waxman) and generics manufacturers want less. On the surface it seems that less protection would benefit consumers because biologics, while generally effective therapies, are typically very expensive to patients. This is because they are expensive to develop, often involving proprietary processes and many years to bring from the lab to the market. Manufacturers are arguing that the only way they can recoup the losses of developing the biologics is to have a longer period of patent protection on the product before it is opened to competition from biosimilars.
At first I was all for legislation reducing the length of time for protection, but the more that I consider the problem, the more I feel that 12 years is fair. The way that I look at it, if companies feel that developing biologics (some of the most effective auto-immune treatment available today are biologics, by the way) is cost-prohibitive because patent protection is lost too quickly, then developers may abandon the production of these important treatments. Furthermore the production of biologics is a very labor intensive and scientifically complex matter, and any competition would likely have to undertake similar expensive manufacturing techniques just to produce a biosimilar. That being said, companies that invest the time and money into producing biologics should have 12 years of market exclusivity for their treatment.
As for the cost of the biologics, I think that future improvements in manufacturing techniques along with competition from other manufacturers will help control the cost of biologics, but these treatments will always be more expensive than standard medications. It's hard to say how this battle will play out, but neither side will go down without a fight.

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