Is The “Golden Rule” Of Biological Drugs At Hand?

I just finished speaking on IP issues involving biomarkers at a Q1 Conference in the Bay Area. Before the conference started, I spoke to the head patent counsel of a well-known bio/pharma company. He said, to my initial shock, that he thought new drugs based on small molecules were on the way out as commercial products. He was mostly focused on the difficulty he was having in getting claims allowed in the PTO, but his comments resonated with the comments of the first speaker, who pointed out, as did others, that it takes about 14.5 years from preclinical work to launch a new drug (small molecule or biological).

Now, taking that as a good estimate, and considering that a patent filed in the U.S on a drug at the beginning of the development period will have only about 5.5 years of life left when the product launches – less if it is filed in the pre-clinical stage – I jotted some quick notes from the speaker’s timeline. Patent term extension based on her figures for clinical trials and FDA approval delay would yield a patent term extension of only about 3.5-4.5 years. So the innovator only has about ten years to make a profit on its investment. The innovator will get five years of data exclusivity when the drug is approved, but the patent has more life than that, so the NCE exclusivity doesn’t add to the “product life cycle.” Also, the innovator can extend only one patent, so the generics have a clear target to zero in on via para. IV filings.

Of course, this is not the entire story, as the innovator can file add-on patents, including “label patents,” but these are both increasingly difficult to obtain post-KSR and easier to attack (e.g., via reexamination). Contrast this with the situation for a new biological drug, as set forth in the Obama Health Care Bill. No matter how long the development period, the innovator gets 12 years of data exclusivity from product approval/launch. Now there is no patent-based exclusivity for the generic company to attack or, I should say, attacking the patents won’t get the generic approved. So they are pretty much stuck in neutral. (See my recent post on the biologicals rules in the Health Care Bill.)

The FDA just announced an NIH-sponsored trial dubbed I-SPY 2 that will use genetic markers from patients’ tumors to identify which of five cancer drugs they will receive. The trial will evaluate the effectiveness of five investigational drugs from Abbott, Amgen, and Pfizer. Guess what? The names given in the post (fdanews.com) all end in “mab” or “nib.” So which business would you rather be in today, if drug discovery and development is your thing?

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