Intellectual property protection is the heartbeat of our industry. Patent and data protection allow us to recoup the very steep investments that go into researching and developing new treatments -- a cost that is north of $1 billion. IP protection also allows a level of certainty. We understand and appreciate that generics are part of our business, but understanding when our patents are likely to expire is integral to the process.
An article last week in The Washington Post told this story nicely. The article, by Howard Schneider, analyzed why IP protection is so important in the complicated biopharmaceutical industry. In part, Schneider wrote:
"The research and development timeline for biotech products is so long that original patents on a promising molecule may have only a few years left in their terms by the time a drug or treatment is licensed. That is not considered enough to spur the flow of investment that makes the industry tick. To extend that period of protection, the Affordable Care Act gave companies an additional 12 years of “data exclusivity” — meaning that the results of tests used in developing the drug cannot be referenced or relied on by companies trying to develop generic substitutes for 12 years after the original drug’s approval.
"In the biotech development process, use of that other research is an important issue. Unlike less complex, chemically derived pharmaceuticals, biotech products are produced from living cell lines. Whereas “small molecule” drugs such as aspirin can be precisely duplicated, generic versions of advanced biopharmaceuticals can only be “biosimilar” — with similar DNA, but not duplicate DNA. The ability to rely, to some degree, on the data and tests generated in the process of approving the original substance helps to lower the cost of generic development and aid in determining if a proposed substitute should be approved."
Michael Soldan, global head of regulatory affairs for biosimilars at Boehringer Ingelheim, painted an even more vivid picture. Soldan compared the process of building a monoclonal antibody to that of building a jet airplane, while simpler biologics are more like building a car (the aspirin, Soldan said, is relegated to bicycle status).
Meantime, we face unusual IP obstacles in select countries around the world. The problems in India are well documented. Less known -- but equally troublesome -- are the problems our industry faces in Canada. The unique "Promise of the Patent" doctrine has been used to invalidate 18 pharmaceutical patents in Canada since 2005. When patents are regularly invalidated 8 years, 6 years, or 5 years after reaching the market -- especially over rationale not found elsewhere in the world -- business certainty is all but gone.
Innovation, and the patients who need it, lose out.