Post by Janet Freilich
Work-arounds (innovations that arise in the course of designing a technology to avoid another inventor’s patent claim) are a long-standing feature of the patent system. The conventional wisdom is that work-arounds are good:
“We have often noted that one of the benefits of the patent system is the incentive it provides for “designing around” patented inventions, thus creating new innovation.”
Read Corp. v. Porter, Inc., 970 F.2d 816, 823 (Fed. Cir. 1992)
But are they?
The answer to this question, like so many in law, is ‘it depends.’ Since the literature provides many examples of the benefits of work-arounds, I wanted to highlight a few examples of perverse incentives and work-arounds gone wrong. The examples come from the pharmaceutical industry. Contrary to popular perception, generic drugs are not always identical to brand name drugs. Generic manufacturers often seek to bring their drug to market before the brand name patent has expired, so they try to ‘work-around’ the brand name patent by making small changes (the FDA does not allow major changes). Unfortunately these changes are sometimes driven by concerns for patent law, not patient safety.
In EKR Therapeutics, Inc. v. Sun Pharmaceutical Industries, 633 F. Supp. 2d 187 (D.N.J. 2009), the plaintiff produced Cardene, a drug to treat hypertension. Cardene cannot be safely administered into the body because it is not isotonic (meaning that it has a different osmotic pressure than cells in the body). EKR solved this problem by mixing Cardene with an excipient to create an isotonic solution. Sun’s generic drug was identical to EKR’s product except that, instead of pre-mixing the drug with an excipient, it contained instructions that the administering physician should mix the solution with an excipient to render the solution isotonic before giving it to a patient.
The plaintiff’s product did not require a mixing step, the defendant’s product did. 99.9% of the time, the administering physician would likely perform the step correctly. But physicians get tired. They make human errors. They might be particularly likely to make errors if they were used to using a product that did not require a mixing step. Is it socially beneficial for patent law to encourage these types of small changes? In a similar case, the brand name company’s patent claimed a drug that was “substantially” pure. The generic company tried to work-around the brand name patent by introducing slight impurities into the product (Aventis Pharma Deutschland GMBH v. Lupin Ltd., No. 2:05CV421, 2006 WL 1582412 (E.D. Va. June 5, 2006)). Yes, the generic companies here demonstrate creativity and innovativeness – but is this where we want innovative efforts to be focused?
Ultimately, the courts in both cases found that the generic drugs infringed the brand name patents under the doctrine of equivalents, so the generic products are not on the market, but the takeaway from these cases is that generic drugs are often slightly different from their brand name counterparts, a difference which is potentially harmful to patients, and a difference that is driven by patent law, not by considerations for patient safety. I gather further examples in my article on The Paradox of Legal Equivalents and Scientific Equivalence, 59 S.M.U. L. Rev. 66 (2013).