Method of Use Patents:...... For All Intents Are UnEnforceable .......... Off-Label Use
"Our method of use patents only protect the product when used or sold for the claimed methods. However, these types of patents do not limit a competitor from making and marketing a product that is identical to our product that is labeled for an indication that is outside of our patented methods, or for which there is a substantial use in commerce outside of our patented methods.
Obtaining proof of direct infringement by a competitor for a method of use patent can be difficult because the competitors making and marketing a product typically do not engage in the patented use.
Moreover, physicians may prescribe a competitive identical product for indications other than the one for which the product has been approved, or off-label indications, that are covered by the applicable patents. Although such off-label prescriptions may directly infringe or contribute to or induce infringement of method of use patents, such infringement is difficult to prevent or prosecute."
Maybe, but Keryx also owns patents related to manufacturing and purification. Over the years it has been difficult to control numerous parameters i.e. % hydration, Fe3+/citrate ratio, free Fe3+ and free Fe2+ among others. The manufacturing process patented by Keryx controls for these and other factors. As such the patents do indeed, "limit a competitor from making and marketing a product that is identical to our product" regardless of the intended use.
I haven't reviewed their other patents. I would note that a method of manufacture is "easier" to design around than a method of treating a condition using various compounds (as the '706 patent claims). The point is, however, that KERX is protected from multiple angles. "Easier" is in quotes because I don't have a bio/chem background and can't speak toward the ease of making a design around for manufacturing and purification. I defer to others on this board who have expertise in that area.