In the case between two
pharmaceutical companies, Warner Chilcott and Teva Pharmaceuticals, the Federal
Circuit court used the appellant’s claim limitation to uphold the district
court’s finding that the claims of two patents were invalid as obvious. The
claims at issue covered the osteoporosis drug Atelvia. Warner Chilcott, the
holder of the patents, filed suit in November 2011 following Teva’s ANDA
application to make and sell a generic version of the drug.
Warner Chilcott owns the ‘459 and
‘460 patents, which are directed to methods of treating osteoporosis, a disease
characterized by abnormal calcium and phosphate metabolism. Warner Chilcott’s
commercial product, Atelvia, is an oral formulation for treating osteoporosis.
According to the company, Atelvia solved the problem of prior osteoporosis
drugs that were rendered ineffective when taken with or soon after a meal by
utilizing a chelating agent to prevent calcium binding. During prosecution, the
scientific claims of the patent were rejected as obvious over a prior art
patnet application. Warner Chilcott later overcame the rejection by amending
the claims and adding the limitation “pharmaceutically effective absorption.”
However, the district court later
found the claims invalid with regard to obviousness, stating that a person of
ordinary skill in the art would have recognized the scientific problems in
osteoporosis and the solution of using chelators to bind a metal ion, as it had
been well explored in prior literature.
Warner Chilcott appealed, arguing
that the district court misinterpreted the meaning of “pharmaceutically
effective absportion” and that the limitation was not applicable only to food
consumption while taking the drug. However, the Federal Circuit affirmed the
district court’s obviousness holding, writing that the prior art essentially
covers the whole scope of Warner Chilcott’s patent and that the only claim
limitation it lacks is “pharmaceutically effective absorption.”
Ultimately, the district court
and Federal Court both ruled that in view of the prior art, Warner Chilcott’s
new method of treating osteoporosis is obvious. More specifically, the courts
believe that any qualified scientist would have known about the efficacy of a
chelating agent to treat osteoporosis.
In conclusion, I believe that the
courts ruled correctly against Warner Chilcott. Their development, while
scientifically beneficial, does not improve enough on prior art and does not
extend far enough from prior art.
Hey Jay. This is a very detailed and informative post. Also, the pharmaceutical industry is a rampant business with which I imagine an extreme amount of conversations are conducted behind closed doors. It's interesting how the court referenced a person with ordinary skill capable of recognizing the the scientific problems with osteoperosis and the binding solution due to literary publications. All in all good post.
ReplyDeleteHey Jay. This is a very detailed and informative post. Also, the pharmaceutical industry is a rampant business with which I imagine an extreme amount of conversations are conducted behind closed doors. It's interesting how the court referenced a person with ordinary skill capable of recognizing the the scientific problems with osteoperosis and the binding solution due to literary publications. All in all good post.
ReplyDeleteHi Jay,
ReplyDeleteI really like how you went into depth about the patents themselves and the process that went into determining whether or not the claims were obvious. I definitely agree with you that the courts ruled correctly in this case. While their development was beneficial, it did not improve enough on prior art.
Hi Jay,
ReplyDeleteThanks for the clear write up and the very clear video. It really allowed me to understand what is going on here. Essentially, what is at challenge here is the chelators method. Interestingly, this does not have much to do with the drug. Yet, because it is a claim - and was deemed invalid - this may jeopardize the whole drug's patent. I would like to further know how the court reached the conclusion regarding any scientist would've known. Anyways, thank you.
Hi Jay,
ReplyDeleteI also agree that Warner Chilcott should have lost because of prior art. Your post mentioned how a person skilled in the art of this pharmaceutical drug would have known to create this oral formulation, and prior art seems to indicate that this oral formulation already existed in some kind of basic form. Thus, Warner Chilcott doesn't seem to be inventing anything new and shouldn't be protected by this patent.
It must be tough for the courts to understand how obvious or non-obvious an invention in a field is with absolutely no understanding of the field.
ReplyDeleteHi Jay,
ReplyDeleteI agree with your point of view on this case. It's interesting that a high number of patent litigation cases arise from the pharmaceutical industry.