The importance of meeting the enablement requirement for patented drugs!

In a recent case, Alza Corporation v. Andrx Pharmaceuticals, LLC, the Federal Circuit affirmed a Delaware District Court’s decision to hold the method claims for treating a Attention Deficit and Hyperactivity Disorder (ADHD) invalid for failure to satisfy the enablement requirement.  The ‘373 patent claimed a method of using methylphenidate (MPH) drug dosage for treating ADHD. 

One of the key elements of the independent claim was the release of MPH at an ascending release rate over an extended period of time.  ALZA markets and sells a product called CONCERTA that embodies the claimed invention.  ALZA’s competitors ((Andrx) produce a drug pursuant to an Abbreviated New Drug Application (ANDA) that has an outer IR coating around a sustained-release inner core. 

ALZA sued Andrx for infringement of the ‘373 and ‘129 patents.  The District Court held that claim 1 of the ‘373 patent was invalid, because it failed to meet the enablement requirement.  Specifically, that the specification failed to enable claim 1, because it failed to disclose a method of using non-osmotic oral dosage forms of using ascending release rates of MPH to treat ADHD. 

The District Court applied the In re Wands factors and held that undue experimentation was required to develop non-osmotic oral dosage forms, such as tablets and capsules.  ALZA asserted that some trial and error was involved in producing non-osmotic tablets and capsules, but a person of ordinary skill in the art would be able to produce them without undue experimentation. 

Andrx asserted and challenged the level of knowledge a person of ordinary skill in the art would have and the specification failed to provide the knowledge required to make non-osmotic tablets and capsules with ascending release rates.  The Federal Circuit upheld the District Court stating that the specification failed to disclose the starting materials or the specific conditions under which non-osmotic tablets and capsules with ascending releases rates for MPH could be created. 

The Federal Circuit went on to state that since this information a part of a claim limitation it was not a minor or trivial omission that could be supplemented by the knowledge of a person of ordinary skill in the art.  Thus, claim 1 of the ‘373 patent was invalid for failing to meet the enablement requirement. 

This Ruling reemphasizes the need to balance the need for providing enough scope to your claim to read on the accused device with the need to ensure that the asserted interpretation can be found within the body of the specification.  If you have any concerns or questions relating to this matter, then please let me know. 

To read more of the Alza v. Andrx, decision please click on the following link: ALZA v. Andrx

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