New Product Launch Clearance How to identify - and quickly resolve - potential impediments to launching a unique new pharmaceutical dosage form *Redacted.

New Product Launch Clearance

How to identify - and quickly resolve - potential

impediments to launching a unique new pharmaceutical dosage

form

*Redacted for public/non-client distribution*Redacted for public/non-client distribution

Glipizide: a standard diabetes drug

Extended-release forms are commonly available

API degrades in acid (e.g., stomach)

Enteric dosage form: a unique new dosage providing a niche life-cycle management opportunity

Industry best practices dictate new product launches first have a freedom-to-operate I.P. search

Lots of I.P. on enteric dosages; lots of I.P. on glipizide

Issued patent on enteric glipizide with swelling tablet core

Swelling core extends release (see illustration at right)

Patent licensed to Asian company Claims glipizide in swelling tablet

core, coated with Eudragit® Is the patent valid? The sheer

volume of the art both eases and impedes this inquiry:

Easier to find relevant art Difficult to find most relevant art

Patent in suit (shown below at left) claims: glipizide API and swelling tablet excipient coated with Eudragit®

Prior art patent (shown below at right) teaches a tablet core (2b) made of “low solubility” API and swelling excipient, coated with Eudragit® (4)

Is the different shape patentable? Is a different non-soluble API (glipizide)?

How to resolve a question like this quickly, to clear a commercial product launch?

Declaratory Judgment in District Court takes perhaps two years or more.

“Rocket docket” court (E.D.Va.) resolution takes one year.

Ex parte reexamination: fast, but no opportunity to respond.

Inter partes reexamination: fast ruling, but slow follow-through, no opportunity to depose, and adverse estoppel effect

Estoppel isn't a problem – if you win.We chose inter partes reexamination

This type of case requires a critical judgment call

Good advocacy Good advocacy demands focus on demands focus on key issues onlykey issues only

Avoid “kitchen sink” Avoid “kitchen sink” briefingbriefing

Estoppel for anything Estoppel for anything which “could have which “could have been raised” been raised”

Avoid having to say we Avoid having to say we “should have, would “should have, would have, could have...”have, could have...”

We contested only 35 of 48 issued claims

We cited only 1 key reference

Ruling found all claims invalid (more than we asked for)

Ruling issued in 60 days. Ruling was cogent: reaffirmed

three (3) times on reconsideration. Commercial launch cleared! Patent owner responded by

pointing out that claimed tablet functions differently than prior art.

2 Key Evidential Issues Our rebuttalsOur rebuttals::

• Inventor's records Inventor's records fail to show claimed fail to show claimed invention.invention.

• Testimony re: tablet Testimony re: tablet function proffered by function proffered by counsel, not witness.counsel, not witness.

Patentee argumentsPatentee arguments::

1)1) Inventor alleged Inventor alleged antedating antedating conception. conception.

2)2) Claimed and prior Claimed and prior art tablets (shown art tablets (shown below) function below) function differently. differently.

Our rebuttal went an extra mile to make the Our rebuttal went an extra mile to make the court's decision easycourt's decision easy::

1)1) Opposing counsel testified that claimed Opposing counsel testified that claimed and prior art tablets function differently. and prior art tablets function differently.

2)2) We replied that counsel cannot provide We replied that counsel cannot provide fact testimony. fact testimony.

3)3)We also provided laboratory data showing We also provided laboratory data showing that claimed tablet (below left) functions that claimed tablet (below left) functions identically to prior art tablet (below right).identically to prior art tablet (below right).

The Board of Appeals found each of our declarations cogent and persuasive.

The Board disregarded en toto each of the patentee's declarations.

Without supporting evidence, it's difficult to win. The Board of Appeals said:

The ultimate Board of Appeals decision, like the Examiner's prior decisions, reads like was been copied from our own brief:

Take-Away Lessons

A new product launch requires fast, predictable resolution of potential infringement questions.

Infringement problems can be cleared up in months rather than years.

Resolution can be not only fast, but reliably predictable and sustainable on appeal.

© 2010 Pharmaceutical Patent Attorneys, LLC

Morristown, New Jersey

For further information on how this approach can be applied to protect your API, contact:

[email protected]+1 (973) 984-0076

This presentation does not constitute legal advice and does not form an attorney-client relationship between the copyright holder

and the viewer.

Certain information has been redacted from this presentation to make it suitable for distribution to the public. Clients may obtain

an unredacted copy on request.