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

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 demands focus on key issues only Avoid kitchen sink briefing Avoid kitchen sink briefing Estoppel for anything which could have been raised Avoid having to say we should have, would 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 rebuttals: Our rebuttals: Inventor's records fail to show claimed invention. Inventor's records fail to show claimed invention. Testimony re: tablet function proffered by counsel, not witness. Testimony re: tablet function proffered by counsel, not witness. Patentee arguments: Patentee arguments: 1) Inventor alleged antedating conception. 2) Claimed and prior art tablets (shown below) function differently.

Our rebuttal went an extra mile to make the court's decision easy: Our rebuttal went an extra mile to make the court's decision easy: 1) Opposing counsel testified that claimed and prior art tablets function differently. 2) We replied that counsel cannot provide fact testimony. 3)We also provided laboratory data showing that claimed tablet (below left) functions 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: +1 (973) 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.