D. Md. L.R. 804.3

Unless otherwise ordered by the Court, in all cases alleging patent infringement based

upon a Paragraph IV certification under 21 U.S.C. § 355, the parties shall make the following

disclosures.

355)

a) Initial Disclosure of Invalidity Contentions

Twenty-eight (28) days from the date of the Scheduling Order, the Defendant shall serve

upon the Plaintiff its Initial Disclosure of Invalidity Contentions that conform to L.R.

804.1.c.

b) Initial Disclosure of Non-Infringement Contentions

With the Initial Disclosure of Invalidity Contentions, the Defendant shall serve upon the

Plaintiff its Initial Disclosure of Non-Infringement Contentions for any patents referred to

in Defendants Paragraph IV Certification which shall include a claim chart identifying each

claim in the patent at issue in the case and each limitation of each claim and shall specifically

identify for each claim which claim limitation(s) are literally absent from the Defendants

allegedly infringing Abbreviated New Drug Application or New Drug Application.

c) Document Production Accompanying Initial Disclosures of Invalidity and Non-Infringement Contentions

With the Initial Disclosures of Invalidity and Non-Infringement Contentions, the

Defendant shall produce or make available for inspection and copying and produce to the

Plaintiff or make available for inspection and copying the documents described in L.R.

804.1.d, as well as a complete copy of the entire Abbreviated New Drug Application or New

Drug Application that is the basis of the case in question and any document or thing that

the Defendant intends to rely on in defense against any infringement contentions by

Plaintiff.

d) Initial Disclosure of Infringement Contentions

Fifty-six (56) days from the date of the Scheduling Order, Plaintiff shall serve Defendant

with an Initial Disclosure of Infringement Contentions for all patents referred to in

Defendants Paragraph IV Certification, which shall contain all disclosures required by L.R.

804.1.a.

e) Document Production Accompanying Initial Disclosure of Infringement

Contentions

Plaintiffs Initial Disclosure of Infringement Contentions shall be accompanied by the

production of documents required under L.R. 804.1.b.