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Abstract

Settlement is almost always preferable to last-man-standing litigation. While litigation posturing is a necessity, all but the largest pharmaceutical houses must avoid suing to a conclusion. The objective is to make a reasonable deal. Having a non-lawyer corporate representative fully engaged in direct settlement efforts, with the assistance of counsel, throughout the process is one way to foster settlement. Also, be sure to propose a Scheduling Order with as many points of decision as possible. In particular, separate Markman claim construction briefings and rulings from summary judgment briefings and rulings. Preparing for the 95 per cent probability of settlement is prudent, cost effective and substantially less bloody.

Abbreviated new drug application (ANDA) Paragraph IV litigation is a unique litigation exercise. Address ANDA Paragraph IV litigation and settlement separately in terms of how the ‘other side’ will react and how the Federal Trade Commission (FTC) will react. The objective is not to sustain or defeat a patent. These are merely aspects of potentially profitable constructions of a settlement agreement.

Keywords

patent litigation ANDA Paragraph IV settlement

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Under the US drug approval regulatory scheme, there is also an opportunity to profit from not marketing a drug. This arises when the FDA's abbreviated new drug application (ANDA) Paragraph IV regulations, patent portfolios and certain planets are in conjunction.

Markman v Westview Instruments, Inc. 517 US 370 (1996).

The CAFC was established in 1982 to bring uniformity to patent decisions. Prior to the establishment of the CAFC, patent decisions of district courts were appealed to the courts of appeal for each region. This led to considerable variation in the respect accorded to patents.

Moore

(2002) ‘Judges equipped to resolve patent cases?’, The Federal Circuit Bar Journal, Vol. 2, No. 12, pp. 1–33 (claim construction statistics).

CVI/Beta Ventures, Inc. v Custom Optical Frames, Inc, 92 F.3d 1203 (Fed.Cir. 1996); CVI/Beta Ventures, Inc. v Tura LP, 112 F.3d 1146 (Fed.Cir. 1997).

Moore

(2000) ‘Judges, juries and patent cases – an empirical peek inside the black box’, Michigan Law Review, Vol. 99, p. 365 et seq. Statistics cover 1,209 cases from 1983–1999.

See, Host: The animal or plant on which or in another organism lives.

For similar reasons, attorneys avoid contacting opposing counsel in front of clients.

It is not atypical for patent litigators focused on taking patent cases to trial to combine the Markman and summary judgment exercises in a manner that precludes a number of settlement junctures.

10.

This will be somewhat restricted in the event of passage of the Greater Access to Affordable Pharmaceuticals (GAAP) Act.

Secrets of Successful Patent (Non)Litigation

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