Intellectual Property Litigation - - BioPharm International


Intellectual Property Litigation

BioPharm International
Volume 1, Issue 8

In addition to out-of-pocket expenses, IP litigation imposes significant intangible costs that should not be underestimated. During discovery, employees are diverted from their regular work by the need to gather documents and collect information for production, educate counsel regarding the technology (especially in patent and trade secret cases), develop litigation strategies, and prepare for depositions. Many of a company's most valuable employees, including executives and senior scientists, often cannot escape the burden of litigation.

Planning Ahead

For many biopharmaceutical organizations, future involvement in IP litigation is a foregone conclusion and the only question is "when?" (or "when next?"). Before filing suit for infringement, patent owners should "kick the tires" on their IP and carefully study the patent, its prosecution history, and the technical literature that existed at the time the application was initially filed (prior art). If there are significant defects in the patent or if there is particularly strong prior art, a patent owner might consider correcting the patent through reissue or reexamination proceedings in the Patent Office before initiating litigation. To facilitate recovery of infringement damages, patent owners who sell products covered by their own patents should mark the products with corresponding patent numbers.

An organization contemplating a lawsuit for trade secret misappropriation may need to act quickly to contain the secret, but ideally it will first identify the trade secret, develop a strategy to prove that such subject matter qualifies as a trade secret, and search for any public information disputing that the subject matter is, in fact, secret.

Organizations intending to initiate IP litigation ought seriously to consider first retaining as consultants any inventors or trade secret developers who are no longer employees, and should recognize that their choice of a forum could greatly influence the speed with which the litigation proceeds. Organizations on either side of anticipated litigation should contemplate developing strategies to deal with electronic discovery. Once litigation begins, time becomes a scarce commodity.

References and Notes

1. Licensing chapter of this guide.

2. Walker JM. Biopharm company alleges rival used trademark in web site metatags. Daily Business Review. 2004 December 7.

3. Signings of Pleadings, Motions, and Other Papers; Representation to Court; Sanctions. In Federal Rules of Civil Procedure. St Paul, Mn: West Publishing Company; 2002, (available at http://

4. Denny WR, Winslow EJ. Electronic discovery: understanding preservation obligations, the potential for cost-shifting, and current developments. ABA Computer & Internet Litigation Journal. 2005 Spring; 6:6

5. Glaxo Wellcome Inc v Genentech, Inc, 136 F2d 316 (D Del 2001).

6. Eli Lilly & Co v Aradigm Corp, 376 F3d 1352 (Fed Cir 2004) (detailing an inventorship dispute over a patent covering aerosolized lispro).

7. 35 USC 271.

8. Rich GS. Extent of protection and interpretation of claims—American perspectives. 21 Int'l Rev Indus Prop & Copyright L. 1990:497,499.

9. Domestic Patents Chapter in this guide.

10. Moore KA. Are district court judges equipped to resolve patent cases? Harvard J of L & Tech. 2001;5:1,11.

11. Hearings Before the Senate Judiciary Committee, 108th Cong, 1st Sess (2004) ("The Law of Biologic Medicine," testimony of Lester M. Crawford, June 23, 2004) (available at

12. Amgen Inc v Hoechst Marion Roussel, Inc, 314 F3d 1313 (Fed Cir 2003) (describing patent infringement litigation initiated by the maker of EPOGEN).

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