Swimming Upstream: Developing and Commercializing Diabetes Products in a Patent Protected World

Abstract

Many, if not most, commercially available diabetes treatment products are protected by some form of intellectual property. This article discusses the development and commercialization of products in view of the state of intellectual property for the diabetes treatment market, with respect to possible discouragement, for some, from seeking patent protection or commercializing a new product under the belief that patent protection is either unavailable or difficult to come by, or for fear of infringing existing patents. Upon closer investigation, the evolution of technology almost always creates opportunities for new improvements, which likely can be patent protected. Furthermore, while avoiding the claims of existing patents is sometimes challenging and opinion based, and thus not a guarantee of avoiding a patent litigation, patent litigation may be delayed and is often settled early on.

Keywords

development Food and Drug Administration infringement intellectual property medical device patent patentability

References

Schumacher

, Small is beautiful. In: The radical humanist. 1973;37: 22.

Herman

Devey

, Future trends in medical device technologies: A ten-year forecast. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM238527.pdf. Accessed August 20, 2012.

Makower

Meer

Denend

FDA impact on U.S. medical technology innovation.

Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).

Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990).

Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130 (Fed. Cir. 1995).

Carroll Touch, Inc. v. Electro-Mechanical Sys., Inc., 15 F.3d 1573, 1576 (Fed. Cir. 1993).

Dolly, Inc. v. Spalding & Evenflo Cos., 16 F.3d 394, 397 (Fed. Cir. 1994).

Graver Tank & Mfg. Co., Inc. v. Linde Air Products Co., 339 U.S. 605, 608 (1950).

10.

Seagate Tech., LLC, 497 F.3d 1360 (Fed. Cir. 2007).

11.

Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130 (Fed. Cir. 1995).

12.

American Intellectual Property Law Association. 2011 report of the economic survey.

13.

Eli Lilly and Company v. Medtronic, Inc., 496 U.S. 661, 110 S.Ct. 2683, 110 L.Ed.2d 605, 58 USLW 4838, 15 U.S.P.Q.2d 1121 (1990).

14.

Kesan

Ball

, How are patent cases resolved? An empirical examination of the adjudication and settlement of patent disputes. Washington University Law Review. 2006;84: 237–312.

15.

Lienhard

, Inventing modern: Growing up with X-rays, skyscrapers, and tailfins. New York: Oxford University Press; 2003.