The quest for market exclusivity in biotechnology: Navigating the patent minefield

NeuroRx

Volumn 2, Issue 4, 2005, Pages 572-578

  Gersten, David M ^a  

^a Third District Court of Appeal ^*  (United States)

Author keywords

Intellectual property; Litigation; Market exclusivity; Patent

Indexed keywords

CYCLOSPORIN; DNA; NEW DRUG;

BIOTECHNOLOGY; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; LAW; LAW SUIT; PATENT; REVIEW; UNITED STATES;

EID: 25844434728     PISSN: 15455343     EISSN: 15455351     Source Type: Journal    
DOI: 10.1602/neurorx.2.4.572     Document Type: Article

References (54)

1. 35 U.S.C.A. §§ 101-103 (2005).
2. 35 U.S.C.A. § 271 (2005).
3. U.S. Const, art. I, § 8, cl. 8 (2005).
4. A "useful" item is capable of achieving some identifiable benefit. Juicy Whip, Inc. v. Orange Bang, Inc., 185 F. 3d 1364, 1366 (Fed. Cir. 1999).
5. Novelty is determined by comparing the invention with "prior art." Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 15 (1966); 35 U.S.C.A. §§ 102(a)-(e), 103 (2005).
6. 35 U.S.C.A. § 113 (2005).
7. Of the patent system's twin purposes, encouraging new inventions and adding knowledge to the public domain, the economic justification is probably the most important rationale. Note, The Disclosure Function of the Patent System (or Lack Thereof), 118 Harv. L.R. 2007, 2008 (2005).
8. For instance, pharmaceutical companies have a disadvantage compared to other inventors seeking patent protection. A new drug's patent term is forty percent shorter than the effective term for other patented products. PhRMA. Pharmaceutical Industry Profile 2004.
9. It can take many years for a potential new drug to advance from a research idea to a drug approved by the FDA, and can cost more than $800 million dollars. PhRMA. Pharmaceutical Industry Profile 2004. There is only a thirty percent chance that an approved drug will produce revenues that match or exceed average research and development costs.
10. There is a $4.44 savings on hospital spending for each additional dollar spent on new medicines. PhRMA. Pharmaceutical Industry Profile 2004.
11. The drug industry launched twenty-four new drugs in 2001, which is half the number of new drugs launched in 1996. Jones & Lunn, "Pharmaceutical Market Exclusivity: Patent and Regulatory Strategies." 21 No. 1 ACCA Docket 81 (2003).
12. Pharmaceutical companies' costs have tripled in the past ten years to $33 billion for research and development of new drugs. PhRMA. Pharmaceutical Industry Profile 2004.
13. PhRMA. Pharmaceutical Industry Profile 2004 (noting that "the industry is currently caught between traditional strategies for developing drugs that seem tapped out and new genomics-based approaches that have yet to realize their full potential").
14. H.R. Rpt. 98-857(I), (June 21, 1984) (reprinted in 1984 U.S. C.C.A.N. 2647).
15. 21 U.S.C.A. §§ 301-397 (2005).
16. Since the Hatch-Waxman Act's enactment, the generic share of the pharmaceutical market soared from less than twenty percent to nearly fifty percent. Generic drug entry prior to patent expiration: an FTC study, Federal Trade Commission (July 30, 2002).
17. 35 U.S.C.A. § 156 (2005).
18. Software developers, too, are experiencing patenting challenges because their field involves rapidly developing technology. Everett, C. Software Terminology: How to Describe a Software Invention in a United States Patent Application. 29 Nova L.R. 693 (Spring 2005).
19. Merck KGAA v. Integra Lifesciences I, Ltd., 125 S.Ct. 2372 (2005).
20. Merrill S, Levin R, Myers M. A patent system for the 21st century, pp. 144-145. Washington, D.C.: The National Academic Press, 2004.
21. For instance, computer engineers have applied algorithms that bioinformatics researchers developed to study DNA genomes to reverse-engineer proprietary computer software. O'Brien, D. Genome Model Applied to Software. Wired News. Available at http://wired-vig.wired.com/news/infostructure/0,1377, 65191,00.html. Accessed April 22, 2005.
22. Schering Corp. v. Amgen Inc., 18 F.Supp. 2d 372 (D.Del. 1998.) (upholding patent for isolated DNA sequences and recombinant DNA methods for producing interferon protein, but noting that proteins having the same action are natural phenomena).
23. This means that "a person may infringe a claim to a metabolite if the person ingests a compound that metabolizes to form the metabolite." Schering Corp. v. Geneva Pharm., Inc., 339 F. 3d 1373, 1380 (Fed. Cir. 2003). In such a case, the patient is directly infringing the patent, and the company holding the patent can sue the company that manufactured the compound ingested by the patient for indirect infringement.
24. Woessner, W. Claiming Metabolites: Federal Circuit Poses New Challenges to Patent Applicants. Schwegman Lundberg Woessner Kluth IP Resource Center. Available at http://www.slwk.com/CM/Articles/Articles112.asp. Accessed May 11, 2005.
25. Deleted in proof.
26. Novartis Pharms. Corp. v. Eon Labs Mfg., Inc., 363 F. 3d 1306 (Fed. Cir. 2004).
27. For instance, pharmaceutical chemist Lian Yu manipulated the organic compound known as "ROY" into six different polymorphs, including red needles, orange plates, and yellow prisms. Goho, A. Tricky Business. Science News Online. Vol. 166, No. 8, p. 122, 21 August 2004. Available at http://www.sciencenews.org/articles/20040821/bob9.asp. Accessed July 25, 2005.
28. Knapman, K. Polymorphic predictions. Mod Drug Discov. 3:53-54, 57, 2000. Available at http://pubs.acs.org/hotartcl/mdd/00/mar/knap.html. Accessed July 25, 2005. Predicting polymorphism is important because it can allow researchers to maximize a compound's desired properties and prevent contamination by an unwanted polymorph during the manufacturing process.
29. Deleted in proof.
30. OSI Pharmaceuticals has obtained a patent for a crystalline polymorph of its cancer treatment Tarceva (TM) (erlotinib), which will extend exclusive protection of Tarceva by approximately five years. OSI Pharmaceuticals Announces Issuance of Additional U.S. Patent for Tarceva; Extends Patent Exclusivity. BioSpace Beat. Available at http://www.biospace.com/news_story.cfm?story ID=20215120. Accessed July 25, 2005.
31. "Stereoisomers" "are molecules that are identical in atomic constitution and bonding, but differ in the three-dimensional arrangement of the atoms." "Enantiomeric drugs" are those made up of two mirror-image molecules that have the same chemical composition. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. PDA's Policy Statement for the Development of New Stereoisomeric Drugs. Available at: http://www.fda.gov/cder/guidance/stereo.htm. Accessed July 25, 2005.
32. Deleted in proof.
33. A. Maureen Rouhi, May 5, 2003, Vol. 81, p. 48, ISSN 0009-2347.
34. Schmidt R. Smart moves on intellectual property. Washington Business Forward. Available at: http://www.bizforward.com/wdc/issues/2002-03/buzzguide/. Accessed May 10, 2005.
35. Where less than $1 million is at risk, the cost of litigation through appeal can reach $500,000; where $1-$25 million is at risk, that figure rises to $2,000,000, and where more than $25 million is at risk, average costs are as high as $3,995,000. Miller J. Building a better bounty: Litigation-stage rewards for defeating patents. 19 Berkeley Tech. L. J. 667 (2004).
36. A patent holder can bring an infringement action against persons who make, use, or sell the patented invention, those who actively induce patent infringement, and those whose acts constitute contributory infringement. 35 U.S.C.A. § 271 (2005).
37. A potential infringer often seeks a declaration of non-infringement and/or patent invalidity in a declaratory judgment action. The potential infringer must establish that an actual controversy exists by showing the declaratory plaintiff has (1) acted in a way that the patentee asserts infringes the patent, or is preparing to act in such a way; and (2) has a reasonable apprehension of suit for infringement that was created by the patentee. See Spectronics Corp. v. H.B. Fuller Co., Inc., 940 F. 2d 631, 634 (Fed. Cir. 1991.);
38. Lang v. Pac. Marine & Supply Co., 895 F. 2d 761, 764 (Fed. Cir. 1990).
39. Patent and Trademark Office Study of Court Determinations of Patent Validity/Invalidity, 1973-1977, 989 Official Gazette 2 (December 4, 1979);
40. see also Baum, "The Federal Courts and Patent Validity: An Analysis of the Record," 56 J. Pat. Off. Soc'y 758 (1974).
41. 5CM Corp. v. Xerox Corp., 645 F. 2d 1195 (2d Cir. 1981).
42. Jurors are randomly selected from voter and/or driver lists. They are disqualified from service only if they, for example, cannot understand English, suffer from a mental or physical infirmity, or have been convicted of a felony without having their rights restored. 28 U.S.C.A. §§ 1861-1878 (2005).
43. http://www.uscourts.gov/courtsofappeals.html.
44. http://www.fedcir.gov/judgbios.html.
45. See § IV., infra.
46. Vanderlande Indus. Nederland BV v. Int'l Trade Comm'n, 366 F. 3d 1311, 1318 (Fed.Cir. 2004).
47. Astrazeneca AB v. Mutual Pharm. Co., Inc., 384 F. 3d 1333, 1337 (Fed. Cir. 2004).
48. Astrazeneca AB v. Mutual Pharm. Co., Inc., 384 F. 3d at 1338.
49. Phillips v. AWH Corp., 376 F. 3d 1382 (Fed. Cir. 2004).
50. Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F. 3d 1354, 1359 (Fed. Cir. 2004).
51. The jury's task may seem straightforward, however, the Federal Circuit's opinion illustrates its complexity. The court summarized the jury's findings as follows: "physicians order assays and correlate the results of those assays, thereby directly infringing" and "a reasonable jury could find intent to induce infringement because LabCorp's articles state that elevated total homocysteine correlates to cobalamin/folate deficiency." Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F. 3d at 1359.
52. Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc., 125 S.Ct. 1413 (2005).
53. Merrill S, Levin R, Myers M. A patent system for the 21st century. Washington, D.C.: The National Academic Press, 2004.
54. American Intellectual Property Law Association. AIPLA Response to the National Academies Report entitled "A Patent System for the 21st Century." Available at: http://www.aipla.org/Template. cfm?Section= By_Topic&template=/ContentManagement/ContentDisplay.cfm&ContentID=5544. Accessed May 10, 2005.