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Timestamp: 2019-04-19 04:48:08+00:00

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Gene Patenting after In re Kubin: The Sky is Not Falling On April 3, 2009, the Federal Circuit issued its opinion in In re Kubin,1 a case watched with great interest by the biotechnology community. While the court did not make a blanket decision that “DNA is obvious,” it did restrict the scope of nucleic acid sequences that will be patentable thereafter, and held that the Supreme Court’s decision in KSR v. Teleflex2 overturned the Federal Circuit’s In re Deuel3 decision. Since Deuel has been used over the past 14 years to support the patentability of DNA, the Federal Circuit’s finding that the Deuel decision’s principles were abrogated by the Supreme Court is disquieting for DNA-patenting applicants and patentees. But Kubin also provides a veritable roadmap on how its more stringent effects can be avoided.
The Federal Circuit found that Kubin’s claims fell within the class of situations when something that is obvious to try is also obvious.
Gene Patenting after In re Kubin: The Sky is Not Falling continued from p. 3 Patents obtained during these times should be easy to distinguish from Kubin, since the predictability that the court found as a result of advances in modern technology was much less evident years ago. Turning to the present day, many (if not most) of the genes patented or applied for were not known prior to their discovery (usually through homology comparisons) as a result of the Human Genome Project (HGP). A fundamental pillar of the court’s decision in Kubin was that p38 was known; that will not be the case for most of the genes identified since the late 1990’s. The Deuel decision said that “what cannot be contemplated or conceived cannot be obvious;” 15 a fortiori, what is completely unknown is unlikely to be determined obvious.
the existence of the protein encoded therefrom was not known; there was not a commercially-available monoclonal antibody specific for the protein; expression cloning was ineffective or unpredictable for that gene; there was no express description in the art on how to isolate the gene; and/or there did not exist in the art an identified cell or tissue source reliably expressing the protein.
should not provoke a sea change in the fortunes of such gene claims. Insofar as it has a tendency to have this effect in the Patent Office, factual challenges, particularly supported by expert declarations, should have the greatest persuasive punch. Distinctions over the factual bases of the Kubin decision are not only the best chance of overcoming obviousness rejections, but the Office must consider such evidence (particularly declaration evidence) and refute it.16 The Kubin decision is likely to increase the challenges in litigation over gene claims, but this is tempered by the high standard of proving invalidity, as well as the factual distinctions mentioned above. The Kubin court did the biotechnology community no favors by interpreting KSR to have overturned Deuel (which KSR did not do explicitly). But the consequences of its overreaction may be alleviated by addressing the obviousness question for each new gene on its own facts, distinct from the considerations that supported the court’s determination of obviousness in Kubin. Endnotes 1. No. 2008-1184 (Fed. Cir. Apr. 3, 2009). 2. 550 U.S. 398 (2007). 3. 51 F.3d 1552; 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). 4. U.S. Patent No. 5,688,690. 5. Joseph Sambrook et al., Molecular Cloning: A Laboratory Manual 43-84 (2d ed. 1989). 6. Porunelloor Matthew et al., Cloning and Characterization of the 2B4 Gene Encoding a Molecule Associated with Non-MHC-Restricted Killing Mediated by Activated Natural Killer Cells and T Cells, 151 J. Immunology 5328-37 (1993). 7. Kubin at 8 (emphasis in original).
8. Id. (emphasis in original). 9. Id. at 12 (internal citations omitted; emphasis in original). 10. Id. at 13 (internal citations omitted). 11. Id. citing (KSR Int’l Co. v. Teleflex, Inc., 127 S. Ct. 1727, 82 U.S.P.Q. 2d 1385, 1394, 1396 (2007)) (emphasis in original). 12. 853 F.2d 894, 903 (Fed. Cir. 1988). 13. Kubin at 15, citing O’Farrell at 90304 (internal citations omitted; emphasis in original). 14. Id. at 15-16 (internal citations omitted, emphasis in original). 15. 51 F.3d 1552, 1558 16. In re Sullivan, 84 U.S.P.Q. 2d 1304 (Fed. Cir. 2007).
Judge Rader) and USPTO Associate Solicitor Janet Gongola regarding Example 11 of the training materials.
subgenus. The Board found, at Finding of Fact 22, that the specification did not teach anything about any variants.
Court [Judge Rader]: What about the conservative substitutions set forth at page 63?
ing activity Y. Therefore, this satisfies the function-structure alternative test for written description, doesn’t it? Gongola: No, your Honor. The functionstructure test requires an identification of a structure common to all members of the genus. We do not have that identification of a common structure. Twenty percent… Court: I’m quoting almost out of PTO’s manual on written description -- verbatim -- when I give my example there, am I not? The variations plus the activity Y -- protein having activity Y -- isn’t that exactly the PTO’s manual on written description?
The USPTO’s New Written Description Training Materials: Impact on Biotech continued from p. 9 such claims until the Federal Circuit has another opportunity to address the written description issue in the context of hybridization variants or percent-identity claims. For comprehensive analyses of other examples from the new written description training materials, readers are encouraged to visit Patent Docs (http://www.patentdocs.org). Endnotes 1. Written Description Training Materials http://www.uspto.gov/web/menu/written. pdf (“Training Materials”). 2. Training Materials at A-1. 3. Id. at 2. 4. 323 F.3d 956 (Fed. Cir. 2002). 5. 355 F.3d 1343 (Fed. Cir. 2004). 6. 358 F.3d 916 (Fed. Cir. 2004). 7. 378 F.3d 1330 (Fed. Cir. 2004). 8. Training Materials at i-ii. 9. Id. at 21. 10. Id. at 21-22. 11. Id. at 22. 12. Id. at 22-23. 13. Id. at 22. 14. Id. 15. Id. 16. Id. at 37. 17. Id. at 37-42. 18. Id. at 37. 19. Id. at 37-38. 20. Id. at 38. 21. Id. at 38-39. 22. Id. at 40. 23. Id. at 41-42. 24. Id. at 41. 25. Elliott, G. (2008, June). The Latest News From the JPO, EPO, SIPO & USPTO. Speech presented at 2008 BIO International Convention. 26. Id. 27. Id. 28. No. 2008-0184 (Bd. Pat. App. & Inter. March 11, 2008).
29. Id. at 10. 30. Id. at 2. 31. Id. at 3. 32. Id. 33. Id. at 3-4. 34. 119 F.3d 1559 (Fed. Cir. 1997). 35. 358 F.3d 916 (Fed. Cir. 2004). 36. Ex parte Porro at 5. 37. Id. 38. Id. 39. Id. at 6. 40. Id. at 8. 41. Id. 42. Id. at 7-8. 43. See, e.g., Training Materials at 37-42. 44. Porro at 9. 45. Id. 46. No. 2008-1184 (Fed. Cir. Apr. 3, 2009). 47. Id. at 2. 48. Id. at 18. 49. Audio of the entire Oral Argument is available at , In re Kubin, case no. 2008-1184.
the applicant provides the Trademark Office with a statement of actual use of the mark in commerce. Trademarks used in association with goods can be placed either on the goods themselves, or, if the nature of the product does not permit direct marking, then the trademark can be placed on the packaging in which the goods are sold, preferably in a conspicuous spot. Trademarks used in association with services can be used on advertisements and brochures that explain the services. For an owner to establish goodwill in a mark, purchasers who view the mark have to understand that the words or symbols used on the product, packaging, or brochure are being used as a trademark or service mark to indicate the source of the goods or services. Typically, the words or symbols are presented in a distinctive font, or a particular color, or in a different size font from the surrounding text, or in capital letters, or in any combination of these aspects, so that the mark is uniquely distinguishable from any surrounding text. The unique appearance of the mark helps the purchaser identify the mark as an indicator of the source of the goods or services.
Failure to give proper notice of your rights can seriously impact your ability to collect damages for infringement.
Remember, when dotting your “i”s and crossing your “t”s, make sure to include your “®”s and “©”s! symbol, and to correct any misuse as soon as it is discovered. Copyrights: Do You Need to Mark? Copyright practice in the United States was formerly riddled with complicated requirements for registration and notice. These requirements frequently put U.S. copyright holders at a disadvantage with respect to copyright holders in other nations who did not face the same procedural hurdles to enforcing their rights. The Berne Convention Implementation Act (“BCIA”) of 1988 sought to remedy that situation by relaxing many procedural requirements, including notice. Today, whether or not copyright notice is required depends on when the work in question was created.
or the abbreviation “Copr.”; (2) the year of first publication of the work (the date may be omitted on certain articles such as pictorial, graphic, or sculptural works, or jewelry); and (3) the name of the copyright owner, or an abbreviation or alternate designation by which the owner can be recognized.16 Providing notice of trademark rights and copyrights can be an important part of your overall intellectual property program. So, keep in mind, when dotting your “i”s and crossing your “t”s, be sure to include your “®”s and “©”s! Endnotes 1. 15 U.S.C. § 1115 (2007). 2. 15 U.S.C. §§ 1051-1141. 3. 15 U.S.C. § 1116 (2007). 4. 15 U.S.C. § 1117 (2007). 5. 15 U.S.C. § 1111 (2007). 6. In re B.C. Switzer & Co., 211 U.S.P.Q. 644 (TTAB 1981). 7. In re A La Vielle Russie, Inc., 60 U.S.P.Q. 2d 1895 (TTAB 2001). 8. Wells Fargo & Co v. Lundeen & Assoc., 20 U.S.P.Q. 2d 1156 (TTAB 1991); Copelands’ Enters., Inc. v. CNV, Inc., 945 F.2d 1563 (Fed. Cir. 1991). 9. Gear, Inc. v. L.A. Gear Cal., Inc., 670 F. Supp. 508 (S.D.N.Y. 1987) vacated, in part, dismissed, 13 U.S.P.Q. 2d 1655 (S.D.N.Y. 1989). 10. Jos. Schlitz Brewing Co. v. United Vintners, Inc., 166 U.S.P.Q. 493 (TTAB 1970); Pan Am. Life Ins. Co. v. Federated Mut. Ins Co., 226 U.S.P.Q. 914 (TTAB 1985). 11. Shatel Corp. v. Mao Ta Lumber & Yacht Corp., 697 F.2d 1352 (11th Cir. 1983). 12. 17 U.S.C. § 405 (2007) (pre-BCIA). 13. 17 U.S.C. § 401(d) (2007). 14. 17 U.S.C. §§ 401-06 (2007). 15. 17 U.S.C. §§ 101-1332. 16. 17 U.S.C. § 401(b) (2007).
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