Abstract
Peptide vaccines and Peptide therapeutics are increasingly entering into the focus of pharmaceutical companies. This section is intended to give a broad overview of areas of law that are particularly relevant to the patenting of peptide vaccines and therapeutic peptides as products and in compositions. The scope of patentable subject matter will be discussed, as it has been the focus of much wrangling and debate in the courts.
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- 1.
Derwent World Patents Index, which is a database containing patent applications and grants from 44 of the world's patent issuing authorities.
- 2.
- 3.
- 4.
Qin and Blankenstein (2000).
- 5.
Kennedy et al. (2003).
- 6.
Dengjel et al. (2006).
- 7.
- 8.
I believe all readers know that there are variants of that claim language which can be applied, but those variants are a mere linguistic variations.
- 9.
Janeway's Immunobiology, 8th edition (1. August 2011), Taylor and Francis ISBN-13: 978-0815342434.
- 10.
The term alludes to 35 U.S.C. 112, which defines the requirements for a patent specification.
- 11.
In the disclosure of WO2010117760 more specific embodiments are described. The shown paragraph was only chosen to demonstrate some general problems.
- 12.
The Patent Cooperation Treaty (PCT) is a treaty which provides a unified procedure for filing and examining patent applications to protect inventions in each of its contracting states. A set of Rules exist which sets forth basic standards for patentability, unity of a patent application, and the like. See http://www.wipo.int/pct/en/texts/rules/rtoc1.htm.
- 13.
Leber (2009).
- 14.
PCT International Search and Preliminary Examination Guidelines, which are non-binding guidelines for searching and examining PCT applications applied by examiners for the different search and examination authorities. Available online under http://www.wipo.int/pct/en/texts/pdf/ispe.pdf.
- 15.
There are circular peptides, but they are disregarded at this point of the discussion.
- 16.
Ambrogelly et al. (2007).
- 17.
PCT guidelines, paragraphs 10.38–10.57.
- 18.
- 19.
- 20.
- 21.
Stewart et al. (2011).
- 22.
Example used in patent applications drafted by the author.
- 23.
Id.
- 24.
Id.
- 25.
Id.
- 26.
Example used in patent applications drafted by the author.
- 27.
Id.
- 28.
Meziere et al. (1997).
- 29.
Lundblad (2005).
- 30.
See Chap. 15 of Coligan et al. (2000) for more extensive methodology relating to chemical modification of proteins.
- 31.
Id 12.
- 32.
Technical Board Decision T 1414/05.
- 33.
This application is assigned to the Columbia University New York, but similar problems exist with other university applications.
- 34.
Id 12.
- 35.
Definition taken from WO2002020616.
- 36.
Viatte et al. (2006).
- 37.
Mayo Collaboration Services vs Prometheus Labs., Inc., Slip. Op. Dkt. No. 10–1150, 566 (2012).
- 38.
35 U.S.C. § 101.
- 39.
Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204 (1980).
- 40.
Gottschalk v. Benson, 409 U.S. 63, 71–73, 93 S.Ct. 253 (1972).
- 41.
Parker v. Flook, 437 U.S. 584, 98 S.Ct. 2522 (1978).
- 42.
In re Nuijten, 500 F.3d 1346, 1355–56 (Fed. Cir. 2007).
- 43.
See Smith-Leahy America Invents Act, Pub. L. 112-29 at § 33(a) (Sep. 16, 2011).
- 44.
Utility Examination Guidelines, 66 Fed. Reg. 1092 at 1093 (Jan. 5, 2001).
- 45.
Id.
- 46.
See id. at (citing Parke-Davis & Co. v. H. K. Mulford Co., 189 F.2d, 103 (S.D.N.Y. 1911); and In re Bergstrom, 427 F.2d 1394, 1401 (CCPA 1970).
- 47.
See, e.g., US Pat. No. 7,470,669 (filed Sep. 27, 2005).
- 48.
See M.P.E.P. § 2107(II)(A).
- 49.
See Association for Molecular Pathology v. USPTO, Dkt No. 2010-1406, --- F.3d ----, 2011 WL 3211513, 99 U.S.P.Q.2d 1398 (Fed. Cir. Jul. 29, 2011).
- 50.
See id. at *2.
- 51.
Id. at *29. Judge Moore only held such claims to be patentable because the USPTO has a long history of allowing such claims. As she stated: If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter. Despite the literal chemical difference, the isolated full length gene does not clearly [*98] have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence. This case, however, comes to us with a substantial historical background. Congress has, for centuries, authorized an expansive scope of patentable subject matter. Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for decades, and, more generally, has allowed patents on purified natural products for centuries. There are now thousands of patents with claims to isolated DNA, and some unknown (but certainly large) number of patents to purified natural products or fragments thereof.n4 As I explain below, I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved. Combined with my belief that we should defer to Congress, these settled expectations tip the scale in favor of patentability.
Id.
- 52.
Id. at *18.
- 53.
Id.
- 54.
Id. at *19. Citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002).
- 55.
Id. at *20.
- 56.
Id. at *19.
- 57.
Id. at *28.
- 58.
Id. at *28–29.
- 59.
Id. at *29.
- 60.
Id.
- 61.
Id. at *31.
- 62.
Id. at *42.
- 63.
Id. at *38.
- 64.
Id.
- 65.
Id. at *42.
- 66.
Id. at *43.
- 67.
Cotropia et al. (2010). The next closest art unit is 1700 (chemicals), in which 56% of cases receive a “112 rejection”.
- 68.
Id. (showing that, in Art Unit 1600, 76% of all cases receive a rejection under 35 U.S.C. 112, whereas 67% of cases receive a rejection under 35 U.S.C. 102 or 103).
- 69.
M.P.E.P. § 2163 (citing Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ 391, 395 (CCPA 1972)).
- 70.
Id. (citing Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005)).
- 71.
David Kappos' Public Blog, “Written Description--Little Used Perhaps, But Extremely Useful to Ensure Claims are Appropriately Scoped” (May 5, 2010), available at http://www.uspto.gov/blog/director/entry/written_description_little_used_perhaps (last accessed Jan. 16, 2012).
- 72.
Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006).
- 73.
Id.
- 74.
Written Description Training Materials, Revision 1 at Example 9, page 31 (Mar. 25, 2008).
- 75.
Id.
- 76.
Id. at Example 10, Claim 2, pages 34–35.
- 77.
Id. at Examples 10 and 11, page 34–37. As explained by the materials:
In this example, there is no disclosure relating similarity of structure to conservation of function. General knowledge in the art included the knowledge that some amino acid variations are tolerated without losing a protein’s tertiary structure. The results of amino acid substitutions have been studied so extensively that amino acids are grouped in so-called “exchange groups” of similar properties because substituting within the exchange group is expected to conserve the overall structure. For example, the expectation from replacing leucine with isoleucine would be that the protein would likely retain its tertiary structure. On the other hand, when non-exchange group members are substituted, e.g., prolinefor tryptophan, the expectation would be that the substitution would not likely conserve the protein’s tertiary structure. Given what is known in the art about the likely outcome of substitutions on structure, those in the art would have likely expected the applicant to have been in possession of a genus of proteins having a tertiary structure similar to SEQ ID NO: 2 although the claim is not so limited.
Id. at 38–39.
- 78.
Id. at 33–42.
- 79.
Id.
- 80.
Ex parte Joo-Eun Bae, Appeal 2009-013469, Application 10/884,862, Decision on Appeal (BPAI Apr. 5, 2010).
- 81.
Id.
- 82.
Id.
- 83.
Id.
- 84.
Falkner v. Inglis, 448 F.3d 1357, 1368 (Fed. Cir. 2006).
- 85.
Id.
- 86.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988); M.P.E.P. § 2164.01(a).
- 87.
In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995).
- 88.
Id.
- 89.
Id.
- 90.
Cross v. Iizuka, 753 F.2d 1040, (Fed. Cir. 1985).
- 91.
Brana, 51 F.3d at 1563.
- 92.
Id. at 1563–64.
- 93.
Id. at 1566 and 1568.
- 94.
In re Angstadt, 537 F.2d 498, 502–503 (C.C.P.A. 1976).
- 95.
See Id. (finding a claim enabled despite encompassing inoperative embodiments where 40 specific embodiments were shown to have the same utility).
- 96.
A “Markush-type claim” is one that recites at least one group of alternative substituents. M.P.E.P. §§ 803.02 and 2173.05(h). It normally follows a claim structure of “A product/process comprising X, wherein X is selected from the group consisting of…”, although other claim structures are acceptable as well. Id. The group introduced by the transitional “selected from the group consisting of” is often referred to as a “Markushgroup”. Id.
- 97.
See 37 C.F.R. § 1.146. This has been strongly criticized as lacking clear support in the statute., see Wegner (2012) Nonetheless, it does not appear that the practice has been challenged in the Courts.
- 98.
M.P.E.P. § 803.02.
- 99.
Id.
- 100.
Id.
- 101.
Id.
- 102.
By “pure peptide/protein claim”, I mean a claim reciting “An isolated peptide/protein comprising an amino acid sequence selected from the group consisting of…” or similar claim structures.
- 103.
Low and Housel (2012).
- 104.
Id.
- 105.
Id.
- 106.
Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7166 (Feb. 9, 2011).
- 107.
Ex parte Degrado, Appeal 2010-005832, App. No. 10/801,951, Order for Further Briefing (BPAI May 9, 2011).
- 108.
See In re Harnisch, 631 F.2d 716, 721–22 (CCPA 1980).
- 109.
See 35 U.S.C. § 121 (reserving divisional applications for inventions for which the Director has required restriction).
- 110.
- 111.
In re Harnisch, 631 F.2d 716, 722 (CCPA 1980).
- 112.
Id.
- 113.
M.P.E.P. § 803.02.
- 114.
37 C.F.R. § 1.146.
- 115.
See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 414 (2007).
- 116.
Id. at 421.
- 117.
In re Kubin, 561 F.3d 1351, Slip Op. at 14–15 (Fed. Cir. 2009).
- 118.
See 75 FR 53654 (2009) (citing Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007) (not obvious to try when any one of a broad class of compounds could have been selected as the lead compound and the particular modifications necessary to obtain the claimed compound are not predictable); Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008) (not obvious when there is no apparent reason why a person of ordinary skill would have chosen the particular starting compound or the particular synthetic pathway that led to the claimed compound and there would be no reason to test for the property possessed by the claimed subject matter); Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008) (not obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture)).
- 119.
Id. (citing In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) (claimed polynucleotide is obvious over a known protein that it encodes, there is a reasonable expectation obtaining the claimed polynucleotide using standard biochemical techniques, and a reason to try to isolate the claimed polynucleotide); Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009) (“compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable”)).
- 120.
In re Kubin, 561 F.3d 1351, Slip Op. at 14–15 (Fed. Cir. 2009).
- 121.
Ex parte Joo-Eun Bae, Appeal 2009-013469, Application 10/884,862, Decision on Appeal at 2 (BPAI Apr. 5, 2010).
- 122.
Id. at 3 and 9–11.
- 123.
Id.
- 124.
Id.
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Acknowledgments
This chapter comprises a contribution related to aspects of US law written by Bryan W. Jones, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Washington, and a contribution related to aspects of Chinese law written by Kening Li, Pinsent Masons LLP, Shanghai.
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Storz, U., Flasche, W., Driehaus, J. (2012). Peptide Vaccines and Peptide Therapeutics. In: Intellectual Property Issues. SpringerBriefs in Biotech Patents. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-29526-3_2
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