Commercialization: Patenting and Licensing in Wound Healing and Regenerative Biology

Hood, W. Chip.; Huizenga, David

doi:10.1007/978-1-62703-505-7_32

Commercialization: Patenting and Licensing in Wound Healing and Regenerative Biology

W. Chip. Hood⁴ &
David Huizenga⁵

Protocol
First Online: 01 January 2013

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Part of the book series: Methods in Molecular Biology ((MIMB,volume 1037))

Abstract

Wound healing and regeneration is an area rich in discovery and progress. Models of resourcing science are changing, thus there are both research funding and commercial incentives for developing intellectual property. This chapter focuses on the initial steps of commercial development of a patentable discovery such as might apply to an invention in this space, and indeed other areas of biomedical science. We cover the basics of patent protection and licensing. First, we address why research results often need to be patented in order to provide an incentive for the financial investment required to move a product through the development and approval process. Second, we discuss the basics of US patent law and address certain pitfalls of premature disclosure of research results. Next, we inform the reader of significant issues relative to ownership of IP in the academic and industrial worlds, in particular the interplay of consulting agreements and employment obligations. Finally an overview of the mechanics of the licensing process is provided.

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Notes

1.
Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980).
2.
Id. at 2208 citing S.Rep.No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R.Rep.No. 1923, 82d Cong., 2d Sess., 6 (1952).
3.
Bilski v. Kappos, 130 S. Ct. 3218, 3226 (S. Ct. 2010) (held that the particular case of a method drawn to steps relating to investment did not meet the patent eligible standard because it violated one of the classes of subject matter).
4.
Bilski v. Kappos, 130 S. Ct. 3218, 3220 (S. Ct. 2010).
5.
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. 35 USC 101.
6.
35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. A person shall be entitled to a patent unless
1. (a)
  The invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or
2. (b)
  The invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than 1 year prior to the date of the application for patent in the USA, or
3. (c)
  He has abandoned the invention, or
4. (d)
  The invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than 12 months before the filing of the application in the USA, or
5. (e)
  The invention was described in—(1) an application for patent, published under section 122(b), by another filed in the USA before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the USA before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the USA only if the international application designated the USA and was published under Article 21(2) of such treaty in the English language; or
6. (f)
  He did not himself invent the subject matter sought to be patented, or
7. (g)
  (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
(Amended July 28, 1972, Public Law 92-358, sec. 2, 86 Stat. 501; Nov. 14, 1975, Public Law 94-131, sec. 5, 89 Stat. 691.)
(Subsection (e) amended Nov. 29, 1999, Public Law 106-113, sec. 1000(a)(9), 113 Stat. 1501A-565 (S. 1948 sec. 4505).)
(Subsection (g) amended Nov. 29, 1999, Public Law 106-113, sec. 1000(a)(9), 113 Stat. 1501A-590 (S. 1948 sec. 4806).)
(Subsection (e) amended Nov. 2, 2002, Public Law 107-273, sec. 13205, 116 Stat. 1903.)
7.
103 Conditions for patentability; nonobvious subject matter.
1. (a)
  A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
2. (b)
  1. (1)
    Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if
    1. (A)
      Claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and
    2. (B)
      The composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.
  2. (2)
    A patent issued on a process under paragraph (1)
    1. (A)
      Shall also contain the claims to the composition of matter used in or made by that process, or
    2. (B)
      Shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.
  3. (3)
    For purposes of paragraph (1), the term “biotechnological process” means
    1. (A)
      A process of genetically altering or otherwise inducing a single- or multi-celled organism to
      
      (i)
      Express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism;
    2. (B)
      Cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
    3. (C)
      A method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).
3. (c)
  1. (1)
    Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was made, owned by the same person or subject to an obligation of assignment to the same person.
  2. (2)
    For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if
    1. (A)
      The claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made;
    2. (B)
      The claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and
    3. (C)
      The application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.
  3. (3)
    For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.
(Amended Nov. 8, 1984, Public Law 98-622, sec. 103, 98 Stat. 3384; Nov. 1, 1995, Public Law 104-41, sec. 1, 109 Stat. 3511.)
(Subsection (c) amended Nov. 29, 1999, Public Law 106-113, sec. 1000(a)(9), 113 Stat. 1501A-591 (S. 1948 sec. 4807).)
(Subsection (c) amended Dec. 10, 2004, Public Law 108-453, sec. 2, 118 Stat. 3596.)
8.
12 Specification.
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.
Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
(Amended July 24, 1965, Public Law 89-83, sec. 9, 79 Stat. 261; Nov. 14, 1975, Public Law 94-131, sec. 7, 89 Stat. 691.)
9.
See for example, the famous line of cases flowing from Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997) (1998).
10.
Supra footnote 8.
11.
“Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376, 231 USPQ 81, 87 (Fed.Cir.1986) (citation omitted).
12.
Burroughs Wellcome Co. v. Barr Lab., Inc., 40 F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed.Cir.1994).
13.
Ethicon 1460 citing See Sewall, 21 F.3d at 416-17; Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624, 225 USPQ 634, 641 (Fed.Cir.1985). “Providing well-known principles” … or [explaining] the state of the art without ever having “a firm and definite idea” of the claimed combination as a whole does not qualify as a joint inventor.” Ethicon at 1460 citing Hess, 106 F.3d at 981 (citing O’Reilly v. Morse, 56 U.S. (15 How.) 62, 111, 14 L.Ed. 601 (1853)). Ethicon 1460.
14.
Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co., 973 F.2d 911, 917, 23 USPQ2d 1921, 1926 (Fed.Cir.1992).
15.
35 U.S.C. § 116.
16.
Ethicon at 1460.
17.
Burroughs Wellcome Co. v. Barr Lab., Inc., 40 F.3d 1223, 1229, (Fed.Cir. 1996).
18.
See foundations for example in the Federal Circuit statements, “It is undoubtedly true that “[i]n some instances, an inventor is unable to establish a conception until he has reduced the invention to practice through a successful experiment.” Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021; Alpert v. Slatin, 305 F.2d 891, 894, 134 USPQ 296, 299 (CCPA 1962) (no conception “where results at each step do not follow as anticipated, but are achieved empirically by what amounts to trial and error”).

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Upstream Partners Inc., Duluth, GA, USA
W. Chip. Hood
Tao Life Sciences Inc., Anderson, SC, USA
David Huizenga

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W. Chip. Hood
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Editors and Affiliations

Virginia Tech Carilion Research Institut, Roanoke, Virginia, USA
Robert G. Gourdie
School of Pharmacy, MCPHS University, Worcester, Massachusetts, USA
Tereance A. Myers

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Hood, W.C., Huizenga, D. (2013). Commercialization: Patenting and Licensing in Wound Healing and Regenerative Biology. In: Gourdie, R., Myers, T. (eds) Wound Regeneration and Repair. Methods in Molecular Biology, vol 1037. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-62703-505-7_32

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DOI: https://doi.org/10.1007/978-1-62703-505-7_32
Published: 20 June 2013
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-62703-504-0
Online ISBN: 978-1-62703-505-7
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