Abstract
The impetus for physicians to participate in the process that translates clinical and benchtop discoveries to commercializable products has arguably never been greater. Medical innovation increasingly provides physicians with an opportunity to create alternative revenue streams. It can also impact career advancement, as many research universities are beginning to consider whether faculty have any patents or pending patent applications, along with more traditional metrics, such as peer-reviewed publications, when making decisions related to professional advancement. Some innovations have been highly successful, such as Dr. Latina’s patent on selective laser trabeculoplasty. As the pace of medical innovation increases, the strategic importance of physician involvement with intellectual property management and the commercialization process continues to grow. Recent changes to the patent laws in the United States have increased the physician’s opportunity to participate in the patent prosecution and the commercialization process.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 1.
See US Patent No. 5,549,596 (filed Oct. 20, 1995).
- 2.
Patent Rights in Inventions Made with Federal Assistance (The Bayh-Dole Act), Pub. L. No. 96–517, 94 Stat. 3019 (1980) (codified at 35 U.S.C. §§ 200–212 (2011)).
- 3.
Id.
- 4.
Senator Birch Bayh, Statement of Senator Birch Bayh to the National Institutes of Health (March 25, 2004), http://ott.od.nih.gov/policy/meeting/Senator-Birch-Bayh.pdf.
- 5.
This figure is the total running royalties from all licenses at each of the given universities and therefore includes both federally funded and non-federally funded innovations. Association of University Technology Managers (AUTM) Statistics Access for Tech Transfer (STATT) 2.0.
- 6.
Bd. of Trs. v. Roche Molecular Sys. (Stanford), 131 S. Ct. 2188, 2196 (2011).
- 7.
Id. at 2203 (Breyer, S., dissenting).
- 8.
35 U.S.C. § 154(a) (1)(2011).
- 9.
Patent Act of 1790, ch. 7, § 1, 1 Stat. 109.
- 10.
US Const. art I, § 8.
- 11.
V Writings of Thomas Jefferson, at 75–76 (Washington ed., 1895).
- 12.
Graham v. John Deere Co., 383 U.S. 1, 9 (1966).
- 13.
Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480 (1974).
- 14.
See Leahy-Smith America Invents Act (AIA), Pub. L. No. 112–29, 125 Stat. 284 (2011) (codified in scattered sections of 35 U.S.C.); Patent Act of 1952, Pub. L. No. 82–593, § 5, 66 Stat. 792; Patent Act of 1870, ch. 230, 16 Stat. 198; Patent Act of 1836, ch. 357, 5 Stat. 117; Patent Act of 1790, ch. 7, § 1, 1 Stat. 109–112.
- 15.
Graham, 383 U.S. at 6.
- 16.
See 35 U.S.C. §§ 101–103 (2011).
- 17.
35 U.S.C. § 101.
- 18.
Diamond v. Diehr, 450 U.S. 175, 185 (1981); Mayo Collaborative Servs v. Prometheus Labs, Inc., 132 S. Ct. 1289, (2012).
- 19.
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)).
- 20.
Gottschalk v. Benson, 409 U. S. 63, 67 (1972).
- 21.
Diehr, 450 U.S. at 187.
- 22.
Mayo Collaborative Servs., 132 S. Ct. at 1289 (2012).
- 23.
Id at 1294–95. See US Patent No. 6,355,623 col. 20:10–25 (“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”); US Patent No. 6,680,302, col. 20:24–43 (“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining a level of 6-thioguanine or 6-methyl-mercaptopurine in said subject having said immune-mediated gastrointestinal disorder, wherein a level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein a level of 6-thioguanine greater than about 400 pmol per 8x108red blood cells or a level of 6-methyl-mercaptopurine greater than about 7000 pmol per 8x108red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”).
- 24.
Id. at 1295.
- 25.
Id. at 1294.
- 26.
Id. at 1294, 1299–1300.
- 27.
See 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature, 3–4, 11–12 (2012).
- 28.
Id. at 10; see Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067–68 (Fed. Cir. 2011).
- 29.
35 U.S.C. §§102–103 (2011).
- 30.
35 U.S.C. § 102.
- 31.
37 C.F.R. § 1.99 (e) (2009). “A submission under this section must be filed within two months from the date of publication of the application (§1.215(a) ) or prior to the mailing of a notice of allowance (§ 1.311 ), whichever is earlier. Any submission under this section not filed within this period is permitted only when the patents or publications could not have been submitted to the Office earlier, and must also be accompanied by the processing fee set forth in § 1.17(i) . A submission by a member of the public to a pending published application that does not comply with the requirements of this section will not be entered.”
- 32.
35 U.S.C. § 102. The pre-AIA § 102 states “[a] person shall be entitled to a patent unless—(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(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 one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (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 twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122 (b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States 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 United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (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.”
- 33.
35 U.S.C. § 102 (a). The post-AIA §102 states “(a) NOVELTY; PRIOR ART.--A person shall be entitled to a patent unless-- (1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or (2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
- 34.
See Leahy-Smith America Invents Act (AIA), Pub. L. No. 112–29, 125 Stat. 284 (2011) (codified in scattered sections of 35 U.S.C.).
- 35.
The 35 U.S.C. § 103 was recently updated by the passage of the AIA. This amendment went into effect September 16, 2012. See id.
- 36.
MPEP § 2141.01 (8th ed. Rev. 9, Aug. 2012); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (explaining that a PHOSITA is “a person of ordinary creativity, not an automaton”); MPEP § 2144.
- 37.
MPEP § 2141.03. “Factors that may be considered in determining the level of ordinary skill in the art may include: (A) ‘type of problems encountered in the art;’ (B) ‘prior art solutions to those problems;’ (C) ‘rapidity with which innovations are made;’ (D) ‘sophistication of the technology; and’ (E) ‘educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate.”’ (Citing in re GPAC, 57 F.3d 1573, 1579 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 962 (Fed. Cir. 1986); Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983)).
- 38.
Eldred v. Ashcroft, 537 U.S. 186, 216 (2003).
- 39.
MPEP § 2164; 35 U.S.C. §112 (2011).
- 40.
MPEP § 201.11; New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294 (Fed. Cir. 2002) (finding that for a nonprovisional application to be afforded the earlier filing date of the provisional application “the specification of the provisional must ‘contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms,’ 35 U.S.C. § 112 ¶1, to enable an ordinarily skilled artisan to practice the invention claimed in the nonprovisional application”).
- 41.
37 C.F.R. § 1.53(c) (2009).
- 42.
37 C.F.R. § 1.9.
- 43.
35 U.S.C. §§ 111–113, 115. Post-AIA an entity can file a nonprovisional application without the inventor’s oath if the inventor is under obligation to assign the invention to the entity. 35 U.S.C. § 115(d).
- 44.
MPEP §§ 1801–1896 (8th ed. Rev. 9, Aug. 2012).
- 45.
There are currently 146 contracting countries. PCT, The International Patent System, WIPO, http://www.wipo.int/pct/en.
- 46.
AIA, Pub. L. No. 112–29, 125 Stat. 284, 285–293 (2011) (codified in scattered sections of 35 U.S.C.).
- 47.
Id.
- 48.
AIA, 125 Stat. at 293–297.
- 49.
37 C.F.R. § 1.99 (2009), MPEP § 1134.01.
- 50.
Id.
- 51.
35 U.S.C. § 122 (2011).
- 52.
Id.
- 53.
See Patent Search, Google, https://www.google.com/?tbm=pts; Search for Patents, United States Trademark and Patent Office, http://www.uspto.gov/patents/process/search/.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media New York
About this chapter
Cite this chapter
Samples, J.W., LaHatte, G. (2014). Considerations in Patenting New Surgical Devices for Glaucoma: The Changing Patent Law Landscape. In: Samples, J.R., Ahmed, I.I.K. (eds) Surgical Innovations in Glaucoma. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8348-9_6
Download citation
DOI: https://doi.org/10.1007/978-1-4614-8348-9_6
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-8347-2
Online ISBN: 978-1-4614-8348-9
eBook Packages: MedicineMedicine (R0)