<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article  PUBLIC "-//NLM//DTD Journal Publishing DTD v3.0 20080202//EN" "http://dtd.nlm.nih.gov/publishing/3.0/journalpublishing3.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" dtd-version="3.0" xml:lang="en" article-type="research article"><front><journal-meta><journal-id journal-id-type="publisher-id">BLR</journal-id><journal-title-group><journal-title>Beijing Law Review</journal-title></journal-title-group><issn pub-type="epub">2159-4627</issn><publisher><publisher-name>Scientific Research Publishing</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.4236/blr.2014.52011</article-id><article-id pub-id-type="publisher-id">BLR-47125</article-id><article-categories><subj-group subj-group-type="heading"><subject>Articles</subject></subj-group><subj-group subj-group-type="Discipline-v2"><subject>SOCIAL SCIENCES &amp; HUMANITIES</subject></subj-group></article-categories><title-group><article-title>Necessity, Criteria (Requirements or Limits) and Acknowledgement of Product Identity of Claims for Product Described by Its Manufacturing Process (Product-by-Process Claims)</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Kotaro</surname><given-names>Kageyama</given-names></name><xref ref-type="aff" rid="aff1"><sub>1</sub></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Kageyama International Law &amp; Patent Firm, Tokyo, Japan</addr-line></aff><author-notes><corresp id="cor1">* E-mail:<email>kageyamalaw@gmail.com</email></corresp></author-notes><pub-date pub-type="epub"><day>23</day><month>06</month><year>2014</year></pub-date><volume>05</volume><issue>02</issue><fpage>114</fpage><lpage>129</lpage><history><date date-type="received"><day>15</day>	<month>March</month>	<year>2014</year></date><date date-type="rev-recd"><day>12</day>	<month>April</month>	<year>2014</year>	</date><date date-type="accepted"><day>4</day>	<month>May</month>	<year>2014</year></date></history><permissions><copyright-statement>&#169; Copyright  2014 by authors and Scientific Research Publishing Inc. </copyright-statement><copyright-year>2014</copyright-year><license><license-p>This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/</license-p></license></permissions><abstract><p>
	It is
inevitably necessary to admit Product-by-Process claims (PBP claims). To make
them effective, their requirements and limits should be clarified, and the
methods to define the product and acknowledge the identity of the product in
their practical exercise should be studied. The author has suggested the
following two view points to examine inventions, 1) considering the difficulty
to predict an invention from the tentative principles and 2) categorizing
inventions into the physicalobject type and the material type. Based on these
two viewpoints, this paper will show the case where the PBP claims are
inevitable. From the above and its opposite side, the criteria for the PBP
claims will be proposed by analyzing the category of inventions, requirements
of manufacturing process steps and the limits of admitting the PBP claims. The
following theory will be composed of: the scope of the PBP claims should
include their identical product to the product described in the claim through
the process of the patent applications and infringement cases because of the
legal stability. Then, the methods of determining the time to define the
product by way of structure or properties and acknowledging the identity of the
product, in the practical exercise of the claims will be suggested. 
</p></abstract><kwd-group><kwd>Product-by-Process Claims</kwd><kwd> Process Limitation Theory &amp; Identical Product Theory</kwd><kwd> An Inventions Formed through Experiments</kwd><kwd> Formation Stages of an Invention</kwd><kwd> Abbott Laboratories v. Sandoz</kwd><kwd> Inc.</kwd><kwd> 566 F.3d 1282 (Fed. Cir. 2009)</kwd></kwd-group></article-meta></front><body><sec id="s1"><title>1. Introduction”<sup>10</sup>.</title><p>(3) Burden of proof</p><p>The person who alleges the claim to be a Genuine PBP claim should prove that it is “impossible or difficult” to define the product directly by its structure or properties as mentioned earlier. If the person is unable to prove it, the claim should be construed as a Quasi PBP claim under the principle that the claims should be construed as it is described.</p><p>In the aforementioned judgment, the court found that the patent is invalid because the product lacks inventiveness. Further, the court held that the claims should be construed under the Process Limitation Theory as Quasi PBP claims (see <xref ref-type="fig" rid="fig4">Figure 4</xref>).</p><p>2. Relationship with examination practice</p><p>The examination standards were set as follows in October 2003: “where it is impossible, difficult or inappropriate for some reason to define the structure of the product which is the subject matter of the invention directly by its properties and so forth, without reference to the manufacturing process thereof, then the product itself may be defined by the manufacturing process thereof”.</p><p>In the current examination standards set in September 2011, the adoption of the Identical Product Theory was clarified.</p><p>As mentioned in (3.4), it would be the most reasonable if the claims are construed consistently by the Identical Product Theory from the examination of application to the infringement suit.</p><sec id="s1_1"><title>6.3. Court Decisions and Examination Practice in EU (The UK, Germany)</title><p>1. Court decisions of patent infringement cases in the UK and Germany</p><p>Construction in infringement cases, which is a problem related to derived right, should be in accordance with laws of respective designating states.</p><p>(1) The UK</p><p>Judgment on Kirin-Amgen Inc v. Hoechst Marion Roussel Ltd. (2004).</p><p>The PBP claims at issue were Claims 19 and 26. The judgment found, according to Paragraph 132 thereof, “I would… revoke the patent on the ground that claim 19 is insufficient… and claim 26 is anticipated”, and states that “Hence the patenting of the two product-by-process claims which have failed”. Some people argue that this judgment construes PBP claims under the Process Limitation Theory (Grant &amp; Smyth, 2010). They adopted the Process Limitation Theory, stating that “if a claim contains limiting parameters, why should not the patentee be taken at their word when it comes to deciding the extent of protection? However, as the claims at issue were not acknowledged as PBP claims, it can be assumed that the judgment just presented the scope of claims of common European patents in the UK, rather than the construction of the scope of PBP claims.</p><p>In other words, under this UK case, the patent was found invalid just as in the case of the aforementioned IP High Court Decision of January 2012, and the claims at issue should be construed as Quasi PBP claims as used in the said IP High Court Decision. Therefore, this UK case cannot serve as a judicial precedent on whether a Genuine PBP claim should be construed under the Identical Product Theory or the Process Limitation Theory<sup>11</sup>.</p><p>(2) Germany</p><p>It has been held that “tendency in Germany remains in favour of the general proposition that process terms are not limiting when considering infringement. A recent decision of the Federal Supreme Court (Thermoplastische Zusammensetzung Xa ZR 100/05-25.2.2010) affirms the view that when assessing infringement, process terms in a claim might not limit the scope of protection” (Grant &amp; Smyth, 2010). Also, Ryuichi Shitara states that “In Europe and Germany, only the Genuine PBP claims are admitted, and the technical scope of the claim and the acknowledgement of content of the claim are construed under the Identical Product Theory” (Shitara, 2013).</p><p>2. Examination standards under EPC (European Patent Convention)</p><p>The “Guidelines for Examination in the European Patent Office (2012)” provides the following with regard to PBP claims (PART F Chapter IV 4.12).</p><p>Claims for products defined in terms of a process of manufacture are allowable only if the products as such fulfill the requirements for patentability. A claim defining a product in terms of a process is to be construed as a claim to the product as such. The burden of proof for an allegedly distinguishing “product-by-process” feature lies with the applicant.</p></sec></sec><sec id="s2"><title>7. Reasonability of Clarification of Invention and Patent-Related Issues by Opinions</title><sec id="s2_1"><title>7.1. Reason to Enable to Provide Grounds of PBP Claims under the Opinions</title><p>When the structure of the product in the invention is unknown, one of the reasonable methods to clarify such structure would be to analyze and examine from (a) the way the invention, which is cognizable by human being, appears (the external appearance, nature) and (b) the process by which an invention is formed because a human being is involved in the production of such invention. The aforementioned (a) is the viewpoint suggested in Opinion 2, and the aforementioned (b) constitutes the viewpoint suggested in Opinion 1. The key point of Opinion 1 is the “(tentative) principle”.</p></sec><sec id="s2_2"><title>7.2. Clarification of Patent-Related Issues Concerning the Formation of an Invention, etc. by the Opinions</title><p>The Opinions suggest additional views from technological and natural-scientific aspects for examining patent- related issues, which had been conventionally examined from social-scientific views only. Further, as mentioned in (7.1), they are reasonable viewpoints to examine the content of inventions from the way in which the invention appears and the process by which the invention is formed.</p><p>Therefore, the Opinions may be useful to resolve the patent-related issues other than the issues discussed in this article and the issues of recognizing an inventor/joint inventors and calculation of contribution ratios between joint inventors as discussed in the Joint Inventor Article, especially for the patent-related issues involving the way in which an invention appears, formation of an invention, and content of an invention.</p></sec></sec></body><back><ref-list><title>References</title><ref id="scirp.47125-ref1"><label>1</label><mixed-citation publication-type="other" xlink:type="simple">ABBOTT LABORATORIES V. SANDOZ, INC. (2009). 566F.3D1282 (FED.CIR.2009); 90U.S.P.Q. 2D1769.</mixed-citation></ref><ref id="scirp.47125-ref2"><label>2</label><mixed-citation publication-type="journal" xlink:type="simple"><name name-style="western"><surname>GRANT</surname><given-names> G.</given-names></name>,<name name-style="western"><surname> &amp; SMYTH</surname><given-names> D. </given-names></name>,<etal>et al</etal>. (<year>2010</year>)<article-title>. THE PROTECTION CONFERRED BY PRODUCT-BY-PROCESS CLAIM</article-title><source> EUROPEAN INTELLECTUAL PROPERTY REVIEW</source><volume> 32</volume>,<fpage> 635</fpage>-<lpage>642</lpage>.<pub-id pub-id-type="doi"></pub-id></mixed-citation></ref><ref id="scirp.47125-ref3"><label>3</label><mixed-citation publication-type="other" xlink:type="simple">HANREIJIHO (1999). NO. 1671, 137-144. (“HANREIJIHO” AND “HANREI TIMES” ARE THE NAMES OF A JAPANESE CASE LAW JOURNAL).</mixed-citation></ref><ref id="scirp.47125-ref4"><label>4</label><mixed-citation publication-type="other" xlink:type="simple">HANREI TIMES (1999). NO. 990, 244-251. (“HANREIJIHO” AND “HANREI TIMES” ARE THE NAMES OF A JAPANESE CASE LAW JOURNAL).</mixed-citation></ref><ref id="scirp.47125-ref5"><label>5</label><mixed-citation publication-type="other" xlink:type="simple">HANREIJIHO (2012). NO. 2144, 51-80 (“HANREIJIHO” AND “HANREI TIMES” ARE THE NAMES OF A JAPANESE CASE LAW JOURNAL).</mixed-citation></ref><ref id="scirp.47125-ref6"><label>6</label><mixed-citation publication-type="journal" xlink:type="simple"><name name-style="western"><surname>KAGEYAMA</surname><given-names> K. </given-names></name>,<etal>et al</etal>. (<year>2012</year>)<article-title>. THE PRACTICE OF RECOGNIZING AN INVENTOR/JOINT INVENTORS AND CALCULATION OF CONTRIBUTION RATIOS AMONG JOINT INVENTORS</article-title><source> JOURNAL OF INTELLECTUAL PROPERTY LAW &amp; PRACTICE</source><volume> 7</volume>,<fpage> 590</fpage>-<lpage>603</lpage>.<pub-id pub-id-type="doi">HTTP://DX.DOI.ORG/10.1093/JIPLP/JPS090</pub-id></mixed-citation></ref><ref id="scirp.47125-ref7"><label>7</label><mixed-citation publication-type="other" xlink:type="simple">KIRIN-AMGEN INC V. HOECHST MARION ROUSSEL LTD. (2004). UKHL 46. JAPANESE TRANSLATION IN “DECEMBER 2004 EDITION OF EUROPEAN IP NEWS”.</mixed-citation></ref><ref id="scirp.47125-ref8"><label>8</label><mixed-citation publication-type="journal" xlink:type="simple"><name name-style="western"><surname>MACEDO</surname><given-names> C. R. </given-names></name>,<etal>et al</etal>. (<year>2009</year>)<article-title>. INFRINGEMENT OF PRODUCT-BY-PROCESS CLAIMS IN US CLARIFIED</article-title><source> JOURNAL OF INTELLECTUAL PROPERTY LAW &amp; PRACTICE</source><volume> 4</volume>,<fpage> 608</fpage>-<lpage>611</lpage>.<pub-id pub-id-type="doi">HTTP://DX.DOI.ORG/10.1093/JIPLP/JPP119</pub-id></mixed-citation></ref><ref id="scirp.47125-ref9"><label>9</label><mixed-citation publication-type="journal" xlink:type="simple"><name name-style="western"><surname>NANJO</surname><given-names> M. </given-names></name>,<etal>et al</etal>. (<year>2002</year>)<article-title>. CONSTRUCTION OF RIGHTS BASED ON PRODUCT-BY-PROCESS CLAIMS</article-title><source> PATENT</source><volume> 55</volume>,<fpage> 21</fpage>-<lpage>28</lpage>.<pub-id pub-id-type="doi"></pub-id></mixed-citation></ref><ref id="scirp.47125-ref10"><label>10</label><mixed-citation publication-type="other" xlink:type="simple">SHITARA, R. (2013). STUDIES ON ACKNOWLEDGMENT OF CONTENT AND CLAIM CONSTRUCTION OF PRODUCT-BY-PROCESS CLAIM—IN RESPONSE TO THE DECISION OF INTELLECTUAL PROPERTY HIGH COURT SPECIAL DIVISION ON JANUARY 27, 2012. LEGAL PRINCIPLES AND PROPOSAL ON INTELLECTUAL PROPERTIES; MEMOIRS OF CELEBRATION IN HONOR OF FORMER JUDGE TOSHIAKI MAKINO’S EIGHTIETH BIRTHDAY. (NOBUHIRO NAKAYAMA, HIROSHI SAITO, AND TOSHIAKI IMURAED. SEIRINSHOIN), 295.</mixed-citation></ref></ref-list></back></article>