1 / 10

Protecting Biotechnological Processes

Protecting Biotechnological Processes. Similarities and differences in the interpretation of the patent before the European Patent Office, US Patent Office and Japanese Patent Office. Diversity of what is patentable.

maverick-robertson
Download Presentation

Protecting Biotechnological Processes

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ProtectingBiotechnological Processes Similarities and differences in the interpretation of the patent before the European Patent Office, US Patent Office and Japanese Patent Office Perani Mezzanotte & Partners

  2. Diversity of what is patentable • In Europe (art.52.1 EPC) and Japan (Art. 29): an invention must be new, inventive and have industrial applicability • In the USA: “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter… may obtain a patent therefor” (35U.S.C 101) Perani Mezzanotte & Partners

  3. Diversity of patentability criteria: • Novelty • In Europe: absolute novelty (Art. 54 EPC) • In USA: relative novelty (35 U.S.C. 102) • In Japan: relative novelty (Artt. 29.1 and 30 of the patent law) • Novelty of proteins in US and EP Perani Mezzanotte & Partners

  4. Diversity of patentability criteria: • Inventive step and non-obviousness: • there is a similar approach in Europe (Art.56 EPC), in the United States (35 U.S.C. 103) and in Japan (Art. 29.2 of the Japanese law); assessment made by the skilled person • Inventive step of proteins in US (ex parte Gray) and EP (Amgen case: T0412/93) Perani Mezzanotte & Partners

  5. Unity of invention:new Biotechnological Process/new Biotechnological product • Japan: Current section 37 and 25.8 of Patent Law (applicable to the applications filed after 1 Jan 2004) Where there are two or more inventions, they may be filed in a single patent application provided that these inventions has a technical relationship defined by an ordinance of the competent Ministry, according to which two or more inventions must be linked so as to form a single inventive concept by having the same or corresponding technical features among them • Europe: Art. 82 EPC The European patent application shall relate to one invention only or a group of inventions so linked as to form a single general inventive concept • USA: restriction Practice 35 U.S.C. 121 “If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions” and 37 CFR 1.141 Perani Mezzanotte & Partners

  6. Interpretation of the scope of the process claim • Europe: if the subject- matter is a process, the protection conferred by the patent shall extend to the products directly obtained by such process (Art. 64.2 EPC) • USA: “Process Patent Protection Act” It is an act of infringement to make, use, sell, offer to sell or import a product “made” using a process patent in the United States, if such manufacture, use, sale or importation occurs during the term of the US patent. • Japan: Art. 68: a Patentee shall have an exclusive right to “commercially work” the patented invention, where Art. 2(3)(iii) defines as “working” acts of using, assigning, leasing, importing or offering … etc. the product manufactured by the patented process Perani Mezzanotte & Partners

  7. “product-by-process” • European Patent Office: these claims confer protection upon the product regardless of the process by which it is prepared and defined (Amorphous TPM/Enichem T0020/94; Guidelines for Examinations, part C, Chapter III, 4.7.b). • United States Office: these claims are admitted and issued if the product is new regardless of the definition of the steps of the process. In spite of this Perani Mezzanotte & Partners

  8. “product-by-process” • United States Office: the US courts tend to interpret and limit the claim “product-by-process” to the sole process. • Atlantic Thermoplastic vs Fatex • Scripps Clinic vs Genetech • Japan: “Identical Product Theory” Perani Mezzanotte & Partners

  9. Sufficiency of disclosure • European Patent Office: “The European patent application must disclose the invention in a manner sufficiently clear and complete to be carried out by a person skilled in the art” Art. 83 EPC • United States Patent Office: The requirement of “enabling” the invention 35 U.S.C. 112 • Japanese Patent Office: Revised Guidelines (applicable to application examined after October 2003): a sustantial interrelation between the description and claims and not phraseological correspondence Perani Mezzanotte & Partners

  10. Thank You for your attention... Elisabetta CATTANEO Perani Mezzanotte & Partners ecattaneo@perani.com Perani Mezzanotte & Partners

More Related