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Biotech Buzz > Posts > BIOTECH BUZZ September, 2012
September 19
BIOTECH BUZZ September, 2012

BIOTECH BUZZ
September, 2012
 

Programs Subcommittee................................................................................................................................ 2
Annual Meeting, Marriott Wardman Park, Washington, DC, October 25 – 27, 2012..................... 2
Committee Social, Thursday, October 25, 6:00 – 7:30, Stone’s Throw........................................ 2
Thursday, October 25: IP Issues in Novel Financing of Biopharm Development........................ 2
Friday, October 26: Antibody Patents and Patenting Antibodies – US and EP............................ 2
Mid-Winter Institute, Tampa, FL, January 30 - February 2, 2013....................................................... 3
Biotech/Chemical/Pharma “Track” – January 31, 2013 –In-House Panels; Diagnostics............ 3
Webinar Subcommittee.................................................................................................................................. 4
Reprise of Annual Meeting Presentations, TBD..................................................................................... 4
Biosimilars in the US, Canada, and EU, September 25, 2012, 12:30 pm EDT.................................... 4
USPTO Subcommittee..................................................................................................................................... 4
Report and Slides from June Biotechnology & Chemical Partnership Meeting............................... 4
Case Law Reports............................................................................................................................................. 5
Akamai Techs., Inc. v. Limelight Networks, Inc., and McKesson Techs., Inc. v. Epic Systems Corp.... 5
Santarus, Inc. v. Par Pharmaceutical, Inc................................................................................................. 5
Diagnostics and Gene Patenting Subcommittee......................................................................................... 5
Personalized medicine white paper – volunteers still wanted........................................................... 5
AIPLA exploring “fix” for Bilski, Mayo, and Myriad – seeking member input................................... 5
International Issues Subcommittee............................................................................................................... 6
EU ruling liberalizes Supplementary Protection Certificate (SPC) system......................................... 6
Bolar exemption in Germany and Poland does not shield 3rd party manufacturers....................... 8
Brazil: New workflow proposed for pharmaceutical applications...................................................... 8
 

Programs Subcommittee

Annual Meeting, Marriott Wardman Park, Washington, DC, October 25 – 27, 2012  

Committee Social, Thursday, October 25, 6:00 – 7:30, Stone’s Throw

After the committee educational session on Thursday, October 25, committee members are planning to gather at the Stone’s Throw restaurant in the Marriott Wardman Park hotel for drinks, snacks, and casual socializing.  Please join us.  The reservation is under “Biotechnology.”  Many thanks to William Childs and Debora Plehn-Dujowich of Drinker Biddle & Reath LLP for organizing this event.

Thursday, October 25: IP Issues in Novel Financing of Biopharm Development

Funding for developing new drugs is tight and risk is high.  Creative financing and partnering structures are allowing companies to access funding to run clinical trials and generate new IP.  The objective of the session is to describe the novel arrangements and IP issues that patent attorneys need to know.  Please join us for a COMMITTEE EDUCATIONAL SESSION for 2 HOURS of CLE, jointly sponsored by the Biotechnology Committee and the Chemical Practice Committee. 
3:30-3:40 
Committee business
 
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3:40 – 4:00 
Overview of novel venture structures and financing arrangements
Joel Nied, Partner, LeClairRyan
 
4:30-5:00 
Big pharma partnerships with small biotech/pharma
Mike Warner, Pfizer, Assistant General Counsel
4:00-4:30
Venture Capital company approaches to investing in clinical development and generation of IP 
Vice President, IP, Flagship Ventures
5:00-5:30
Partnerships with government to commercialize new technologies 
Cindy Fuchs, Technology Development Coordinator and Patent Attorney for the National Institute of Diabetes and Digestive and Kidney Diseases
 

Friday, October 26: Antibody Patents and Patenting Antibodies – US and EP

Please join us for a COMMITTEE EDUCATIONAL SESSION for 2 HOURS of CLE, jointly sponsored by the Biotechnology Committee and the IP Practice in Europe Committee. 
 
The EP panel will explain and critique the EPO’s approach to inventive step and claim scope for antibodies. 
 
<> <> <>
Antibodies and the EPO
Andrew G. Smith
Ass’t General Patent Counsel
Eli Lilly and Company Limited
Erl Wood Manor
Windlesham, Surrey UK
International Antibody Patenting Strategy
Michalski • Hüttermann & Partner, Neuer Zollhof 2
D-40221 Düsseldorf DE
Patenting Antibodies in Europe
D Young & Co LLP
Briton House, Briton Street
Southampton SO14 3EB UK
 
 
The US panel will focus on compliance with 35 U.S.C. § 112(a) (written description).  A representative of the USPTO is being requested to explain its “antibody exception” to written description.  Confirmed panelists are Amy Hamilton of Eli Lilly and Company, Professor Chris Holman of the University of Missouri – Kansas City School of Law, and Hans Sauer of BIO.
 
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The PTO’s “Antibody Exception”
Kristi Swart (invited)
Solicitor’s Office
or  
George Elliott (backup)
Director 1640, 1650, Tech Support
A Corporate View
Amy E. Hamilton (confirmed)
Deputy General Patent Counsel
Eli Lilly and Company
 
An Academic View
Chris Holman (confirmed)
Associate Professor of Law
UMKC School of Law
An Industry View
Hans Sauer (confirmed)
Deputy General Counsel for IP
Biotechnology Industry Organization (BIO)
 

Mid-Winter Institute, Tampa, FL, January 30 - February 2, 2013

The theme of 2013’s MWI is the value of IP to business success.  “C-level” executives, general counsel, and general patent counsel from a wide range of companies have already agreed to attend, make keynote addresses and/or be on panels.  We expect many business people to attend. 
Florida in general and Tampa/St. Pete are loaded with biotech.  See BioFlorida’s BioPulse and eFlorida’s Life Science reports.  A report at BioFlorida’s site gives the following rankings for Florida’s bio companies:
• #2 for number of bioscience companies (5,102)
• #6 for bioscience employment (78,062)
• #1 in bioscience distribution companies (2,982)
• #2 in medical device companies (498)
• #4 in drugs & pharmaceuticals companies (155)
In additional to meeting in a bio-hotbed state and city, the temperatures in Tampa will be pleasantly warm – 75 – 80 °F (24 – 27 °C).  Join us in Tampa for a different kind of meeting. 

Biotech/Chemical/Pharma “Track” – January 31, 2013 –In-House Panels; Diagnostics

We are seeking participation from venture funders, private research institutions, the US government, and companies that develop and market diagnostics, medical devices, commodity chemicals, specialty chemicals, research tools, vaccines, biosimilars, and animal health products. Each panelist will have a few minutes to describe his/her company’s business.  A moderator will then ask questions to evoke information about and discussion of the role of IP (all IP, but with particular focus on patents) in protecting products and services.  One panel will have representatives from a range of companies in these industrial sectors. 
Diagnostics Panel.  Another panel will have business people or in-house counsel from entities involved in innovation and commercialization of diagnostics.  Judy Roesler of the Biotechnology committee will moderate this panel.  Topics will include how diagnostic products and services are commercialized without patent protection, IP prioritization strategies, budget considerations, licensing approaches, regional variations in IP strategies around the world, enforcement, freedom to operate issues, IP success stories, etc. 
In light of concerns that recent section 101 (eligibility) and 271(e)(1) cases would negatively affect correlation-based diagnostics and personalized medicine, the panel will provide business perspectives about the impact of recent cases on innovation and product development in the diagnostics industry.  The discussion could include consideration of legislative proposals.  We are seeking business people or in-house counsel from large and small diagnostics companies, component and kit providers, therapeutics-development companies, universities, and LDT businesses to be panelists.
Please contact Judy Roesler, Jim Kelley or Carol Nielsen if you know of business people or in-house counsel who would be great panelists.

Webinar Subcommittee

Reprise of Annual Meeting Presentations, TBD

The speakers at our Annual Meeting, discussed above, will reprise their presentations in a webinar on a date yet to be determined.  The presentations relate to antibody patenting in the US and Europe and novel venture financing for biotechs. 

Biosimilars in the US, Canada, and EU, September 25, 2012, 12:30 pm EDT

The Committee will present a webinar on the latest developments with respect to biosimilars on September 25, 2012, at 12:30 pm Eastern time.  The speakers will include Noel Courage of Bereskin Parr's Toronto office on Canada and the EU, John Engel of Engel & Novitt on the FDA guidance documents and other developments, and Denise Kettelberger of Faegre Baker Daniels' Minneapolis office on litigation-related topics.  An e-mail invitation went out on Tuesday, September 11, around 6:00 pm Eastern so please check your inbox or spam folder if you do not recall seeing it or contact Lynn Tyler for another copy.
 
The Committee expresses its sincere appreciation to our sponsors, Barnes & Thornburg, Bereskin Parr, and Engel & Novitt!!
 

USPTO Subcommittee

Report and Slides from June Biotechnology & Chemical Partnership Meeting

On September 5, several members attended the Biotechnology & Chemical Partnership meeting at the USPTO.  The USPTO’s slides and Suzannah Sundby’s report are available at our microsite.  Andrew Hirshfield, Deputy Commissioner for Patent Examination Policy, gave a presentation on recent examiner training and developments under 35 U.S.C. 101.  William Covey, OED, presented on OED misconduct issues and the recent final rule covering such.  Sally Lane, APJ PTAB, covered the final rules for administrative trials, and Hiram Bernstein, OPLA, covered the final rules for inventor oath/declarations.  Mary Till, OPLA, gave a presentation on the proposed first-to-file rules.  Martin Rater, Office of Patent Quality Assurance, gave a presentation on how the USPTO reviews the quality of its patent processing and examination.  Esther Kiplinger, Chief Patent Counselor, Wilson Sonsini Goodrich & Rosati, gave a presentation on civility and best practices in prosecution.  If you want the USPTO to address an issue in a BCP meeting, please let Suzannah Sundby or Julie Meigs know or send your ideas to Cecilia Tsang at the USPTO.
The next BCP meeting is expected a joint session with the Medical Device group and is expected to be December 5, 2012. 

Case Law Reports

Akamai Techs., Inc. v. Limelight Networks, Inc., and McKesson Techs., Inc. v. Epic Systems Corp.

Case Nos. 2009-1372 and 2010-1291 (Fed. Cir. Aug. 31, 2012) (holding “that all the steps of a claimed method must be performed in order to find induced infringement, but that it is not necessary to prove that all the steps were committed by a single entity”).  Reported by Lynn C. Tyler and Jennifer L. Schuster, Barnes & Thornburg LLP, Indianapolis, IN.
 

Santarus, Inc. v. Par Pharmaceutical, Inc.

Case Nos. 2012-1360, 2012-1380 (Fed. Cir. Sept. 4, 2012) (holding that adequate support for a negative claim limitation was present when the specification described a reason to exclude the negative limitation).  Reported by Debora Plehn-Dujowich, Drinker Biddle & Reath LLP, Philadelphia, PA.

Diagnostics and Gene Patenting Subcommittee

Personalized medicine white paper – volunteers still wanted

The Diagnostics and Gene Patenting Subcommittee is preparing a white paper titled IP Issues Relating to Personalized Medicine.  The leaders of this effort would welcome additional volunteers to assist with drafting and editing.  If you are interested, please contact the appropriate Section Leader:
 
Section I: Discussion on Prometheus v. Mayo Decision, including USPTO guidelines and a focus on how the holding may impact bioinfomatics IP; Section Leader:  Ling Zhong, Ph.D., Esq.  RatnerPrestia
 
Section II: Discussion on Myriad decision; Section Leader:  Karen Canady, Ph.D., Esq.  canady+lortz LLP
 
Section III: Discussion on Confirmatory Genetic Testing, including aspects of regulatory and legislative activity in diagnostics that may impact IP for genetic testing used in personalized medicine; Section Leader:  Judy Roesler, Esq.  Roesler Law Offices, PLLC

AIPLA exploring “fix” for Bilski, Mayo, and Myriad – seeking member input

The Legislative Subcommittee of AIPLA’s Patent Law committee is exploring potential legislative “fixes” for the Bilski, Mayo, and Myriad decisions.  Biotechnology committee members Ling Zhong, Suzannah Sundby, Denise Kettelberger, and Eric Mirabel are actively involved in this effort. 
 
Several proposals can be found at the Patent Law microsite:
  1. Delete Section 101 altogether.
  2. Amend 101 by replacing “Whoever invents or discovers” with “Whoever claims” and delete the terms “new and” each time it occurs.
  3. Amend 101 by adding to the list of subject matter categories after “compositions of matter” the phrase “, including diagnostic and personalized medicine inventions.”
  4. Add the following to the end of 101:
 An invention that produces a useful, concrete, and tangible result shall not be denied eligibility for a patent on the ground that it is directed to a law of nature, natural phenomenon, or abstract idea.
  1. Add the following to the end of 101:
A determination of patentability under this section shall be made upon subject matter being otherwise determined as patentable under sections 102, 103, and 112 of this title. For the purposes of patentability determinations made under sections 102, 103, and 112 of this title, patentability under this section is presumed.
  1. Rewrite 101 as follows:
(a)     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 therefor, subject to the conditions and requirements of this title.
(b)     (1) Claimed inventions that recite laws of nature, natural phenomena, or abstract ideas without applying them to useful purposes are not eligible for patent protection.
(2) A determination under (b)(1) shall be on the basis of the claim as a whole.
(3) A determination under (b)(1) shall not be negated by considerations of post-solution activity or technological environment.
  1. Amend the AIA §102 by adding a new paragraph (e) as follows:
 (e) Conditions for patentability and novelty shall not be part of a determination of patent eligibility under §101.
  1. Amend the AIA §102 by adding a new paragraph (e) as follows:
(e) Claimed inventions that satisfy the conditions of patentability under §§102, 103, and 112 by reciting laws of nature, natural phenomena, or abstract ideas without applying them to useful purposes are not eligible for patent protection.
 
If you have a proposal, please provide it to one of the Biotech committee representatives or to Lance Reich, a member of the Patent Law Legislative Subcommittee.  You will eventually be able to make comments at the Patent Law microsite. 
 

International Issues Subcommittee

EU ruling liberalizes Supplementary Protection Certificate (SPC) system

Contribution by René Raggers, EP&C, Utrecht, The Netherlands
On July 19, 2012, the eagerly-awaited judgment of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Pharmaceuticals was issued. It is believed by many experts that the CJEU's judgment will have a liberalizing effect on the granting of supplementary protection certificates and presents new opportunities for extending patents through SPC filings.
The CJEU decided on a reference made in a dispute between Neurim Pharmaceuticals and the UK Intellectual Property Office (UKIPO). The latter had refused to grant an SPC based on a marketing authorisation granted in June 2007 for "Circadin". Circadin is a formulation of melatonin for use as a medicinal product for human use for insomnia, which was covered by a European Patent.
The refusal by the UKIPO was because it had identified an earlier veterinary marketing authorisation for the same active ingredient for medical use in sheep to regulate breeding activity, and therefore, Neurim's marketing authorisation for Circadin was not the first marketing authorisation to place the active ingredient melatonin on the market.
The CJEU was asked for a preliminary ruling on the question which marketing authorisation is to be regarded as being a "first" marketing authorisation in the sense of Articles 3 and 13 of the SPC Regulation.
The CJEU clarified that the mere existence of an earlier marketing authorisation as such does not preclude the grant of an SPC, as long as the marketing authorisation concerns a different application of the same product for which a marketing authorisation has been granted (C-130/11, item 1 of the Court's ruling).
The Court ruled:
1.      Articles 3 and 4 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.
2.      Article 13(1) of Regulation (EC) No 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.
3.      The answers to the above questions would not be different if, in a situation such as that in the main proceedings where the same active ingredient is present in two medicinal products having obtained successive marketing authorisations, the second marketing authorisation required a full application in accordance with Article 8(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, or if the product covered by the first marketing authorisation of the corresponding medicinal product is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant.
Paragraph 25 of the judgment states: "Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product." (emphasis added)

Bolar exemption in Germany and Poland does not shield 3rd party manufacturers

Contribution by René Raggers, EP&C, Utrecht, The Netherlands
This summer, the Regional Court in Düsseldorf (Germany) and the Higher Regional Court in Gdansk (Poland) ruled that the Bolar exemption and the experimental-use exemption only apply to the party doing the testing. A third party that manufactures and sells to the testing party is not exempted.
In the case at hand, a Polish manufacturer placed advertisements for an active ingredient protected by a patent, and sold the active ingredient to generic companies, also in Germany. When the patentee sued the Polish manufacturer, the manufacturer argued that its activities are exempted by the Bolar exemption since the generic companies were going to use the active ingredient for testing purposes only.
Both the German and the Polish court however rejected this argument; as long as the third party cannot be seen as a co-organizer of the trials, the sales of the active ingredient is a commercial exploitation and a clear-cut case of patent infringement.

Brazil: New workflow proposed for pharmaceutical applications

Contribution by Benny Spiewak, Zancaner Costa, Bastos e Spiewak Advogados, São Paulo Area, Brazil
On May 24, 2012 the Brazilian Official Gazette published Inter-Ministerial Ruling no. 1056, which reports the outcome of the working group formed by the Brazilian Ministry of Health (MoH), the Ministry of Industry & Development (MDIC) and the Office of the Federal Attorney General (AGU). In brief, the working group suggests a new workflow for the assessment/review of certain patent applications.
The report recommends that, before being analyzed by the Brazilian Patent Office, MDIC´s INPI (Industrial Property Institute), all patent applications claiming pharmaceutical products and/or processes are to be initially assessed by ANVISA, i.e. the MoH's Health Agency. If ANVISA grants its approval to the patent application, then it will be assessed by the INPI.
The working group's report does not elaborate on the matter and does not, for instance, set appeal mechanisms, should ANVISA deny granting its approval. Whilst there are no timelines established by the Inter-Ministerial Ruling no. 1056, it requires both ANVISA and INPI to further develop specific pieces of regulation, establishing the conditions upon which the suggested workflow would effectively be performed. Such an update is of relevance, as it ratifies Brazil's controversial "dual examination" system, which is challenged by certain players for its alleged incompatibility with Brazil's obligations under TRIPS. In addition, ANVISA and INPI do not share the same approach towards patentability requirements. Finally, Inter-Ministerial Ruling no. 1056 jeopardizes the chances of having ANVISA's competence restricted to health-related, regulatory aspects of products. Local players and institutions are analyzing the consequences of the published ruling.

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