Patent Docs

USPTO Continues to Expand Patent Prosecution Highway

By Donald Zuhn --

USPTO and ROSPATENT Begin Patent Prosecution Highway Pilot Program

On Monday, the U.S. Patent and Trademark Office announced that it had agreed to partner with the Federal Service for Intellectual Property, Patents and Trademarks of the Russian Federation (ROSPATENT) in establishing a Patent Prosecution Highway (PPH) pilot program.  As with other PPH programs, the USPTO-ROSPATENT PPH will permit an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from either ROSPATENT or the USPTO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.

The USPTO-ROSPATENT PPH pilot program will begin on September 1, 2010, and continue for one year.  USPTO requirements for participation in the USPTO-ROSPATENT PPH pilot program can be found here, and ROSPATENT requirements for participation in the program can be found here.  A form for making a PPH request in the USPTO will be available on September 1 on the USPTO-ROSPATENT PPH webpage.

USPTO Director David Kappos noted that "[a]s the USPTO and other patent offices throughout the world face challenges of increased patent filings and growing backlogs, it is important that we work together to find ways to streamline processing and avoid redundancy."  According to Director Kappos, PPH programs are "an important step toward the goal of maximizing reutilization of work done by other offices."  ROSPATENT Director General Dr. Boris Simonov said that the PPH would help decrease the backlogs of unexamined patent applications in both offices as well as establish international standards of carrying out patent search and examination.

USPTO-NBPR PPH Continued

On July 1, the USPTO announced that the PPH pilot program between the USPTO and the National Board of Patents and Registration of Finland (NBPR), which began on July 6, 2009 (see "USPTO Initiates Patent Prosecution Highway Pilot Program with Finland Patent Office"), was being extended past the original July 6, 2010 deadline.  The USPTO notice indicated that the offices had agreed to continue the program in order to collect more information before making any formal decision regarding the program.

USPTO and HPO Launch PPH Pilot Program

On June 30, the USPTO announced that it had agreed to establish a PPH pilot program with the Hungarian Patent Office (HPO).  The USPTO-HPO PPH was the eleventh such program established by the USPTO over the past four years (with the USPTO-ROSPATENT PPH becoming the twelfth).  Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), HPO, and ROSPATENT.

The USPTO-HPO PPH pilot program began on July 1, 2010.  The program will continue for a period of one year, at which time the pilot may be extended for one additional year in order to adequately assess the program's feasibility.  The USPTO and HPO will evaluate the results of the pilot program to determine whether and how the program should be fully implemented after the trial period.  USPTO requirements for participation in the USPTO-HPO PPH pilot program can be found here.  In addition, the 12-page notice provides thirteen examples (with figures) of applications that would satisfy the requirements.

USPTO Eliminates PPH Fee to Make Special

In May, the USPTO published a notice in the Federal Register (75 Fed. Reg. 29312) announcing the elimination of the fee for the petition to make special under the PPH programs.  Prior to May 25, an applicant wishing to enter one of the PPH programs was required to pay the petition fee under 37 C.F.R. § 1.17(h).  According to the notice, "[t]he elimination of the petition fee . . . is expected to encourage greater PPH participation."

The notice indicates that "PPH applications have proven, on average, to take significantly less time to prosecute than non-PPH applications."  Stating that "[t]he PPH has proven to be a useful work-sharing vehicle," the notice presents some statistics in support of this assessment, noting that more than 2,500 PPH requests had been received as of February 2010, that the first action allowance rate (25%) and overall allowance rate (93%) for PPH applications is about double that of non-PPH applications, and that the average number of actions per disposal (1.7) for PPH applications is "significantly less" than that for non-PPH applications.

Mexican Patent Office Excludes Formulation Patents from Linkage Gazette

By Alejandro Luna --

On Friday, August 13, 2010, the Mexican Trademark and Patent Office (IMPI) made available through its website the new edition of the Linkage Gazette (Mexican health and IP law regulations require IMPI to publish a gazette every six months listing patents in force that cover allopathic drugs).  Regrettably, IMPI decided to exclude formulation patents, limiting the inclusion criteria to compound patents.  There are formulation patents included in the list derived from individual Court orders in litigation proceedings where the non-inclusion of specific formulation patents in the Gazette was contested.

The current non-inclusion of formulation patents disregards a petition by the Pharmaceutical Association of R&D companies (AMIIF), and does not follow the jurisprudence of the Mexican Supreme Court ruling that formulation patents are to be included in the Linkage Gazette (see "Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations").

Legally, as an administrative authority, IMPI is not bound to follow judicial precedents; nevertheless, there is broad dissatisfaction with the political decision taken by IMPI regarding the denial to include formulation patents in the Linkage Gazette, since following the Supreme Court's criterion would have avoided further litigation from patent holders.

The non-inclusion of valuable formulation patents can be contested within the next fifteen working days.  Any litigation proceeding at this point will benefit from Supreme Court precedent, which is mandatory for District and Circuit Courts and provides guidelines to decide these cases.

Of course, inclusion of formulation patents in the Linkage Gazette provides grounds to prevent or challenge marketing authorizations granted to third parties in violation of formulation patents which in many cases have expiration dates beyond the initial compound patent.

Additionally, inclusion of formulation patents is pivotal, as the formulation of drugs is reviewed by the Regulatory Authority (COFEPRIS) upon studying applications for marketing authorizations.  Since safety and efficacy of a drug reviewed by COFEPRIS is not limited to compounds, there is no rationale to limit the linkage regulation to compound patents by the linked authorities (IMPI and COFEPRIS), particularly when the highest Court in México has decided that formulation patents for allopathic medicines including an identified compound should be included in the Gazette.

A copy of the Gazette can be found here.

Alejandro Luna is a partner at Olivares & Cia in Mexico.  He can be contacted at alf@olivares.com.mx.

COFEMER and AMELAF Comment on Biotech Regulations in Mexico

By Juan Serrano --

Following up on the note for future regulations to approve biotechnological drugs in Mexico (see "Mexico to Issue Regulations for Approval of 'Biocomparable' Drugs"), documents with comments have been uploaded to the official website of the Federal Commission for Regulatory Improvement (COFEMER).

The first of these documents is an official communication from COFEMER to COFEPRIS (the authority which oversees approvals) referring to the regulatory impact that the provisions will have, which was made public on August 9, 2010.  COFEMER is requesting, amongst other things, the following:

- A justification for the elimination of the 3-year period in the Roche-Bolar-like research exemption in order to verify compliance of provisions in the Industrial Property Law.

- Justification for each requirement to approve biocomparable drugs.

- Additional information on cost impacts that the new regulations will have on industry participants.

- Additional information on reductions of public health expenditures derived from the regulations.

This communication has been delivered by COFEPRIS which will have to make the necessary justifications and adjustments to its proposal, before submitting anew to COFEMER.  There is no specific deadline contemplated for this purpose.  After the project is revised, if modifications are made, a new 30-day period will be granted to the general public to provide comments.

The second document contains a review by the Mexican Association of Pharmaceutical Laboratories (AMELAF) with a proposal for modifications to the project of regulations.  In this proposal, the main items are the following:

- Concerning the Roche-Bolar-like exemption, AMELAF is proposing to change the wording in order for linkage review by COFEPRIS to be made only in regards to the first "molecule" (active ingredient) patent, which would be applicable both to biotech and chemical drugs.  This goes directly against the decision by the Mexican Supreme Court, which interpreted linkage regulations to include patents covering pharmaceutical formulations as well (see "Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations").  This specific proposal is very likely to be contended by AMIIF, and/or individual patent holders.

- AMELAF is also proposing to make most regulatory requirements for the approval of a biocomparable drug subject to the discretion of the Ministry of Health on a case by case basis.  The current project contains mandatory pre-clinical and clinical trials, pharmacodinamics studies, immunity response studies in animals and in vivo studies.  The proposal by AMELAF is to make all of these requirements applicable "if necessary."

Whereas this proposal could have some merit in order to avoid studies that would prove to be unnecessary for specific drugs, it should be allowed only if a correlating provision providing for regulatory exclusivity is passed, in order to maintain a balance between the innovators making the initial studies and subsequent market entrants.  No such provision is contained in the project.

- Additionally, AMELAF is proposing that the term for COFEPRIS to approve a biotech drug be reduced from 235 to 180 working days, and that, if that term expires without a response, then the application is understood as granted.  This last item is not likely to be approved, as it could result in the authorization of drugs without full review of the applications by the corresponding authority, which might generate sanitary risks.

A copy of the two documents mentioned in this article can be found here.

Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs.  He can be contacted at jls@olivares.com.mx.

Argentine Patent Office Issues Regulation Restricting Divisional Filings

    By Ignacio Sanchez Echagüe --

The Argentine Patent Office (Instituto Nacional de la Propiedad Industrial, INPI) has issued Regulation No. 147/2010, which restricts the ability of applicants to file divisional applications once substantive examination has begun.

The regulation, which went into effect on July 16, 2010, allows applicants to file divisional applications until notice of substantive examination has been served.  No divisional applications will be allowed thereafter, unless they are made in response to a request from the Argentine Patent Office.  Once substantive examination has begun, if the examiner finds that the application has more than one object, the applicant will be requested to divide it within 30 days; should the applicant fail to do so, the application will be deemed as having been abandoned.  In all cases, the basic application must be alive and pending.

This new regulation modifies the prior practice of the Argentine Patent Office, which allowed applicants to file divisional applications at any time during prosecution up to the final decision of the main application.

Regulation No. 147/2010 raises concerns as it may unlawfully restrict patent rights, thus providing grounds for challenge.

Ignacio Sanchez Echagüe [IMSE@marval.com.ar] is an attorney with Marval, O'Farrell & Mairal in Buenos Aires, Argentina.

Mexico to Issue Regulations for Approval of "Biocomparable" Drugs

    By Juan Serrano --

The Mexican General Health Law was reformed on June 11, 2009 to include an article 222 bis, which defined biotechnological drugs, and allowed for the approval of "biocomparables."  The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all specific regulations pertaining to the approval of these biocomparables.

Even though the 180-day period expired on March 8, 2010, work on the project of regulations has continued, with input being provided by both the Mexican Association of Pharmaceutical Research (AMIIF) and the National Association of Drug Manufacturers (ANAFAM).

This past week, COFEPRIS (the Mexican regulatory authority) made the project of regulations available to the public, through the official website of the Federal Commission for Regulatory Improvement (COFEMER).

At this point, a period of 30 working days has been given to any interested party that wishes to provide comments to this project through COFEMER's website, after which the project can be either published or further analyzed.

The main items in this project are:

• A definition of comparability tests between an innovator and a biocomparable drug.

• An indication that biocomparable drugs will use the same name for the active ingredient as the innovator.

• The Health law regulations currently contain a 3-year period Roche-Bolar-like research exemption (related to the possibility of submitting an application for a marketing authorization before patent expiration, with intent to launch after the date of expiry).  This 3-year period is eliminated, and the submission can now be made at any time.  The modification in the corresponding article will also be applicable to chemical drugs.

• The timelines that COFEPRIS will have for approval of both innovator and biocomparable drugs are established.

A copy of this document can be found here.

Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs.  He can be contacted at jls@olivares.com.mx.

EU Commission Unveils Latest Patent Reform Proposal

    By James DeGiulio --

Earlier this year, we reported that the European Competitiveness Council unanimously adopted a legislative package designed to create a single EU Patent and EU Patent court (see "Europe Takes Step Closer to Single EU Patent and Patent Court").  However, as noted, EU Patent translations remained a sticking point in the December 2009 legislative package, ending with the Council declining to address translation arrangements.  Rather, it was suggested that they should be handled in a separate regulation.

On July 1, the European Commission released its latest EU Patent proposal, particularly seeking a compromise over EU Patent translation arrangements.  Despite the fact that Europe's businesses have long supported the simplification of the language regime, preserving national languages under the new system is still important to some member states, even if it is not commercially feasible.  A European patent validated in 13 EU countries today costs about €20,000, of which nearly €14,000 is spent on translation.  According to the Commission, an equivalent U.S. patent will cost about €1,850.  Under the current proposal, costs for an EU patent covering 27 member states would be less than €6,200, only 10 percent of which would be due to translations.

If the proposal succeeds, applicants could file for a patent in any language, and the EPO will examine and grant patents in English, French, or German.  The granted EU Patent will include translations of the claims in all three official languages.  According to the Commission, most of Europe's patents are already filed in those languages.  No other translations will be necessary unless a legal dispute arises over the patent.  In the case of legal disputes, an alleged infringer or the court may require that the patent holder provide a translation into the official language of a particular EU member state.

However, the proposal still faces resistance from certain EU members, such as Spain and Italy.  This is significant, for the European Council must unanimously agree to the current translation arrangement proposal before the patent system becomes official.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law.  Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at degiulio@mbhb.com.

European Gene Patent Scope Limited by Landmark EU Court Ruling

    By Devanand Crease --

The much anticipated ruling in Monsanto Technology v Cefetra (Case C-428/08) has now issued and confirms the earlier indications that within the European Union (EU) patent protection for gene sequences only extends to material in which the patented gene is actually performing its function.  In Monsanto's case (European Patent No. 0 546 090), claims to an isolated herbicide resistance gene sequence were not held to extend to cover soya meal derived from transgenic plants and containing trace amounts of the patented gene, because the residual genetic material was not actually performing its intended function in the soya meal.

The Court of Justice of the EU handed down its ruling following a referral from a Dutch Court.  Determination of whether soya meal from Argentina, where Monsanto did not have patent protection, infringed Monsanto's European gene patents when imported into Europe revolved around interpretation of Article 9 of Directive 98/44/EC (the "Biotech Directive").

Article 9 of the Biotech Directive states:

The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material . . . in which the product is incorporated and in which the genetic information is contained and performs its function.

The European Court took the view that because it is a requirement to disclose the function of a DNA sequence for it to be patentable, it follows that the patented DNA must be able to perform its function in the material in which it is incorporated in order to benefit from that patent protection.

The judgment applies to all patented gene claims within the European Union and, thus, applies to patents granted in the UK, Germany, and France amongst others.  The judgment also has retroactive effect even to patents filed before implementation of the Biotech Directive into national laws.

Dr. Crease is a Partner at Keltie in London, UK.

Mexican Congress Amends IP Law

    By Juan Serrano --

On June 18, 2010, a decree was published in the Federal Official Gazette, reforming several provisions of the Mexican IP law related to patent practice.  The main amendments are the following:

a) The industrial application requirement for patentability was modified to include a need to demonstrate the possibility of "practical utility" of the invention, and to fully support such utility in the written description.

b) In a period of six months after the publication of the patent application, information related to patentability of an invention can be filed before the Mexican Patent Office (IMPI) by any third party.  If filed, the information may be considered at the Examiner's discretion and it will not suspend the application process.  The person filing the information will not be considered a party to the application, and will not have access to the patent file, nor immediate legal standing to challenge a granted patent, as was intended in the initial project of reform.

c) After a patent is granted, any third party can inform IMPI of causes of invalidity.  The authority may consider such information discretionally to initiate an ex officio cancellation proceeding.

d) A provision is added defining the act of attempting an infringement action when a previous request for infringement has been denied, referring to the same patent.  This provision is not very clear and it is likely to cause controversy in the future.

e) According to the Mexican IP Law, injunctions can be imposed during the course of a patent infringement action, and the title holder will have to post a bond in order to secure possible damages arising from those injunctions, if the infringement is denied.  Likewise, the injunctions can be immediately lifted if the alleged infringer files a counterbond in favour of the plaintiff.  A paragraph has been added to the corresponding article, indicating that the amount of the counterbond will have to be 40% higher than the amount of the bond.

It is noteworthy that the original project of reform was promoted by National Association of Drug Manufacturers (ANAFAM), the member companies of which participate mostly in the generic drugs market.

This initial project included, among other issues, two separate pre and post grant opposition proceedings, which would practically delay the granting and therefore the possibility for effective enforcement of patent rights.  The project also intended to include additional causes of invalidity related the use of patent rights in activities in violation of the Federal Competition Law.

This project was reviewed (and modified) by the Senate, which determined that the majority of the amendments proposed were unnecessary, including the two issues mentioned above.  The final project was ratified by the Chamber of Deputies, without further modification, and will come into force on September 20, 2010.

Juan Serrano is a Mexican Attorney with a Master of Laws Degree from the University of Toronto.  He can be contacted at jls@olivares.com.mx.

PCT Member States Endorse Recommendations to Enhance International Patent System

    By Donald Zuhn --

On Friday, the World Intellectual Property Organization (WIPO) announced that the member states of WIPO's Patent Cooperation Treaty (PCT) had endorsed a series of recommendations for enhancing the international patent system.  The announcement came at the conclusion of PCT Working Group discussions that took place from June 14-18, 2010.  WIPO Director General Francis Gurry noted that the recommendations would "go a long way in creating the conditions that will enable WIPO member states to gain greater benefits from the international patent system."

The recommendations that the member states endorsed were set forth in a "fairly lengthy" 66-page, 212 paragraph WIPO study entitled "The Need for Improving the Functioning of the PCT System," which the PCT Working Group had commissioned in May 2009.  The study examines how the PCT has measured up to its stated aims, and is based on response to a Questionnaire the International Bureau distributed to Offices, Contracting States, and other interested parties in November 2009.  The Executive Summary of the study states that:

The Working Group decided that efforts should continue on improving the PCT, noting that the system can and should function more effectively on behalf of all stakeholders, within the existing legal framework, without limiting the freedom of Contracting States to control substantive patent law issues as well as national search and examination procedures.

Among the "simple changes" the study proposes are to allow third parties to comment on pending applications, make national search reports available, and encourage applicants to file higher quality applications and correct defects before entering the national phase.

Discussing the track record of the PCT, the study declares that:

Almost 32 years after the beginning of operations of the PCT system, it can be stated that not only have most (though not all) of the expectations of the founders of the PCT been met, many have been exceeded to an extent which the founders of the PCT could not have envisaged.

The study notes that the PCT has expanded from 18 member states as of June 1, 1978 to 142 member states today.  (The original member states were Brazil, Cameroon, the Central African Republic, Chad, the Congo, France, Gabon, Germany (Federal Republic of), Luxembourg, Madagascar, Malawi, Senegal, the Soviet Union, Sweden, Switzerland, Togo, the United Kingdom, and the United States of America.)  The study also notes that while a "modest" 636 international applications were filed in the first six months of PCT operations in 1978, more than 1.8 million applications were filed between 1978 and 2009, and 155,900 applications were filed in 2009 alone.

The study sets forth eleven problems or challenges facing the PCT, including worldwide application backlogs, the timeliness of the International phase, and examination quality.  With respect to the backlogs, the study states that "backlogs in many (but by no means all) Offices of PCT Contracting States continue to increase, both in terms of absolute numbers and in terms of pendency."  The WIPO announcement regarding the study pegs the worldwide backlog at roughly 4.2 million unprocessed patent applications.  As for the timeliness of the International phase, the study notes that 26% of international applications were published without an International Search Report (ISR) in 2009 and 6% of all ISRs were delivered more than 30 months from the priority date (i.e., at a time when the international application might already have been required to enter the national phase).  Finally, with respect to examination quality, the study acknowledges that "[t]he patent system generally is frequently criticized for allowing too many patents to be granted which are invalid according to the relevant national laws as well as for the time and cost involved in challenging patents which are believed to be invalid."

The final 24 pages of the study are devoted to discussing and evaluating a number of options for addressing the problems and challenges facing the PCT.  The WIPO press release notes that among the options specified in the study are measures to help reduce the worldwide application backlog and improve the quality of granted patents, including, for example, the deployment of computer systems that allow third parties to alert patent offices about information relevant to patentability.  In addition, the study recommends that other electronic systems be developed to support technology transfer by promoting the licensing of inventions and helping to identify information about technologies that are in the public domain.

U.S. Trade Representative Releases Special 301 Report on Global IPR

    By Kevin E. Noonan --

At the end of last month, the U.S. Trade Representative, Ron Kirk, issued the 2010 Special 301 Report, which according to the USTR website "reflects the Administration's resolve to encourage and maintain effective [Intellectual Property Rights (IPR)] protection and enforcement worldwide" by identifying "a wide range of serious concerns, ranging from troubling 'indigenous innovation' policies that may unfairly disadvantage U.S. rightsholders in China, to the continuing challenges of Internet piracy in countries such as Canada and Spain, to the ongoing systemic IPR enforcement challenges in many countries around the world."

The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These watch lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

This report, on the state of intellectual property rights worldwide, identifies eleven countries on a "Priority Watch List" and another 29 on a "Watch List," all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List of the report lists China, Russia, Algeria, Argentina, Canada, Chile, India, Indonesia, Israel, Pakistan, Thailand, and Venezuela; the only country not on this list that was on the list last year is Israel.  (Israel's status is "pending" in the Report, which states that "Israel has entered into an understanding with the United States whereby it will address key outstanding IPR issues").  Countries on this list "do not provide an adequate level of IPR protection or enforcement, or market access to persons relying on intellectual property protection."  The Report "identifies a wide range of serious concerns, ranging from troubling 'indigenous innovation' policies that may unfairly disadvantage U.S. rights holders in China, to the continuing challenges of Internet piracy in countries such as Canada and Spain, to the ongoing systemic IPR enforcement challenges in many countries around the world.

This year, the Watch List names Belarus, Bolivia, Brazil, Brunei, Columbia, Costa Rica, Dominican Republic, Ecuador, Egypt, Finland, Greece, Guatemala, Italy, Jamaica, Kuwait, Lebanon, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Romania, Spain, Tajikistan, Turkey, Turkmenistan, Ukraine, Uzbekistan, and Vietnam.  Countries not on the Watch List this year that were listed last year include Czech Republic, Hungary, Saudi Arabia, and Taiwan.

The Report notes that public response to a Federal Register Notice used to prepare the Report showed a "significant increase" over the number of responses filed in 2009, and provides access to these comments (www.regulations.gov, docket number USTR-2010-0003) as well as the testimony of 23 witnesses at a public hearing.  The Report notes some "positive accomplishments," including "improved efforts by trading partners the Czech Republic, Hungary, and Poland," all of which are not on this year's Watch List.

The Report discusses initiatives to strengthen IPR internationally, including the World Trade Organization, bilateral and regional initiatives, the Anti-Counterfeiting Trade Agreement, trade preference program reviews and "expanded international communication" efforts.  It also outlines international trends in counterfeiting and piracy "involving the mass production and sale of a vast array of fake goods, including items such as counterfeit medicines, health care products, food and beverages, automobile and airplane parts, toothpaste, shampoos, razors, electronics, batteries, chemicals, and sporting goods."  It notes that there are a "greater diversity in the types of goods that are being counterfeited, as well as the production of labels and components for these fake products," and a "rapid growth in the piracy of copyrighted products in virtually all formats, as well as counterfeiting of trademarked goods."  The Report also discusses Internet and digital piracy, facilitated by "increased availability of broadband Internet connections around the world."  These concerns are specifically noted in Brazil, Canada, China, India, Italy, Russia, Spain and Ukraine, including unauthorized retransmission of sporting events particularly in China and the Netherlands.  The Report also sets forth as a "growing area of concern" trademark infringement of country code top level domain name extensions.

As it did last year, the Report contains a section on "Intellectual Property and Health Policy," specifically relating to the 2001 Doha Declaration on the TRIPS Agreement.  The Report states that the U.S. "respects a country's right to protect public health, in particular, to promote access to medicines for all."  Accordingly, the Report states that the U.S. "respects our trading partners' rights to grant compulsory licenses" consistent with the provisions of the Doha Declaration, including provisions of the August 2003 agreement whereby countries are permitted to grant such compulsory licenses not only for producing pharmaceuticals for internal use but also for export to countries unable to produce drugs themselves.  Accordingly, the Report states that the U.S. "will work to ensure that the provisions of our bilateral and regional trade agreements are consistent with these views and do not impede the taking of measures necessary to protect public health."  On the other hand, the Report contains a section outlining the USTR's efforts to "reduce market access barriers faced by U.S. pharmaceutical and medical device companies in many countries," specifically calling out Japan, Poland, Algeria and Indonesia as countries of particular concern in this regard.

The Report contains in a final section a review of U.S. activities in the WTO to resolve disputes with countries such as China and the EU over trade issues.

Section II of Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.  Section III of the Report identifies "notorious markets" for places in the world where "[g]lobal piracy and counterfeiting continue to thrive."  These include several websites (TV Ants, B2B and B2C websites in China, Webhards in Korea, Allofmp3.com clones in Russia) and physical markets (Baidu, Lowu Market, Silk Market  and Yiwu in China; Bahia in Ecuador, Greenhills, Quiapo, Binondo, Makati Cinema Square, and 168 Mall in the Philippines; Gorbushka and Rubin Trade Center and Savelovskiy Market in Russia; Harco Glodok in Indonesia; Petrivka Market in Ukraine; Panthip Plaza, the Klong Thom, Saphan Lek and Baan Mor shopping areas, the Patpong and Silom shopping areas, the Mah Boon Krong (MBK) Center, the Sukhumvit Road area, Nehru Place, Palika Bazaar, Richie Street, Burma Bazaar Manish Market, Heera Panna, Lamington Road, the Mumbai Fort District, and Chandni Chowk in India; Tepito, Plaza Meave, Eje Central, Lomas Verdes, Pericoapa Bazaar, San Juan de Dios, Simitrio-La Cuchilla, and Pulgas in Mexico; La Salada in Argentina; and the Tri-Border Region between Paraguay, Argentina and Brazil).

The U.S. Trade Representative Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  Western governments have been frustrated, particularly with regard to pharmaceutical products, in implementation of international trade treaties designed to increase IP rights protection.  As in earlier years, the Report is in some ways the answer to the question, "What are we going to do about it?"  So far, the honest answer seems to be "not enough."

For additional information regarding this and other related topics, please see:

• "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
• "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008

EPO Search Fees Set to Decrease on April 1, 2010

    By Christopher P. Singer --

The U.S. Patent and Trademark Office sent out an e-mail alert on March 26, 2010 advising that it has been informed by the International Bureau of the World Intellectual Property Organization (WIPO) that the European Patent Office (EPO) will decrease its search fee when acting as the International Search Authority (ISA).  The fee change will become effective on April 1, 2010.  The EPO currently charges $2515 to act as the ISA.  According to the e-mail announcement, as of April 1, 2010 the EPO will charge $2485 to act the ISA.  A revised PCT Fee Schedule will be made available here.

Of course, April 1, 2010 also marks the effective date of the more substantive changes to EPO rules, including revisions to divisional application filing requirements, mandatory responses to EPO-issued search reports and opinions, and additional requirements relating to amending applications.  A brief overview of those three particular rule changes can be found here.

USPTO and UKIPO Announce Plan to Reduce Global Application Backlog

    By Sarah Fendrick --

The U.S. Patent and Trademark Office (USPTO) announced in a March 10, 2010 press release that it has joined forces with the UK Intellectual Property Office (UKIPO) to develop a plan to reduce patent processing backlogs in both offices.  The joint effort is a result of the hindrance the patent backlog is believed to have on the global economy.  Specifically, in a study conducted by the London Economics, it was estimated that patent backlogs cost the global economy as much as $11.4 billion each year.

In the USPTO release, Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos commented that:

Every quality patent application that sits on the shelf represents jobs not created.  For that reason, the USPTO has made reduction of the patent backlog our highest priority.  At the USPTO, we have already undertaken substantial reform of our system for processing patent applications.  Work-sharing is an important feature of this reform.  Thus far, however, our work-sharing efforts at the USPTO have largely been applicant driven and therefore dependent on whether individual applicants know about, and appreciate, the clear benefits of work-sharing.  So I am particularly delighted that we are today embracing with the UK an office-driven mechanism for reutilization of work.

Each Office has committed to developing plans to ensure the work product of patent applications filed jointly at the USPTO and the UKIPO will be utilized for patent processing in each office.  The USPTO and UKIPO will identify areas in which resuse of information can occur among the two offices to increase efficiency and reduce backlog.

Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations

    By Juan Serrano --

Back in 2003, Mexico enacted linkage regulations to avoid the granting of marketing authorizations in violation of patent rights.  The system created by these regulations is far less elaborate than the one set forth by the Hatch-Waxman act in the U.S., as there is no extension/term restoration, and there is no possibility for Paragraph IV-type applications.

This system was intended to be simple:  two provisions were added to the health and IP law regulations establishing that the Mexican Patent Office (IMPI) is bound to publish a specific gazette every six months, listing those patents in force that cover allopathic drugs.  The regulatory authority (COFEPRIS) has to observe the patents listed in this gazette, request information from IMPI if necessary, and deny applications for marketing authorizations which would invade patent rights.

Nevertheless, controversy arose from the moment the provisions were enacted.  IMPI immediately stated that the linkage benefit would only be applicable to patents covering active ingredients per se, and therefore formulation patents were not to be listed nor observed by COFEPRIS.  Thus, the first gazette was published including only active ingredient patents.

R&D Pharma companies decided to challenge this criteria through individual constitutional actions before Mexican District Courts, arguing that a correct interpretation of linkage provisions should cause for all pharmaceutical product patents to be published.  Most courts agreed on this, resulting in over 40 decisions in favor of patent holders over a period of six years.  The vast majority of these cases were handled by the Mexican IP Firm Olivares & Cia.

As two Circuit Courts issued opposing decisions, indicating that the linkage system was indeed limited only to active ingredient patents, the case was brought to the attention of the Mexican Supreme Court, which recently made its decision public.

In a closely contested 3-2 decision, the Supreme Court determined that product patents, including those covering pharmaceutical formulations are to be included in the Gazette.  The Court also made reference to the co-related obligation by COFEPRIS to observe these patents.

Even though this decision is only mandatory for Courts, and not for administrative authorities, we expect that both IMPI and COFEPRIS will observe it, which is a step in the right direction for a strong IP system in Mexico.

Additional information regarding this topic can be obtained here.

Juan Serrano is a Mexican Attorney with a Master of Laws Degree from the University of Toronto.  He can be contacted at jls@olivares.com.mx.

Swiss-type Claims Are No Longer Acceptable at the EPO

     By Bradley Crawford --

On February 19, 2010, the European Patent Office Enlarged Board of Appeals issued its decision in In re Abbott Respiratory, G 0002/08 (EPO Enlarged Board of Appeal 2010).  In this decision, three questions were considered by the Enlarged Board, but only the third question will be considered here:

(3)  Are any special considerations applicable when interpreting and applying Articles 53(c) and 54(5) EPC 2000?

While the exact meaning of this question is not immediately evident to U.S. practitioners, the Board was being asked to consider the need for Swiss-style claims in light of EPC 2000 coming into force on December 13, 2007.

Before discussing the Board's decision, it may be useful to review the two types of "use" claims that existed in Europe before the passage of EPC 2000 and up to the issuance of this opinion.  The first and broadest type of use claim is the first medical use claim, which may be written as:

Compound X for use as a medicament.

The second and more narrow type of use claim is the Swiss-style claim, which may be written as:

The use of compound X for the manufacture of a medicament for treating of disease Y.

After considering the changes made by EPC 2000, the Board answered the question as follows:

Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83.

Thus, the use of Swiss-style claims is to be forbidden in the future.  Elsewhere in the opinion, the Board states that applicants must stop using Swiss-style claims no later than three months after the opinion is officially published in the Journal of the EPO, which has not happened yet.

The Board also noted that this new rule has "no retroactive effect."  Consequently, patents that issued with Swiss-style claims will not be impacted.

If Swiss-style claims cannot be used, then what format can be used?  Rather than using Swiss-style claims in the future, applicants should use second medical use claims, which may be written as:

Substance X for the treatment of disease.

Europe Takes Step Closer to Single EU Patent and Patent Court

    By James DeGiulio --

On December 4, 2009, the European Competitiveness Council unanimously adopted a legislative package designed to create a single EU patent and EU patent court.  In a press release issued by the Council of the EU, the Council concluded that enhancing the patent system in Europe is a necessary prerequisite for boosting growth through innovation and for helping European business.  The EU patent reform package is designed to circumvent many of the impediments to innovation that European companies face, including the high prosecution costs of filing in multiple countries and the legal uncertainty of patents enforced by one country and not another.  This uncertainty often leads to prolonged litigation disputes, as the average litigation case under the current fragmented system lasts for 2.8 years.  Critics argue that brand pharmaceuticals take advantage of these time-consuming legal challenges to keep generics from entering the market.

Under the current system, the European Patent Office (EPO) serves as the primary examining body in Europe, but the issuance of patent rights are still handled by individual countries.  Under the proposed reform package, rather than each country granting individual patents, the EPO would grant an "EU patent," which would have unitary effect in the 27 member states of the European Union.  The European Commission has long argued that a fragmented patent system and the absence of a single European Patent have impeded the growth of technology companies in the EU.  Indeed, according to the press release, patent protection in 13 EU states costs 11 times as much as patent protection in the United States.  A similar EU patent plan was originally proposed by the European Commission in 2000 under the Lisbon strategy, but negotiations stalled in 2004 due to disagreements on language.

Language remains a sticky issue for the implementation of the EU patent.  Under the present system, translation costs can be a major expense in protecting new technologies in Europe.  Likewise, how to address translation costs for the EU patent remains unclear.  The December legislative proposal sidestepped addressing these translation arrangements, instead suggesting that it should be handled in a separate regulation.

The second major reform, the proposed "European and EU Patents Court (EEUPC)," will have exclusive jurisdiction over infringement and validity issues concerning EU patents.  The judges of the EEUPC would have a high degree of specialization in patent litigation and technical expertise.  The new court would involve initial hearings at both local and centralized level, but establish one common appeal court.  In the initial stages of the reform, parties will be able to continue to use national courts, allowing confidence to build up gradually in the new system.  The Council estimated a unified court would save up to €289 million ($429 million) a year for European companies by eliminating parallel litigation in each separate member nation.  More specific details on the proposed EEUPC can be found in the press release.

The reform proposal still needs to undergo an official review by the European Council and the European Parliament before being passed into law, since these changes will likely require amendments to the European Patent Convention (EPC).  In addition, the European Court of Justice has yet to deliver an opinion on the compatibility of the patent court and draft agreement with EU treaties.  This opinion is expected at the earliest by summer 2010.

James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law.  Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at degiulio@mbhb.com.

GSK Announces "Open Innovation" Strategy to Combat Neglected Tropical Diseases

    By Donald Zuhn --

In January, GlaxoSmithKline announced a series of initiatives for developing new medicines to combat diseases that disproportionately affect the world's poorest countries.  The initiatives, which comprise GSK's "open innovation" strategy, were outlined in a speech given by GSK Chief Executive Andrew Witty to the Council on Foreign Relations on January 20th.  These initiatives include:

• Making more than 13,500 malaria compounds freely available;
• Establishing new collaborations for sharing IP for treating neglected tropical diseases;
• Pledging to create a sustainable pricing model for a malaria candidate vaccine;
• Providing $8 million in seed funding for an "open lab"; and
• Awarding African Malaria Partnership grants totaling $2.5 million.

GSK described the collection of potential malaria drugs as having been obtained following a screen of its pharmaceutical compound library of more than two million molecules for those that might inhibit the malaria parasite Plasmodium falciparum.  The company noted that it took five scientists a year to identify the more than 13,500 compounds that GSK is now making freely available.  GSK also noted that it would make the chemical structures and associated assay data freely available to the public via scientific websites.

With respect to the company's goal to share IP for neglected tropical diseases, GSK said that it was handing the administration of the tropical diseases patent pool it developed last year to an independent third party, BIO Ventures for Global Health (BVGH).  Last March, GSK formed the patent pool to aid in the discovery and development of new medicines for the treatment of sixteen neglected tropical diseases (as defined by the U.S. Food and Drug Administration), including tuberculosis, malaria, blinding trachoma, buruli ulcer, cholera, dengue/dengue haemorrhagic fever, racunculiasis, fascioliasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, soil transmitted helminthiasis, and yaws.  In August, Alnylam Pharmaceuticals contributed more than 1,500 of its RNA interference (RNAi) patents to the pool (see "Alnylam to Donate RNAi Patents to Patent Pool").  Mr. Witty (at left) told the Council that the pool "was never meant to be a 'GSK pool'," and therefore, that he was "delighted" to be able to hand its administration over to BVGH.  Both GSK and BVGH have also entered into an agreement with the Emory Institute for Drug Discovery (EIDD) to join the patent pool and further open up knowledge, chemical libraries, and other assets in the search for new medicines for neglected tropical diseases.  In addition, GSK will be collaborating with iThemba Pharmaceuticals to identify new medicines for treating tuberculosis.

GSK also outlined a pricing strategy it has developed for the malaria candidate vaccine RTS,S, which is currently in Phase III trials in seven African countries.  The company noted that the drug, if shown to be effective, would be priced so as to recover the cost of its development plus a small return intended to be fully reinvested into research and development of second-generation malaria vaccines or vaccines for other neglected tropical diseases.

The company's "open lab" initiative would provide research space for up to 60 scientists at GSK's research center at the Tres Cantos Campus in Spain.  The Tres Cantos Campus is dedicated to the research and development of new medicines for diseases of the developing world.

In outlining the company's open innovation strategy, Mr. Witty told the Council that GSK wanted "to be a company that is truly a partner in addressing the healthcare challenges in the world's poorest countries, no matter how difficult they are.  A restless company, never satisfied with what it has achieved, but always looking for ways of doing more."

Gene Patenting: Australian Potpourri

    By Kevin E. Noonan --

Gene patenting, and proposed bans on the practice, have garnered several newspaper reports and responses from professional groups around the world.

Australian Senate Panel Debates Gene Patenting

The Community Affairs Committee of the Australian Senate is investigating whether genes should be patentable in that country, according to a December 12th report in The Australian ("Patently tricky dispute drags on: who owns your genes").  The debate was sparked, according to a report, by a letter from Genetic Technologies (GTG), a Melbourne testing lab, to eight public pathology laboratories regarding its rights to testing the BRCA1 and BRCA2 genes, under an exclusive license from Myriad Genetics.  The report notes that any aggressive enforcement of GTG's licensed rights under the Australian patents may have been stayed by a change in the company's board of directors, as well as the uncertainty created by the lawsuit in New York brought by the ACLU over the corresponding U.S. patents.

The Senate panel held six public "inquiries" from March through September 2009, and received 72 primary and several additional submissions from various individuals and groups.  Predictably, the account reports that these submissions fall into two groups:  those that contend that gene patenting under Australian law is proper and is having the desired effects of promoting investment and access, and those who contend that it is ethically wrong to permit genes to be patented.  Another important aspect of the debate in Australia is its international commitments and agreements, which would prevent Australia from "going it alone."

The opposition bases its arguments on purported ethical concerns, and additionally proposes a "middle ground" based on copyright, wherein "[a]nyone who wants to use your IP must tell you and pay you," according to Luigi Palombi (at left), a gene patenting opponent and Australian National University patent law expert.  Ironically, this idea is the reverse of the canard spouted by the late author Michael Crichton in the op-ed pages of The New York Times, to the effect that gene patent holders could ask individuals for infringement damages because their cells were using the patented genes.  (For anyone not reading this space, that assertion is false.)  It is hard to imagine how the scheme proposed by Professor Palombi would encourage or even permit development of genetic-based technologies in Australia.

One other academic is cited in the piece, Professor Laurie Zoloth (at right) of Northwestern University.  Two quotations stand out:  first, she asserts as an argument against gene patenting that it would be like "[p]atenting the sun."  This phrase, the title of a biography of Dr. Jonas Salk and his development of the polio vaccine, loses some of its rhetorical force when one realizes that Dr. Salk tested his vaccine on the children in a local home for the mentally retarded, with little if any oversight and neither parental or any other kind of informed consent.  One of the reasons genetic technologies are so cost-intensive is that such practices, as well as other, more well-known consequences of lax regulation like the Thalidomide and diethylstilbestrol disasters, resulted in more stringent regulatory oversight.  Accordingly, the cost of bringing a new drug or therapy to market is much higher in view of these requirements, but the alternative is unthinkable.  This is particularly the case for genetic testing having the consequences of detecting BRCA1 or BRCA2 mutations.  Patents on genes support the investment needed to ensure that the genetic tests that come to market are reliable, and that we don't develop the genetic equivalent of "patent" medicines.

The other quote from Professor Zoloth that stands out is her assertion that genetic information should be part of a "creative commons" that is freely available to all comers, and that "[e]ventually the work will be commercialized," purportedly being the role of venture capitalists and philanthropy.  The depths of misunderstanding in this statement are chilling:  first, the information relating to genes is part of the "creative commons" insofar as anyone wants to use that information.  The proof of this statement is in the nearly 3,500 scientific journal publications that can be accessed from public databases like PubMed merely by typing "BRCA1" or "BRCA2" into the search engine.  The latest of these papers was published this fall, something directly contrary to the assertions that gene patenting inhibits basic research.  If that were the case, the number of these publications would have decreased dramatically once the patents were granted.  And if that were the case, it would not have been the conclusion of every single study done to date that patenting has not had an inhibiting effect on genetic research.  And, of course, the blasé statement from Professor Zoloth that "[e]ventually the work will be commercialized" ignores the realities that nothing will be commercialized that cannot be protected (unless her use of the word "eventually" is in the historical sense).  While it may be true that such things would "eventually" happen, it is undoubtedly true that under a gene patenting ban they would happen much more slowly, if at all.  In human terms, that means less diagnostic and therapeutic advances and more suffering.  Funny position for a bioethicist to be taking.

The Australian Senate panel has postponed its report, originally due in November until March 18, 2010.  It's possible that the committee has realized that the issue is more complicated than simply deciding gene patenting is "wrong."  Perhaps it will realize in the ensuing months that gene patenting is necessary, and beneficial, for Australia and the rest of the world.

Australian Patent Attorneys Attempt to Inject Rationality Into Gene Patenting Debate

A panel put on by the Institute of Patent and Trademark Attorneys of Australia (IPTA) strongly supported gene patenting in Australia, saying the ban proposed by opponents would "bring the Australian biotech industry to its knees," according to independent reports by the Australian AP and Australian Life Scientist ("Ban drives 'biotech industry to its knees'").  The reason:  the difficulties in attracting investment without patent protection, according to Trevor Davies, IPTA councilor.  "[I]f biological materials couldn't be patented . . . there is a likelihood that important advances in medicine would not be realized in Australia because there wouldn't be patent protection," he said.

The panel, made up of patent lawyers, biotech entrepreneurs, and academics, analogized the importance of patents for biotechnology with mining leases in the mining industry, and reminded listeners that the cost of "transforming a promising field of research into a market-ready product -- like a life-saving medical test -- was about a billion dollars."  Without patent protection, the panel said that biotech or pharma companies simply would not support investment in this work.  Banning gene patents would "remove the incentive for people to invest," according to University of Melbourne patent law professor Andrew Christie (at left).  Professor Christie rebutted the frequently-heard complaint that patenting genes somehow gives patent-holders "control" over an individual's body, saying in effect nobody "owns you."

Dr. Tania Obranovich (at right), a patent attorney and former research scientist, stated that permitting gene patenting encourages private investment which facilitates bringing therapies to market.  She reminded the audience that Gardisil, the cervical cancer vaccine, would not have gotten to market without protection of certain human papilloma virus genes.  Dr. Obranovich also contended that gene patents do not inhibit basic research.

The panel made one concession to the protests of the anti-gene patenting crowd:  they supported a change in Australian law to clarify that basic genetic research using patented genes would not constitute an infringing act, based on some uncertainty in how Australian law has been interpreted by the courts.

Australian Cancer Researcher Against Patenting Genes

Professor Ian Frazer (at right), President of Cancer Council Australia (as well as former Australian of the Year and inventor of the cervical cancer vaccine) wrote an article in The Australian in August critical of gene patents ("Sharing genes is patently obvious: gene patent inquiry").  Professor Frazer is entitled to his opinion, of course (although it is unlikely that the cervical cancer vaccine is unpatented), but his arguments would be more persuasive if fewer of his statements in support of them were less fantastical.

For example, Professor Frazer contends that "there is no more invention in isolating and characterising biological material that exists in our bodies, using existing research techniques, than in collecting and arranging a set of postage stamps."  Even insofar as this statement can be interpreted as commenting on advances in biotechnology over the past twenty-five years, it ignores (even rhetorically) the difference between a gene in a chromosome and an isolated copy (typically a cDNA copy) of that gene.  While the Human Genome Project has set forth thousands of previously-unknown open reading frames in chromosomal DNA (sections that could, but do not necessarily, encode for protein), the apt analogy is not with postage stamps.  It is with a parts list for an automobile, in which you try to assemble it without being able to look under the hood.  While the amount of genetic information obtained over the past decade has been monumental, it is inchoate with regard to the function, if any, of most of it.  This will preclude patentability for many genes, but it should not preclude patent-eligibility.  Second, Professor Frazer states, "claiming a monopoly on the use of a particular gene sequence in an already existing diagnostic test method can lead to restricted public access to vital diagnostic services."  Ignoring the rhetorical flourish of "monopoly," there is no "already existing diagnostic test method" for diagnosing a particular disease, or propensity for contracting a disease, in the absence of the "particular gene sequence."  Even then, the mere existence of the gene sequence is not enough:  a sufficiently high correlation must be established so that the result of an assay for a particular mutation reliably indicates that a patient does, or does not, have a higher likelihood of disease than the "wildtype" population.  Identifying the sequence, establishing the correlation and satisfying regulatory requirements that would prevent unreliable tests from coming to market requires investment, which requires some way to increase the likelihood for a return on that investment.  Patents do that.

Professor Frazer's argument, as he develops it, is rooted in a mistaken belief that permitting genes to be patented will inhibit basic research.  He alleges that permitting genes to be patented can eliminate "the competitiveness and information sharing essential to the development of genetic therapies," which therapies he conceded should be rewarded by a patent.  He cautions against restricting use of patented genes in research, which could "delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy."  The problem with this argument is there is no evidence for it:  study after study has shown that patenting does not restrict research use of patented genes, and even the most notorious of the patented genes, BRCA1 and BRCA2, have been the subject of almost 3,500 research papers published in the scientific literature in the face of patents on those genes.

Professor Frazer also says that the "collegial tradition of sharing raw data among researchers must be allowed to continue unfettered so new technologies can be developed to benefit all."  Maybe science is practiced differently in Australia, but the collegiality of data sharing in academia is typically severely limited to data already submitted to a scientific journal for publication.  Ironically, patenting (including gene patenting) fosters collegiality since it establishes a legal priority date for an inventor's invention.

The Professor also cites "Pasteur's immunology discoveries" and "Florey's penicillin antibiotic" as examples of inventions "gifted to humankind for global benefit."  On the contrary, Louis Pasteur patented what was commercially-valuable to him in the 19th century (improved yeast strains for winemaking) and the tragedy of Florey's "gift" of penicillin is well-know to have required World War II for its commercial development under government grants; prior to the war no pharmaceutical company would commercialize penicillin precisely because there was no patent protection to stimulate investment.

Professor Frazer ends his piece by recommending that, until gene patenting is banned in Australia, "non-commercial use of gene sequence information should be encouraged for research and diagnostic purposes."  Ironically, if Australia bans gene patents such "non-commercial use" is all Australians are going to have.

Photograph of the Australian Senate Parliament House (above) by Chensiyuan, from the Wikipedia Commons under the Creative Commons license.

USPTO and India's DIPP Sign Memorandum of Understanding

    By Sarah Fendrick --

On November 23, 2009, the U.S. Patent and Trademark Office and India's Department of Industrial Policy and Promotion (DIPP) announced the signing of a Memorandum of Understanding (MOU) regarding comprehensive bilateral cooperation on intellectual property rights (IPR) protection and enforcement.  The MOU was signed in an effort to create a cooperative relationship between the USPTO and India's Intellectual Property Organisation.  In order to facilitate this cooperative effort, a number of initiatives have been proposed including programs that provide "exposure to patent examination practices, exchange of information on patent databases and patent manuals, IPR awareness programs, exchange of information on traditional knowledge and genetic resources, exchanges of best practices, and other matters."

In addition to the signing of the MOU, India granted access to U.S. patent examiners of its new traditional knowledge search tool.  The new search tool is a digital database containing 200,000 traditional medicine formulations on Ayurveda, Unani, and Siddha, and thousands of years of India's accumulated traditional knowledge.  The search tool provides an English translation of the 30 million pages in the database opening a vast amount of knowledge that was once unsearchable.  The newly acquired access to the database will help address the issue of misappropriation of traditional knowledge through the mistaken issuance of patents, a growing concern in the global economy.

According to a press release regarding the MOU, "[t]he two offices will immediately begin planning the implementation of these cooperative projects under the MOU."

Recent Fee Increases for Foreign Patent Offices Acting as ISA for the PCT

    By Christopher P. Singer --

Within the last month, a number of foreign patent offices that act as International Searching Authorities (ISA) for the PCT announced fee increases to their search fees.  IP Australia and the Korean Intellectual Property Office both enacted search fee increases that have been effective since September 15, 2009.  The search fee for IP Australia to act as the ISA is now $1,278, while the search fee for the Korean Intellectual Property Office is now $729.

Effective on October 1, 2009, the European Patent Office (EPO) also increased its search fee to act as the ISA.  The EPO will now charge $2,378 to act as the ISA.  The up-to-date PCT fee schedule is available online here.

Updated Web Address for PCT Legal Administration

With the recently launched redesign of the U.S. Patent and Trademark Office's website, a number of the previously assigned web addresses have been changed.  The PCT Legal Administration recently sent out an e-mail notification advising of its new address, which can be found here.

To navigate to the site from the USPTO's top page, click on the "Patents" tab on the top menu bar, click on "Resources and Guidance" from the drop down menu, and from that page, click on "International Guidance," located below "Type of Patents."

Thailand Becomes PCT Member State

    By Christopher P. Singer --

Back on September 24, 2009, WIPO announced that Thailand deposited its instrument of accession to the Patent Cooperation Treaty (PCT), becoming the 142nd contracting state of the treaty.  The current list of contracting states can be viewed here.  The accession by Thailand means that in any international application filed on or after the effective date (December 24, 2009), Thailand (TH) will automatically be designated, and as it will be bound by Chapter II of the Treaty, will automatically be elected in any demand for international preliminary examination filed in respect of an international application filed on or after December 24, 2009.  Also, as of that date, nationals and residents of Thailand will themselves be able to file PCT applications.