Recent Brazilian Federal Court Decision Involving Genetic Heritage and Traditional Knowledge

On May 22, 2013, the Federal Court from the State of Acre in Brazil (which is North of Brazil) handed down an important decision involving alleged access to genetic resources and traditional knowledge. The State of Acre recognizes the right of indigenous and local communities to determine the use of their traditional knowledge associated with their genetic heritage. “Genetic heritage” refers to information of genetic origin contained in samples of plant, fungal, microbial or animal specimens, in the form of molecules and substances deriving from the metabolism of such living beings within the national territory, on the continental shelf, or in an exclusive economic zone. “Associated traditional knowledge” encompasses information or practices of an indigenous or local community having real or potential value and associated with the genetic heritage. Indigenous and local communities that create, develop, hold or preserve traditional knowledge associated with genetic heritage are guaranteed certain rights to that genetic heritage and traditional knowledge. Among those rights are: (1) the right to prevent unauthorized third parties from using or carrying out tests, research or investigations relating to associated traditional knowledge; (2) the right to prevent third parties from disclosing or broadcasting data or information that incorporate or constitute associated traditional knowledge; and (3) the right to derive profit from economic exploitation by third parties of associated traditional knowledge—a right which is owned by the community.

The Federal Public Ministry (FPM) filed a civil lawsuit against five companies that had developed soaps containing an oil having emollient properties obtained from the seed of a palm tree called “murumuru.” Astrocaryum murumuru bears edible fruits and is native to the Amazon Rainforest. Murumuru butter extracted from the seeds may be used as a moisturizer.

The FPM alleged that the use of moisturizing oils derived from murumuru is a part of the genetic heritage and associated traditional knowledge of the Ashaninka people (an indigenous group of people living in the rainforests of Peru and in the State of Acre Brazil). According to the FPM, the defendant companies violated several of the rules laid down by Provisional Measure No. 2,186-16 when they improperly appropriated and exploited part of the intangible heritage of indigenous Ashaninka community by using genetic heritage and the associated traditional knowledge of the oil from the murumuru tree to develop soaps. The Brazilian Patent and Trademark Office (INPI) was also included as a defendant in the lawsuit for granting certain patents and trademarks relating to soaps containing murumuru.

Brazilian Provisional Measure No. 2.186-16 of August 23, 2001 (the Measure) seeks to protect the benefits, rights and obligations concerning access to traditional knowledge and components of genetic heritage in Brazil for purposes of scientific research, technological development and biological prospection. It preserves the exchange and dissemination of components of genetic heritage and associated traditional knowledge practiced within indigenous and local communities of the country for their own benefit. The Measure allows access to components of genetic heritage within the national boundaries of Brazil only with the authority of the Union. Furthermore, the use, marketing and exploitation of genetic heritage are subject to inspection, restrictions and benefit sharing as specified in the Measure. Significantly, the Measure primarily regulates “access” to components of genetic heritage and traditional knowledge in Brazil.

The FPM claimed that the companies’ use of the murumuru tree violated several of the rules laid down by the Measure. However, the Federal Judge ruled that there was no violation of the Measure because several of the defendant companies had not carried out any scientific research or technological development related to the genetic heritage that might be characterized as an “access.” The Judge reasoned that there had been no illegal access to genetic heritage or associated traditional knowledge since: (1) the information and properties of murumuru were obtained from scientific documents published during the 1940’s (in other words, this information was in the public domain); (2) one of the companies obtained an authorization for accessing murumuru from another region, the State of Amazonas; and (3) another company obtained murumuru oil from a manufacturer which has obtained such oil from the Ashaninka.

This decision is significant because it holds that a company will not “access” genetic heritage, and thus, will not need an access authorization to share benefits, if it simply explores properties of genetic heritage disclosed previously in the public domain (such as in the scientific literature). Therefore, this decision may have a positive impact on the defense against several fines imposed in 2010-1012 by an environmental authority due to alleged illegal access to genetic heritage. Several of those fines were imposed against companies that were simply using certain Brazilian plants in order to produce products the properties of which were disclosed a very long time ago.

This post was written by Serene Sahar, Lisa Mueller and the Dannemann Siemsen firm.

Proposed Increase in Official Fees in Connection with Patent Filings in India

On May 6, 2013, a notification appeared in the Official Gazette (which publishes notices from the Indian Government), proposing a significant increase in the official fees for filing patent applications (including original, convention and PCT applications) in the Indian Patent Office (IPO). According to the notification, IPO intends to double the current fees for most patent filings, especially fees for filing a new application, fees associated with filing of an excess number of claims {presently, claims in excess of 10 require the payment of an additional $19 U.S. dollars (USD) per claim} and fees associated with filing an excess number of pages {presently, if a specification (including the claims, abstract and drawings) contains more than 30 pages, an additional fee of $10 USD per page is required}. Moreover, IPO is proposing a surcharge of 10% for Applicants who choose to file their patent applications in paper rather than electronically using India’s electronic filing system.

Objections to the notification are due by June 21, 2013 and the draft is likely to be tabled for acceptance before the Indian Parliament during the Monsoon session commencing on July 26, 2013. In view of this, it is expected that these proposed fees will not likely become effective for another 1-2 months, at the earliest. Applicants with convention and PCT National Phase applications in the near future, who wish to take advantage of the currently lower fee schedule, should consider filing their applications no later than August 1, 2013, just to be on the safe side.

This post was written by Lisa Mueller and the attorneys at Chadha & Chadha.

Section 3(d) of the Indian Patents Act – Part II

This is part II of a two part posting examining Section 3(d) of the Indian Patents Act.  Part I examined the genesis of Section 3(d).  This post provides patent drafting strategies to reduce the risk of receiving a Section 3(d) objection as well as overcoming such a ground of objection if received during prosecution and/or an opposition.

Section 3(d) provides that inventions that constitute the “mere discovery of a new form of a known substance which do not result in enhancement of the known efficacy of that substance” do not constitute patent eligible subject matter.  According to the explanatory note, inventions directed to salts, esters, polymorphs, metabolites, pure forms, new forms having a certain particle size, isomers, mixtures of isomers and derivatives of known substance are patent ineligible unless these new forms “differ significantly in properties with regard to efficacy”.

The term “efficacy” is defined in Webster’s dictionary as “the capacity to produce an effect”.  In the Glivec decision, the Indian Supreme Court took a much narrower view of the term “efficacy”, saying that for drugs administered to treat diseases, “efficacy” meant “therapeutic efficacy”.  Additionally, the Supreme Court stated that evidence demonstrating a link between an increase in bioavailability for a new form and an increase in therapeutic efficacy could be used to avoid or overcome a Section 3(d) objection.  In fact, in an order dated November 29, 2012, the Controller for Patents found that a patent application claiming a beta form of Rifaximin (106/DELNP/2008) was new and did not constitute patent ineligible subject matter under Section 3(d).  In this case, the Applicant (Alda Wassermann, S.P.A), in order to overcome an objection raised under Section 3(d), submitted an affidavit that provided data proving that the beta form of Rifaximin B had an in vivo absorption level that was about 100 times less than Rifaximin (which was disclosed in U.S. Patent No. 4,341,785 and was the closest prior art), thereby resulting in a reduction of the toxicity 100 times due to absorption (this fact had been disclosed on page 5 of the specification as originally filed).  Therefore, although the beta form of Rifaximin had a similar effect as Rifaximin, it was 100 times less toxic and showed enhanced efficacy over the prior art.

Given the importance of the Indian market for pharmaceuticals, it is important for patent drafters to keep Section 3(d) in mind when drafting patent applications for new forms of known substances, particularly if there is a desire to ultimately file and prosecute such applications in India.

When drafting a patent application for a new form of a known substance, it is important to include in the specification as much detail regarding the novel properties, which establish the enhanced therapeutic efficacy of the new form.  It would also be helpful to include a comparison of the properties of the new form with those of the closest prior art.  Most importantly, it is recommended to include in the specification data that establishes a link between the properties of the new form and enhanced therapeutic efficacy of that form.  Also, the improvement in therapeutic efficacy should be significant and should not merely be an incremental improvement when compared to the closest prior art.  What constitutes a “significant” improvement will need to be determined on a case-by-case basis and will depend also on the prior art.

In many instances, however, data demonstrating an improvement in therapeutic efficacy will simply not be available at the time of filing.  If the drafter finds him or herself in this situation, it is recommended, as mentioned above, to include in the specification as much detail as possible regarding the new properties of the new form along with a comparison to the closest prior art.  Once the application is filed at the appropriate Patent Office, it would be advisable to begin generating data to demonstrate the enhanced therapeutic efficacy of the new form compared to the closest prior art.  Such data could be submitted in an affidavit during prosecution, if the Examiner raises a Section 3(d) objection.

Strategies for responding to a Section 3(d) objection raised during  prosecution and/or an opposition will depend on the data contained in the application as well as the prior art.  If the application as filed contains data demonstrating improved therapeutic efficacy for the new form and this improvement is significant over the prior art, the Applicant should respond to the Examiner by specifically pointing to the parts of the specification that disclose such data.  Additionally, consider filing an affidavit by an expert in the field attesting that in his/her opinion that the data in the specification clearly demonstrates improved therapeutic efficacy of the new form over the prior art.  Further, consider filing a request to schedule a hearing (namely, an interview) with the Controller in order to discuss the data in the specification so as to facilitate his or her understanding as to why the new form does not constitute patent ineligible subject matter under Section 3(d) and thereby overcome the objection raised. 

If the specification does not contain any data demonstrating improved therapeutic efficacy of the new form over the prior art, the applicant will need to file an affidavit with this data.  However, it is important to note that any post-filing data demonstrating improved therapeutic efficacy must find some basis for support in the specification of the application as originally filed.  Although, not explicitly worded in the Indian Patents Act, it is preferable to provide as much data demonstrating the enablement of the invention at the time of filing as possible. Without such data, the likelihood of overcoming a Section 3(d) objection during prosecution and/or an opposition is reduced.  With respect to such an affidavit, the affidavit should contain a detailed description of the experiments or clinical trials conducted and the results clearly establishing enhanced therapeutic efficacy of the new form over the prior art form.  The affidavit should include a comparison of the results with the new form and the closest prior art.

As shown in the case involving Indian Patent Application 106/DELNP/2008, it is possible to overcome a Section 3(d) objection.  The key is presenting the appropriate data to the Indian Patent Office to demonstrate the enhanced therapeutic efficacy of the new form over the closest prior art.  Applicants should have a strategy for providing and presenting this data prior to the start of prosecution in the Indian Patent Office in order to maximize their chances for allowance.

This post was written by Anthony Wenn, Lisa Mueller and the attorneys at Chadha & Chadha.

Section 3(d) of the Indian Patents Act – Part I

There has been considerable press regarding the decision by the Indian Supreme Court in April, 2013, rejecting Novartis’ patent application for the beta-crystalline form of Imatinib Mesylate (known as “Glivec”).  In fact, many have considered this case to be a “test case” regarding the judicial interpretation of Section 3(d) of the Indian Patents Act.  In view of the significance of this decision, it is imperative for those drafting and prosecuting pharmaceutical and biotech patent applications in India to understand this section of Indian patent law.

This is Part I of a two part posting examining Section 3(d).  This post examines the genesis of Section 3(d).  Part II will provide patent drafting strategies to reduce the risk of receiving a Section 3(d) rejection as well overcoming a rejection received during prosecution and/or an opposition proceeding.

At the time of its independence from Great Britain in 1949, India’s patent system was governed by the British enacted Patents and Designs Act of 1911 (1911 Patent Act).  The 1911 Patent Act provided product (including for pharmaceuticals and agrochemicals) and process patent protection and was considered to benefit foreigners far more than Indians.  In April 1972, the Patents Act of 1970 (1970 Patent Act), which was the first comprehensive patent law written solely by the Indian bicameral legislature, came into effect replacing the 1911 Patent Act.  The 1970 Patent Act specifically excluded from patentability product patents directed to food or medicines or drugs (which included insecticides, germicides, fungicides, etc.) and substances prepared or produced by chemical processes (including alloys, optical glass, semi-conductors and inter-metallic compounds).  It is in the 1970 Patent Act that Section 3(d) first appeared:

 “Section 3.  What are not inventions.- The following are not inventions within the meaning of this Act,-

(d) the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant…”

Up until the early 1970’s, India imported most of its essential bulk drugs.  At that time, many in India felt that the country was too dependent on foreign drug manufacturers and that this reliance had resulted in the high cost of drugs in India.  As a direct result of the passage of the 1970 Patent Act, many Indian companies began manufacturing bulk drugs.  This increase in local manufacturing resulted in the rapid rise of the Indian pharmaceutical industry. As a result, India quickly became a major supplier of cheap drugs to a number of developing and under developed countries.

Although the 1970 Patent Act encouraged the production of generic drugs, the unavailability of product patent protection for pharmaceuticals discouraged innovation. When India joined the World Trade Organization in 1995 it was required to comply with obligations under the TRIPS agreement, which required India to revise its patent law to provide product patent protection for pharmaceuticals.  The Indian Parliament struggled to pass a new patent act that not only complied with TRIPS but also did not negatively impact public health (namely, an increase in the cost of drugs in India).  During the course of debate in Parliament, an amendment to Section 3(d) (as well as deletion of Section 5 (which excluded product patents in the fields of drugs, chemicals and food items)) was proposed by the Government in order to alleviate the fears of the Opposition members regarding the re-introduction of product patent protection for pharmaceuticals and agricultural chemicals. Specifically, the Government argued that the proposed amendment to Section 3(d) addressed the concern of the Opposition members with respect to the abuse of product patents for pharmaceuticals and agricultural chemicals. The proposed amendment was accepted and Section 3(d) was amended in the Patents (Amendment) Act of 2005 (2005 Patent Act) and currently reads (additions are shown in bold):

 “Section 3.  What are not inventions.- The following are not inventions within the meaning of this Act,-

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”

As shown in bold, the amendment added (1) the phrase “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” and (2) the explanation.  As stated by the Supreme Court in the Glivec case, “[T]he amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds”.

In an attempt to prevent evergreening, and extended monopolies, Section 3(d) stipulates that only those pharmaceutical “derivatives” that demonstrate significantly enhanced “efficacy” are patentable. In this regard, Section 3(d) draws a vivid distinction between “evergreening” and incremental innovation. By allowing only derivatives with added efficacy to be patentable, Section 3(d) encourages further improvement and development of existing technologies that help bring improved products to the market, thereby also addressing public health needs.

In its opinion in Glivec, the Supreme Court had the burden of defining the term “efficacy” as it is used in Section 3(d), which has no statutory equivalent in any other patent act in the world. According to the Supreme Court, the test of efficacy is different for each drug and will depend upon the desired or intended result of that product.  In the case of drugs to be administered to treat diseases, the test of efficacy is “therapeutic efficacy”.   Specifically, the court stated “What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seem above, is its therapeutic efficacy.”  The Supreme Court stated that an increase in bioavailability could be used to protect an invention under Section 3(d) if evidence was provided to establish that such an increase leads to a greater therapeutic efficacy.  As will be explained more in the next post, Applicants relying on bioavailability to establish patentability will need to establish a link between increased bioavailability and an increase in the therapeutic efficacy of their claimed drug.

This post was written by Anthony Wenn and Lisa Mueller.  Thanks to the Chadha & Chadha firm for reviewing this posting and providing their comments and insights to the BRIC Wall on Section 3(d).