Brazilian Innovation: A Patent Success

Posted under Ache, Acheflan, Biotechnology, Blog, Brazil, commercialization, Companies, Diagnostics, Funding, innovation, Intellectual Property, IP, Medical Devices, Medical Supply, Michael Ryan, patent, Patent Reform, Patently BIOtech, Pharmaceutical Patent, Pharmaceuticals, Public Policy, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The story of Acheflan highlights the role of patents in homegrown innovation in developing countries.  Professor Michael Ryan of Georgetown reviewed several case studies (including Acheflan) in Brazil that highlight the differences in biomedical innovation both pre- and post-intellectual property reforms.

In the early 1980’s, Ache Laboratorios Farmaceuticos (a Brazilian generics manufacturer) became aware of a plant that grew near coastal cities that local fishermen would mash into an oil rub to serve as an anti-inflammatory and anti-scarring medicine.  Ache wanted to develop the plant into a product they could bring to the Brazilian and worldwide markets.  Ache realized that to develop the product they would need to isolate the active ingredient and then take it through toxicology studies, animal testing, and human clinical trials to demonstrate the safety and efficacy of the product.  However, Brazilian patent law at the time prohibited patenting of pharmaceutical patents.  While Brazilian patent law allowed for process patents, Ache quickly realized that competitors could easily reverse engineer the product and make their own version.  Ache did not pursue the project.

When Brazil reformed its patent law in 1996 to allow patents on pharmaceutical products, Ache resumed work on the shelved project.  Now they could finally invest in the project with a promise of a return guaranteed by a patent.  Not having the capacity to conduct research, Ache established research partnerships with Brazilian professors.  From 1998-2004, some 100 university agronomists, biochemists, pharmacologists, and medical doctors were involved in taking the product through isolation and toxicology studies.

The company launched the product, Acheflan, in 2005 and the years of hard work paid off.  Acheflan is the first medicine innovated and introduced in the marketplace by Brazilians and within a year the product received a 30 percent share of the anti-inflammatory market.  By the end of 2007, its market share exceeded 40 percent (beating out competitors among established global pharmaceutical companies).  The company is in the process of launching the product worldwide.

While Brazilian patent laws still require much improvement to lay the foundation for its future as a developed country, this case study is one of many suggesting that even incremental positive changes to the IP environment can catalyze commercialization of Brazilian innovation.

IPCC Features Update on Patent Reform Implementation

Posted under America Invents Act, Blog, Companies, Diagnostics, Funding, Intellectual Property, Intellectual Property Counsels' Committee, Medical Devices, Medical Supply, patent, Patent Reform, Patently BIOtech, Pharmaceuticals, PTO, Public Policy, Startups, United States Patent and Trademark Office, Universities, USPTO, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The BIO Intellectual Property Counsels Committee Fall Conference featured an update on the implementation of the Leahy-Smith America Invents Act by Janet Gongola, Associate Solicitor of the U.S. Patent and Trademark Office (PTO).

Some provisions of the Leahy-Smith America Invents Act took effect immediately when it was signed into law in September. Ms. Gongola reported that of the 20 provisions that must be implemented by the PTO, eight have been implemented and another ten are in final review and will be posted in the Federal Register in mid- to late-January for a 60-day notice and comment period.

The law required the PTO to undertake seven studies, two of which have begun. The PTO recently held public hearings on prior user rights and international patent protection and is accepting comments on both topics until mid-November. BIO provided testimony on the importance of international patent protection for small businesses.

Ms. Gongola encouraged the audience to submit comments throughout the process as the PTO is eager for feedback from the users of the patent system.

The PTO has an online guide to the Leahy-Smith America Invents Act where you can subscribe to alerts, listen to archived webcasts of public hearings, and view a timeline of implementation highlights.