India Compulsory License: A Times of India Article Says It’s Not Helping the Poor

Posted under access, access to medicine, Bayer, Blog, Companies, compulsory license, cost, Diagnostics, drug cost, Essential Medicine, Funding, india, Indian Patent Office, Intellectual Property, Medical Devices, Medical Supply, Natco, patent, Patently BIOtech, Pharmaceuticals, Public Policy, Sorafenib, Startups, Universities, Videos, World Health Organization by biotechnow@bio.org (Biotechnology Industry Organization)

India recently issued a compulsory license on Bayer’s liver and kidney cancer drug (Sorafenib) with the stated goal of providing access to India’s poor. However, the Times of India recently ran the article Cheap generics drugs no panacea for India’s poorest, quickly dispelling this myth:

“The compulsory license system might not really work because poor people cannot even afford the discounted price,” said G. Balachandhran, former head of the National Pharmaceutical Pricing Authority (NPPA), India’s drug price watchdog regulator.

“Instead of dealing on a case-to-case basis, India needs to have a policy that will bring more and more people under medical cover … We need to increase the health insurance penetration, so that even poor people can afford treatment,” he added.

“Only 15 percent of India’s 1.2 billion population is covered by health insurance, according to business lobby group the Federation of Indian Chambers Commerce & Industry, meaning even at a lower price, Nexavar will be out of reach for many.

“Still, the head of Pfizer, the world’s largest drugmaker, told Reuters on March 12 that there were around 100 million people in India with “wealth equivalent to or greater than the average European or American, who don’t pay for innovation”.

While Natco will profit off someone else’s investment and innovation, it seems the company’s compulsory license gift from Indian regulators will do little to help India’s suffering masses.

BIO IP Counsels Conference Agenda Topics

Posted under AIA, AIA implementation, American Invents Act, BIO, biosimilars, Blog, Companies, Diagnostics, Events, Funding, Intellectual Property, Intellectual Property Counsels' Committee, IPCC, Medical Devices, Medical Supply, Patently BIOtech, Pharmaceuticals, process patents, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Join us in Austin for BIO’s Intellectual Property Counsels Committee Conference on April 16-18.  Agenda topics are below.

The Decline of Process Patents:

This session will examine the enforceability of process claims and how it has led to the recent controversy around divided infringement. Unlike claims to machines, manufactures, and compositions, process claims can be divided up by different actors, or by jurisdiction, and conceivably even by time.  Right now the focus is on different claim steps that are performed by different entities, where the law doesn’t provide a remedy for direct (and therefore indirect) infringement – a widening loophole in Section 271(a), (b), (c) and (f). We will discuss this issue and examine how it affected cases involving Abbott, Cardiac Pacemakers, McKesson and Centillion.

Patentability – The Writing on the Wall: Personalized Methods of Treatment and the Evolving “Printed Matter” Doctrine

In the U.S. Supreme Court appeal of Prometheus v. Mayo, a case dealing with the patent-eligibility of a biomarker-assisted treatment claim under Section 101, the United States have proposed an alternative theory of invalidity that may foreshadow the way the USPTO will treat claims that incorporate newly discovered biological correlations. This panel will discuss the government’s theory – an extension of the “printed matter” doctrine recently developed in King Pharmaceuticals v. Eon Labs – and explore how it can be extended to, distinguished from, or reconciled with the holding in Prometheus. The panelists will trace the development of the printed matter doctrine from its origins in cases involving simple labeled articles and board games to its recent implications for complex biomedical processes, and provide recommendations for in-house prosecutors.

The Regulatory Tide Is Coming In: FDA and Industry Get Ready for Biosimilars

This panel will provide an update on recently-issued FDA guidance, what’s happening in the industry, including updates on likely biosimilar applications, what’s next at FDA, FDA’s involvement in determining applicable dates for the 12-year data exclusivity period, how FDA will handle data packages, and reviewer access to originator BLAs for purposes of evaluating a biosimilar application.

The Coming Storm of Biosimilars Litigation

With the creation of the biosimilars litigation scheme and the recent enactment of the AIA, there will be many different avenues by which patents can be asserted and challenged.  If patent litigation were a chess game, this new world if chess on a 3-dimensional board.  This panel will discuss patent enforcement and challenges in federal court before, during and after a biosimilar application is considered by the FDA, including acts of artificial infringement under the BPCIA and the scope of the 271 (e)(1) safe harbor, as well as ITC actions and Patent Office proceedings.

AIA Implementation and Strategy

This session will survey the recent waves of PTO draft regulations implementing the America Invents Act and highlight important considerations for in-house practitioners in preparation for upcoming effective dates. Among other topics, an expert panel of in-house, USPTO, and law firm practitioners will discuss PTO draft regulations governing supplemental examination and the new opposition-type proceedings, the operation of the new “reasonable likelihood” threshold for inter partes reexam and inter partes review, demystifying the grace period for inventor disclosures, assignee filing under the AIA, a Primer on the new prior commercial user defense, and filing and disclosure strategies under the AIA.

Seeking Guidance: Updates on Federal Circuit Activity

Our panel will provide an update on recent patent cases from the Federal Circuit, including how the district courts have dealt with same issues in the wake of the Federal Circuit’s guidance. Particularly, the panel will focus on cases dealing with injunctions and patentability, and provide perspectives from in-house counsel, outside counsel, and academia. The panel will engage the audience in a hypothetical fact pattern applying the principles from one of the lines of cases presented.

**Updated Agenda.

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.