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December 12, 2013

China IP Conference at George Washington Law School Suggests Reforms Making Progress

GW Law China IP Conference 2013

Yesterday, The George Washington University Law School hosted its third annual China Intellectual Property ("IP") Conference: Patent and Trade Secrets: A Public Discussion on How to Protect Technologies in China. The Conference focused on the impact of the resolution and spirit of the recent Third Plenum of the 18th Communist Party on the commercial rule of law and IP. Moderated by Mark Cohen, Senior Counsel, China, United States Patent and Trademark Office ("USPTO") and John Whealan, Intellectual Property Advisory Board Associate Dean for Intellectual Property Law Studies, George Washington Law School, the Conference featured a deep bench of legal experts from academia, government, corporations, trade associations, and domestic and international law firms. Keynote speakers included Randall R. Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit, David J. Kappos, Former Director, USPTO, and Teresa Stanek Rea, Former Deputy Director, USPTO. Rather than a typical PowerPoint-type presentation format, the Conference featured roundtable discussions with input from the audience, who included seasoned IP prosecutors and litigators with experience in China.

The first panel discussed overall fiscal and other developments in China and how they related to IP changes. Whealan noted that it has been difficult to develop an Chinese economy that depends on IP when the corporate managers are government employees (i.e., no "real" managerial class) and the judicial system is semi-legislative (e.g., it added copyright law before there was a formal copyright law). Rader said that the Chinese use IP as an "area of experimentation" beyond the usual, where he saw some positive movement in the judicial system. For example, Rader explained that he used to say that companies should use something other than the courts to enforce their patent rights; now, he thinks if you do "everything right," you can win. Rader has also been involved in IP information/education exchanges with the Chinese judicial system, which has helped to lead to thoughts about developing a specialized IP court in China. He was also encouraged by the selection of a lawyer for the Supreme People's Court. Further, over time he has witnessed a transformation from China's manufacturing economy that undervalued IP to an economy more dependent on innovation, where there has been a need for greater IP protections.

Cohen observed that while China has been developing its IP program, there has been less emphasis to protect pharmaceutical patents and no national trade secret protection. In some sense, China approached IP protections backward: first there was IP (1983) then there was property law (2007), which never allowed IP law to develop properly. Cohen believed that the Chinese judicial system needs more transparency--important or "embarrassing" cases often are deliberately not published, leading to disclosure of "model decisions" that do not mirror what happens, and no "real Markman [claim interpretation] cases." Added to that are provincial government control differences, Conrad Wong, Attorney-Advisor, Enforcement Unit, Office of Policy and External Affairs, USPTO, described, and differences of opinion regarding nondisclosure agreements (e.g., employees believe they are not bound by IP rights to their previous employer).

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November 8, 2013

FLH Sponsors Korea-Maryland, USA Bio Expo 2013 in Rockville, Maryland

On November 8, 2013, FLH's key FDA/Regulatory Partners Charles J. Raubicheck and Brian J. Malkin will present on a variety of FDA/Regulatory topics at the 3rd Annual Korea-Maryland, USA Bio Expo. The Expo will showcase the best opportunity meet with Korea's leading pharmaceutical, biotechnology, and medical device companies. The main show dates including these and other presentations are November 7th and 8th at the Universities at Shady Grove Conference Center in Rockville, Maryland. Specifically, Mr. Raubicheck and Mr. Malkin will present on: Guidelines for Current Good Manufacturing and Quality Control, Generic Pharmaceutical Development Manufacturing, Discussion of Current Drug Shortages Affecting the U.S. Market, Current Initiatives for Underserved Diseases, Current Initiatives for Repurposing Pharmaceuticals and New Development, Biosimilar Strategies and Current Guideline Discussion, and Biosimilars/Follow-on Biologics, Pertinent FDA Guidance.

The Expo features:

  • Korea's regional officials from the Gangwondo, Jellonamdo, Kyeongsangnamdo, and Chungcheonbukdo Provinces will be in attendance.
  • Evening Reception with presentations from Korean companies and their technology development on November 7th from 6:00pm-8:30pm.
  • Seminars from industry professionals on business development and regulatory affairs.

  • Exhibitors from U.S. and Korea presenting opportunities from both countries to build collaborations.
  • General admission to the exhibition hall is free to the general public.

Frommer Lawrence & Haug LLP is proud to be a sponsor of Korea-Maryland, USA Bio Expo 2013 and looks forward to participating in this event to help make it be one of the greatest international fairs between Korea and the United States to foster mutual cooperation for the development of new pharmaceuticals, medical robotics technology, stem-cell research, medical devices, environmentally-friendly energy research, and additional innovations.

November 8, 2013

Korea-Maryland USA Bio Expo Held in Rockville, Maryland Last Week

Korea-MD, USA Bio Expo Opening Ceremonies.JPGOn November 7 and 8, 2013, FLH attorneys Brian J. Malkin, Charlie J. Raubicheck, and Scot B. Pittman attended and participated as sponsors of the 3rd Annual Korea-Maryland, USA Bio Expo. The Expo hosted leading Korean pharmaceutical, biotechnology, and medical device companies at the Universities at Shady Grove Conference Center in Rockville, Maryland. The event provided networking opportunities and seminars from industry professionals with the goal to encourage collaboration of Korean biotechnology businesses utilizing the resources in the Washington, D.C. area.

The opening ceremonies featured presentations by a variety of local and Korean representatives committed to helping Korean business set up operations in the United States, particularly Maryland, and specifically Montgomery County. The speakers included:


  1. Ambassador for Green Growth & Environment, Kyungryul An

  2. Embassy of the Republic of Korea, Consul-General Do-ho Kang

  3. Maryland Secretary of State, John P. McDonough

  4. BioMaryland Center Executive, Director Judy Britz

  5. Montgomery County Executive, Isiah Leggett

  6. Montgomery County Department of Economic Development Director, Steve Silverman

  7. Hanbat National University Graduate School, Dean Byung Wook Ahn

  8. George Washington University, Department Chair of East Asian Languages and Literatures Young-Key Kim-Renaud.

The Maryland representatives highlighted some of the advantages for doing business in Maryland. For example, Maryland offers income tax credits equal to 50% of an eligible investment for investors in Qualified Maryland Biotechnology Companies ("QMBCs"). This tax credit program offers incentives for investment in seed and early stage, biotech companies, up to $250,000. To qualify, companies are required to: be less than 15 years old; have their headquarters and base of operations in Maryland; employ fewer than 50 people, and have a valid certification from the Department of Business and Economic Development ("DBED"). Investors are required to submit applications prior to making an investment. DBED reviews the applications and issues initial credit certifications within 30 calendar days.(http://www.choosemaryland.org/businessresources/pages/biotechnologyinvestmenttaxcredit.aspx ). Chevy Chase, Maryland also is home to a branch of NEA, one of the country's largest venture capital funds, with the potential to help support Maryland businesses such as those in the biotechnology field.

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November 5, 2013

Korea-Maryland, USA Bio Expo 2013 in Rockville, Maryland Later this Week

korea-MD Bio Expo.jpgOn November 6-9, 2013, the 3rd Annual Korea-Maryland, USA Bio Expo will showcase the best opportunity meet with Korea's leading pharmaceutical, biotechnology, and medical device companies. The main show dates are November 7th and 8th at the Universities at Shady Grove Conference Center in Rockville, Maryland. Some of the major events associated with this Expo include:

  • Korea's regional officials from the Gangwondo, Jellonamdo, Kyeongsangnamdo, and Chungcheonbukdo Provinces will be in attendance.
  • Evening Reception with presentations from Korean companies and their technology development on November 7th from 6:00pm-8:30pm.
  • Seminars from industry professionals on business development and regulatory affairs including FLH's key FDA/Regulatory Partners Charles J. Raubicheck and Brian J. Malkin. Topics that will be covered on the main show dates include: (1) Investigational New Drug (IND) Process - Nonclinical, (2) Chemistry Manufacturing and Controls (CMC) Process, (3) Clinical Study Design Phase I, Phase II, Phase IIA, Phase III - Drugs, (4) Pharmacometrics and Clinical Study Design, (5) Current Good Manufacturing Practice (cGMP) and its Role in Regulatory Drug Quality, (6) Current Drug Shortages and Orphan Drug Disease Pharmaceutical Development, (7) Innovative Strategies for New Drug Development, and (8) the Patent Process for Drug Repurposing Development.
  • Exhibitors from U.S. and Korea presenting opportunities from both countries to build collaborations.
  • General admission to the exhibition hall is free to the general public.

Frommer Lawrence & Haug LLP is proud to be a sponsor of Korea-Maryland, USA Bio Expo 2013 and looks forward to participating in this event to help make it be one of the greatest international fairs between Korea and the United States to foster mutual cooperation for the development of new pharmaceuticals, medical robotics technology, stem-cell research, medical devices, environmentally-friendly energy research, and additional innovations.

March 8, 2012

Foreign Drug Inspection Budget Requests--Focus on China

by Howard E. Rosenberg, Ph.D.

Made in China.bmpThe rapidly increasing flow of foreign drugs into the United States is illustrated by the fact that nearly 40% of the drugs Americans take are made overseas, and about 80% of active pharmaceutical ingredients are imported. Approximately half of medical devices used in the United States also come from abroad. These foreign goods often follow complex paths through multi-step supply chains to reach the United States.

This dynamic is very evident in the U.S. trade with China. From 2007 to 2011, the number of shipments of FDA-regulated products from China increased by 62 percent. This represented a fundamental change in both the economic and security landscape, and, as a result, FDA is requesting a budget authority increase of $10 million to strengthen the safety of foods, drug products, and ingredients exported from China to the United States.

The increased budget would allow FDA to improve its food and drug inspection and analytical capabilities by increasing its presence in China with 16 inspectors, and by adding three U.S.-based analysts. The Agency currently has eight staff members working in China. They serve at posts established in 2008 and 2009 in Beijing, Shanghai, and Guangzhou. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will inspect sites of clinical trials. FDA will also conduct follow-up inspections to ensure that firms continue to manufacture food and medical products under safe conditions.

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November 21, 2011

National Pharmaceutical Pricing Policy Proposed by Indian Government

by Howard E. Rosenberg, Ph.D.

Indian money.bmpLast week, India proposed a new National Pharmaceutical Pricing Policy. Price control for drugs was first introduced in India in 1963 and over time modified on various different principles but remained broadly based on the principle of effecting control over the prices of essential drugs. The most recent Drug Policy of 1994 focused on controlling bulk drugs. In the Drug Policy of 1994, a list of 74 bulk drugs was identified and those drugs, as well as the formulations, based on these drugs (currently about 1577 in number) were brought under the price control regime.

India is now the 3rd largest producer of medicines by volume but is only 14th in terms of value globally. The industry's production turnover has increased from Rs 51 billion in 1990 to around Rs 1 trillion in 2009-2010 of which Rs 420 billion is exported. After liberalization of the economy and when Foreign Direct Investment in the pharmaceutical sector was brought in, a new pharmaceutical pricing policy was introduced in 2002 but was challenged and thus never implemented, so the 1994 Drug Policy continued in force. However, the National List of Essential Medicines ("NLEM") of 1996 was revised and the list notified as NLEM- 2003 and again in 2011 as NLEM- 2011. Various drug policies adopted from time to time have tried to cope with the challenge of striking a balance between enabling industry to grow and at the same time ensuring affordable and reasonable prices to the consumers, particularly the poorer masses.

The principles surrounding the new proposal for regulation of prices are: (1) Essentiality of Drugs, (2) Market Based Pricing, and (3) Control of Formulations. The new policy is based on regulating the prices of the formulations only. This is different from the earlier principle of regulating the prices of specified Bulk Drugs and their formulations. Bulk Drugs are not considered to fully reflect the "Essentiality" of the actual drug due to the possible applicability of the Active Pharmaceutical Ingredient ("API") in manufacture of various other formulations which may be non-"Essential" for the larger healthcare requirements of the population.

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September 15, 2011

Glivec®'s Patent Questions in India Remain--Is It As Efficacious in Removing Judges As It Is in Cancer?

by Howard E. Rosenberg, Ph.D.

supremecourtindia.jpgNovartis's patent application for a novel crystal form of the cancer drug imatinib mesylate was rejected in India by the Chennai patent office back in 2006, citing that Indian patent law does not allow patent exclusivity for derivatives or marginally innovated forms of known drugs unless it is proved that it enhances the treatment value substantially. The issue concerns the interpretation of Section 3(d) of the Indian patent law, a clause peculiar to India and also potentially at odds with the Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS").

Section 3 (d) of the Indian patent law lists out one such non eligible patentable subject matter:

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 process results in a new product or employs at least one new reactant.

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.


In essence, section 3(d) aims to prevent the phenomenon commonly referred to as "evergreening" by providing that only those pharmaceutical derivatives that demonstrate significantly enhanced "efficacy" are patentable. (See, for example, The 'Efficacy' of Indian Patent Law: Ironing out the Creases in Section 3(d) by Shamnad Basheer & T. Prashant Reddy)

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February 24, 2011

Chinese Government to Support its Own Chemical and Pharmaceutical Companies to Develop their Exports

by Howard E. Rosenberg, Ph.D.

Yuan.jpgAccording to Shanghai Securities News last week, China will allocate billions of yuan to support domestic chemical and pharmaceutical companies in their development of overseas markets. The Chinese government has outlined a draft of the new policy where it may invest up to 5 billion yuan ($759.29 million) in the sector. According to reports, the policy will be released in the first half of this year.

During the 12th Five-Year Plan (2011-2015), China is expected to support more companies in their overseas certification to export products to the U.S., Japan, and Europe. The focus will be on improving companies' current good manufacturing practices ("cGMPs") to the levels adopted in these countries. Over 20 companies met the cGMP standards during the 11th Five-Year Plan, and it is thought that the future prosperity of China's chemical and pharmaceutical companies will depend on more of them meeting cGMPs. During the next five years, over a hundred companies are predicted to obtain these levels.

Yu Mingde, President of the Chinese Pharmaceutical Enterprises Association said, "In the next five years, the government will assist some 60 producers in the sector with the goal of reaching international quality standards of manufacturing, and also help the sector realize total export volume of more than $4 billion." The cGMP requirements adopted in Europe and the U.S. will be harder for Chinese drugs to meet, but, at the same time, once met, will benefit them more, added Yu.

China produces most of the world's active pharmaceutical ingredients ("APIs"), Guo Fanli, a pharmaceutical analyst with CIC Industry Research Center, was reported as saying last Thursday. "The majority of the API drugs produced in China are exported to Africa, since it is hard for Chinese drug producers to comply with the quality standards of Western countries," Guo said.

For a country the size of China to have just 20 companies producing APIs to cGMPs and to aim for only another 100 companies to achieve that standard over the next 5 years is surely inadequate. A vast amount of pharmaceutical intermediates already come out of China and presumably this suggests they are not being made to cGMPs. There have been several instances where contamination by impurities in Chinese APIs has led to deaths. For China to allay fears, not only domestically, and to restore confidence with the FDA, the European Medicines Association, and other health authorities, far more of an effort must be channeled locally into regular inspections of all those companies wishing to market pharmaceuticals and to ensure they always meet cGMPs.

January 27, 2011

India's Data Exclusivity Provisions and Agreements with the EU

by Howard E. Rosenberg, Ph.D.

India EU.jpg Whenever the U.S. or the European Union ("EU") discuss entering into Free Trade Agreements ("FTA") with other countries, they always press for the inclusion in any agreement of a data exclusivity period for pharmaceuticals. The current discussions by the EU with India are no different, and it appears to be one of the proposals that is still holding up any agreement.

The Trade Related Aspects of Intellectual Property Rights Agreement ("TRIPS") requires that data disclosed during registration of pharmaceuticals should remain undisclosed to third parties. TRIPS is an international agreement administered by the World Trade Organization ("WTO") that sets down minimum standards for many forms of intellectual property regulation applied to nationals of other WTO Members that was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade in 1994. However, the EU is going one step further in requiring a time period restricting use by the Indian pharmaceutical registration authority in accessing the data in support of generic medicines. The EU state in the draft:

The Parties shall guarantee the confidentiality, non disclosure and non reliance of data submitted for the purpose of obtaining an authorisation to put a pharmaceutical product on the market. For that purpose, the Parties shall ensure in their respective legislation that any information submitted to obtain an authorisation to put a pharmaceutical product on the market will remain undisclosed to third parties and benefit from a period of at least [...] years of protection against unfair commercial use starting from the date of grant of marketing approval in either of the Parties.

In general terms the EU's own data exclusivity period is around 10 years with the US around 5 years for new chemical entities.

The EU Commission states it is ready to show the necessary flexibility and fully take into account the specificities of the Indian legal system, the policy developments on this issue within India, its developing country status and the role it plays with regard to production of essential generics for the developing world.

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January 14, 2011

India Poised to Inspect Overseas Manufacturing Sites

by Howard E. Rosenberg, Ph.D.

CDSC.jpgLast July, the Drugs Controller General of India ("DCGI"), which is akin to FDA, proposed to implement overseas inspections of manufacturing sites as a consequence of the banning of the import of raw materials from ten Chinese drug companies that supplied products without having the mandatory drug manufacturing standards. It has now been reported that in about two weeks the DCGI will begin inspections of manufacturing facilities from where Indian companies source their active pharmaceutical ingredients and intermediates for pharmaceutical production. The pilot program will initially focus on Italy and China and, if successful it will then be extended and introduced for all countries.

The Central Drugs Standard Control Organisation is already in the process of pulling together a team of fifteen to twenty drug inspectors, trained in auditing and inspection of sites in accordance with international standards.

Dr. Surinder Singh, Drugs Controller General of India, said, "Currently there are 1364 sanctioned posts, and around 864 are filled up. We need at least 3,100 drug inspectors in the country." http://www.business-standard.com/india/news/dcgi-plans-to-raise-drug-inspectors-tally-in-india/417975/ Dr. Singh has already pointed out that there was a need for overseas inspections, saying that it is the responsibility of the indenting agents to make the manufacturers aware of the rules and regulations of the country. "As of now they have poor knowledge of the Drugs and Cosmetics Act, poor understanding and interpretation of the drug rules of the country. In fact, surprisingly at times, even their submissions are not complete. It is the responsibility of the indenting agents to make them aware of these laws and also to ensure that these companies follow the rules and regulations of the country if they want to do business in India."

If successful, India's move to inspect manufacturing sites may lead to greater cooperation with FDA inspectors for pharmaceutical products imported from India.