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Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Practical and legal preparation for young companies seeking technology transfer

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ABSTRACT: This paper looks at the basic law of intellectual property as it applies to a small biotechnology company or start-up. It focuses on the systems and attention to paperwork required so that the company can maximise its intellectual property protection.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Susan Kling FinstonThis is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

India’s new Prime Minister  Narendra Modi has asked Ministers to set ambitious targets for the first 100 days of government,. While the BJP Party Manifesto calls for implementation of incentives for R&D Intensive Enterprises, BioPharma wallahs eagerly await clear signals on IP policy directions, where latest reports indicate that the Modi Government’s first act may be to expand pharma price controls by raising the number of drugs on the essential medicines list.

My earlier posting on the BJP victory addressed urgently needed regulatory reforms to restore luster to Indian drugs, devices and clinical research and ensure patient safety domestically and in highly regulated markets alike. For insights into potential patent law priorities – and leaving the important issues of data protection and patent linkage for another day –  let’s look back ten years, and revisit the policies of the prior BJP Government.

As full disclosure, I represented the international innovative pharmaceutical industry in a number of developing countries including India in the run-up to the WTO 2005 deadline for adoption of product patent protection. I remember vividly the excitement in the room at the World Economic Forum (WEF) in New Delhi on December 6, 2004 as we awaited remarks of then-Minister of Industry and Commerce Kamal Nath.  Speaking to the WEF plenary late in the afternoon, Nath electrified the crowd with his pronouncement that India would not be wishy-washy in meeting its WTO trade obligation to adopt product patents for pharmaceuticals, and that it would be good for India. Three weeks later, Nath ushered in the new era of product patent protection on December 27, 2004 with a detailed policy Statement outlining the rationale behind the BJP’s Ordinance relating to the Patents (Third) Amendment.

Let’s review the pharma / biotech highlights in the Ministry of Commerce and Industry Statement–keeping in mind that the Ordinance was watered-down by leftist amendments before passage in March of 2005 (after the BJP Government was voted out of power).

  • The pharma and IT industry are described as sunrise sectors for India, increasingly following R&D-based strategies for innovative growth, and dependent on patent protection:

“Thus, while Indian companies spent not even a fraction of a percent on R & D ten years ago, today the larger Indian companies are spending in the region of 6 to 8 percent of their turnover on R & D. (The norm for major MNCs is 12%). The transformed Indian pharma industry is itself looking for patent protection – particularly the bio-tech sector, in which India has aggressive prospects.”

  •   Continued growth of Indian Indian pharma exports to the lucrative US market depended then, as now, on maintaining a patent system consistent with WTO norms:

“When we joined the WTO ten years ago Indian pharma exports were less than 4000 crore rupees. A decade later our pharma exports are 14,000 crore rupees, and account for more than a third of the industry’s turnover. This is the result of the confidence built up in our industry due to our progressive adherence to our IP commitments. Now we are poised to achieve an annual compounded growth rate of 30% in order to double our pharma exports in three years. Some 60 billion dollars worth of drugs are going off patent in the next few years. Indian industry can grab a lion’s share of this – provided we are a bona fide member of the international trading community[.]”

  • India also stood to gain from adoption of effective patent protection with growth in contract research organizations (CRO) services:

“Apart from manufacture of drugs, the pharma industry offers huge scope for outsourcing of clinical research. We have a vast pool of scientific and technical personnel, and recognized expertise in medical treatment and health care. India can take advantage of our strength in this provided we have the right legal framework in place, which provides IP protection to the results of that research.”

  • The vast majority of drugs would remain ‘off-patent,’ including essential medicines, preventing steep price rises:

“The fear that prices of medicines will spiral is unfounded. In the first place we must realize the fact that 97% of all drugs manufactured in India are off-patent, and so will remain unaffected. These cover all the life-saving drugs, as well as medicines of daily use for common aliments. In the patented drugs also, in most cases there are always alternatives available.”

  • The Act sought to balance access, affordability, and conformity with international IP protection norms:

“The Act ensures that the reasonable requirements of the public with respect to availability and affordability are taken care of. Public interest particularly public health and nutrition is protected. The law effectively balances and calibrates Intellectual Property protection with public health concerns and national security. By participating in the international system of intellectual property protection, India unlocks for herself vast opportunities in both exports as well as her potential to become a global hub in the area of R&D based clinical research outsourcing, particularly in the area of bio-technology.”

While hindsight is 20/20, in retrospect the Ministry of Commerce and Industry Statement appears prescient in identifying key stakeholders and the broader social and economic benefits of a product patent protection. Undoubtedly, the BJP Ordinance itself suffered from lacunae – and received significant criticism from the international innovative BioPharma industry.  At the same time, the Ordinance was recognized as a critical watershed and a substantial, positive step to move India closer to the patent mainstream.  The identified deficits in the BJP Ordinance subsequently were compounded and multiplied by subsequent Leftist amendments, effectively undermining patent protection needed by India’s innovative BioPharma companies and MNCs alike.

Let’s hope that ten years on the Modi Government may see the broader picture beyond price controls for essential medicines and may introduce patent reforms needed to reset the balance between access, affordability and effective patent protection.  This would go a long way to meet the BJP Manifesto to support R&D Intensive Small and Medium Sized Enterprises (SMEs) needed for creation and assimilation of new technologies, e.g., novel diagnostics, devices, therapies and cures for patients in India and globally.

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Global BiotechnologyI will be discussing the 2014 issue of Scientific American Worldview at 12:45 in Room 3 at BIO2014 along with Mike May, the project editor.

I continue to measure global biotechnology innovation in this sixth edition, which is also the foundation I use for my talks on global biotechnology (see my recent talk on Building Biotechnology in India).

In addition to the comparative global biotechnology innovation scorecard which I edit, Worldview also includes subjective stories of global innovation, highlights of selected countries, and profiles of industry leaders.

I look forward to your comments and critiques — check out Scientific American Worldview at http://www.saworldview.com

Find top-performing patent attorneysI am seeking input on a new project which helps you identify top-performing patent attorneys.

PatentStat.com uses cutting-edge research on patent strength to identify top-performing patent attorneys and patent firms in 35 technology areas. Attorneys are scored by their average grant time, the number of claims allowed, citations, and other factors.

As an added bonus, PatentStat also profiles patent examiners, creating a tool for patent counsel to better understand their examiner. Average grant times and other metrics for each examiner are posted, helping inform time and financial budgeting decisions.

I invite you to check out the site in development at http://www.PatentStat.com and I look forward to your comments.

 

I continue to measure global biotechnology innovation in the sixth edition of Scientific American Worldview. This special publication is the foundation I use for my talks on global biotechnology (see my recent talk on Building Biotechnology in India).

I will be serving on a panel on June 26th at 12:45-1:45 in Room 3, and David Brancaccio, host of Marketplace Morning Report will be moderating a discussion with industry leaders at 2pm.

In addition to the comparative global biotechnology innovation scorecard which I edit, Worldview also includes subjective stories of global innovation, highlights of selected countries, and profiles of industry leaders.

I look forward to your comments and critiques — check out Scientific American Worldview at http://www.saworldview.com

Drug Patent Expirations for June 2014

Tradename Applicant Generic Name Patent Number Patent Expiration
BETOPTIC PILO Alcon betaxolol hydrochloride; pilocarpine hydrochloride 5,635,172 Jun 3, 2014
LOCOID LIPOCREAM Precision Dermat hydrocortisone butyrate 5,635,497 Jun 3, 2014
ATACAND HCT Astrazeneca candesartan cilexetil; hydrochlorothiazide 5,958,961 Jun 6, 2014
NEVANAC Alcon Pharms Ltd nepafenac 5,475,034 Jun 6, 2014
ILEVRO Alcon Res Ltd nepafenac 5,475,034 Jun 6, 2014
EDARBI Arbor Pharms Ireland azilsartan kamedoxomil 5,958,961 Jun 6, 2014
TAZORAC Allergan tazarotene 6,258,830 Jun 7, 2014
TAZORAC Allergan tazarotene 5,914,334 Jun 7, 2014
ACTONEL WITH CALCIUM (COPACKAGED) Warner Chilcott calcium carbonate; risedronate sodium 5,583,122*PED Jun 10, 2014
NAPRELAN Almatica Pharma Inc naproxen sodium 5,637,320 Jun 10, 2014
FROVA Endo Pharms frovatriptan succinate 5,637,611 Jun 10, 2014
ACTONEL Warner Chilcott Llc risedronate sodium 5,583,122*PED Jun 10, 2014
ATELVIA Warner Chilcott Llc risedronate sodium 5,583,122*PED Jun 10, 2014
XELODA Hoffmann La Roche capecitabine 5,472,949*PED Jun 14, 2014
HUMALOG MIX 50/50 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,461,031 Jun 16, 2014
HUMALOG PEN Lilly insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 50/50 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,747,642 Jun 16, 2014
HUMALOG Lilly insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 75/25 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 50/50 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,461,031 Jun 16, 2014
HUMALOG MIX 75/25 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,461,031 Jun 16, 2014
HUMALOG MIX 50/50 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,747,642 Jun 16, 2014
HUMALOG MIX 75/25 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,747,642 Jun 16, 2014
HUMALOG MIX 50/50 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 75/25 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,461,031 Jun 16, 2014
HUMALOG KWIKPEN Lilly insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 75/25 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,747,642 Jun 16, 2014
HUMALOG MIX 50/50 Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,474,978 Jun 16, 2014
HUMALOG MIX 75/25 KWIKPEN Lilly insulin lispro protamine recombinant; insulin lispro recombinant 5,474,978 Jun 16, 2014
SOLARAZE Fougera Pharms diclofenac sodium 5,639,738 Jun 17, 2014
SOLARAZE Fougera Pharms diclofenac sodium 5,929,048 Jun 17, 2014
IMAGENT Imcor Pharms Co dimyristoyl lecithin; perflexane 5,639,443 Jun 17, 2014
SOLARAZE Fougera Pharms diclofenac sodium 5,852,002 Jun 17, 2014
MARQIBO KIT Talon Therap vincristine sulfate 5,741,516 Jun 20, 2014
MARQIBO KIT Talon Therap vincristine sulfate 5,814,335 Jun 20, 2014
MARQIBO KIT Talon Therap vincristine sulfate 5,543,152 Jun 20, 2014
ZEMPLAR Abbvie paricalcitol 5,587,497*PED Jun 24, 2014
YAZ Bayer Hlthcare drospirenone; ethinyl estradiol RE37838 Jun 30, 2014
BEYAZ Bayer Hlthcare drospirenone; ethinyl estradiol; levomefolate calcium RE37564 Jun 30, 2014
YAZ Bayer Hlthcare drospirenone; ethinyl estradiol RE38253 Jun 30, 2014
BEYAZ Bayer Hlthcare drospirenone; ethinyl estradiol; levomefolate calcium RE37838 Jun 30, 2014
ACOVA Pfizer argatroban 5,214,052 Jun 30, 2014
YAZ Bayer Hlthcare drospirenone; ethinyl estradiol RE43916 Jun 30, 2014
BEYAZ Bayer Hlthcare drospirenone; ethinyl estradiol; levomefolate calcium RE43916 Jun 30, 2014
YAZ Bayer Hlthcare drospirenone; ethinyl estradiol RE37564 Jun 30, 2014
BEYAZ Bayer Hlthcare drospirenone; ethinyl estradiol; levomefolate calcium RE38253 Jun 30, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Maryland and Virginia unite at 2007 Mid-Atlantic Bio Conference

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ABSTRACT:   

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Asian biotechnology innovation
Asian biotechnology innovation

My paper on global biopharmaceutical productivity has been published in the latest issue of Nature Biotechnology.

This paper is a refinement of my work ranking international biotechnology for Scientific American Worldview, and draws on the DrugPatentWatch database.

In this paper I investigate the locations of drug inventors, as measured by patents covering marketed drugs. The result, which may surprise many readers, is that the bulk of the innovation still occurs in the legacy pharma regions — Western Europe, the United States, and Japan.

I have many thoughts on why larger Asian countries like India, South Korea, and China demonstrate little innovation in biopharmaceuticals (and I’ve expressed these views at length in my talks, and here and here), and I have also published prescriptions for smaller nations.

Given the poor output of patents covering marketed drugs from countries such as China, one must ask whether vigorous pro-patenting policies (China leads the world in patent applications — but not in grants) are appropriate. Additionally, one must ask if Western metrics for innovation should be applied to other contexts.

To access the full paper (paywall), see http://www.nature.com/nbt/journal/v32/n6/full/nbt.2933.html

For more information on the DrugPatentWatch database, see http://www.DrugPatentWatch.com

Journal of Commercial BiotechnologyMassBio and the Journal of Commercial Biotechnology have partnered to provide MassBio members with free and discounted subscriptions.

  • New MassBio members can get a free 1 year digital subscription to the Journal of Commercial Biotechnology
  • Existing MassBio members can get a 20% discount on Journal of Commercial Biotechnology subscriptions

Members should contact editor@CommercialBiotechnology.com to activate their free subscription or to purchase a discounted subscription.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

To discuss a partnership with your organization, contact editor@CommercialBiotechnology.com .