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Activery The amorphization specialist

Activery The amorphization specialist

Activery believes that amorphous drugs provide new and innovative routes to final dosage forms with differentiated pharmacokinetics

Creating new paths to differentiated medicines

Creating new paths to differentiated medicines

In Activery we believe that solid state modifications may lead to a critical changes in your active pharmaceutical, thus to a differentiated drug or to a brand new innovative medicine  

Activery, the solid state specialist

Activery, the solid state specialist

Activery possess unrivalled specialist expertise about different crystallization techniques and expert knowledge in the field of solid state modulation.  

Particles and nanoparticles for special uses

Particles and nanoparticles for special uses

In Activery, we design and produce particles for special uses where size matters such as nanoparticles for cancer treatment. Through our technology you would enable new administration routes or renewed performance of your drug formulation.  

Market news
Mylan confirms generic Lescol patent challenge PDF Print E-mail
 Medical Patent News


Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.
Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. The company filed an ANDA with the U.S. Food and Drug Administration (FDA) in June. Novartis filed a lawsuit Oct. 10 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,354,772.

Fluvastatin Capsules, used in the treatment of high cholesterol, had approximately $60 million in sales for the twelve months ending June 30, 2008, according to IMS Health.

Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities
 
Reformulated combination corticosteroid/anti-infective brands will continue be integral to the treatment of psoriasis and dermatitis PDF Print E-mail
 BUSINESS INSIGHTS


The Dermatology Market Outlook to 2013Our healthcare portfolio of reports can be used across a wide range of business functions to assess market conditions and devise future strategy. Our reports cover key areas including strategy, industry analysis, market outlook, new business opportunities and strategic insight.

“The UK is forecast to have the highest prevalence rate of dermatitis in 2013 at 7.96%. This is closely followed by France with a prevalence rate of 7.86% accounting for a dermatitis population of close to five million. Overall the seven major markets together will have 48.97 million sufferers in 2013...”

• Increased safety concerns will restrict future growth for topical immunosuppressants such as Novartis’ Elidel and Astellas’ Protopic. Both these products have a declining market presence due to the FDA’s black box label warning in 2005 for potential cancer risk.

• Major branded oral acne treatments including Roaccutane will face growing generic competition over the 2008-2013 period.

Leading brands in the topical acne treatment market are only expected to achieve marginal growth, while the total market for acne treatments is expected to amass $3b of revenue in 2013.

• The market for psoriasis treatments is forecast to register strong growth between 2008-2013, driven by the performances of key drugs such as Raptiva, Taclonex, Soriatane.

• The corticosteroid market is estimated to value $3.7b by 2013.

Reformulated combination corticosteroid/anti-infective brands will continue be integral to the treatment of psoriasis and dermatitis and will continue to be the primary growth drivers within the area.

• Leo Pharma is believed to feature the strongest R&D pipeline in the dermatology market, with five projects currently in the mid to late stages of development. However, most leading companies have sparsely populated pipelines.

The dermatology market remains highly competitive, with developers ranging from Big Pharma to biotechnology and specialty pharmaceutical firms. In recent years levels of innovation in the area have dwindled, allowing generic competition to erode the market share of several leading brands across major drug classes. As leading players continue to lose ground to smaller, specialised players, opportunities are being created for companies that can implement effective lifecycle management and identify lucrative niches.

 

“The dermatology market is dominated by sales of original brands and "other branded products" sold under an alternative brand. Collectively, the two categories represented 64% of the market in 2007. Overall, the strongest growth was derived from the "other brands" segment, which registered 14% growth over 2006, with sales of $3.7b...“

• Assess the epidemiology and forecast prevalence of major dermatological disorders including acne, psoriasis, dermatitis, rosacea across key geographies including the UK, Japan, France, Germany, Italy, Spain and the US.

• Evaluate the performances and strategies of major dermatology developers by examining the sales focus by drug class, currently marketed products and R&D portfolios of Bayer Schering, Galderma, GSK, Leo Pharma, Novartis, J&J, Roche, Sanofi-Aventis, Schering-Plough and Stiefel Labs.

 

• Generics threaten branded oral acne treatments. The majority of anti-acne brands, excluding Roaccutane and Diane, are based on generic molecules and formulations. This is expected to cause a shift in developmental focus to topical acne treatments and lead to a collapse in the value of the branded oral acne market.

• The future of corticosteroids. Triple combination products and reformulations are continuing to revive the sales of corticosteroid brands following poor performance in 2006. However, widespread genericization is threatening to stifle future growth in this class.

• Competition intensifies for psoriasis treatments. New molecular entities are largely focused upon psoriasis indications. The market is likely to witness strong growth in the forecast period as anti-TNF therapies such as Enbrel and Humira maintain strong performances.

 

 

Chapter 3: Global market analysis Corticosteroids: Market analysis by drug class The global corticosteroid market grew by 9.7% over the period 2006–07, accounting for $1.4bn in sales. Topical plain corticosteroids, which contain dermatological products with one or more corticosteroids and no other active ingredients, form the major share of the market at 75.5%. This class of corticosteroids also grew at a higher rate of 11%, compared to the second class of corticosteroids which have an anti-infective agent in combination. The latter class recorded a growth of 6.1% over its 2006 sales of $336m. Olux—Stiefel Labs’ drug for scalp psoriasis—was the leading corticosteroid drug in 2007, while Nestlé's Clob X had the second highest market share at 19.8%. Schering-Plough’s Diprogenta, indicated for corticosteroid responsive dermatoses, had the highest market share in the second category of corticosteroid formulations, at 10.4%. Key brands analysis: Olux Olux foam is a super-potent topical corticosteroid indicated for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, as well as the short-term topical treatment of mild to moderate plaque-type psoriasis of nonscalp regions (excluding the face and intertriginous areas). In March 2007, Stiefel Labs launched Olux in 50 gram and 100 gram canisters in the US. The product generated revenues of $100m in 2007, 25% up on its 2006 revenues. In clinical studies, Olux was shown to safely and effectively reduce the symptoms associated with psoriasis and eczema. Olux foam is marketed as being easier to apply than an ointment or cream, while lacking the sticky feel associated with such products. Further, the product is designed to be non-stinging and contains ingredients with moisturizing properties, which are believed to be appropriate for not only patients with psoriasis but also those with eczema.

 

 

DERMATOLOGICAL DISORDERS

• Introduction

• Acne

- Overview

- Epidemiology

- Forecast epidemiology

• Psoriasis

- Overview

- Epidemiology

- Forecast epidemiology

• Dermatitis

- Overview

- Epidemiology

- Forecast epidemiology

• Rosacea

- Overview

- Epidemiology

- Forecast epidemiology

• Infectious diseases of the skin

- Overview

- Viral infections of the skin

- Bacterial infections of the skin

- Fungal infections of the skin

- Epidemiology

- Viral infections of the skin

- Bacterial infections of the skin

- Fungal infections of the skin

- Forecast epidemiology

- Viral infections of the skin

- Bacterial infections of the skin

- Fungal infections of the skin

CHAPTER 3: GLOBAL MARKET

ANALYSIS

• Introduction

• Market analysis by country

• Licensing trends

• Market analysis by drug class

• Leading brands dynamics

• Dermatology sales forecast to

2013

• Key events in the dermatology market

- Biologics expected to drive growth in the psoriasis market - FDA requires class labeling and strengthened warnings for all four leading anti-TNF therapies - Topical acne market moving towards combination products

- Black box warning for Elidel and Protopic to adversely impact growth - Roche’s Roaccutane plagued by side-effect concerns and limited risk management

programs

• Acne treatments

- Market analysis by drug class - Leading acne treatment brands by drug class - Key brands analysis

- Differine

- Roaccutane

- Acne treatment sales forecast

to 2013

• Psoriasis treatments

- Market analysis by drug class

- Leading psoriasis treatment

brands by drug class

- Key brands analysis

- Raptiva

- Soriatane

- Psoriasis treatment sales

forecast to 2013

• Corticosteroid treatments

- Market analysis by drug class

- Leading corticosteroid

treatment brands by drug

class

- Key brands analysis

- Olux

- Corticosteroid treatment

sales forecast to 2013

• Anti-infective treatments

- Market analysis by drug class

- Leading anti-infective

treatment brands by drug

class

- Key brands analysis

- Lamisil

- Bactroban

- Aldara

- Zovirax

- Anti-infective treatments

sales forecast to 2013

• Non steroidal products

- Market analysis by drug class

- Non steroidal brands by drug

class

- Key brands analysis

- Elidel

- Protopic

- Non steroidal treatments

sales forecast to 2013

CHAPTER 4: PIPELINE

ANALYSIS

• Introduction

• Key trends in R&D

- Celgene’s apremilast may be

an alternative to current

anti-TNF therapies

- Intense competition in

psoriasis, but voclosporin

could compete on better

side-effect profile and cost

- Collagenex (Galderma)

licenses becocalcidol from

QuatRx

- Reformulation products

gaining traction

• Dermatology pipeline

• Leading drugs in development

• Profiles of key pipeline products

• Recently marketed drugs

- Altabax

- Desonate (desonide

hydrogel)

- Humira

Table of Contents (contd.)

- Ziana

- Oracea

- Taclonex

• Drugs in registration

- Ustekinumab (CNTO–1275)

- Panaclar/BG-12

• Drugs in Phase III clinical

studies

- Voclosporin (ISA-237)

- ABT-874 (formerly J-695)

• Drugs in Phase II clinical studies

- Apremilast (CC-10004)

- COL-118

• Pipeline forecast

CHAPTER 5: COMPETITIVE

LANDSCAPE

• Introduction

- Sales performance of leading

players

• Detailed analysis of leading

dermatology players

• Stiefel Labs

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Johnson & Johnson (J&J)

- Overview

- Sales focus by drug class

- R&D pipeline analysis

• Sanofi-Aventis

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Novartis

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• GlaxoSmithKline (GSK)

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Galderma

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Leo Pharma

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Bayer-Schering Pharma

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Schering-Plough

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

• Roche

- Overview

- Sales focus by drug class

- Marketed product portfolio

- R&D pipeline analysis

- Strategic and growth analysis

LIST OF FIGURES

• Mechanism of acne formation

• Disease progression and

symptoms of acne

• Common forms of psoriasis

• Types of dermatitis

• Types of contact dermatitis

• Subtypes of rosacea

• Types of viral infections

• Types of bacterial infections

• Types of fungal infections

• Global dermatology market

share by geography, 2007,

US$m

• Sales of types of dermatology

brands, 2006–07

• Prevailing R&D approaches,

2008

• Leading recently launched

products and late-stage R&D in

the dermatology market, 2008

• Market share of key players by

sales value, 2007

• Projected market share of key

players by sales value, 2013

• Market share and ranking of

leading players in the global

dermatology market, 2007–13

For the following companies:

• Dermatology sales by drug

class, 2007

- Stiefel Labs

- J&J

- Sanofi-Aventis

- Novartis

- GSK

- Galderma

- Leo Pharma

- Bayer Schering

- Schering Plough

LIST OF TABLES

• Estimated prevalence of

dermatological conditions

across the seven major

markets, 2007

...SAVE £300/€435/$575 as a special pre-publication offer

when you order by Friday 31st October 2008...

Table of Contents

For the following disorders:

• Estimated prevalence across

the seven major markets, 2007

• Forecast epidemiology across

the seven major markets,

2007–13

- Acne

- Psoriasis

- Dermatitis

- Rosacea

- Viral infections of the skin

- Fungal infections

- Bacterial infections

• The global dermatology market

by drug class 2006–07

• Leading brands in the global

dermatology market, 2006–07

• Dermatology market sales

forecast by drug class 2007–13

• The global acne market by drug

class, 2006–07

• Leading acne treatments in the

global dermatology market,

• Anti-acne products sales

forecast, 2007–13

• The global psoriasis market by

drug class, 2006–07

• Leading psoriasis treatments in

the global dermatology market,

2006–07

• Anti-psoriasis sales forecast,

2007–13

• The global corticosteroid

market by drug class, 2006–07

• Leading corticosteroid

treatments in the global

dermatology market, 2006–07

• Corticosteroid treatments sales

forecast, 2007–13

• The global anti-infectives

market by drug class, 2006–07

• Leading anti-infective

treatments in the global

dermatology market, 2006–07

• Anti-infective treatments sales

forecast, 2007–13

• Non steroidal treatments by

drug class, 2006–07

• Non steroidal treatments in the

global dermatology market,

• Other leading dermatology

treatments sales forecast,

2007–13

• Dermatology pipeline by

indication and stage of

development, 1H2008

• Product Overviews

- Altabax

- Desonate

- Humira REVEAL data

- Humira versus placebo

- Ziana

- Oracea

- Taclonex

- Ustekinumab

- Panaclar

- Voclosporin (ISA-237)

- ABT-874

- Apremilast

- COL-118

• Dermatology disorders pipeline

forecast, 2008–13 ($m)

• Leading Players in the global

dermatology market,

2007–13 ($m)

For the following companies:

• Leading dermatology product

portfolio, 2006–07

• Dermatology R&D product

pipeline, 2007 (where

appropriate)

- Stiefel Labs

- J&J

- Sanofi-Aventis

- Novartis

- GSK

- Galderma

- Leo Pharma

- Bayer Schering

- Schering Plough

- Roche
 
Top generic companies : new report PDF Print E-mail
The Top 10 Generic Pharmaceutical Companies: Positioning, performance and SWOT analyses
Item description

‘The Top 10 Generic Pharmaceutical Companies’ is a new report published by Business Insights that analyzes the size, structure and competitive landscape of the global generics market.

The global generics market grew at a faster pace than the global pharma market in 2007, with a CAGR of 16.4% during 2004–2007. Regular patent expirations of blockbuster drugs are the primary growth driver of the industry.
Rising healthcare expenditure has also contributed to industry expansion, with governments coming under growing pressure to provide low cost alternatives to branded drugs. However, the generics market is changing due to the threat from authorized generics, competition from players in emerging countries and increasing consolidation. Teva’s acquisition of Barr Pharmaceuticals is the latest example of companies attempting to improve their market strength and geographical reach via divestments and acquisitions.

‘
Some key findings from this report...

• The global generics market reached $90.7m in 2007, representing a three-year CAGR of 12.1%. Sales of generic drugs are expected to increase by 14–15% in 2008, as compared with branded pharmaceutical growth of 6–7%. Much of this growth will be driven by the introduction of pro-generic reforms to major markets.

• The top 10 generics companies accounted for 28.5% of the global market in 2007. Many leading players are actively updating their product portfolios, seeking growth opportunities in emerging markets, pursuing cost optimization and investing in R&D capabilities.

• The US attained generics sales worth $25.4m in 2007, accounting for 26.3% of global market. However, the generics markets of EU countries have a higher growth rate than the US, and accounted for 14.2% of the global sales in 2007.

• Generics companies are currently facing a number of major challenges including continued pricing pressure, authorized generics, a lack of patient awareness and distrust among healthcare prescribers.

• The nervous system (NS) and cardiovascular system (CVS) were the largest generics therapy areas among the top 10 companies in this report, with a 2007 market share of 31% and 28% respectively.

Key issues examined in this report...

• Growing presence of branded companies. Branded Pharma companies are increasingly involved in generics production to win back revenues that would otherwise be lost due to patent expiry. After launching their own authorized generics, branded companies are able to delay and inhibit the entry of pure generic players by undercutting price and market share during the exclusivity period.
• Rising pressure on pricing. The long term sustainability of generic pharmaceutical companies is coming under threat after government initiatives to promote low cost generics have contributed to product devaluation and reduced profit margins.
• Increased consolidation. Generic manufacturers are consolidating in order to compete with rising numbers of specialty pharma companies who possess greater scale and R&D capabilities. The regulatory framework for authorized generics also provides easy market access for specialty developers, forcing pure generic players to consolidate in order to achieve greater vertical integration, scale and R&D skills.

Table of Contents

Executive Summary
Industry overview
Novartis (Sandoz)
Teva
Mylan
Ratiopharm
Apotex
Pfizer (Greenstone)
Sanofi-Aventis (Winthrop)
Watson
Bayer
Stada


Top trends in the industry 43
Changing paradigms towards emerging markets 43
The generics manufacturing base is shifting to low cost hubs 45
Growing legislative support for 'follow-on biologics' 46
Increasing participation of branded Pharma companies in generics industry 47
Consolidation 49
Top ten generic companies 50
Global ranking 50
US/5EU consolidated 50
Therapeutic focus of the top 10 51
Key marketed products of the top 10 53
Geographic focus of the top 10 54
US ranking 54
EU ranking 55

Chapter 3 Novartis (Sandoz) 58
Summary 58
Business description 59
Geographic focus 60
Marketed products 61
Major therapeutic focus 62
Growth strategies 63
Focus on difficult-to-make and biosimilar generics 63
Acquisitions and divestments 64
SWOT analysis 65
Strengths 66
Size and leading generics position 66
Dynamic launches 66
Weaknesses 67
Development setbacks 67
Opportunities 67
Strong pipeline 67
Threats 68
Legal proceedings 68

Chapter 4 Teva 70
Summary 70
Business description 71
Geographic focus 72
Marketed products 73
Major therapeutic focus 74
Growth strategies 76
Acquisitions and divestments 76
SWOT analysis 77
Strengths 78
Leading generics market position 78
Global infrastructure 78
Weaknesses 79
Distribution model 79
Opportunities 79
Focus on hospitals and institutional channels 80
Threats 80
Failure to obtain market exclusivity in the US 80

Chapter 5 Mylan 84
Summary 84
Business description 85
Geographic focus 86
Marketed products 87
Major therapeutic focus 88
Growth strategies 89
Acquisitions and divestments 90
SWOT analysis 91
Strengths 91
Leading market position in Asia Pacific 91
Growth through strategic acquisitions 92
Weaknesses 92
Dependence on a few key products 92
Opportunities 93
Growing generics demand 93
Threats 93
Merck Generics litigations 93

Chapter 6 Ratiopharm 96
Summary 96
Business description 97
Geographic focus 97
Marketed products 99
Major therapeutic focus 99
Growth strategies 100
Focus on biosimilars 100
Acquisitions and divestments 101
SWOT analysis 102
Strengths 102
Leading position in Germany 102
Weaknesses 103
Dependence on European market 103
Opportunities 103
Biosimilar filgrastim 103
Launch of generic Plavix 103
Threats 104
Competition in German generics market 104

Chapter 7 Apotex 106 
 
CCN, Abraxis BioScience and AstraZeneca Announce Collaboration to Conduct Anti-Cancer Drug Studies PDF Print E-mail
CCN, Abraxis BioScience and AstraZeneca Announce Collaboration to Conduct Anti-Cancer Drug Studies

ABRAXANE® in Several Cancer Types to Be Evaluated Along with Correlation of Response Rates and Expression of SPARC

FORT WASHINGTON, Pa.--(BUSINESS WIRE)--The National Comprehensive Cancer Network (NCCN), Abraxis BioScience (NASDAQ:ABII), and AstraZeneca (NYSE:AZN) today announced that they have entered into a collaboration to conduct multiple investigator-initiated studies of Abraxis BioScience’s anti-cancer drug ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound), which is based on the company’s proprietary tumor targeting technology known as the nab™ platform.

The NCCN studies will evaluate ABRAXANE in the treatment of breast, non-small cell lung, head and neck, melanoma and ovarian cancers. The clinical research will include investigations of tumor gene expression by microarray and the expression of SPARC, (secreted protein acidic and rich in cysteine), a protein that is over expressed and secreted in many cancers. SPARC, a known prognostic factor for poor survival in a number of tumor types1, is an albumin binding protein that may mediate an enhanced anti-tumor effect of ABRAXANE via a SPARC- albumin interaction2.

“Collaborating with NCCN Member Institutions allows us to tap into their collective expertise to develop safer and more effective treatments for cancer. ABRAXANE has become a leading treatment option for metastatic breast cancer, and we are pleased to support this critical research designed to investigate ABRAXANE in several oncology indications,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “The research will also evaluate whether SPARC expression leads to increased clinical response with ABRAXANE due to the interaction of SPARC and albumin.”

Abraxis and AstraZeneca, which have a co-promotion agreement for marketing ABRAXANE in the United States, are providing funding in support of the clinical studies. Investigators at seven NCCN Member Institutions are recipients of awards from NCCN for the clinical studies conducted at their centers.

"AstraZeneca is pleased to support the NCCN Oncology Research Program in collaboration with Abraxis Oncology," said Lisa Schoenberg, Vice President of Specialty Care, AstraZeneca. "This program can be beneficial by providing a better understanding of ABRAXANE in different tumor types. Support of the NCCN program is further evidence of AstraZeneca’s commitment to oncology research."

The NCCN Oncology Research Program (ORP) facilitates all phases of clinical research by identifying clinical investigators and initiating trials at NCCN Member Institutions. The NCCN ORP draws on the expertise of investigators at 21 of the world’s leading cancer centers and helps to establish collaborations with pharmaceutical and biotech companies in order to advance therapeutic options for patients with cancer. 
 
Business case: Atorvastatin Patents in Norway PDF Print E-mail
 Ranbaxy Successfully Challenges Atorvastatin Patents in Norway



Rulings in Favor of Ranbaxy on All Four Patents Will Support the Launch of Atorvastatin in Norway


Ranbaxy Laboratories Limited (RLL) announced that the Norwegian Appeals Court today handed down a favorable decision for Ranbaxy in its case against Pfizer, involving key Norwegian patents on Atorvastatin in Norway. Atorvastatin is a cholesterol-lowering drug which is marketed by Pfizer as Lipitor(R).
The Oslo City Court had previously sided with Ranbaxy by finding non-
infringement of two of Pfizer's Norwegian patents (No. 177,566 and No. 180,199) covering particular intermediate compounds. It had, however, denied Ranbaxy's assertion of non-infringement on Pfizer's Norwegian patent (No. 177,706) also covering particular intermediate compound, which was then appealed by Ranbaxy. In today's decision, the appeal court upheld the city court ruling on the '566 and the '199 patent but overturned the adverse ruling on the '706 patent. The Norwegian Appeals Court also found Pfizer Norwegian process patent (No. 309,322) relating to a process for manufacturing amorphous Atorvastatin to be invalid. This patent had been earlier revoked by the EPO. The decision will now allow Ranbaxy to market Atorvastatin Tablets in Norway. "This is a most important decision for Ranbaxy as it completely validates our position in relation to the Atorvastatin patents," said Jay Deshmukh, Senior Vice President, Global Intellectual Property for RLL. He further added, "This decision will allow Ranbaxy to market an affordable, generic dosage form of Atorvastatin that will be of benefit to Norwegian patients."

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

 
Patenting Nanotechnology Invention PDF Print E-mail
Patenting Nanotechnology Inventions:
Jeremy M. Stipkala, Ph.D. IPfrontLIne.com

Imagine that you have created nano-sized particles of a known drug, providing a new way to deliver that drug to a patient. Or perhaps you have pioneered sol-gel processed colloids of a metal oxide known to be a powerful catalyst. Now you want to exploit the fruits of your research and sell a product based on your invention. But first, you must protect those fruits and the further investments needed to turn your invention into a viable product, by applying for a patent. But how do you patent your nanotechnology invention when the drug or the metal oxide catalyst is already known?


Software Licensing Agreements

To obtain a patent, your invention must be useful, new, and not obvious.1 The nano-sized drug and colloidal catalyst are clearly useful, and they are new if no one has reported making them before. Whether those products are obvious presents a more difficult question, however, since the molecular drug and the bulk metal oxide catalyst are known. Can you patent a known material just by changing its size? When it comes to nanotechnology, the answer most likely is 'yes.' This article discusses how to show the nonobviousness of nanotechnology inventions when those inventions build on materials known in forms significantly smaller or larger than nano-sized.

Section 103 of Title 35 of the United States Code describes when an invention is obvious and therefore unpatentable:

A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.2

Determining whether the "subject matter as a whole would have been obvious" requires a comparison of the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the pertinent art.3 Also, so-called "secondary considerations," such as whether the claimed invention possesses unexpected results or enjoys commercial success, must be evaluated.4

The obviousness analysis applies to our hypothetical situation as follows. The pharmaceutical prior art teaches the same compound useful for the same purpose as you would use your nano-sized version—treating some disease or condition. Also, the catalysis prior art teaches your metal oxide in bulkier form for catalyzing the same reaction that you describe in your patent application. The difference with the prior art in both cases, however, is that your invention is nano-sized. Some case law suggests, however, that merely changing the size does not impart patentability. For example, merely scaling up a polymerization reaction5 or increasing the size of a package of lumber6 would not necessarily make those differently sized inventions patentable.

But those situations are very different from your nanotechnology invention. Remember that we also have to look at the level of ordinary skill in the art. Was the level of skill in the pharmaceutical or catalysis art high enough so that the ordinarily skilled artisan could make your nano-sized version of the prior art?

To your advantage, a product is not obvious as a matter of law unless a process for making that product is also obvious. Cases involving novel crystalline forms of drugs illustrate this. For example, in the case In re Irani, the patent applicants claimed as their invention "Crystalline anhydrous amino tri(methylene phosphonic acid) ["ATMP"]."7 The prior art taught amorphous ATMP. The prior art also taught other amino phosphonic acids in crystalline forms and the same use for those acids as disclosed by the applicants. The patent examiner at the United States Patent and Trademark Office rejected the applicants' crystalline anhydrous ATMP as obvious and therefore unpatentable in light of that prior art. On appeal, the Court of Customs and Patent Appeals (the precursor to today's Court of Appeals for the Federal Circuit) reversed, holding that the claimed form of ATMP was indeed patentable. The court stated, "we are not convinced that the references of record would lead one of ordinary skill in the art to expect that ATMP could exist in a crystalline, anhydrous form, or, assuming such an expectation, that the references would render obvious a method by which such ATMP could be produced."8

It may happen, however, that the examiner evaluating your patent application will still reject your invention as obvious. She might combine prior-art references teaching the drug or the catalyst of your invention with other prior-art references teaching processes for making nano-sized materials such as sol-gel process art. With that combination, the examiner may insist that your invention is obvious. That is, she may find that the differences between your invention and the prior art are so small that the ordinarily skilled artisan could make your invention. If that happens, you can still obtain a patent if you can show that your nanotechnology possesses properties not shared by the prior art.

The Federal Circuit has provided guidance on what to do in this situation in the case In re Dillon.9 The Dillon applicant developed tetra-orthoesters as fuel additives to reduce soot formation upon combustion. One prior-art reference taught tri-orthoesters as additives to hydrocarbon fuels to dewater those fuels. Another prior-art reference taught both tri-orthoesters and tetra-orthoesters as water scavengers for hydraulic fluids. The examiner rejected the tetra-orthoester invention as obvious, because the similar structures and similar uses of the two compounds suggest that similar properties would be shared by both compounds. The Federal Circuit agreed. However, the court explained that the Dillon applicant could still obtain a patent if she had offered "a comparison of test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art does not have[.]"10 Significantly, it is not enough to point out that a newly discovered property is not disclosed in the prior art.11 Rather, you must show that the newly discovered property does not exist in the prior-art compound or material.

Therefore, it makes sense to compare your nanotechnology invention to the materials disclosed in the prior art to find different or improved properties. Your nano-sized drug particles might be administered more easily than the drug in conventional form, for example, by topical administration or inhalation. You could measure pharmacokinetics and pharmacodynamics to demonstrate more effective uptake and distribution of your nano-sized drug in vivo. Or you could show that your colloidal catalyst uses substantially less catalytic material because of its dramatically increased surface area. Such data need not be available when you file your patent application, although if you have the data, you might include it. You can develop that data after you file your patent application, once the examiner identifies the prior art closest to your invention. Then you can present the data to the examiner, knowing that "[t]here is no question that all evidence of the properties of the claimed [invention] and the prior art must be considered in determining the ultimate question of patentability[.]"12

Conclusions

In sum, you can argue the patentability of your nanotechnology invention by pointing out that methods for making your invention were not obvious. Like new crystal phases, new nano-sized materials are difficult to make in the laboratory and even more difficult to manufacture in mass quantity. That is true even if general methods of nano-synthesis are known. For example, second-year chemistry majors know how to make crystals in the laboratory, but they also know that crystallization is a fickle process that does not readily yield other crystal phases or even crystals of other compounds. Similarly, the process you used to make your nano-sized invention invention -- such as the sol-gel process -- may be known, generally speaking. However, obtaining well-behaved colloids through sol-gel process chemistry can be daunting to say the least. Finding that right mix of time, temperature, and other conditions requires inventive skill and deserves a patent.

If that argument does not work, you can demonstrate unexpectedly improved properties or properties not shared by the known-sized material. After all, sometimes size does matter.

Footnotes

1 35 USC §§101–103.

2 35 USC §103(a).

3 Graham v. John Deere Co., 383 US 1, 17, 148 USPQ (BNA) 459, 467 (1966).

4 Id., 383 US at 17-18, 148 USPQ at 467; see also in re Dillon, infra note 9.

5 In re Rinehart, 531 F.2d 1048, 1052-53, 189 USPQ (BNA) 143, 148 (CCPA 1976).

6 In re Rose, 220 F.2d 459, 463, 105 USPQ (BNA) 237, 240 (CCPA 1955).

7In re Irani, 427 F. 2d 806, 166 USPQ (BNA) 24 (CCPA 1970).

8 Id., at 427 F.2d at 808, 166 USPQ at 26 (citing In re Cofer, 354 F.2d 664, 148 USPQ (BNA) 268 (CCPA 1966)).

9 In re Dillon, 919 F.2d 688, 16 USPQ2d (BNA) 1897 (Fed. Cir. 1990) (en banc).

10 Id., 919 F.2d at 692-93, 16 USPQ2d at 1901 (internal citations omitted).

11 Id., 919 F.2d at 693, 16 USPQ2d at 1901 (overruling In re Wright, 848 F.2d 1216, 6 USPQ2d (BNA) 1959 (Fed. Cir. 1988)).

12 Id.

 
 
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