Finding patent documents that are owned by a given corporation of interest is often referred to as “assignment searching,” because the owner of a patent is formally called the “assignee” in the US patent system. There are several major obstacles that can prevent searchers from finding documents that are assigned to a given corporation of interest; performing a simple search on the corporation’s name in a given patent database will often yield only partial results.

One major obstacle to this kind of searching is that assignment data may not be printed on the document face at the time of publication, and thus may not be available in certain electronic databases. This scenario is extremely common for US published patent applications, as applicants do not have to include this assignment information when patents are filed. Finding these “hidden” documents can be critical to a search project. Strategies to combat this obstacle include:

•  Search the Agent/Correspondent field – Sometimes the name of the company will be in the “representative,” “agent,” or “correspondent” field of the patent.
• Search the assignment data which appears in various patent legal status databases – Sometimes this data will not appear on a published application’s face, but will be included in that country’s re-assignment records.ŠŠ
• Search a database organized by patent family - Even if the search is for US patent documents only, searchers should expand to other non-US collections rather than limiting the search to US results. This kind of search may find non-US family members held by the assignee of interest, allowing searchers to infer that the company may possibly hold the US family member as well.ŠŠ

 Search a database that predicts probable owners – Some patent databases use special logic to predict probable assignees for unassigned patents – for example, algorithms can check the representative/agent field to look for a corporate address, or may check the inventor field to see if a well-known corporate inventor suddenly has a patent application upon which his or her company name does not appear. Innography and IFI Claims are two examples of databases which can make this type of prediction.

Another obstacle that arises in assignment searching is that the company name may have multiple variant spellings, and/or may have been transliterated to or from a language that does not use Latin characters. This concern will affect almost every assignee and inventor name; the reality is that no company name can totally escape from misspellings when it is represented on patent documents, and that any patent which is filed internationally may have the company and inventor names transliterated into other languages. Strategies to combat this problem include using a search engine with a “browse index” or “expand” feature to show index entries with similar spellings, such as PatBase or STN, or using a search database that offers standardized assignee names, such as the DWPI fileHYPERLINK “” , or IFI Claims. Further, to ensure that an assignment search covers all of the corporate divisions that are of interest, a corporate tree database may be used to identify subsidiary names.

 Finally, it is possible that a search will miss documents that may have been re-assigned to the company of interest, due to the possibility that only original ownership data may be contained in the chosen database. To combat this possibility, searchers can extend their search by querying re-assignment databases and legal status registers for the countries of interest. In addition, the INPADOC legal status database is another source for re-assignment information for certain countries, although its coverage is dependent upon self-reporting from the national patent offices.

For more in-depth information on any of these options, please see the Best Practices article on Assignment Searching hosted on Intellogist, your source for expert answers to your patent search questions. If you are a newcomer to prior art searching, see the General Searching best practices wiki article to learn about basic search techniques which are broadly applicable to many types of searches.  In addition, Intellogist also offers specialized techniques which may be applied to validity or infringement searches.

In addition, if you’d like to learn more about being an effective prior art searcher, you might like to consider one of the upcoming Advanced Courses from Patent Resources Group, The Art and Science of Patent Searching.

Everyone involved in companion animal medicines must be aware of the main stages in the development programme, and be able to relate their responsibilities to the expertise and needs of the scientists and commercial members of the team.

This course was designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It took the participants through all the stages in the development of a veterinary medicinal product for companion animals, for which a marketing authorisation is sought in the European Union. Presentations covered pharmaceutical and process development, toxicological, pharmacological, safety risk assessments, clinical development, and EU regulatory submissions. An important part of the course was devoted to working on case studies in the workshop sessions.

If you would like further information about this course which will be run again early in 2011, please contact andrea.james@management-forum.co.uk

Click here to go to the conference webpage.

Despite ongoing efforts to develop new technology solutions, legislative actions, or enforcement strategies to combat counterfeit drugs, it seems no one has yet found the weapon to finally bring down the $800 billion (and growing) counterfeit drugs industry. But pharmaceutical manufacturers, take note. The US Food & Drug Administration (FDA) recently released a document – “Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-counterfeiting” – that states that incorporating physical chemical identifiers (PCIDs) into drug formulations could be a cost-effective way of differentiating the genuine from the counterfeit.

According to an article on the subject by Gareth Macdonald for in-pharmatechnologist.com, ideal PCID candidates are pharmacologically inactive and would be “food additives, colorants, or excipients with established safety profiles”. Macdonald said that just like other anti-fake labeling methods, PCIDs can easily be detected in the laboratory. But what’s different – and better – about them is that they can also be easily identified by patients, medical practitioners and pharmacies. The draft guidance also emphasized that the PCIDs should be tested for potential toxicity, and for any interaction they may have with the drug’s release technology.

A security printing and imaging blogger has some worries, though. According to a post by Steven Simske for communities.hp.com, the FDA advice:

Goes against a trend to include less, rather than more, exogenous chemicals — dyes, expedients, etc. — in food and drugs

Does not clarify if the list of PCIDs to add is public knowledge (“with established safety profiles”) – and therefore easier for the would-be counterfeiter to obtain – or that PCIDs used should only be sold by authorized suppliers to authorized buyers to prevent insidious insiders who order PCIDs and sell them for profit to counterfeiters

Does not consider that incorporating PCIDs may complicate the authentication process –requiring the deployment of specialized analysis equipment and personnel – while track and trace and authentication through the appropriate combination of security printing may be easier, and more cost-effective, scalable, and effective

Meanwhile, should pharmaceutical manufacturers heed FDA’s advice, Colorcon is ready to offer exclusive tablet identification and authentication systems. A world leader in film coatings, modified release technologies, functional excipients, and tablet branding services, Colorcon provides a complete line of customized film coating and ink formulations that can be used to give a unique appearance to solid oral dosage forms (SODFs) — making it easier for a patient or pharmacists to identify the product at a glance. According to the company, these excipients offer established safety profiles, do not interact with core components, and have no potential effect on the quality, performance, and stability of the SODF — all of the important pharmacological and toxicological considerations covered in the FDA guidance document.

Incorporating PCIDs into pharmaceuticals may have its pros and cons – but with the FDA behind it, it’s surely an idea worth examining. As recently appointed FDA commissioner Margaret Hamburg said, “Drug counterfeiting is a serious public health concern,” and the agency is committed to ensuring that fake products are stamped out.

Did you know?

Texas ranks 2nd in the nation in terms of number of patents granted
Virginia has the highest concentration of technology workers in the nation
Washington State has the 2nd highest innovation capacity in the nation*
New York accounted for more than 10% of all trademarks applications filed by US residents

Intellectual property works – from sea to shining sea. And this fact is borne out by the comprehensive study on the importance of intellectual property (IP) and innovation in America – recently released by the US Chamber of Commerce’s Global Intellectual Property Center (GIPC). GIPC’s Fact Sheets provide a look at the roles innovation and creativity play in each of the 50 states, highlighting local companies along with interesting IP facts and figures.

Looking at the Fact Sheets, it becomes obvious that all across America, intellectual property plays a vital role in creating jobs, saving lives, advancing global economic growth, and generating best-in-class solutions to global challenges. For example, before looking at the list, try to match which state made which innovation:
Utah                                                            Xerox technology
Idaho                                                           the assembly line
Kansas                                                        modern GPS products
Oklahoma                                                    world’s first airplane
Michigan                                                      the first artificial heart
Wyoming                                                     shopping carts
Iowa                                                            frozen French fries
Tennessee                                                   slicing machine for sliced bread
North Carolina                                              cotton candy
Washington State                                         the turbojet engine

From life-saving drugs to cell phone technology, IP is part of Americans’ everyday lives, supporting industries that employ nearly 18 million workers, account for more than $5 trillion of the US gross domestic product, and represent 40 percent of US economic growth. That’s why, besides revealing eye-opening information, the GIPC’s State Fact Sheets project is significant for putting the spotlight on the importance of IP to economic growth and human advancement in each and every state across the country. Part of an interactive, easy-to-use map available online and in print format, the project serves as a resource for legislators, policymakers, and the public to identify and promote successful companies, inventors, creative artists, and innovative enterprises in all fifty states, and better understand the role they play in the American economy and society.

According to Mark Esper, executive vice president of the Chamber’s GIPC, “America has a story to tell, and each story is unique…The value of innovation can be found in every corner of the country, and every state and community plays a role in helping us all achieve the American dream. The State Fact Sheet project captures this spirit of innovation and entrepreneur[ship] and will prove to be a useful resource in highlighting the role IP plays in our lives.”

Bottom line: GIPC’s State Fact Sheets project makes the case – and a strong one – for IP.

* Noted by the Information Technology & Innovation Foundation’s 2008 Index

About the GIPC
The U.S. Chamber is the world’s largest business federation representing more than 3 million businesses and organizations of every size, sector, and region. The Chamber’s Global Intellectual Property Center is working around the world to champion IP as vital to creating jobs, saving lives, advancing global economic growth, and generating breakthrough solutions to global challenges.

This article was provided by the BPCouncil.

WHY WE HAVE INTRODUCED A MEDICAL DEVICE TRAINING ACADEMY

Management Forum receive numerous requests for specific training on niche topics which may not attract a wide audience, however are essential for success in the particular field.

Therefore, from these requests we have designed a number of focused courses and the first set were held on 26-30 October 2009.  By becoming a member of the Academy you will have the opportunity to request your training needs, influence the course content and develop your CPD training strategy.

HOW TO JOIN?

- Register for one or several of the following events:
o Technical File Documentation Review – 11 October 2010

o Risk Management for Medical Devices And IVDs – 12 October 2010

o Supplier Management and Purchasing Controls for Medical Devices and IVDs – 13 October 2010

o Managing Medical Device Software Projects – 14 October 2010

- Register via email (registrations@management-forum.co.uk) fax or post.

BENEFITS OF BECOMING A MEMBER:

-    *Receive a £50 discount voucher on a future one or two day Management Forum Medical Device course

-    Have an opportunity to request your training needs and input into your future CPD training strategy

-    *Receive a complimentary on-line soft skills training course (see courses available)

-    Make connections via our Medical Device Training Academy blog

-    *Receive a free OnDrugDelivery Medical Device Report

-    Get targeted automatic updates on future courses

-    *Receive a 15% discount on selected Wiley Blackwell publications

*This applies to new members only.

We are delighted that The Medical Device Training Academy is supported by:

What IP subject would you like to be developed during a conference?

Suggestions are very welcomed, so do not hesitate to leave a comment or to contact sarah.packham@management-forum.co.uk with new ideas!

Thank you for your help!

* Many companies are cutting down on time and resources invested on brand protection.
* Economic uncertainty makes it even more critical to have a comprehensive and ongoing anti-counterfeiting strategy in place.
* Authentication technologies provided by IAA member-companies protects global products valued in the hundreds of billions.

The economic slowdown and poor business climate may have caused companies to cut down on efforts that must continue precisely because of today’s uncertainties.  According to a recent survey by the intellectual property firm Marks & Clerk*, as much as 80 percent of managers said that they were ‘too busy’ to spend more time on brand protection or get involved only when a counterfeiting or competitive threat has emerged. Just a fifth of the respondents are spending more time on brand protection.

Against this backdrop, the International Authentication Association (IAA), a global organization that fights counterfeiting, has stressed the need for brand and product owners to have a comprehensive and ongoing anti-counterfeiting strategy in place, warning them against reducing the time and resources invested in brand protection.

It’s easy to see why. The survey results come at a time when the threats of counterfeiting and piracy are spiraling and brand protection has never been more urgent. The latest report by the Organisation of Economic Development (OECD) estimates that the global counterfeiting market has now topped $200 billion, while the Counterfeiting and Intelligence Bureau (CIB) predicts fake goods will make up to seven percent of world trade.

David Howard, IAA Chair, explains: “There’s no doubt that budgets are under threat in the current climate but not protecting your brand correctly is not an option…Counterfeiters need little excuse [during] the best of times and economic hardship is likely to be a recipe for increased criminality. If companies are cutting back on their anti-counterfeiting efforts, the market will be more attractive for fakes.”

While companies must inevitably take a hard look at their costs, combating counterfeits has proven to be an effective way to maintain revenues and market share. Howard added: “The costs of protecting your products are low compared to the problems and financial headaches that counterfeiting and infringement [bring to] a business …”

IAA – A Leading Voice for Brand Protection
The IAA comprises 20 of the world’s leading brand owners and suppliers of authentication technologies, including flagship brands Johnson & Johnson, Honeywell, 3M Brand and Asset Protection, Authentix, Dupont Authentication and Hologram Industries, to name a few.

The organization’s raison d’etre is to promote the use of authentication technologies as an integral part of an effective anti-counterfeiting strategy. Education is a key element of this agenda, with the IAA playing a prominent role in educating government agencies, inter-government organizations and brand owners about the roles and uses of authentication.

Howard, who is also director of product protection at Johnson & Johnson, explains: “While counterfeiting and piracy are age-old problems, the globalization of world trade has seen an exponential increase in the [problems'] scale and [impact] …Increased trade, new technologies and ‘grey’ markets, particularly the internet, have intensified [an] already acute [situation].
“The International Authentication Association is an important voice for the authentication community. It will promote and explain the uses of authentication in a climate when the potential to benefit from these technologies has never been greater,” Howard concluded.

A Range of Authentication Technologies from IAA Member Companies
To combat threat of counterfeiting worldwide, brand owners use an array of authentication technologies to protect their products as part of anti-counterfeiting strategies. Today, technology provided by members of the IAA protects global products valued in the hundreds of billions, including the majority of the world’s currencies, numerous passports, ID cards and other vital documents as well as everyday items such as jewelry, mobile phones, computers and clothing. Authentication solutions include:

* Overt devices visible to the naked eye such as a hologram or color-changing ink
* Hidden devices such as ultraviolet inks or scrambled images, often revealed to the human eye through handheld inspection devices to increase the level of security
* More sophisticated covert devices such as chemical tags in packaging or electronic and embedded codes
*  Forensic devices requiring laboratory analysis

A combination of these components is often incorporated into a single device for greater efficacy.

Increasing Awareness and Appreciation of the Value of Authentication
According to David Howard, “Authentication technologies are on the front line of the war against counterfeiting every day …Unfortunately the role that they play and the impact that they have are not fully appreciated. One of the key aims of the IAA will be to change this and build a better appreciation of the value of authentication in an anti-counterfeiting and brand protection strategy.”
With this goal in mind, the IAA is developing a new Authentication Framework – expected to be completed in late 2009 – that will help to develop a common understanding of authentication, its value and, most significantly, assist brand owners in making the case for authentication and how they should go about it.

For more information about the IAA, visit its website at: www.internationalauthenticationassociation.org

Article provided by the:

* The implications of Myriad’s exclusive right to the BRCA1 and BRCA2 genes
* Arguments for patenting human genes
* Is the price of innovation well worth its benefits to mankind?

The American Civil Liberties Union, together with the Benjamin N. Cardozo School of Law-affiliated Public Patent Foundation (PUBPAT), recently filed a lawsuit against the US Patent and Trademark Office (USPTO), Myriad Genetics, and the University of Utah Research Foundation. The latter two hold the patents on the BRCA genes, the mutations (BRCA 1 and BRCA2) of which are responsible for most cases of hereditary breast and ovarian cancers.

According to an ACLU press statement, the patents give Myriad the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes (at a cost of $3000) and to prevent any researcher from even looking at the genes without Myriad’s permission. ACLU officials stated that this would hamper clinical diagnosis; discourage research on possible future mutations of the BRCA2 genes; and have negative consequences on women who need medical screening but can’t afford Myriad’s test, want a second opinion on test results, or seek other options for inconclusive results.

The lawsuit – filed on behalf of breast cancer and women’s health groups, scientific researchers’ associations, pathologists and laboratory professionals – charges that granting the patent to Myriad is illegal because genes are “products of nature” and unconstitutional because limiting the free flow of information violates the First Amendment.

But other experts disagree. An article by Rosalie Westlenskow for The New York Times quoted genome science and ethics expert Robert Cook-Deegan, who said that the granting of patents for human genes encourage invention by rewarding researchers, leads to investments in businesses that own patents, and prevents “free riders” who pay nothing to sell a product that cost the original developers millions. “The system of innovation will not work…if, as soon as you put something on the market, someone else can make your product and they don’t have to pay you anything,” he added.

To those who would argue that gene patents negatively impact research, other evidence contradicts it. Westlenskow’s article also quoted Scott Kieff, law professor and research fellow at Stanford University, who said that other  countries that have stricter rules about gene patents have not seen as much innovation as the United States, where an increase in new drugs and devices in the market was seen after 1980, correlating with the increase in gene patents.

To those who would say that this case can be won based on Section 101 of the Patent Law (that defines patentable subject matter), other experts contend that while a naturally occurring biomolecule is not patent-eligible by itself, one that is isolated and purified with sufficient human intervention that it acquires “markedly different characteristics” from their naturally occurring counterparts is patent-eligible – an interpretation, says law professor and blogger Chris Holman says has not been challenged for 25 years..

What about moral and ethical implications? Genes are the basic unit of heredity and, with modern technology, researchers have been able to isolate specific genes that carry an associated risk of illness. According to an article on the lawsuit by Elizabeth Landau for cnn.com, some experts say that while a moral argument could be made that human genetic material belongs to all or that human genome is sacred, what can be said, states molecular biology professor Lee Silver, when one considers that about 25 percent of human genes are shared by chimpanzees.
Indeed, the patent law says nothing about ethics. And of course, companies should not use patents to profit unreasonable and exploit people at risk. On the other hand, patents do serve these very same people. Silver said that the patentability of such tests (such as Myriad’s diagnostic test) is what gives companies the incentive to create them in the first place. In the same article, M. Sara Rosenthal, a bioethics expert, cited another example of a good use of a gene patent -. the insulin gene, which eventually led to essential treatments for diabetes.

Obviously, gene patenting is not a question of absolutely right or absolutely wrong. Remember, too, that such patents expire 20 years after application. The bottom line though is, with all the pros and cons, does the potential harm to patients outweigh (or not) the benefit to mankind that comes from encouraging innovation?

The outcome of ACLU vs. Myriad may provide the answer.

Article provided by the:

Delegates per countries: