Myriad Case Decided

A decision in the  "Myriad Case" has  the biotechnology community, intellectual property attorneys  and investors breathing a sign of relief.  A US Federal Circuit Court of Appeals ruled on Friday, July 29, that US patent law allows for the patenting of human genes.  The court overturned an earlier district court decision that patents claiming diagnostic tests based "isolated" human genes were invalid. The Federal court held that "analyzing or comparing method claims" were invalid in light of other recent case law including Prometheus v. Mayo and Bilski v. Kappos.  This strongly suggests that patent holders work with their outside counsel to  review pending and granted diagnostic method claims in light of these decisions.
Here are a few good summaries:
Ruling Upholds Gene Patent in Cancer Test   New York Times
Appeals Court Decides Isolated DNA Patentable, Myriad Analytical Claims Not  Genome Web


Debbie

GEN News Story - Difficulty in Patenting Improved Antibodies

In Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Feb. 23, 2011), the U.S. Court of Appeals for the Federal Circuit (the Federal Circuit) recently revisited the written description requirement set forth in 35 U.S.C. § 112, first paragraph, and invalidated Centocor’s U.S. Patent No. 7,070,775 (the ‘775 patent), thus clarifying the standard as applied to antibody patent claims. Read more....   Difficulty in Patenting Improved Antibodies

As always, we encourage you to share your thoughts.

Best to all,

Debbie Robertson

Blog Find: Genomics Law Report Following the Myriad Gene Patent Litigation

The Genomics Law Report has become an important blog on genomic patent issues.  Blogger Dan Vorhaus is doing a great job reporting on the Myriad Gene Patent Litigation on his blog, Genome Patent Law. Read here.

Video: Health 2.0 response to The Machine is Us/ing Us

Video --The Machine is Us/ing Us

Attention Startups - A new blog with a great list to join

Brad Hargreaves, an entrepreneur in residence at Tipping Point Partners has a new blog, startup adventures in NYC that is informative and a humorous break from raising money and other startup activities.  What would your company's drink look like?  Leave a comment with your company's drink and we will post it and forward it to Hargreaves.

Genetics and Health Video Contest

Given that the Patent Finds readers are smart and creative types.  I thought you would enjoy a contest.  Genetic Alliance is sponsoring GeneScreen 2010, a short video/film contest.  All entries must be about GENETICS and HEALTH and complement one of the themes for their next conference.  For more information go to the GA website-http://geneticalliance.org/genescreen2010.rules




This sounds fun!

Funding for Early Clinical Trials

Article from Genome Web

NCI Offers $10M for SBIR Bridge Awards

January 27, 2010

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The National Cancer Institute will pump $10 million in 2010 into Small Business Innovation Research Bridge Awards, which it will use to fund development of cancer diagnostics, therapies, and imaging technologies.
This funding program is used to help small businesses make their way through the funding gap referred to as the "valley of death" between the end of SBIR Phase II funding and later financing rounds that are necessary to move a product or service on toward the market.
NCI said on Tuesday that this new award opportunity will fund as many as ten small business projects. The most recent Bridge Awards averaged around $3 million, and went to fund Lpath Therapeutics; OptaSonics; Guided Therapeutics; Gamma Medica-Ideas; Altor BioScience; and Koning Corporation.
NCI said that the Bridge Awards are "a cutting-edge new model" enabling investors and NCI to "share in the investment risk in order to accelerate the most promising small business innovations to commercialization."

What NOT to do when an inventor will not sign a patent document

A major cause of angst in a start-up companies is an inventor who can not or does not want to sign assignment and declaration documents required by the United States Patent Office.  This is not a major issue when the inventor is obligated to sign as the result of an employment or license agreement.  In this case, you can discuss with your patent counsel the filing of a Petition under 37 CFR § 1.47(a).

CEOs and company managers may be especially interested in a cautionary tale from Wesley Overson of Morrison & Foerster LLP  regarding what NOT to do. (Synopsis by Robert Platt Bell)

Pending Legislation- "Biosimilar" Products and Market Exclusivity

Legislative committees in both the Senate and the House approved bills that would authorize the FDA to create an approval pathway for follow-on biologic, or "biosimilar," products that would guarantee manufacturers 12 years of market exclusivity for a new biologic agent before any biosimilar product could be approved, even in the absence of a valid patent. Manufacturers could also obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product, such as those that could lead to changes in administration schedules (e.g., from weekly to monthly). Supporters argue that these much longer periods of protection from competition are fair because the development higher costs for biologic medications.  I have listed a variety of summaries and opinion pieces about this legislation below:

New York Times Blog published 11/3/2009

Foley Lardner Online Published 11/2/2009

New England Journal of Medicine published 10/14/2009

BioPharm International published 7/1/2009

Fierce Biotech Blog publsihed 3/18/2009

What is your opinion on this bill?  How will it impact your patent strategy or your clients strategy? Join the conversation on this subject by leaving a comment or provide a link to additional summaries or commentary.  If you do not have a Google account or wish to remain Anonymous, use the Anonymous setting.

 

And the winners are.....

Six Tips on How to Spot a Winning Biotech, From Dendreon Co-Founder Chris Henney....story here 

What about a compound that works?!  I would really like to know what people think.  Add a comment or send an email to me.

Biotech Opinion- Red Flag Warning

Five Red Flags to Watch Out For in a Biotech, From Dendreon Co-Founder Chris Henney....story here 

Let me know if you agree by adding a comment or sending an email to me.

 

 

Debbie 

USPTO Rescinds Proposed Controversial Patent Rule Changes

The Director of the USPTO David Kappos has signed a new Final Rule rescinding the proposed and highly controversial regulations restricting patent applicants from protecting their intellectual property.  In 2007 propose rules restricted the number of continuation applications as well as the number of claims that could be included within each application.

Click here for the full story.

Abbott Acquires Visiogen for Cash-$400M

Abbott is expanding its vision care portfolio with the acquisition of California based Visiogen. Read the press release here. At the center of Visiogen's business is their accomodating intraocular lenses (IOL) named Synchrony. These IOLs have the potential to eliminate the need for glasses or contact lenses by providing improved vision at any distance with less glare and other side effects.

Start your own "Kitchen Cabinet" with Technology Marketing experts

Main Entry: kitchen cabinet
Function: noun
Date: 1832
1 : an informal group of advisers to one in a position of power (as the head of a government)

Like many of the Patent Finds readers, I have used a close group of friends of advisers to help me with key decisions in my career and build my businesses. With the growing role of social media in communications, I have added a Technology Marketing group to my own kitchen cabinet to help me market my consulting group.

Social media technologies such as twitter, blogging, social bookmarking and other technologies are offering information to users faster and more efficiently that traditional print media or website. Recently I followed this year's Tour de France this year by watching the television broadcast and following the twitter feeds of some of the key participants only venturing to a website when I wanted more detail.

Even if you do not see yourself twittering or collecting followers on facebook, there are a few things that are sure to be true:
1. your target audience is likely to look for information using social media technologies,
2. these technologies can be used to increase traffic to your website, direct your company branding or help you create a buzz around your research or a new product launch and,
3. new social media technologies arrive on the scene each week.

Patent Finds highly recommends Bialick/Turpin and Associates, a Washington DC based Technology Marketing firm, for setting up social media plan for your individual, small or midsize companies. This group has a creative and a technology expert who are good at putting together a manageable plan that supports your business goals and fits into your budget. Their consultants work with you to create a workable strategy, implement it and train internal staff to maintain the social networking program. If you do not have the internal staff to support the system, Bialick/Turpin will monitor it for you.

I also found Bialick/Turpin's blog helpful. In addition to being informational, I found that the company keeps the customer's resources in perspective. One such post, "Blogger Inflation" discusses how to use free tools to start a blog and how many man hours are necessary to make it an effective marketing tool.

I think it is also important to mention that your should clearly articulate your business goals to the consultants at Bialick/Turpin. It will help them put together a better plan for you. Mention Patent FindS when you call.

Survey Endorses Longer Market Exclusivity

Study Endorses Longer Market Exclusivity For Drugmakers (read here)

By Brian Gromley

The NationalVenture Capital Association released study results Friday that it hopes will help convince lawmakers that biologic drugmakers should enjoy a long period of market exclusivity before follow-on versions of their products are allowed on the market.

The study says the cost of capital for early-stage biotech companies is over 20%, or about twice as high as policymakers have assumed. This suggests that biologic drugmakers need at least 12 years of market exclusivity to make a return on their investment, according to the NVCA, which commissioned the research.

Part 3-Developing a Patent Strategy: Choosing Patent Counsel

Patent costs often represent a significant part of the operating budget of a startup or midsized technology company. After many desperate conversations with colleagues experiencing patent angst, I thought a post on selecting a patent counsel might be helpful to Patent FindS readers.
Just like many things in life, the source of angst over patent issues is often the result of poor communication and unmanaged expectations between the client and their patent counsel. These issues can be addressed by:
-- finding the appropriate patent counsel,
--incorporating your considering your business goals into your IP strategy
--setting an IP budget.

Because patent filings and other intellectual property are critical to a company, the process of finding an attorney seems challenging for many and down right scary for the rest of us. There are several articles on the Internet that provide advice (sometimes good advice) on choosing a patent counsel. This blog post specifically identifies areas that I have found to be very important in the attorney selection process for my clients, which include entrepreneurs, startup and midsize companies and research foundations.
Here we go:
Begin your search for a patent counsel by asking your colleagues or investors for a referral.
Although your colleagues may look for different qualities in an attorney, it is likely that their recommendation signals either good communication skills or an excellent knowledge of patent law.
Consider law firm size when identifying two or three attorney candidates.
1. Solo or small group IP practice (1-5 attorneys)
Over the last several years, technology centers have observed a growing number of patent attorneys leaving large law firms to open solo or small group practices. These "boutique" patent firms typically have reduced billing rates, allowing companies to file their early patent applications at a lower cost. In many small firms, the client works directly with the senior partner. When interviewing a smaller firm, it is important to determine their experience in your technical field.
2. Large patent firm (more than attorneys) or a large general practice law firm with IP division
Larger patent firms focus on having a group of patent attorneys and scientific advisors with relevant experience in a number of technical areas. You will likely find a patent attorney familiar in your technical field. The large firms also have access a large network of attorneys and often have experience in alternative patent strategies (e.g. accelerated examination), patent licensing and litigation. During your initial client meeting, you will meet with a partner or senior associate. Typically less experienced associate will draft the patent applications or patent office responses under the partner's direction. The larger firms usually bring a larger price tag which requires internal management to keep the costs low. Investors sometimes prefer that their portfolio companies the use of a large, well-known law firms.
Attorney with or without Ph.D
In my opinion, the scale tips towards selecting attorneys based on their experience prosecuting patent filings in your field of interest rather than their graduate degree. In addition to their law degree and patent bar certification, patent attorneys generally have an undergraduate or graduate degree in a technical field (e.g. chemistry, engineering, etc.). An attorney should also have access to technical experts. This expertise can reside with scientific analysts or other attorneys.
Set up a face to face interview
1. Ask to meet the team who will be assigned to your patent docket. Listen to the introductions, the team should include the partner or senior associate, key associates and if necessary, a scientific analyst.
2. Determine who will be working on your case. Will the partner at the meeting oversee the work of others? Are you meeting the attorney actually writing new applications or patent office responses? What is their experience in your technical field? Who will work with you to set and maintain the patent strategy?
3. Be prepared to simply explain your primary invention and why a patent is important to your business plan. Explain how your device, compound or platform technology will be commercialized. Bring a list of your competitors.
4. Evaluate the team's working knowledge of your field of interest. Does the team ask good questions? Do they seem to understand your explanation of the invention?
5. Trust your instincts. Do you like the legal team and do you feel comfortable asking questions? Or does team use legal jargon and just speak to each other during the meeting? Does the team seem realistic and optimistic or do they start the conversation by complaining about the United States patent office rules?
6. Ask for references. Most importantly, call the references before making a decision.
Budget
Do not leave your attorney meeting without discussing budget. Ask the attorneys to take a look at your current patent portfolio and estimate their fees and expenses for the next year and for drafting a new patent application. While fees for drafting applications or responding to office actions vary according to the invention and the complexity, the law firm should be able to provide you with a range of fees and expenses. If they can not estimate costs at the meeting, followup the next day by email or with a telephone call.
Business and regulatory experience
Evaluate the legal team's experience at aligning IP with the company’s business plan or regulatory strategy. I have used very good patent attorneys who deferred to other experts to assist in developing business and regulatory strategies. That can work, as long as this expertise is included in the patent strategy. Again, trust your instincts.
Heads up: Investor opinion
Occasionally, investors will have"strong" opinions on which law firm their investment uses for patent prosecution.

Gene Patent challenge-One to watch

Last month, the New York Times reported on a Texas breast cancer patient who took a genetic test to see if she also had an increased risk for ovarian cancer. Before she had the surgery to remove her ovaries, the patient asked for a second opinion and found no other test was available. The development of a second test was blocked, in part, to a gene patent held by Myraid. The patient filed a lawsuit against Myriad and the Patent Office, challenging the USPTO decision to grant a patent on a gene to Myriad. The lawsuit, organized by the ALCU, claims that the issue is not only a question of patent law, but of the First Amendment. Read the story here.

Excellent summary on patenting genes

Patent Docs, a biotech patent law and news blog, has published a great summary of the issues surrounding patenting genes. Take a look at the post . And the counter point, "The unwanted consequences of banning gene patenting."

Part 2-Developing a Patent Strategy: Capturing Internal Intellectual Property

When asked to review the IP portfolio of a technology company, we generally find well-described inventions developed by the early scientists or company founders and a spattering of related in-licensed technology. Once the initial inventions are filed, the senior management's attention often turns to getting the research up and going and of course, raising capital.

As expected, the intellectual property within the company continues to grow as the researchers and engineers expand upon the initial invention and develop new products and methods. Recording this important new IP using invention disclosures, remains a bottleneck in most nonprofit or for profit organizations. I have listed a few important points to consider when capturing and documenting new internal IP. As always, this blog is not intended as legal advice, I strongly suggest that you consult with your attorney to discuss the disclosure of a new invention.

Consult with your patent counsel and review the relevant patent law.
In the United States, priority goes to the inventor who can demonstrate that they are the first to conceive and reduce an invention to practice. This law makes it critical that companies encourage inventors routinely document their inventions in an invention disclosures and in laboratory notebooks. The invention disclosures and notebooks will be important support in any challenge to the patent validity.

Emphasize the role of invention disclosures on continued company success.
In a perfect world, a company should establish an IP and patent policy early in its development and make recording new inventions part of the company culture. In the real world, we suggest that the company review its commercial goals with its scientists and engineers on a regular basis and emphasize their important role in finding and recording their new discoveries. "One of the things that I have observed is that scientists naturally think more in terms of publishing scientific papers rather than disclosing inventions with a commercial use", says Franco Serafini, partner at Themis Law. "I remember a meeting when I sat down with a group of scientists to help them draft a business plan about what the uses of their invention. Discussion of their scientific disclosure led to a set of claims on multiple new uses."

Provide an online access to a straightforward invention disclosure form.
Surprisingly (at least to me), we found a common barrier for scientists and engineers to record their inventions, is the disclosure form itself. Typical invention disclosure forms seem to be confusing and do not allow inventors to easily summarize the details of their invention. Often there is no opportunity to explain how the invention it relates to current and future company goals. The invention disclosure forms, whether downloaded from the internet or (preferably) received by your patent counsel, are simply guides. At a minimum, a complete invention disclosure should include:

1. A complete disclosure. The invention disclosure serves as the basis for future patent filings. It is important to remember that anything not included in the disclosure and the resulting patent application will not be included in a granted patent.
2. A clear and complete explanation of the discovery or invention. This includes a description of how to use the invention (especially important in chemical discoveries), the process of making the invention and any alternate uses. The disclosure should be in sufficient enough detail that a person in the same field could pick up the invention and use or make it. No legal ease is necessary, pictures are very helpful. When disclosing a new device, describe each part, explain how they work individually and how they work together.
3. Please define any new or unusual scientific terms or abbreviations.
4. Use your imagination and describe how else might the invention work? Are there less desirable, ways of making the invention work? Alternate uses?
5. Clarify how this invention is different from what has gone before. We know that it is "better", describe why is it better, or what makes it better. Go ahead, don't be modest, tell us everything.
6. A summary of how this invention solves a problem and/or compliments the current or future business or regulatory plans.
7. Prepare a list of all the individuals who were part of conceiving the disclosed invention. If there is one inventor, the sole inventor must have conceived the ideas in all aspects of the invention. You should list additional inventors if they conceived of at least one the idea detailed in the disclosure. The final determination will be made by the patent attorney when the patent claims are filed in the USPTO.
8. The written disclosure should be dated and typed or handwritten in ink. In addition to having the disclosure signed and dated by the inventor or inventors, two or more individuals capable of understanding the technology should review, sign, and date the written disclosure as witnesses.

Create an internal contact within the company to receive invention disclosures.
An individual designated to receive invention disclosures seems to streamline the process and help keep legal costs under control. Companies should implement an invention disclosure protocol where the documents are transferred as a confidential memo directly from the inventor to the company's legal department and then to their patent attorneys. The legal cost to receive and store the invention disclosures should be minimal.

Calender a quarterly email (or in person) reminder to inventors regarding filing invention disclosures.


Contact me, if you or your company needs a template invention disclosure form to record undisclosed intellectual property. Otherwise, good luck and happy disclosing.

Questions? Contact Debbie Robertson using Linked or by email.

Next Week: Developing a Patent Strategy: Choosing a patent counsel.
Previous blogs: Developing a Patent Strategy: Non-Disclosure Agreements

J.P. Morgan Securities CEO Conference Call Series- Nuvasive

J.P. Morgan Securities Inc. continues their MedTech CEO Conference Call Series on Friday June 19th at 8am PST. This week’s call features Alex Lukianov, the CEO of Nuvasive.

The dial in information is as follows:
Dial in: 888-790-4327 or 773-756-0257, Passcode: MedTech
Replay is available through 6/25: 866-509-3931 or 203-369-1918, Passcode: 2323

Facebook Username Registration-Protect the use of your business names

Facebook Inc. has announced that beginning at 12:01 am EDT on June 13, 2009, Facebook users will be allowed to create personalized usernames for their Facebook pages, in the form ”facebook.com/yourname”.

There is a risk that some Facebook users will attempt to incorporate third party brands into their personalized Facebook usernames.

To address this potential problem, Facebook has provided an online procedure for brand owners to prevent their trademarks from being registered as Facebook usernames. Information for brand owners is available online . The online procedure for registering trademarks is at http://www.facebook.com/help/contact.php?show_form=username_rights.

The relevant registration form should be completed for each trademark by no later than Friday, June 12, 2009.

Part 1- Developing a Patent Strategy: Non-Disclosure Agreements

A Non-Disclosure Agreement (NDA) is often the first legal document, a new business downloads from the internet. NDAs are are an important part of a company’s risk management strategy, designed to minimize the risk of an unauthorized disclosure of a company's proprietary and confidential information. Because NDAs can often differ, I have listed some of the key areas that are important to discuss with your attorney before signing a confidentiality agreement. Understanding the key elements of this type of agreement will save you time and money. As always, this blog is not intended as legal advice, I strongly suggest that you consult with your attorney prior to signing any important document.
Note: Levine Bagade Han LLP is offering a template NDA to Patent FindS readers at no cost. Send an email requesting the NDA to attorney Johney Han and mention Patent FindS.

Primary functions of Non-Disclosure Agreement
1. NDAs are often used to minimize the risk of public disclosure prior to filing patent application.
NDAs are used when the details of an invention are disclosed prior to filing a patent application. Inventors often use a NDA to ensure that all discussions about their invention with investors or other parties are confidential and not considered a public disclosure. In the United States, patent applications must be filed within one year of the first public disclosure and most of the remaining countries require a patent filing before any public disclosure. Using a NDA can be effective strategy but there is a continued risk of a breach. It is generally felt that a NDA alone should not be the only protection used to safeguard the inventions that serve as a basis for your business. To protect your ability to pursue US and foreign rights to an invention, it is recommended that a patent application should be filed prior to disclosure.

2. NDAs may also be used to minimize the risk of unauthorized disclosure of proprietary information during a discussion with a third party such as an investor, potential employee or vendor.
There are many business situations where the NDA clarifies what information disclosed in your discussions is confidential and minimizes the risk against its unauthorized disclosure. For example, Company A needs to reveal data and other trade secrets to the vendor (e.g. CRO) in order to initiate clinical trials. In this situation, the NDA is designed to minimize the risk that unauthorized recipients will gain access to the proprietary information.

Important considerations in reviewing a NDA:
1. Definition of Confidential Information
The definition of the confidential information is generally considered the most important part of the NDA. Most NDAs contain a general definition of “Confidential Information”. The scope of the confidential information most important to your company should be clearly defined by you. In the section identified as Confidential Information, the following statement may exist:
“Each party shall disclose to the other certain confidential and proprietary information and materials relating to ____________.”
This section provides an area to clearly limit the scope of the confidential information being discussed (e.g. name (not structure) of new chemical entity).

2. Form of confidential information
Within the definition of the confidential information, you often find language defining when and in what form the information is confidential.
“One often overlooked aspect of nondisclosure agreements (NDA) is that not all communications between the contracting parties may be considered confidential under the terms of the NDA. A disclosing party should not assume that all communications, whether oral or in writing, will be considered confidential” says Johnney Han, partner at Levine Bagade Han LLP.“For instance, there may be a provision indicating that oral communications between the parties are considered confidential under the NDA only if the substance of the oral communication is reduced to a writing by the disclosing party and forwarded to the receiving party within a set time period. Another example is that only communications between the parties which are written in a document and which is physically marked as "Confidential" or "Secret" may be considered confidential under the NDA”.

3. Purpose of the NDA
The purpose of an NDA (e.g. business relationship, testing etc.) should be defined in the “Confidential Information” section . Note, that if the relationship with the other party changes, the NDA must be amended.

4. Strength of NDA- Provisions not to disclosure or use
In a confidentiality agreement, it is important that the Recipient of the confidential information agrees not to disclose the information to third parties. Typical issues faced in negotiating this provision in an NDA include:
a. whether to limit access of Recipient employees to a "need to know" basis. If you (as the Recipient) are a virtual or small company, you may want to include your consultants or other “agents” of your company in this provision.
b. restricting the use information to the purpose set forth in the agreement. If your NDA is used for business discussions, the recipient should not use the information in research planning or other unrelated activities.

5. Limits
Practically every non-disclosure agreement has an exception list that describes information that may not be considered confidential. These exceptions can include:
-the information known to Recipient before it was revealed by the Discloser.
- information was revealed to the Recipient by a third party.
-information that becomes publicly known.
-information that is requested by order of a government agency.
-information that is independently developed.

6. Term
The term of the NDA is important. A typical NDA term can range from 6 months to 5 years. Often times, the term depends on the confidential information being disclosed and when (if ever) it will be disclosed to the public. Risks to the disclosure of trade secrets (e.g. information not disclosed by the public records) may be minimized by agreements that last indefinitely.

7. Location of Court Action
Notice the location that any court action related to the NDA will be brought. If your company is based in California, and you enter into a NDA lists New York, the cost in time and money to enforce the agreement significantly increases.

8. Other considerations
There are a number of other provisions that are found in different forms of a NDA. Bitlaw.com provides a list of provisions for consideration:
-a provision allowing the remainder of an agreement to stay in effect even if a portion of the agreement is found to be unenforceable,
-a provision stating that the agreement is binding on heirs and assigns,
-a provision calling for a return of confidential materials after use by Recipient,
-a provision stating that the Discloser has the right to receive an injunction from a court if the agreement is breached,
-a provision specifically specifying that the Discloser owns all confidential information,
-a provision specifying that disputes should be arbitrated, and
-a provision governing the controlling law for the contract.
Please discuss with your attorney to determine if any of these provisions are necessary to protect your company.

Questions or comments? Contact Debbie Robertson using Linked or by email.

Next week's discussion: Capturing Internal Intellectual Property