2013 -Upcoming changes in US Patent Law

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On September 16, 2011, President Obama signed the Patent Reform Act of 2011 ( also called the Leahy-Smith America Invents Act (AIA)) into law.  I am working with all my clients and their patent attorneys to update our patent strategies in light these important changes in the patent law.  Especially important to inventors and IP managers are the following changes which goes into effect on March 16, 2013:

1. First to File:  US Inventors who file their inventions in patent applications first will have priority over inventors who file later.  Previously, the US patent law granted priority to the inventor who was first to invent and documented their invention.  One exception to the new law is an inventor who publishes his invention.  The inventor can files a patent application within one year of the publication.  The invention will have priority over other patent applications filed within the intervening year between publication and patent filing. It is key that companies review all their current invention disclosures and prepare to file them as patent applications on or before March 16, 2013.
2. Redefining Prior Art: All US and foreign publications published before a patent applications filing date will be considered prior art.  It is important to emphasize to all employees and consultants to be careful is disclosing, selling or using an invention before it is filed.  Many attorneys are suggesting that their clients file early and often to avoid this issue.
3. Derivation Proceedings:  To protect against theft of an invention, the patent office allows for a derivation proceeding.  In the case where an inventor 1 claims that patent claims issued to another inventor 2 were indirectly or directly derived from this/her invention, a derivation proceeding can be requested.  Inventor 1 has the burden of proving the claimed invention was derived from his original invention. The statute of limitations for filing for a derivation proceeding is one year after the issuance of the patent. The patent community will be watching this new type of proceeding carefully.

I strongly suggest that companies make the investment and spend an hour with their patent counsel to set your company's patent strategy in light of these new rules.  

Happy New Year!
Debbie

Competitive Landscape Building: Searching US patents and applications for gene sequences

http://www.patentlens.net/daisy/patentlens/landscapes-tools/sequences.html

As part of my role as a IP strategist, I strongly encourage all of my clients to rely on expert legal counsel to file and prosecute their patent applications.  In an effort to streamline this process and manage my client's expectations, I work with the inventors and company attorneys to develop a competitive landscape around each new invention using a variety of patent databases and search engines. This approach is useful during patent prosecution and often provides important answers to questions that often arise during financing activities.

When working with new or engineered gene, I typically start with the sequence search to avoid missing something due to differences in nomenclature.  My first stop is the NCBI's BLAST (Basic Local Alignment Search Tool) site which allows me to find regions of homology between my DNA and/or protein sequence and entries in the NCBI sequence database.  A typical output includes a list of genes with homologous sequences, the statistical significance of the matches and information on functional and evolutionary relationships.  

I supplement this information by searching US patents and patent applications for my new gene sequence.   This process is made easy using a search utility developed by Cambia's Patent Lens Sequence Project.  This search site uses NCBI's BLAST software to search sequences that are listed in the specifications and claims of US patents and published patent applications.  Below is a sample output from a search of Mus musculus erythropoietin (EPO) mRNA sequence in the Cambia database.  The numerical score in the search result is a hypertext link to information that provides more detailed alignment and homology data. 

Sequences producing significant alignments:             Score  

gb|AR308789.1|AR308789 Sequence 3 from Patent US6555343  250    
gb|GV939069.1|GV939069 Sequence 11 from Patent US74...   248    
gb|AR926143.1|AR926143 Sequence 12 from Patent US70...   244    
gb|GZ136886.1|GZ136886 Sequence 21 from Patent US81...   228    
gb|GZ136885.1|GZ136885 Sequence 20 from Patent US81...   228    
USRE40911_2 Sequence 2 from Patent USRE40911             208    
gb|AR477490.1|AR477490 Sequence 2 from Patent US6696411  208    
gb|GC662854.1|GC662854 Sequence 5 from Patent US744...   202   

The sequence data in the Cambia system is a little out of date but it often gives me a starting point for more detailed patent searching.

Happy searching,

Debbie  

Patents of Steve Jobs

How will the Mayo v. Prometheus decision change your patent strategy?

Busy healthcare executives are sitting up a little straighter in their Aerons after the March Supreme Court decision that held that the personalized medicine method claimed by Prometheus can not be patented because it 'sets forth the laws of nature".  With the personalized medicine testing market exceeding $28 billion in 2011 and thousands of Power Point presentations claiming the value of personalized medicine, this court decision is worth a serious look and a conversation with your patent counsel.
Excerpts from the March 2012  Supreme Court opinion read:

• "The patents before us concern the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn’s disease and ulcerative colitis. When a patient ingests a thiopurine compound, his body metabolizes the drug, causing metabolites to form in his bloodstream. Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective". 

• "Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6–TG in the blood (of a patient who has taken a dose of a thiopu­rine drug) exceed about 400 pmol per 8x108 red blood cells, then the administered dose is likely to produce toxic side effects. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law". 

• "The question before us is whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible pro­cesses that apply natural laws? We believe that the answer to this question is no."

How does this effect current and future patent filings?   Drs. Karen Potter and Stephanie Seidman (McKenna Long; Aldridge, LLP) have reviewed the Prometheus opinion and provided important guidance to patent practitioner.  In the recently published article, Guidepost for patent eligibility , Potter and Seidman summarize the decision, offering readers that:

• "Absent legislative intervention by Congress, future litigation will provide more detailed guidance. The patent practitioner, however, should be careful to draft patent applications that support an array of claims, including claims that include at least an additional step that implements any claimed measured “natural” correlation for a specific or particular purpose or in a non-conventional manner. In addition, since the law is in flux, and applications can take years to prosecute and often are filed in numerous jurisdictions with different standards, applications should include claims that embody a newly discovered correlation."

Debbie


Referenced article:

Guidepost for patent eligibility
Submitted by Karen G. Potter and Stephanie Seidman, McKenna Long ; Aldridge LLP
Published by San Diego Transcript on May 8, 2012.

    A patent directed to a medical diagnostic testing procedure in a human being recently has been invalidated by the Supreme Court in its decision in March in Mayo v. Prometheus. This decision affects the status of claims in patents and pending application in the field of diagnostic testing and, particularly, personalized medicine, such as claims to methods of selecting patients for treatment with a specific drug, and methods of monitoring and assessing efficacy of treatment as it progresses. Such methods are grounded in discoveries of parameters that correlate an activity of a drug in a patient with a treatment outcome upon which treatment decisions can be made. It is this type of claim that was at issue in Mayo v. Prometheus. The claims in the patent at issue in Mayo v. Prometheus included steps of: testing patients administered with a thiopurine drug for levels of a metabolic byproduct of the administered drug; and associating the measured levels of the metabolite to a particular treatment decision regarding dosage. The claims, however, did not include implementation of the correlation, so that any medical professional who measures the level of these known metabolites could be alleged to infringe the claim. It was argued, and the Supreme Court found, that the claim recited nothing more than what occurs in the patient, which is a law of nature. The Supreme Court reasoned that the conversion of the administered drug to its metabolites was a natural process, and that the discovery of this process was no different from the discovery of any law of nature, such as Newton’s laws, which are not patentable subject matter. The Supreme Court stated that affirmative steps of “administering” a drug to a patient and “measuring” levels of the metabolites, which are not themselves laws of nature, did not save the patent because these steps were conventional. This decision provides guidance regarding what may not be patentable, and provides limited guidance regarding what is patentable. The U.S. Patent Office, whose rules, while not binding, will be the barrier encountered by patent applicants, has stated that a claim that includes steps that encompass a law of nature should include other elements so that the “claimed process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.” Absent legislative intervention by Congress, future litigation will provide more detailed guidance. The patent practitioner, however, should be careful to draft patent applications that support an array of claims, including claims that include at least an additional step that implements any claimed measured “natural” correlation for a specific or particular purpose or in a non-conventional manner. In addition, since the law is in flux, and applications can take years to prosecute and often are filed in numerous jurisdictions with different standards, applications should include claims that embody a newly discovered correlation.

Deal: Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate

Merck and Endocyte Inc. announced on April 16, 2012 that they have entered into an agreement potentially worth almost $1B.  The deal will develop and commercialize Endocyte's investigational therapeutic candidate vintafolide (EC145). Vintafolide is currently being evaluated in a Phase III clinical trial for platinum-resistant ovarian cancer, (PROCEED trial) and a Phase II trial for non-small cell lung cancer (NSCLC); both studies are also using Endocyte's investigational companion diagnostic agent, etarfolatide (EC20).

Under the agreement, Merck will gain worldwide rights to develop and commercialize vintafolide. Endocyte will receive a $120 million upfront payment and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory and commercialization goals for vintafolide for a total of six cancer indications.

If vintafolide receives regulatory approval, Endocyte will receive an equal share of the profit in the United States (U.S.) as well as a double digit percentage royalty on sales of the product in the rest of the world.  Endocyte has retained the right to co-promote vintafolide with Merck in the U.S. and Merck has the exclusive right to promote vintafolide in the rest of world.

Endocyte will be responsible for the majority of funding and completion of the PROCEED trial.   Merck will be responsible for all other development activities and costs and have all decision rights for vintafolide.

Press Release-read more

Debbie

Pharma interest in virtual Biotech makes it the new black

Pharmaceutical companies are teaming up with venture capital groups to expand the well-known virtual biotech company model to help bring biotech products to market.  The virtual model uses a bare bones management team and advisors to develop one or two drug or medical device products for larger pharma companies.  Interestingly for Patent FindS readers, the VC-Pharma alliance is used to fund multiple startups.

FierceBiotech reported on the collaboration of Astella Pharma and venture capital groups to fund the startup Telsar Pharma to develop an ulcerative colitis drug owned by Astellas.  Read more....

Debbie

Issued Patent Renewal Rates by Industry

In a recent blog post, Renewal Rates by Tech Centers , the patent law blog, PatentlyO, has listed percentage of issued patents for which the first maintenance fee was paid by technology industries in a recent blog post, .  While all tech industries spent their budget on patent renewal fees, the Biotechnology and Organic Chemistry sector was the lowest at 81%.

Comments (or reader opinions) on the blog post cited the low value of issued biotech patents with narrow claims or failure of compounds in clinical testing.  Read more.....

Debbie

Amgen Co-Founder, George Rathmann dies

I was a graduate student rotating through Winston Salser's lab at UCLA when Amgen was founded.  I saw many of my friends leave the university for this exciting adventure.    The  Los Angeles Times is reporting that George Rathmann, the company's first CEO, died Sunday in Palo Alto.  


"Rathmann, a chemist by training , was a co-founder of Amgen and served as its chief executive. He helped raise $19 million to fund the firm and assembled a roster of inventive, young scientists who worked in makeshift trailers in then-rural Thousand Oaks."

Debbie

How will the changes in the patent law affect your patent strategy?

Jim Singer, partner at Fox Rothschild. LLP, has outlines some of the major changes in the patent law and the dates that they will be implemented in this informative blog post.  

On Friday, September 16, 2011, President Obama signed the America Invents Act into law.  As described in a previous IP Spotlight post, the new law creates several immediate and important changes to U.S. patent law.  However, some of the most important changes will not take effect until late 2012 or early 2013.  The following is a summary of changes that patent applicants should prepare for over the next 12-to-18 months..read more

QB3 and Deloitte join forces to support new life science innovation

The California-based incubator, QB3, (California Institute for Quantitative Biosciences) has entered into a collaboration with Deloitte to develop new life science technologies.  According to UCSF's Kristen Bole, Deloitte, will provide "consulting, audit, tax and financial advisory services, will provide its services at no cost to help QB3 develop an “innovation ecosystem,” bringing together the four pillars of the bioscience community – academic research, government, industry and investors".  It is unclear, at this time, the value of the Deloitte collaboration and what Deloitte gets for their money. 
To read more: http://vcresearch.berkeley.edu/news/qb3-deloitte-collaborate-drive-california-bioscience-innovation.

Debbie.

Monoclonal antibody partnering on the increase in Cancer

Current Partnering has released a recent its Cancer Monoclonal Antibody Partnering Report has showing an increase in partnering deals involving monoclonal antibody therapy in the past twelve months.

Since 2007 there has been a steady interest in the research and development of monoclonal antibodies as a treatment for various cancers, and this interest peaked in 2011 with over 70 deals partnering deals announced.

Figure 1: Cancer monoclonal antibody partnering by year – 2007-12

Unsurprisingly, the most frequent stage of development at signing of a partnering deal is discovery, followed by preclinical, and then phase I, phase II and phase III, as shown in figure below.

Figure 2: Cancer monoclonal antibody partnering by stage of development – 2007-12

According to the report, the primary oncology disease targets for monoclonal antibody partnering include lymphoma, breast, pancreatic, lung, melanoma and solid tumors.

The primary bigpharma companies participating in monoclonal antibody partnering in oncology include Pfizer, Sanofi, GSK, Amgen, Bayer, Takeda and Biogen Idec, all of whom have participated in six or more deals since 2007.

Monoclonal antibody partnering on the increase in cancer | Current Partnering

Mexican Institute of Industrial Property Patent Prosecution Highway Extended

The USPTO announced the continuation of the Mexican Institute of Industrial Property (IMPI) Patent Prosecution Highway (PPH) pilot program. The PPH allows a Mexican application having claims deemed allowable/patentable to be filed in the US and "advance out of turn for examination".

For more information: http://www.uspto.gov/patents/init_events/pph/mx-ext.pdf.

Debbie.

"Like" Patent FindS on Facebook!

"Like" Patent FindS on Facebook and follow us on Twitter. Follow us - become a fan to get important updates and helpful tips.
Debbie.

Deal: Allylix raises $18.2 million to produce specialized flavor and fragrances

Germany’s BASF Venture Capital has invested $13.5 million in a financing round that raised a total of $18.2 million for Allylix, the San Diego-based renewable chemicals startup that uses fermentation technology and genetically engineered yeast to produce specialized flavor and fragrance chemicals.

According to Xconomy,  existing investors Avrio Ventures, Cultivian Ventures, and London-based agribusiness company Tate & Lyle also participated in the round. 

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.

Amgen expands oncolytic virus program with $1B acquisition of BioVex

Oncolytic viruses are now recognized as an important new strategy for treating cancerous tumors.  In addition to Genelux,  BioVex, Jenneres, Oncolytic Biotech and Oncos Therapeutics are working on releasing positive clinical data sets.  The value of this technology was confirmed by the $1B acquisition of BioVax by Amgen in 2011.  BioVex is developing OncoVEX (GM-CSF), a novel oncolytic vaccine for head and neck cancer currently in Phase 3 clinical development.

In this deal, Amgen will pay up to  $425 million in cash at the closing of the transaction and up to $575 million in additional payments upon the achievement of certain regulatory and sales milestones.  BioVex will become a wholley owned subsidary of Amgen.

Several other companies active in the oncolytic virus space including the Genelux Corporation, Jennerex, Oncolytic Biotech and Oncos Therapeutics.


Debbie

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.

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.

 

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.