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Patent Reform Bill, Accelerator, Recodagen, Advanced Cell Technology, Catholic Healthcare West, Phase Bioscience, NIH Funding

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Senate Judiciary Committee Proposes Amendments for Patent Reform Bill
 
The Senate Judiciary Committee this week released more than a dozen possible amendments to the Patent Reform Act awaiting consideration in the Senate.
 
Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), said in a statement that the proposed amendments “are the first step forward in perfecting our bill and ensuring it has the support needed to become law.”
 
The Senate’s Judiciary Committee passed the legislation last July [BTW 07/23/07], but it has yet to be considered in the full Senate. Majority Leader Harry Reid (D-Nev.) “has signaled” that the chamber could take up the bill in April, according to Leahy’s statement. 
 
The amendments released Wednesday include:
  • The elimination of “best mode” as a ground for invalidating a patent, but retaining it as a requirement to obtain a patent;
  • The restoration of third-party ex-parte reexamination;
  • Assurance that any Federal Circuit judge who does not reside within a 50-mile radius of Washington, DC, must use the chambers of an existing courthouse in the district where they reside;
  • A technical amendment to allow for appeal to the Federal Circuit of USPTO board interference decisions commenced prior to the date of the Act;
  • The removal of interference-related provisions, which are replaced with new derivation-related provisions;
  • Limitations on interlocutory appeals of claim construction orders to those for which the District Court “determines there is a reasonable basis for disagreement and the appeal may advance the ultimate termination of the litigation;”
  • Codification of the Federal Circuit court’s ruling that infringement is only willful if the infringer acts with objective recklessness of the patent;
  • Assurance that the appointment of patent and trademark judges is “consistent” with the Appointments Clause;
  • A technical amendment to clarify that the Patent Board’s duties include the conduction of derivation proceedings;
  • The correction of an inconsistency that would “preclude requesting or maintaining a post-grant review proceeding after a final decision in litigation on the same patent, based on any issue that was raised or could have been raised, in the litigation;”
  • A definition of “final decision” in the estoppel provision; and
  • A severability clause.
“We’re encouraged to see this progress toward a compromise, one that will be functional for interested stakeholders,” said Committee Member Orrin Hatch (R-Utah), in a statement. “These amendments are yet another sign that we can work through the few remaining issues.”
 
Leahy said that additional amendments to address issues including venue, post-grant review, damages, and inequitable conduct are expected to be released in the coming weeks. 
 
Further information on the amendments is available here.
 
The House of Representatives passed its own version of the patent reform bill last year [BTW 09/10/07].
 

 
Accelerator Spawns Seventh Startup: Cancer Therapeutics Firm Recodagen
 
Privately held biotech development firm Accelerator said this week that it has formed the seventh company in its portfolio — a developer of cancer therapeutics called Recodagen.
 
The company has raised a Series A financing round from Alexandria Real Estate Equities, Amgen Ventures, ARCH Venture Partners, OVP Venture Partners, and WRF Capital.
 
Recodagen’s technology is based on a novel class of disease targets discovered and developed in the laboratory of Suzanne Lindsey at Washington State University and Texas Tech University.
 
The company said its first lead target appears to aid tumor cell invasion and dissemination associated with metastasis. “To our knowledge, this target is the only known tumor cell-specific protein that increases tumor cell invasion, which makes it an important area of research with significant implications for diagnostic and therapeutic developments,” Lindsey said in a statement.
 

 
CHW to Serve as Clinical Trial Site for ACT’s Phase II Heart Disease Study
 
Advanced Cell Technology said this week that it has signed an agreement with members of the Catholic Healthcare West healthcare system, to serve as ACT’s first clinical trial sites for its Phase II myoblast study for the treatment of heart disease.
 
CHW’s Chandler Regional Medical Center and Mercy Gilbert Medical Center will carry out the study, which is expected to begin “soon,” ACT said.
 
ACT is developing an autologous adult stem cell therapy for the treatment of heart disease. The company said that has successfully completed four Phase I clinical trials and received clearance from the Food and Drug Administration to begin Phase II trials.
 
The trial, called Catheter-Based Delivery of Autologous Skeletal Myoblasts for Ishemic Cardiomyopathy, or CAuSMIC, will focus on patients who are not eligible for angioplasty or coronary artery bypass surgery, and who have not responded to medical therapy or therapy with a pacemaker or defibrillator device.
 

 
Phase Bioscience Secures $1M Loan, Plans Move to New HQ
 
Durham, NC-based Phase Bioscience said this week that it has closed a $1 million secured equipment loan with SVB Silicon Valley Bank and that it plans to move to larger headquarters and laboratory facilities.
 
The company has raised around $8 million in venture funding from Fletcher Spaght Venture Partners, Hatteras Venture Partners, and Johnson & Johnson Development Corporation.
 
PhaseBio said it has signed a lease on 6,000 square feet of office and laboratory facilities at Aerial Center in Morrisville, NC.
 
The company is developing Elastin-Like Peptide technology, which it said improves the half-life, safety, formulation and other pharmaceutical attributes of compounds in development. The technology was licensed in part from Duke University.
 

 
Senate Passes Resolution that Could Raise NIH Budget by $2.1B
 
The US Senate late last week passed a resolution that would add $2.1 billion to the White House’s proposed National Institutes of Health budget for 2009.
 
Senators Arlen Specter (R – Pa.) and Tom Harkin (D – Iowa) added the extra funds to the President’s proposed $29.5 billion through an amendment to a budget resolution that will set the limits on the spending frame for upcoming debate on the 2009 budget.
 
“The funding for the National Institutes of Health is grossly insufficient,” Specter said in a statement. “This increase in funding will enable the National Institutes of Health to continue to produce remarkable achievements in scientific advances,” he added.
 
“Boosting our nation's investment in the NIH will ensure the nation's top scientists can continue to deliver the life-saving biomedical research that provides hope to millions of Americans," Sen. Harkin, who chairs the committee that handles appropriations for the NIH and a number of other agencies, said in a statement.  
 
The amendment passed the Senate by a vote of 95 to 4, although the budget resolution itself passed by a smaller margin of 51 to 44.

The Scan

Just Breathing

A new analysis suggests that most Mycobacterium tuberculosis is spread by aerosols from breathing, rather than by coughing, the New York Times reports.

Just Like This One

NPR reports that the World Health Organization has hired a South African biotech company to recreate mRNA vaccine for SARS-CoV-2 that is similar to the one developed by Moderna.

Slow Start

The Wall Street Journal reports that Biogen's Alzheimer's disease treatment had revenues for July through September that totaled $300,000.

Genome Research Papers on Cancer Chromatin, Splicing in the Thymus, Circular RNAs in Cancer

In Genome Research this week: analysis of bivalent chromatin sites, RBFOX splicing factors' role in thymic epithelial cells, and more.