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Posts Tagged ‘ Biotechnology ’

Patents are Just the Start

Posted: Monday, Sep 1, 2014 @ 11:35 am | Written by Dr. Kristina Lybecker | 14 comments
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Posted in: Biotechnology, Congress, Dr. Kristina Lybecker, Government, Guest Contributors, IP News, IPWatchdog.com Articles, Patents, Pharmaceutical, Technology & Innovation

Patents encourage and protect innovation. That’s undeniable, but it’s naïve to believe that’s all we need to develop the new products that evolve into the industries that bolster the dynamic U.S. economy. Patents, and other forms of intellectual property protection, are a necessary prerequisite, but incentivizing innovation requires more. Just as plants require sunshine, water and nutrients to grow, innovation needs more than simply patent protection to thrive. To thrive innovation requires a climate that is conducive for business success.

Sadly, Capitol Hill is frequently the setting for both grandstanding and pandering, and given the prevailing political and public sentiment it is also frequently a place where businesses find an inhospitable welcome. A recent case in point: Three senior members of Congress (Henry Waxman, Frank Pallone Jr., and Diana DeGette) have started a joint investigation into the pricing of Sovaldi, a breakthrough drug for hepatitis C produced by Gilead Sciences (NASDAQ: GILD). Rather than applaud the health benefits that this drug will deliver, Congress is grilling the company on their pricing decision, striking fear in the investment community, and indirectly undermining the healthcare innovation that is so desperately needed.



Successful Phase 1 Trial for Parkinson’s Vaccine

Posted: Thursday, Aug 7, 2014 @ 11:42 am | Written by Steve Brachmann | No Comments »
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Posted in: Biotechnology, Food & Drug Administration, Government, Guest Contributors, IP News, IPWatchdog.com Articles, Steve Brachmann, Technology & Innovation

Parkinson’s disease is a progressive neurological disorder that affects the nervous system of an affected individual and can cause devastating effects in a person’s motor abilities. Parkinson’s is the second-most common brain disease behind Alzheimer’s, and 1 in 100 adults over the age of 60 develop the disorder. Symptoms include tremors, slowed movement, rigid muscles, loss of automatic movements and speech impairments. These symptoms can be mild for years and can be barely noticeable in early stages, but they worsen in time and can bring about a list of complications including sleep disorders, dysfunction of bodily systems and cognitive problems.

One issue with treating and preventing the disease is the fact that the underlying cause of the disease is largely unknown, although many factors involved with the disease have been identified by researchers. The presence of Lewy bodies, or clumps of microscopic biological material, within a patient’s brain cells is a major indicator of Parkinson’s disease.

Another unknown factor in the progression of Parkinson’s disease is the role of the protein alpha-synuclein. In the brains of healthy patients, this protein is fairly common and may even play a role in brain functioning. Although it’s still unclear exactly how alpha-synuclein affects those with Parkinson’s, this protein is a major component of Lewy bodies. A lot of research has gone into attempts to understand the role of alpha-synuclein and Lewy bodies in this disease, and into the development of therapies that target the aggregation of alpha-synuclein.



An Agency Responds: USPTO’s Challenge to Create Post-Myriad Examination Guidelines that Translate Supreme Court Decision into Day-to-Day Action

Posted: Sunday, Jun 1, 2014 @ 9:00 am | Written by David Kappos | 3 comments
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Posted in: Biotechnology, Government, Guest Contributors, IP News, IPWatchdog.com Articles, Patentability, Patents, Technology & Innovation, USPTO

When the Supreme Court hands down a decision bearing on a hotly contested area of law, it means the work has just begun for any agency tasked with administering its consequences. Last term, the Court rendered such a decision in Association for Molecular Pathology v. Myriad Genetics, adding a new wrinkle to the already confounding question of patentable subject matter under §101 of the Patent Act.

In the wake of this important decision, the United States Patent and Trademark Office (USPTO) was left to struggle with perhaps the only question more difficult than the one before the Court: how to translate the decision into routine examination guidance affecting hundreds of thousands of pending patent applications. In March, the USPTO released a memorandum titled Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products in an effort to address that question.

As companies consider current cases related to patents before the Supreme Court, they would be wise to learn from the challenges the USPTO faced in implementing the Myriad decision. And for the reasons set forth below, we believe that the USPTO and the entire business community are well served by engaging in rigorous public debate about the guidelines that should be established to implement the decision from the Supreme Court.



Leveraging Spin-Out Companies to Support Global Health

Posted: Wednesday, Apr 9, 2014 @ 9:00 am | Written by Erik Iverson | Comments Off
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Posted in: Biotechnology, Guest Contributors, International, IP News, IPWatchdog.com Articles, Licensing, Patents, Pharmaceutical, Technology & Innovation, Universities

Recently IPWatchdog.com published an article that cited the work we do at the Infectious Disease Research Institute (IDRI) as an example of how dedicated individuals and corporations can work together to transform science into global health solutions. By integrating capabilities, we strive to create an efficient pathway to bring scientific innovation from the lab to the people who need it most.

I write today to explain more about what IDRI does and why leveraging spin-out companies supports global health initiatives.

One of the most important engines in populating and growing the life sciences sector within the United States is the practice of universities spinning out new technologies into startup biotechnology companies. This, in turn, drives the development of new drugs, vaccines and other much-needed health products.



Survey of Life-Science Patent Practitioners

Posted: Thursday, Feb 27, 2014 @ 2:10 pm | Written by Sumant Pathak | Comments Off
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Posted in: Biotechnology, Guest Contributors, IP News, IPWatchdog.com Articles, Pharmaceutical

A team of law students, who are members of the Intellectual Property Law Fellowship at the Thomas Jefferson School of Law in San Diego, California, are working on a Research Project directed toward aiding patent practitioners in developing international patent filing strategies for biotechnology and pharmaceutical companies. The team is working to amass statistically significant survey data on the countries patent practitioners are filing patents in for their biotechnology and pharmaceutical clients most often, and the factors considered when making the decisions to file.

As countries modernizes their economy, and more particularly the life science industry keeps growing, the demand for biotech and pharmaceutical products will likely increase. With increased demand, the market competition and incentive for companies to patent their research and products will likely increase as well. Once the results of the survey are published, policy makers will have more information on the factors patent attorneys from different countries consider most important when making their filing decisions. The results will also give life-science patent practitioners better information as to where in the world they can promote their legal services and partner with foreign law firms for patent applications being filed.

The survey is open to patent practitioners from any country who prosecute patents in the biotechnology or pharmaceutical sectors. The survey can be found by following the hyperlink below. All personally identifiable information will be kept confidential. It should take approximately 15 minutes to complete. We will appreciate if you take the survey prior to March 7, 2014.



Patent Erosion 2013: What Would the Founding Fathers Think?

Posted: Sunday, Dec 29, 2013 @ 11:22 am | Written by Gene Quinn | 26 comments
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Posted in: Congress, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, US Economy

James Madison, father of the Constitution and proponent of strong patent rights.

As the end of 2013 approaches and I look back on what has transpired I am saddened to see that through the year patent rights have continued to erode. It is difficult to comprehend just how far the pendulum has swung. At one time strong patent rights were viewed by our Founding Fathers as obviously necessary. Now any patent rights are ridiculed as a relic of the past that simply stands in the way of innovation. The reality, however, is that patents don’t stand in the way of innovation; patents foster innovation. But so many won’t even take the time to inform themselves. Rather they equate “innovation” with a new consumer product. But to innovate is to do something new. Innovation has nothing in and of itself to do with a new products or services.

What those urging a weaker patent system want is the ability to release products and establish services regardless of whether they are infringing others. But those who infringe are not innovators, at least not in the most broad sense. Sure, they may have improved something, but if they are infringing then what they have done is copy an innovator. How and why that isn’t self-evident is a mystery. Copying is not innovating!

And if patents were getting in the way of innovation then why aren’t we seeing a standstill in the smartphone industry? The arguments made by the anti-patent crowd are ridiculous on their face, yet decision makers just nod their head in agreement as if they speak the gospel. The truth is the smartphone industry started with the iPhone in late 2007. It is just 6 years old! The phones from 2007 look and function nothing like the smartphones do today, and every new version has new improvements, better battery life, stronger structural integrity, glass that is harder to break, operates faster, has better cameras, etc. etc. For an area that is allegedly being suffocated by  patents there sure is a lot of readily apparent improvement.



Biotech and Pharma Update: News for December 2013

Posted: Friday, Dec 27, 2013 @ 7:55 am | Written by Gene Quinn | Comments Off
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Posted in: Biotechnology, Federal Trade Commission, Gene Quinn, IP News, IPWatchdog.com Articles, Pharmaceutical

What follows below is a review of some of the biotech and pharma news stories that caught my attention during the month of December 2013. I also recommend you take a look at Protecting Data Exclusivity, Protecting the Future of Medicine, written by Dr. Kristina Lybecker.

  1. Actavis Confirms Generic NuvaRing® Patent Challenge
  2. Fitch Puts Negative Outlook on Bristol-Myers
  3. Agios Pharmaceuticals Added to NASDAQ Biotechnology Index
  4. AstraZeneca Loses at the Federal Circuit on Omeprazole
  5. Amgen Announces Positive Results From 52-Week Phase 3 Study Of Evolocumab
  6. Merck and GSK Collaborate on Regimen for Advanced Renal Cell Carcinoma
  7. Mylan Acquires Rights to LAMA Respiratory Compound from Pfizer
  8. Mylan Enters Settlement Agreement for First-to-File Generic Version of TARGRETIN®
  9. Teva and Pfizer Settle  Viagra® Patent Dispute
  10. Everett Laboratories Acquires Quinnova Pharmaceuticals
  11. Savient Receives Bankruptcy Approval to Sell Assets to Crealta Pharmaceuticals
  12. FTC Settles with Mylan over Agila Acquisition
  13. Absorption Pharmaceuticals, Kaiser Permanente Clinical Trial of Promescent®
  14. Imagenetix Patent Survives Reexamination
  15. Actavis Announces Agreement on Asacol® HD Patent Challenge Litigation
  16. FDA Fast Tracks Savara Pharmaceuticals Antibiotic AeroVanc to treat MRSA
  17. Fitch Gives Johnson & Johnson AAA Rating
  18. Purdue Pharma, Impax Labs Settle OxyContin Patent Litigation
  19. Sales of Antiretroviral Drugs for HIV Predicted to Decrease


A Myriad of Tips on Biotech Patent Prosecution

Posted: Monday, Nov 25, 2013 @ 7:55 am | Written by Dolly Krishnaswamy | 1 Comment »
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Posted in: Biotechnology, Dolly Krishnaswamy, Guest Contributors, IP News, IPWatchdog.com Articles, Patent Prosecution, Patents

“It’s never good news when your area of the law is on 60 minutes,” says Courtenay Brinckerhoff, partner at Foley & Lardner LLP at the 2013 AIPLA Annual Meeting. It’s no secret that the Association for Molecular Pathology v. Myriad Genetics case had more than its fair share of media buzz. The decision, holding that isolated DNA was not patent eligible, left many of us wondering how to best address the needs of our biotech clients going forward.

First, a quick recap on Myriad for those of you that have been busy focusing on the fallout of CLS Bank v. Alice Corp. (For more on CLS Bank see herehere, here and here.

The main claims at issue in this case are the isolated DNA claims. Claim one is broad enough to cover naturally occurring DNA, and claim two is specific to synthetic DNA. In 2010, the district court came out with a decision holding that DNA was not patent eligible subject matter, which was a bit of a shock to us. Most of the rationale was focused on the idea that DNA embodies information, and regardless of what the actual molecule looks like, Myriad’s claim is for that defining characteristic. The case went up to the Federal Circuit where former chemist Judge Lourie held that technically the isolated DNA is different than natural DNA, because you have to break the covalent bonds to isolate the methylated gene. There were, of course, also policy reasons to uphold the claim like the reliance of the biotech industry on the USPTO already having granted these sorts of patents for nearly 20 years.