Cure-All Drugs: Realities and Roadblocks

By Jill StarbuckPellegrino & Associates

Imagine a drug that can take away all of your ailments, maybe even cure or prevent them. Now, believe it. Those drugs—called biotech drugs or personalized drugs—are a reality today. They are produced from living organisms instead of chemicals found in standard prescription drugs. Typically administered via injection or intravenously, biotech drugs are used to treat the following types of diseases: autoimmune, cancer, degenerative, infectious, and neurological.

But these amazing drugs may be in jeopardy if a recent suggestion by the Supreme Court to invalidate two gene patents upholds.[1] The Supreme Court requested that an appeals reconsider its decision to uphold the patents involving genes associated with breast and ovarian cancer, claiming that a diagnostic blood test used involved a law of nature, and therefore is not patentable. The Supreme Court’s ruling regarding the diagnostic test patent may affect the patentability of genes in the future. Patent owner, Myriad Genetics, a biopharmaceutical company focused on drug development and genetic testing for cancer, has been arguing its case that these types of patents have been upheld by the Supreme Court for more than 30 years.

Patents are important to inventors because they protect new inventions and improvements made to those inventions for a specified amount of time. During that specified time, the inventors have to reveal to the public their inventions and all the components that make those inventions function. While this may seem counterproductive, patents give the inventors the right to exclude others from entering the market with the same idea. Therefore, if the Supreme Court’s suggestion to invalidate gene patents is upheld, it could have huge implications for the future of medicine.

If genes and diagnostic tests cannot be patented in the future, then biotech drugs would essentially be removed from the pharmaceutical industry. Because of the complexity of biotech drugs, inventors spend a tremendous amount of time and money on trying to prove the therapeutic value of the drugs and that they work. Without patents, all the time and money would be wasted as others could imitate and sell the drugs without any effort.

Thus, eliminating patents would result in an abrupt halt to new treatment methods because there would be no incentive for companies to create, research, or introduce new drugs in the market.

Statistics from 2010 show that there are approximately 294[2] public biotechnology companies in the United States, which was a 25% decrease from 2007. While most biotech companies were made up of small, privately owned companies that relied on venture capitalists for funding, many have been acquired by large pharmaceutical companies looking for the perfect drug or cure.

According to Freedonia, an international business research company, the U.S. biologics industry is worth $74.3 billion, with an expected 6.5% increase annually through 2015.[3]What this all means is that scientists are getting closer to finding cures for debilitating and life-threatening diseases. The enabling factors are genes and diagnostic tests to target specific individuals with specific conditions, thus becoming more “personalized.” Without these factors, cure-all drugs may not become a reality. Without patents, companies may end up with no way to ensure exclusivity in the market, which will deter investment in new biotech products.


[1] http://www.nytimes.com/2012/03/27/business/high-court-orders-new-look-at-gene-patents.html?_r=1

[2] http://www.bloomberg.com/news/2010-10-05/shrinking-u-s-biotechnology-sector-lost-25-of-companies-in-past-3-years.html

[3] http://www.freedoniagroup.com/biologics.html


By Jill StarbuckPellegrino & Associates

ICLEF • Indiana Continuing Legal Education Forum, Indianapolis, IN

Posted in Intellectual Property Blog0 Comments

Notes on Negotiations: NBA Negotiations in Sacramento

NBA Negotiations in Sacramento
Written by Marty Latz, Latz Negotiation Institute

Watching parties engage in high profile negotiations is, for us, one of life’s great pleasures.  A current example is the negotiation between the Maloof family, owner of the NBA’s Sacramento Kings, and Kevin Johnson, the Mayor of Sacramento and a former star player for the NBA’s Phoenix Suns, to keep the team in Sacramento.

Last spring, the Maloofs engaged in discussions to move the team to Anaheim, California but decided not to file a required request with the NBA to move the team.  By agreeing to voluntarily limit their leverage (by putting on hold their Plan B of moving the team to Anaheim), the Maloofs sought to generate some positive momentum which they hoped would result in more movement and dollars from their Plan A counterpart – Mayor Johnson and the City of Sacramento.

With much fanfare, the parties recently announced they had reached a tentative deal, which then subsequently fell apart as they negotiated the details – and which some have suggested was due to nibbling by the Maloofs.  Last Friday Mayor Johnson accused the Maloof’s of backing out and stated, “We can’t do more than we’ve done.  It’s impossible.”

In response, George Maloof mentioned on Monday that, while “[o]ur intention is to stay in Sacramento,” another city had reached out to the family over the weekend in an effort to persuade them to move (an attempt to ratchet up the pressure by publicly putting their Plan B back on the table).

What do you think will be the next move here?

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Marty Latz is the founder of Latz Negotiation Institute, a national negotiation training and consulting company, and ExpertNegotiator, a Web-based software company that helps managers and negotiators more effectively negotiate and implement best practices based on the experts’ proven research.  He is also the author of Gain the Edge! Negotiating to Get What You Want (St. Martin’s Press 2004). He can be reached at 480-951-3222 or Latz@ExpertNegotiator.com

ICLEF • Indiana Continuing Legal Education Forum, Indianapolis, IN

Posted in Negotiation/Mediation Blog0 Comments

The Power of “No”

Notes on Negotiation
Written by Marty Latz, Latz Negotiation Institute

Facebook, the world’s largest social networking service, is buying Instagram for around $1 billion in cash and stock.  Instagram is the most popular free photo-sharing application on Apple’s App Store and has over 30 million users.

An interesting aspect of this deal is that Instagram’s CEO, Kevin Systrom, reportedly said no to Facebook several times. Mark Zuckerberg, Facebook’s CEO, first tried to hire Systrom in 2004 and sought to acquire Instagram more than once.

The lesson here is the importance of getting your timing right and having the foresight to say “no” when a deal is premature.  Systrom could have sold out much earlier for significantly less money.  Instead, he waited until Instagram had become the market leader.  From a negotiation perspective, he smartly maximized his leverage before closing this blockbuster deal.

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Marty Latz is the founder of Latz Negotiation Institute, a national negotiation training and consulting company, and ExpertNegotiator, a Web-based software company that helps managers and negotiators more effectively negotiate and implement best practices based on the experts’ proven research.  He is also the author of Gain the Edge! Negotiating to Get What You Want (St. Martin’s Press 2004). He can be reached at 480-951-3222 or Latz@ExpertNegotiator.com

ICLEF • Indiana Continuing Legal Education Forum, Indianapolis, IN

Posted in Negotiation/Mediation Blog0 Comments

Family Law Case Review: B.C. v. D.H.

Case: In Re the Paternity of: B.H. by next friend: B.C. (Father) v. D.H. (Mother) (NFP)
by Mike Kohlhaas, Bingham Greenebaum Doll  

FACTS AND PROCEDURAL HISTORY:
In 2007, Mother became pregnant after being romantically involved with both C.C. and B.H.   Mother gave birth to Child in 2008. The following day, B.H. filed a Verified Petition for Immediate Paternity Order in Fayette Circuit Court, alleging B.H. was the father of Child. As a result of that petition, Mother was ordered to submit Child to DNA testing. On the same day Mother was served with the genetic testing order, Mother and C.C. executed a paternity affidavit stating C.C. was Child’s biological father.

Nevertheless, the subsequent genetic testing showed a 99.9997% probability that B.H. was Child’s father.

Mother’s counsel appeared in B.H.’s paternity matter and filed a motion to dismiss based upon various factors.

Within a week of Mother’s receipt of the genetic testing results, C.C. filed a pro se Verified Petition to Establish Paternity in Hancock Circuit Court. The Petition did not disclose the pending Fayette County matter, nor the existence of the DNA testing. Concurrently, an Agreed Entry between Mother and C.C. – establishing paternity and support/custody arrangements – was submitted, and was approved by the Hancock Circuit Court the following day.

The same day that the Agreed Entry was approved in Hancock Circuit Court, a hearing was held in Fayette County on Mother’s motion to dismiss. The Agreed Entry from Hancock County was entered into evidence. Following the hearing, the Fayette County court dismissed B.H.’s action, but gave 10 days leave to amend. B.H. never amended his paternity petition.

Instead, B.H. subsequently went to the Hancock Circuit Court and filed a motion to intervene in C.C.’s paternity cause, and filed a Verified Petition for Relief of Judgment for Fraud Upon the Court. B.H.’s motion to intervene was granted. Following a hearing, the Hancock Circuit Court issued an order finding that the Agreed Entry establishing C.C.’s paternity was procured through fraud, including the non-disclosure of the pending Fayette County matter. The Hancock Circuit Court then voided the Agreed Entry that had established C.C.’s paternity. Mother appealed.

The Court of Appeals undertook a detailed analysis of the requirements to set aside an order based upon fraud. Ultimately, the Court of Appeals concluded that “the execution of the paternity affidavit, combined with the timing of the filing of the Hancock County proceeding, appear to have been part of a plan or scheme to suppress the true identity of [Child’s] biological father, which resulted in the issuance of a paternity order by the Hancock Circuit Court that prevented B.H. from ‘having an actual day in court[.]’” As such, the trial court’s order setting aside the paternity order based upon fraud was affirmed.

Judge Riley dissented, concluding that the trial court erroneously voided the paternity affidavit in light of relevant statute and case law. She also expressed public policy concerns that voiding C.C.’s paternity could leave Child a “child of no one.”

To view the text of this opinion in its entirety, click here: In Re the Paternity of: B.H. by next friend: B.C. (Father) v. D.H. (Mother) (NFP)

ICLEF • Indiana Continuing Legal Education Forum, Indianapolis, IN

Posted in Family Law Case Review0 Comments