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TUNIS (Reuters) - A Tunisian court sentenced a local rap singer on Thursday to six months in jail for a song insulting the police and government in a case likely to fuel debate over free speech under the Islamist-led government, his lawyer said.
Critics say free expression has been threatened under the governing coalition led by the moderate Islamist Ennahda party, which won an election after a 2011 uprising ousted a secular dictatorship. The government rejects those accusations.
"Tunisian rapper Ahmed Ben Ahmed, known as Klay BBJ, has been sentenced to six months in jail for insulting the authorities in his songs," Ghazi Mrabet, his lawyer, told Reuters after the decision.
He said the sentencing related to songs performed insulting the government and the police at a Tunisian festival.
Last July, a Tunisian court released a rap singer named Wled 15, who was detained after he described police as dogs in one video.
Critics have accused Ennahda authorities of encouraging intolerance for secular views and lifestyles by failing to prevent militant Islamist Salafi attacks on certain cultural institutions and individuals.
Hardline Salafis disrupted several concerts and plays last year, saying they violated Islamic principles. They also ransacked the U.S. Embassy in September 2012 during worldwide Muslim protests over an internet video.
The North African nation, which started the 2011 "Arab Spring" revolts, has been caught in a political deadlock since July between Ennahda and its secular opponents who want the government to step down and make way for elections.
(Reporting by Tarek Amara; Editing by Patrick Markey and Peter Cooney)
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up By Joyce Frieden, News Editor, MedPage Today
WASHINGTON -- Synthetically created combinations of DNA are not naturally occurring and are therefore patent-eligible, but whole genes such as BRCA1 and BRCA2 occur naturally and can't be patented, the Supreme Court ruled unanimously Thursday.
"The Patent Act permits patents to be issued to '[w]hoever invents or discovers any new and useful ... composition of matter,' but 'laws of nature, natural phenomena, and abstract ideas' are 'basic tools of scientific and technological work' that lie beyond the domain of patent protection," wrote Justice Clarence Thomas in the 9-0 decision.
The ruling came in a case entitled Association for Molecular Pathology v. Myriad Genetics. The petitioners argued that genes are a product of nature and therefore patents on BRCA1 and BRCA2 genes held by biotechnology firm Myriad Genetics were invalid. Salt Lake City-based Myriad Genetics argued that it could legally patent the genes because once they were isolated from the body, they were no longer a product of nature.
Mutations in BRCA1 and BRCA2 genes raise a woman's risk of developing breast and ovarian cancer.
A district court in 2010 ruled the patents invalid because they were products of nature. The Court of Appeals for the Federal Circuit in 2011 disagreed, setting up the case for the Supreme Court.
During oral arguments at the Supreme Court in April, Chief Justice John Roberts said he disagreed with the appellate court's reasoning. In that court, the judges likened the patents to the patenting of a baseball bat. A tree isn't patent eligible, but a bat -- once extracted from the tree and carved -- is eligible.
"The baseball bat is quite different," Roberts said. "You don't look at a tree and say, 'well, I've cut the branch here and cut it here and all of a sudden I've got a baseball bat.' You have to invent it, if you will."
Justice Stephen Breyer said he supported allowing companies like Myriad to be able to patent the process by which they find and extract certain gene segments -- just not genes themselves.
In its decision invalidating Myriad's patent, the Supreme Court said that "Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes ... Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself" meet the criteria for a patent.
In addition, "Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together," Thomas wrote. "The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Instead, they focus on the genetic information encoded in the BRCA1 and BRCA2 genes."
The justices said that it is important to note "what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad's patents ... and are not at issue in this case."
The ruling "is a validation that things that are wrong can be made right," Arupa Ganguly, PhD, one of the original plaintiffs in the case, told MedPage Today in a phone interview. "I'm ecstatic."
Ganguly, a professor of genetics at the University of Pennsylvania in Philadelphia, said her laboratory was asked by Myriad in 1999 to "cease and desist" from doing BRCA1 and BRCA2 tests because of Myriad's patents.
The ruling means a lot for patients because "testing can improve, prices can be controlled, and people can have more access" to the tests, Ganguly said, noting that before the patents were invalidated, researchers could do work on a patient's blood sample but could not share their test results with patients.
The ruling will allow more companies to get into the market for BRCA1 and BRCA2 tests, increasing competition and driving down prices, said Rebecca Nagy, MS, president of the National Society for Genetic Counselors.
The ruling "appears to ... open up the test to other labs as long as the technique they use goes straight from naturally occurring DNA," said Nagy, a certified genetic counselor at Ohio State University in Columbus. "That will have a huge impact on how we practice and on delivering services to these women."
The ruling was "somewhat of a compromise" because it still allows patenting of composite DNA (cDNA), she noted. "If the [genetic] test utilizes genomic DNA -- which many of them now do -- and they don't have to create a step to do cDNA, another lab is free to use that [test]."
Although most genetic tests today use whole DNA, there are some cases in which testing is more complete if cDNA is used, Nagy said.
Some have argued that invalidating the patents will discourage biotechnology firms from developing genetic tests, but Ganguly disagreed. "The commercial research is not about the natural [gene] sequence," she said. "The commercial interest is what you do with that gene sequence. Do you design something new? Or find a new pathway to target for therapy? That will go on just like before."
Joyce Frieden
News Editor
Joyce Frieden began her career in medical journalism 26 years ago at Harcourt Brace Jovanovich, working as a news editor for Physician’s Management, Modern Medicine, Hospital Formulary, and several other medical magazines. Since then, her byline has appeared in Business & Health magazine, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News and ObGyn News. Her freelance clients have included Physician’s Weekly, UPI, WebMD, Reuters Health, Drug Topics, the Washington Post, and Washingtonian magazine. She is the recipient of a Jesse H. Neal award presented for editorial excellence by American Business Media, and is co-coordinator of the Washington chapter of the Association of Health Care Journalists.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up By Joyce Frieden, News Editor, MedPage Today
So-called "pay-for-delay" arrangements between generic and brand-name drug companies are not inherently legal, and each instance must be considered on a case-by-case basis, the Supreme Court ruled Monday.
In the 5-3 decision overruling the 11th Circuit Court of Appeals, Justice Stephen Breyer, writing for the majority, listed five reasons why the appellate court erred in giving blanket immunity to pay-for-delay agreements, in which brand-name drugmakers pay or compensate generic drug companies in exchange for a later entry date of the cheaper generic version of a drug: "A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects""One who makes such a payment may be unable to explain and to justify it""Such a firm or individual may well possess market power derived from the patent""A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent""Parties may well find ways to settle patent disputes without the use of reverse payments"
"In our view, these considerations, taken together, outweigh the single strong consideration -- the desirability of settlements -- that led the Eleventh Circuit to provide near-automatic antitrust immunity to reverse payment settlements," Breyer wrote.
Justice Samuel Alito recused himself from the vote.
The case, known as Federal Trade Commission vs. Actavis, involved Solvay Pharmaceuticals, which was granted a patent for AndroGel -- a topical testosterone medication for hypogonadism -- in 2003, 3 years after getting FDA approval for the drug. Later that year, generic drugmaker Actavis filed an Abbreviated New Drug Application for a generic version of the drug, as did Paddock Laboratories. Solvay then sued Activas and Paddock but settled with them in 2006 under a pay-for-delay agreement.
Under the settlement, Actavis agreed not to market its generic until the end of August, 2015, 65 months prior to the expiration of Solvay's patent. In return, Solvay agreed to pay Actavis $19-30 million a year for 9 years. Solvay made similar agreements with Paddock and with a third company, Par Pharmaceutical, which had joined forces with Paddock to litigate the patent claim.
The Federal Trade Commission (FTC) -- which claims that such pay-for-delay agreements cost American consumers $3.5 billion a year in the form of higher drug prices -- sued Solvay in 2009, claiming the settlement violated antitrust laws. The Eleventh Circuit rejected the FTC's arguments, ruling that as long as the settlement didn't extend beyond the patent expiration it was legal and not an antitrust violation.
"In our view ... reverse payment settlements such as the agreement alleged in the complaint before us can sometimes violate the antitrust laws," Breyer wrote for the court. "We consequently hold that the Eleventh Circuit should have allowed the FTC's lawsuit to proceed."
On the other hand, the justices said they refused to automatically designate all pay-for-delay settlements as illegal.
"The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale ... and the lack of any other convincing justification," Breyer wrote. "The existence and degree of any anticompetitive consequence may also vary as among industries. These complexities lead us to conclude that the FTC must prove its case as in other rule-of-reason cases."
"The rationale behind a payment of this size cannot in every case be supported by traditional settlement considerations," he continued. "The payment may instead provide strong evidence that the patentee seeks to induce the generic challenger to abandon its claim with a share of its monopoly profits that would otherwise be lost in the competitive market."
In their dissent, Justices Antonin Scalia and Clarence Thomas, led by Chief Justice John Roberts, argued that patents represent exceptions to antitrust laws.
"The correct approach should therefore be to ask whether the settlement gives Solvay monopoly power beyond what the patent already gave it," Roberts wrote for the dissenting justices. "The Court, however, departs from this approach, and would instead use antitrust law's amorphous 'rule of reason' to inquire into the anticompetitive effects of such settlements. This novel approach is without support in any statute, and will discourage the settlement of patent litigation."
In carving out this new approach, "the majority today departs from the settled approach separating patent and antitrust law, weakens the protections afforded to innovators by patents, frustrates the public policy in favor of settling, and likely undermines the very policy it seeks to promote by forcing generics who step into the litigation ring to do so without the prospect of cash settlements," Roberts concluded. "I would keep things as they were and not subject basic questions of patent law to an unbounded inquiry under antitrust law."
Joyce Frieden
News Editor
Joyce Frieden began her career in medical journalism 26 years ago at Harcourt Brace Jovanovich, working as a news editor for Physician’s Management, Modern Medicine, Hospital Formulary, and several other medical magazines. Since then, her byline has appeared in Business & Health magazine, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News and ObGyn News. Her freelance clients have included Physician’s Weekly, UPI, WebMD, Reuters Health, Drug Topics, the Washington Post, and Washingtonian magazine. She is the recipient of a Jesse H. Neal award presented for editorial excellence by American Business Media, and is co-coordinator of the Washington chapter of the Association of Health Care Journalists.
