In a closely watched case, the Federal Circuit has rejected Dr. Reddy's novel approch to drug patent challenges.
Last year’s decision by the U.S. Food and Drug Administration to limit 30-month stays in pharmaceutical patent challenges isn’t likely to ease the pathway to the market for generic makers, according to a new study.
In a historic move, Malaysia’s government has issued the world’s first compulsory license, allowing a local firm to import patented anti-HIV/AIDS drugs from an Indian generic maker under fixed prices.
Indiana University has filed a lawsuit against German drug maker Merck & Co., seeking to add a university scientist as an author to patents for vaccines against the human papilloma virus with a projected market value of $2 billion.
Guidant Corp. has acted to decisively settle the medical device maker’s legal challenges in the lucrative market for drug-coated stents, penning yet another settlement agreement with a major competitor.
Pfizer has filed a patent infringement lawsuit in New York federal court against Dr. Reddy’s after the Indian generic maker filed an ANDA with the FDA for a copycat version of the hypertension drug Norvasc.
Health insurers Aetna and Humana have filed an antitrust lawsuit against the maker of the painkiller Oxycontin, asserting that Purdue Pharma illegally blocked the sale of less expensive generic versions.
Only a week after being hit by a lawsuit by rival Inverness in Germany, Medical device maker Quidel Corporation struck back with its own patent infringement lawsuit against Inverness and Applied Biotech over lateral-flow technology used in diagnostic tests.
In a rare respite in the increasingly litigious market for drug coated stents, medical device makers Boston Scientific and Guidant Corporation agreed to settle a number of lawsuits in which each has accused the other of patent infringement.
The World Health Organization has set up a commission to review how intellectual property rights affect the creation of new drugs against “diseases of poverty” in the developing world.
Amgen won a court ruling that threw out a patent challenge to its arthritis treatment Enbrel, one of the biotech company’s best-selling drugs.
In another sign that India is moving toward data protection for drug patents, the government has formed a high-level panel to explore whether the country should legislate a ban on unfair use of data furnished to regulators.
Pfizer has met with setbacks in Canada and the U.S. in its effort to protect its $1.7 billion erectile dysfunction drug Viagra from competition from Eli Lilly’s Cialis.
Drug companies are developing trademarks for new products at an early stage in an effort to entrench a brand in the minds of physicians, a new survey has found.
The Food and Drug Administration is laying the early groundwork for approving generic versions of biotechnology medicines, a policy move riddled with controversy, according to a published report.
The Centers for Disease Control and Prevention is reviewing a 1990 agreement that assigned California biotech company Chiron Corp. exclusive rights to the discovery of hepatitis C in 1987, according to a published report.
The U.S. Court of Appeals for the Federal Circuit has upheld a lower court’s dismissal of the University of Rochester’s lawsuit against Pfizer over the patent for the best-selling arthritis drug Celebrex.
The Federal Trade Commission has officially closed its antitrust investigation into accusations that Allergan tried to block generic competition for its Acular eye drug.
Canada’s federal government has reintroduced to Parliament proposed changes to drug and patent laws that will make it easier for developing countries to obtain cheaper generic drugs.
Energizer Holdings has fired another legal volley in the patent litigation between its Schick-Wilkinson Sword unit and Gillette, charging that the archrival’s flagship products sold under the Mach3, Mach3Turbo and Venus brands infringe three Schick patents.