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PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

Chinese FDA Unveils Plan for Regulatory Reform

The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more

China Issues Human Genetic Resources Management Regulations

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more

Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible

Seven organizations of health care professionals argue in an amici brief filed in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") that Myriad's isolated DNA and cDNA claims, as well as claim...more

A Look At Abbott’s Citizen Petition Against The Biologics Price Competition And Innovation Act

When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the...more

Gene Patents and Diagnostics: The Economics of Innovation

The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael...more

mHealth Stakeholders: Bullet List of Legal Considerations

You are a device maker, an app or software developer, a potential investor, a healthcare provider, a healthcare payor or an insurer and you see opportunities in mobile health (mHealth). You have an idea for a revolutionary...more

China 20/20 Legal and Regulatory Developments - April 27, 2012

In This Issue: - Measures to Supervise Overseas Investments of Central Enterprises - Provisions Governing Overseas Manufacturers of Imported Food - China to Amend Measures for Foreign Invested Medical...more

Do Diagnostic Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)? (And If So, Would That Address Justice Breyer's...

Sometimes solutions to thorny issues are within our grasp if only we looked in the right place. The Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. raises the specter of the...more

USPTO Holds First Hearing on "Second Opinion" Genetic Testing

The U.S. Patent and Trademark Office held the first of two planned hearings aimed at fulfilling one of the reporting provisions of the Leahy-Smith America Invents Act (see "USPTO to Hold Hearing on Genetic Diagnostic...more

Forecasting Forthcoming ‘Biosimilar’ Drug Regulations

Traditional pharmaceuticals (small molecule drugs) have long been subject to widespread generic competition under the generic competition provisions of the Drug Price Competition and Patent Term Restoration Act, aka...more

European Commission Finds “Pay For Delay” Deals On The Decline In Europe But Pharma Sector Antitrust Scrutiny Continues

On July 6, 2011 the European Commission (Commission) published the results of its second monitoring exercise of patent settlements in the pharmaceutical sector (Second Monitoring Report). The Commission notes “with...more

Newsletter Pharma

Case law in pharmaceuticals: trademarks, patents and regulatory issue...more

Perchance to Dream … Or Not

Back in the 1960s, counting sheep gave way to a lilting commercial ditty as a means for solving the age-old problem of falling asleep: “Take Sominex tonight and sleep, safe and restful sleep, sleep, sleep.” If you took two...more

A New Guide for the Journey to Drug Name Approval

Clearing U.S. pharmaceutical trademarks for use and registration is more complicated and unpredictable than clearing marks in other industries. Unlike trademarks in other fields, pharmaceutical marks must be approved by the...more

Unique Active Ingredient in Drug Product Can Mean Patent Term Extension

The U.S. Court of Appeals for the Federal Circuit recently affirmed two separate district court decisions finding that patents on newly approved pharmaceutical active ingredients are eligible for patent term extension under...more

Antitrust: Commission confirms unannounced inspections in pharmaceutical sector

On 30 November 2010, European Commission officials carried out unannounced inspections at the premises of a number of pharmaceutical companies in several Member States. Reason was the Commission's suspicion that they may have...more

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