News & Analysis as of

Naming of Interchangeable and Biosimilar Biological Products Likely to Be Same

Earlier this fall, FDA issued a draft guidance proposing a middle-road approach to naming biosimilars. Unlike small-molecule drugs, where the branded and generic drug share the same nonproprietary name (also referred to as a...more

What Are the IP Provisions of the TPP?

The Obama Administration released the approved text of the Trans Pacific Partnership (TPP) agreement last week, and it is substantially (and perhaps entirely; there has not been sufficient time to compare) the same as the...more

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

Final Text of Trans-Pacific Partnership Released

At long last, the final text of the Trans-Pacific Partnership, a free trade agreement among a dozen Pacific Rim nations, has now been made available to the public. The chapter on intellectual property, however, does not...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

Trans-Pacific Partnership Has Challenges, Opportunities for U.S. Companies

The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

What May Be the IP Provisions of the Trans Pacific Partnership Agreement

The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and interested parties in the United States,...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

101 Patient Organizations Ask Congress to Curb IPR Abuse

Last month, in a letter to the Senate and House Committees on the Judiciary, 101 patient organizations expressed "concern[] that, as currently written, H.R. 9 [the Innovation Act] falls short of preserving important patent...more

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences,...more

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

Pacific Rim Countries Reach Historic Agreement on the Trans-Pacific Partnership, But Will Congress Approve It?

Trade ministers from 12 Pacific Rim countries announced, on October 5, 2015, that they had reached an agreement in principle on the Trans-Pacific Partnership (TPP). The TPP would arguably be the largest free trade agreement...more

Trans-Pacific Partnership agreement on term of data exclusivity for biological pharmaceuticals, not patent term

Five years of negotiations have culminated this week in the signing of the Trans-Pacific Partnership (the “TPP”) agreement by 12 countries from the Pacific-rim region, including the US and Australia. While the partnership...more

Update on Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

Under 35 U.S.C. § 271(e), filing an Abbreviated Biologics License Application (aBLA)—like filing an Abbreviated New Drug Application (ANDA)— can be an act of patent infringement resulting in ‘artificial’ injury to a patentee....more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Blog: Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs,...more

Amgen Sues Hospira in Fourth Lawsuit Under the BPCIA

On September 18, 2015, Amgen sued Hospira in a fourth lawsuit under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The lawsuit concerns Hospira’s proposed biosimilar of Amgen’s Epogen (epoetin alfa)....more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

Amgen v. Sandoz – Did the Federal Circuit Just Doom the New Biosimilar Approval Pathway?

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

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