Patents – Page 15 – IP Law Watch

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Nov 13 2014

Amgen, Inc. has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA 2014 P 1771) on October 29, 2014, requesting that the FDA mandate compliance with the framework for biosimilar applications laid out by the Biologics Price Competition and Innovation Act.

To read the full alert, click here.

High Court Confirms That Extension of Time Provisions Apply to Requests for Pharmaceutical Extensions of Term

Nov 11 2014

In a recent decision, the High Court of Australia has ruled that the extension of time provisions of the Australian Patents Act 1990 (Act) can be used to extend the time for requesting an extension of term of a patent relating to a pharmaceutical substance.

The dispute was based on a request by Lundbeck to extend the term of Australian patent 623144. The extension of term request was filed after the applicable deadline and was, therefore, accompanied by an application for an extension of time. Read More

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

Nov 05 2014

There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014 when Sandoz Inc.’s (“Sandoz”) biosimilar application for a biosimilar of Amgen Inc.’s (“Amgen”) Neupogen® was the first accepted by FDA under section 351(k) of the Public Health Service Act. Apparently, Sandoz has refused to engage in the “patent dance” in accordance with the BPCIA, leaving Amgen without a dance partner. Amgen did not take kindly to being stranded on the dance floor and has opted to sue Sandoz for its allegedly unlawful refusal to follow the BPCIA’s patent resolution procedures.

To read the full alert, please click here.

Restrictions to Filing Divisional Applications Under New Zealand’s New Patent Law

Oct 17 2014

The New Zealand Patents Regulations 2014 have effectively introduced a five year deadline for filing divisional applications.

The deadline arises as a result of restricting the period in which examination of a divisional application may be requested. In this regard, examination must be requested within five years of the date of filing of the parent application, or for a series of divisional applications, within five years of the date of filing of the first application in the series. Read More

Further Amendments to Australian Patent Law Coming Soon

Oct 07 2014

Earlier this year, the Intellectual Property Laws Amendment Bill 2014 (2014 Bill) was introduced into Parliament by the Coalition Government. The Bill represents a revised version of the Intellectual Property Laws Amendment Bill 2013 (2013 Bill) introduced by the previous Labor Government. The 2013 Bill lapsed when the Federal Election was called in August 2013.

The most significant aspects of the 2014 Bill are as follows:

Introduction of a single patent attorney regulatory regime and a single patent application and examination process for Australia and New Zealand.
Enabling Australian pharmaceutical manufacturers to apply to the Federal Court for a compulsory licence to manufacture generic versions of patented drugs to supply to developing countries. Read More

Patents for Humanity: It’s Not Just an Invention

Sep 25 2014

The deadline for submission of applications for the U.S. Patent & Trademark Office (USPTO) competition, PATENTS FOR HUMANITY, has been extended to October 31, 2014. The purpose of the program is to incentivize patent owners, applicants and licensees to use their technologies to address humanitarian issues in any of the following categories:

medicine
nutrition
sanitation
household energy
living standards. Read More

Special Leave Sought to Appeal Gene Sequencing Decision to the High Court of Australia

Sep 25 2014

We recently reported on the decision by a five judge bench of the Full Court of the Federal Court of Australia (Full Court) which found that Myriad Genetics Inc’s patent covering the isolated BRCA1 gene is valid. The Full Court unanimously rejected an appeal by Ms. Yvonne D’Arcy from a decision by Justice Nicholas at first instance. Read our alert here.

It is now being reported that Ms. D’Arcy has sought special leave to appeal the decision to the High Court of Australia (High Court).

Purple is the New Orange: FDA Releases a Purple Book for Biosimilars

Sep 15 2014

On September 9, 2014, the U.S. Food and Drug Administration (“FDA”) published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products. Read More

Australian Patent Examination Reports Issuing Faster Than Expected in Some Technology Areas

Sep 12 2014

Prior to commencement of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which came into effect in April 2013, the Australian Patent Office was inundated with requests for examination from applicants wishing to have their applications examined under the current law.

This flood of examination requests led the Patent Office to last year advise that first examination reports would likely issue, on average, about 19 months after examination is requested. We have recently been advised by the Patent Office that the backlog of applications awaiting examination is starting to clear and that examination reports are now issuing, on average, about 16 months after examination is requested. Read More

Australian Courts Confirm Status Quo for Patenting Gene Sequences

Sep 05 2014

Today, a five-judge bench of the Full Court of the Federal Court of Australia unanimously decided that Myriad Genetics Inc’s (Myriad) patent covering the isolated BRCA1 gene (Patent) is valid.

In Yvonne D’Arcy v Myriad Genetics Inc & Anor (5 September 2014) the Full Federal Court rejected the reasoning of the U.S. Supreme Court, when it found in 2013 that certain claims of a closely related U.S. Patent of Myriad were invalid as the claim to isolated nucleic acid was a claim to a “product of nature” and not patentable subject matter.

For the pro-patent lobby and the biotech industry, this is good news for innovation in life sciences in Australia.

Category:Patents