Novartis v. Breckenridge: Obviousness-Type Double Patenting Explained

Without trying to summarize this well-written opinion by Judge Chen, I simply recommend that you store it somewhere and pull it out when you have a tricky obviousness-type double-patenting situation and want a thorough review of the doctrine. The opinion reviews both the facts of the present dispute, which involved pre- and post-URAA filing dates, and of the precedent, a Gilead case and an AbbVie case – with clear charts as well.

Posted in Double Patenting, Obviousness | Tagged , , , , , | Leave a comment

IP Update – Canada | New Patent Rules released: 12 Notable Changes & Tips

Canada flagGuest Post from David Schwartz and Jeff Leuschner of  Smart & Biggar.

On December 1, 2018, the Canadian government released its proposed new Patent Rules in the Canada Gazette, Part I. This is one of the last steps necessary for implementing significant changes to Canada’s patent law, which are expected to come into force in 2019.

There will be many changes to Canadian patent law and practice. In this article we discuss the most notable changes expected, and some tips for safe and effective practice under the new rules.

Six changes to look forward to

The intent of many of the changes is to implement the Patent Law Treaty and to help minimize the risk of loss of rights. Changes we look forward to include:

1. Restoration of priority will be available

Currently, in order to make a valid priority claim in Canada, the Canadian patent application must be filed no more than 12 months after the filing date of the priority application.

The new system will allow for the 12-month priority period to be extended to 14 months if the failure to meet the 12-month deadline was unintentional. This change will bring Canadian practice into line with the right of restoration of priority provided for in Rule 49ter of the Regulations under the PCT.

However, the Federal Court of Canada can reverse the restoration of priority and declare the priority claim invalid if it is later determined that the failure to meet the 12-month deadline was intentional.

Tip: The “unintentional” standard for restoration of priority in Canada will likely be easier to meet than a “due care” standard applied by some other patent offices. Consider Canada as a favourable choice for situations in which restoration of priority must be relied upon.

Continue reading

Posted in Int'l Practice and Policy | Tagged , , , | Leave a comment

Life Science Patenting to Iancu – “We need help too!”

In his remarks presented at the recent 10th Annual Patent Law & Policy Conference at Georgetown University Law School, USPTO Director Andrei Iancu outlined the analytical framework for the new, eagerly awaited, PTO Guidance on patent eligible subject matter. Although his remarks touched on the judicial exception for claims directed to “pure discover[ies] of nature, like gravity or electromagnetism, and mentioned technologies such as computer viral screening and methods of medical treatment, the focus of his remarks was on the patent eligibility of “prohibited abstract ideas.”

He defined abstract ideas as falling into one of three categories: 1) mathematical concepts, 2) certain methods of organizing human interactions… [such as] advertising, marketing and sales activities [e.g., Bilski or Alice] and 3) mental processes, “which are concepts performed in the human mind, such as forming an observation, evaluation, judgment or opinion.” Director Iancu then focused on the overriding importance of determining whether or not a claim is simply directed to a judicial exception or is “a practical application of otherwise excluded subject matter….for example, we should be able to differentiate between [a claim drawn to] electromagnetism itself, on one hand, [and claims to] toys that communicate with each other using electromagnetic signals, on the other.” Not surprisingly, he cited Diehr approvingly.

His proposed analytical framework for examiners attempting to resolve the s. 101 question is first, to “look to see if the claims fall within the four statutory categories: process, machine, or composition of matter (This is not new, we always do this). If so, examiners then determine if the claims recite subject matter within one of the judicial exceptions, categorized as I just described (This is the new approach.)” If they do not the Examiner moves on to ss. 102, 103 and 112. If they do, the examiners “would assess whether the claims integrate the exception into a practical application of the otherwise excluded material. If so, the claim passes the 101 test and eligibility analysis is concluded.”

Continue reading

Posted in Patentable Subject Matter | Tagged , , , , , , , , | Leave a comment

Kumar v. Iancu – The Dangers of an Overstuffed Preamble/Note on 37 CFR Part 4.

Clopidogrel Tablets

On November 7, 2018, the Fed. Cir. issued a summary affirmance of the PTAB’s interference decision of September 6, 2016, in Kumar v. Sung (Patent Interference 14/322,039) which found that the claims of U.S. Pat. No. 8,541,422 were obvious over a single prior art reference. Since the Senior Party had dropped out – its patent was found to be obvious as well – the PTO intervened as the defendant in Kumar’s appeal to the Fed. Cir.

The PTO Brief filed in the appeal is of interest due to the thoroughness of its reasoning that, basically, affirmed breaking the preamble into two “limitations”, one of which gave life to the claim as a method of treatment and one which was ignored as a statement of intended use. The main claim is directed to a method of treating thrombosis with S-oxo-clopidogrel, the active metabolite of clopidogrel (Plavix®). While it was known that S-oxo-clopidogrel was more potent in mice than clopidogrel, the ‘422 patent attempted to claim the use of the metabolite to treat patients that do not respond well to clopidogrel:

  1. A method of [1] reducing or alleviating inter individual platelet response variability and metabolite loading in humans in [2] the treatment or prophylaxis of thrombosis or embolisms [1] observed following the administration of clopidogrel comprising administering to a person in need thereof, a composition containing an effective amount of S-oxo-clopidogrel or [an analog thereof or its salt] [Ed. note: I added the numbers to the preamble and shortened the irrelevant part of the claim.

Continue reading

Posted in Obviousness | Tagged , , , , , , , , | Leave a comment