Gene Quinn, at IPWatchdog, has been working on developing a list of the top 50 patent blogs based on a combination of objective and subjective criteria.

These are all great blogs and trying to put them in any kind of “ranking” makes little sense since many are narrowly tailored and have different emphasis and audiences.  I was pleasantly surprised that I’ve had a chance to meet many of the bloggers at various events and I’m going to make it a goal to meet all of them.

Without fanfare, here is the top 50:

  1. Patently-O
  2. IPWatchdog.com
  3. IP Kat
  4. Spicy IP
  5. Patent Baristas
  6. Intellectual Property Watch
  7. Patent Docs
  8. 271 Patent Blog
  9. BlawgIT
  10. Patent Prospector
  11. The Invent Blog
  12. IP Think Tank and The Prior Art

  13. Orange Book Blog
  14. IPJUR and European Patent Caselaw

  15. Promote the Progress
  16. IP NewsFlash
  17. Anticipate This!
  18. Patentably Defined
  19. India Patent
  20. Intellectual Asset Management
  21. Against Monopoly
  22. Patent Circle
  23. I/P Updates
  24. PHOSITA
  25. IP Spotlight
  26. Chicago IP Litigation
  27. The IP Factor
  28. Patent Arcade and File Wrapper

  29. Securing Innovation
  30. Patents 101 and IP Estonia

  31. PatLit
  32. Just An Examiner
  33. The Business of Patents
  34. Patentability
  35. Inventive Step
  36. Holman’s Biotech IP
  37. Washington State Patent Law
  38. California Biotech Law
  39. Patent Infringement Updates and Patent Assassins

  40. Russian Patents
  41. Georgia Patent Law
  42. Patentnapsis
  43. Honoring the Inventor
  44. OC Patent Lawyer
  45. Nanomedicine & IP
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Innovation patents are second tier patents similar to utility models, having a lower threshold for patentability and a relatively short term of eight years compared to standard patents.

A recent appeal court decision confirms that inventions that include features that are known and obvious can still sustain valid innovation patent protection in Australia.

The Decision

  • encourages the filing of applications for innovation patents, as many new products and methods will qualify for innovation patent protection in Australia, and
  • confirms that when faced with an allegation of infringement of an innovation patent, it is difficult to successfully challenge the validity of the innovation patent.

On 30 June 2009, three Judges of the Federal Court handed down their decision in Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81. In this decision, their Honours upheld the validity of three innovation patents relating to roadside posts. A consistent feature of the patent claims was the formation of the posts from sheet spring steel so as to make them ‘elastically bendable’ and the specification as filed asserted this to be a development of the invention over the prior art. A similar post formed from laminated sheet spring steel was found in a prior art document and Dura-Post asserted that the claims of the innovation patent were invalid over this prior art document.

However, the patents also claimed in combination with the use of spring steel, a number of other features that were not described in the prior art document:

  1. a marker hole to help install the post at the correct depth
  2. a barb serving to anchor the post into the ground
  3. a tapered end to help with driving the post into the ground
  4. ribs to resist buckling, and
  5. certain specific dimensions.

These additional features were all separately known features of prior art roadside posts made from materials other than sheet spring steel. In issue was whether the threshold for a valid innovation patent of an ‘innovative step’ was satisfied by a spring steel roadside post with any of these features.

The Australian Patents Act 1990 (Cth) provides that an invention is taken to have an innovative step if it has a point of difference over the prior art that makes a ‘substantial contribution to the working of the invention’. Their Honours rejected the contention by Dura-Post that this inquiry involved first identifying the purported advance in the field of the invention and then asking whether the differences between the claims and the prior art make a substantial contribution to that advance. Instead, the Court said that the invention is defined by the claims alone and falls to be determined on a claim by claim basis.

In the context of the claimed roadside post, this meant the question was whether the claimed features (1 to 5 above) made a substantial contribution to the way the roadside post functions. The question was not whether the claimed features contributed to the claimed function of the roadside post of being elastically bendable.

Their Honours therefore affirmed the first instance decision that each of features 1 to 5 above made a substantial contribution to the working of the post and therefore were each sufficiently innovative to sustain valid patent protection.

What does this mean?

The Full Court has confirmed that it is difficult to successfully challenge the validity of an innovation patent on the basis of a lack of innovative step. Even though all of the features of a claim may be known and obvious to combine together, this alone will not invalidate a claim for lack of innovative step. This places the owner of an innovation patent in a powerful position when seeking to assert its patent rights. Combined with the accelerated grant and examination procedure for innovation patents, there should be a strong incentive to file applications for innovation patents.

Overall, the decision of the Full Federal Court confirms that innovation patents are a powerful tool to rapidly obtain and enforce exclusive rights to an invention.

Today’s post is by Guest Baristas Ben Mott, Patent Attorney, Patrick Sands, Senior Associate, Melbourne and Carl Harrap, Senior Associate, of Freehills in Sydney.

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“To amend the public health service act to establish a pathway for the licensure of biosimilar biologic products, to promote innovation in the life sciences.” Amendment No. 297.

The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) to create a follow-on biologics (FOB) pathway that provides 12 years of data exclusivity for brand-name biologic drugs.

The measure passed 16 to 7, despite an earlier decree by the Obama administration that a seven-year exclusivity limit sounded good.

The committee considered several other proposals including voting down one by Sen. Sherrod Brown (D-OH), which would have provided only 7 years of exclusivity for brand name biologics.  Sen. Edward M. Kennedy (D-MA), chairman of the HELP committee, voted by proxy to support the 12-year limit.

The vote was a small victory for major biotech drugmakers, which have been pushing for a period of 12 to 14 years before generic equivalents could be approved.  Biotech companies have been pushing for a longer period of data exclusivity saying that it can take 15 years and a $1 billion to develop and market a biotech drug so they need the longer period to make back their investment.  Generic drugmakers, not surprising, would like the exclusivity period limited to five or seven years.

This is just as small step since the Senate plan could change when the healthcare bill goes to the floor for a vote. It also must be approved by the House.

So, what will the final number be for exclusivity?  Try Follow-On Blackjack.

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batellelogoBattelle Memorial Institute, an an international science and technology enterprise that explores emerging areas of science, develops and commercializes technology, and manages laboratories, is offering a seminar on medical device development through it’s Life Science Solutions division.

What: Medical Device Development 101 Seminar

Who: Presented by BIOSTART

Where: Health Foundation of Greater Cincinnati
3805 Edwards Road Cincinnati, OH 45209

When: 1:00pm to 6:00pm on Tuesday, August 4, 2009.

RSVP: by Friday, July 24th to Diane Dunivant, BIOSTART, at 513.475.6610 or ddunivant@biostart.org

Come and learn how Battelle’s unique integration of science and technology delivers innovative life science solutions.  A networking reception is included.

Get the flyer here (pdf).

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The recent (and ongoing) scare about swine flu has invited queries about the arrangements which governments have in place to deal with outbreaks of epidemic diseases in their populations. Many governments, including Ireland, have agreements in place with pharmaceutical companies to produce and supply anti-viral or other appropriate treatments within a certain time-frame.

The usual trigger for such agreements to kick into effect is the elevation of the particular illness to “pandemic” status by the WHO. Swine flu was declared a pandemic by the WHO on 11 June 2009. This contractual route appears to be the most appropriate way of dealing with the problem.

However it is also worth noting that many governments have made provision in their patent laws to side-step the patents which might apply to protect pandemic treatments, in order to enable them to deal with a crisis effectively including by arranging to produce medical treatments themselves. While there is currently no proposal to invoke such provisions in Ireland,  it is likely to be impractical for the government to invoke such provisions and could risk damage to the State’s relationships with pharmaceutical manufacturers.

Part V (Sections 76 – 78) of the Irish Patents Act 1992 (as amended) permits the use of inventions “for the service of the State”. This is separate to the compulsory licensing provisions under Part IV of the Act, which can also be invoked by any Minister of Government as well as by private parties. Section 77 provides an express exemption to the government or any of its Ministers to do “for the service of the State” certain acts which would otherwise amount to an infringement of a patent: they may (a) make, use, import or stock any product which is the subject-matter of a product patent or which is obtained from a process patent, or may sell or offer that product for sale; and (b) supply or offer to any person the means for putting the relevant invention into effect.

These provisions would extend as far as to permit the government to parallel-import medicines from outside the EU, notwithstanding patent rights which might normally be relied upon to prevent such importation. “Service of the State” means, simply, a service financed out of government funds. In other words, if the State pays for the product, then the State will be deemed to be using the invention which is represented by the product for the “service of the State” and so will meet the pre¬condition imposed by Section 77. The State does not need to show that there is some underlying immediate social need or emergency to able to rely on the exemption. Section 78 specifies certain express uses which the State is entitled to make of the relevant product, for example for “the maintenance of supplies and services essential to the life of the community”, but these are additional provisions only, and the use of the general power in Section 77 is not dependent on them.

However, the government is not entitled to a free ride under Section 77. Instead, the relevant government minister who is invoking the provision must agree licensing terms with the patent proprietor, either before or after the use of the patent by the State has occurred. If terms cannot be agreed, the matter must be referred to the Irish High Court, who in turn may appoint an arbitrator to determine the dispute.

Unfortunately, Section 77 does not lay down any particular matters for the Court/arbitrator to consider in determining an appropriate level of compensation for the proprietor or any other terms, save that they can take account of any benefit or compensation which the proprietor may have already received (directly or indirectly) from the State.

There are also a few interesting add-ons to Section 77:  in any Court proceedings to adjudicate disputed terms, the Government is entitled to put the validity of the relevant patent in issue and to apply to have it revoked; also, if the Government no longer requires the relevant products, it may sell off its extra stock and any subsequent purchaser of the product cannot be attached for patent infringement for dealing in those products.

What is interesting (and probably ultimately limiting) about the provisions is that they make no reference to medicinal product licensing rules. Arguably, therefore, any medicine imported into the State in reliance on Section 77 would still require a marketing authorization which was valid for Ireland. Ireland’s marketing authorization legislation does not exempt the State from these rules nor does it make any provision for the State to side-step those rules.

At best, the government would be forced to rely on exemptions permitting named-patient supply under individual prescriptions issued by doctors on a patient-by-patient basis, which would not seem to be very satisfactory. Further, the State would still be liable to purchase the products in compliance with public procurement rules, which would seem odd given that there is an underlying assumption (at least politically) that the provisions should only be used to deal with emergency situations or exceptional circumstances.

There is an individual defense available to patent infringement claims under Section 42(c) of the Patents Act 1992 (as amended) which permits pharmacies to prepare individual treatments for patients on foot of a doctor’s prescription. This mirrors the exception in the marketing authorization legislation for unlicensed medicines to be supplied to named patients under an individual prescription. However, Section 42(c) is unlikely to provide a basis for a widespread, strategic approach by the government for dealing with a pandemic outbreak, unless it was confident of individual pharmacists’ abilities to make up complicated treatments, which they are highly unlikely to have the facilities or expertise to do.

(via Philip Lee Solicitors, Dublin, Ireland)

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The saga of the PTO’s rulemaking authority continued on March 20, 2009 when the Federal Circuit issued its 55 page decision in Tafas v. Doll holding that aside from the rule limiting continuations, the other rule changes were procedural in nature and the PTO does have the rule-making authority to implement the rules limiting the number of claims in each application, providing for Requests for Continued Examination (RCEs) and requiring Examination Support Documents (ESDs).

Now, an eleven member en banc panel has voted to rehear the case en banc. Tafas v. Doll, 2008-1352 (Fed. Cir. 2009)(Order, per curiam). In its en banc order, the Federal Circuit vacated the panel decision, set up a briefing schedule and said it would announce an oral argument at a later date.

Two of the new rules, Final Rule 78 and Final Rule 114, pertain to continuation applications and requests for continued examination (“RCEs”) and were issued – according to the USPTO — to address the “large and growing backlog of unexamined patent applications.”  Final Rule 75 requires an applicant who submits either more than five independent claims or twenty-five total claims to provide the examiner with information in an examination support document (“ESD”).  Final Rule 265, requires an applicant to conduct a pre-examination prior art search.

On one hand, the Federal Circuit said the Patent Office can make up procedural rules all it wants, saying:

[On] review of a procedural rule that has been issued by the USPTO, we will give Chevron deference to the USPTO’s interpretation of statutory provisions that relate to the exercise of delegated authority. …

The Final Rules may “alter the manner in which the parties present . . . their viewpoints” to the USPTO, but they do not, on their face, “foreclose effective opportunity” to present patent applications for examination.

On the other hand, it agreed with the district court finding that Final Rule 78’s requirement for the third and subsequent continuation applications was inconsistent with the text of 35 U.S.C. § 120, saying:

Thus, Rule 78 is invalid because it attempts to add an additional requirement—that the application not contain amendments, arguments, or evidence that could have been submitted earlier—that is foreclosed by the statute.  Because the statute is clear and unambiguous with respect to this issue, the USPTO’s reliance on Chevron and Brand X is unavailing.

It’s not clear why the Federal Circuit is revisiting the case en banc.  It could be to clarify the groundrules for procedural rulemaking.  It could be to reverse itself on Rule 78.  Either way. look for additional rounds of briefing.

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Earlier, the Australian courts were asked consider the meaning of “the filing date of the complete application” in clause 2.2(1A) of the Patents Regulations 1991 in the context of a divisional application. (Mont Adventure Equipment Pty Limited v Phoenix Leisure Group Pty Limited [2008] FCA 1476)

In the case at hand, the Applicant, Mont Adventure, filed a complete application for a standard patent. On 22 November 2006 and with the aim of obtaining immediate patent rights to commence infringement proceedings against the Respondent, Mont Adventure filed a complete application for an innovation patent as a divisional application of the standard patent application and also filed request for expedited examination.

Prior to filing the standard patent application, Mont Adventure’s products were offered for sale to the public.

Section 24(1)(a) of the Patents Act provides a grace period if there was a publication or use of the invention within 12 months before the filing date of the complete application.

The issue before the court was whether for the purpose of determining the validity of the Innovation Patent, the filing date of the complete application within the meaning of clause 2.2(1A) of the Patent Regulations was:

(a) the filing date of the complete application for the Standard Patent Application; or
(b) the filing date of the complete application for the Innovation Patent?

The earlier court held that the “complete application” to which cl 2.2(1A) refers is the complete application for the Innovation Patent and therefore the information made publicly available by the sale of products could be taken into account in determining whether the invention claimed in the Innovation Patent is novel or involves an innovative step.

Now, the appeal court has upheld the patentee’s appeal. The appeal court has unanimously found that the continuation/divisional should receive the same grace period benefits as the parent application.Rest easy, continuations/divisionals can now be validly derived from a timely filed parent application.

The appeal decision can be viewed here:  Mont Adventure Equipment Pty Ltd v Phoenix Leisure Group Pty Ltd [2009] FCAFC 84 (7 July 2009).

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Teva Pharmaceuticals USA, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., is making a full-court press on getting the word out on the need for follow-on biologics.  In its “Year of Affordable Healthcare” campaign, Teva is putting put together videos to argue for generics, just as the White House is making its position known on the need for biogenerics (read: need for lower costs).

The program commemorates the 25th anniversary of the Waxman-Hatch Act which created the modern generic drugs industry and features videos that ask the “man on the street” in Washington, D.C. what they think about healthcare in the U.S.   It wouldn’t take the Amazing Kreskin to guess that people want lower healthcare costs.  It’s a thorny issue with some biotech therapies costing as much as $500,000 annually.

See more here.

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