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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791L10-NYCThe American Conference Institute’s Maximizing Pharmaceutical Patent Lifecycles, the 10th Anniversary Edition will be held at the Helmsley Park Lane Hotel, New York, New York, on Wednesday, October 7, 2009 to Thursday, October 8, 2009.

Overview

This 10th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry leading conference. This year’s conference will help you prepare for the sweeping changes currently underway by providing you with:

  • Focused panels on the pending Follow-On Biologics and Patent Reform legislation that will allow you to assess how both legislative proposals will impact pharmaceutical patent life cycle management
  • Access to key officials from the FTC’s Bureau of Competition’s Health Care Division and the EC’s DG Competition’s Pharmaceuticals Task Force who will provide you with direct insights into the logic of these agencies on some of the most pressing antitrust matters currently affecting the industry
  • An in-depth review of new FDA determinations regarding exclusivity, forfeitures, patent listing and delistings and strategies for incorporating these guidelines into your initial life cycle management plan
  • Analyses of key cases that have affected patent life cycle strategies and tips for using these rulings to your advantage

Also, this year they have added the following specialized class:

Hatch-Waxman Boot Camp – A Primer on IP Basics and Regulatory Fundamentals

This Boot Camp, together with in-depth Master Classes for brand names and generics on:

  • New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World
  • Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters

will offer hands-on practical advice on core Hatch-Waxman principles as well as some of the most critical day–to–day concerns for both sides of the pharmaceutical industry.

Nearly 2,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for nearly the last ten years.

Register today to reserve your place at this timely event by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line.

Let me know if you are interested in attending, anyone who attends the conference as a referral from Patent Baristas is entitled to $200 off the registration price. Just drop me a line for the keycode.

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ABAReviewLast week’s book review was on the Annual Review of Intellectual Property Law Developments: 2006-2008, by the American Bar Association (ABA) Section of Intellectual Property Law. This week, we’re giving you a chance to get your own copy for free (reg. price: $149.95).

Through various circumstances (yes, my fault), the ABA Section sent me two copies of the Annual Review.  I offered to return my extra copy but the ABA Section told to pass along to someone in need.  Now, I’m giving everyone a shot at picking up their own copy.

For everyone to have an equal chance, my secretary will randomly select a winner from everyone who submits a new comment on the PatentBaristas.com website.  One entry per person — multiple comments will not increase your chances.  Comment spammers will be disqualified.  Entries must be submitted by midnight on Monday, July 6th, 2009, and must state a compelling reason why you should receive your own copy of the Annual Review.

There are a few, uh, provisos. Ah, a couple of quid pro quo.

We reserve the right to disqualify any entry that looks like it isn’t legitimate. The winner will be contacted at the email address entered or available on their website. Failure to respond within 5 days will result in the prize being given to someone else.  The winner must live somewhere that we can ship directly using standard shipping.

Otherwise, all of the previous iBarista iPod Giveaway Terms and Conditions still apply.  You don’t even have to vote Patent Baristas as Top IP blog.

That’s it.

Good luck.

The Annual Review of Intellectual Property Law Developments: 2006-2008 is also available in hardback from the American Bar Association and in soft cover by pre-order on Amazon.

Today’s review is by Guest Barista Steven J. Goldstein, Vice Chair for Intellectual Property at Frost Brown Todd LLC and Adjunct Professor of Law at the University of Cincinnati.

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The Obama Administration sent out a warning shot that seven years is enough time to protect brand-name biotechnology medicines from generic competitors.  In a letter to Representative Henry Waxman (D-CA), the White House set out that seven years “strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.”

In looking for a way to create an abbreviated pathway for the FDA to approve generic biologic therapies (a/k/a biogenerics or follow-on biologics), there are lots of questions about how to achieve the proper balance between innovation and competition. The sticking point (in general) has been that the brand name drugmakers and generics can’t agree on how long a biotech drug should be on the market before a generic drugmaker can market a generic.

The Biotech Industry Organization has called for 14 years of market exclusivity, while generic makers want the period limited to no more than five years of protection. Not to be confused with patents, data exclusivity is the period after the FDA approves a product during which an imitator can’t rely on the innovator’s clinical data for safety and effectiveness. It can run during and longer than the period of patent protection.

All this is not a surprise given that the U.S. government is the largest consumer of medical care via medicare and medicaid and the fact that sales of biotech drugs were $40.3 billion last year. With creating a governmental health care system at the top of the priority list, ways to cut costs will be key.

BIO President and CEO Jim Greenwood issued a statement regarding biosimilars:

The Biotechnology Industry Organization continues to support strongly the development of a pathway for the review and approval of biosimilars.

We are extremely concerned that the seven years of data exclusivity called for by the administration in the letter points to a risky short cut to biosimilars. We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS as well as unmet medical needs.

As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures. We continue to believe that fourteen years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances.

It seems that the administration based its policy on the Federal Trade Commission (FTC) report released earlier. The report, released June 11 said generic versions of expensive biotechnology drugs would reduce the amount of money spent on healthcare in the United States; however, brand-name manufacturers push for “the 12- to 14-year regulatory exclusivity period is too long to promote innovation,” particularly since brand-name companies “likely will retain substantial market share” after generic competitors are approved.  The report also found that competitors would likely enter the market only for drugs that had more than $250 million in annual sales, and only two to three generic entrants would be expected.

From the Report:

A Twelve- to Fourteen-Year Exclusivity Period is Unnecessary to Promote Innovation by Pioneer Biologic Drug Manufacturers

[P]ioneer biologic drug manufacturers are very likely to continue to earn substantial revenues even after the entry of FOBs. FOBs are unlikely to introduce their products at price discounts beyond 10 to 30 percent. Moreover, FOBs are likely to have difficulty rapidly growing their market shares as compared to generic small-molecule drug products. Indeed, projections are that branded biologic drugs are likely to maintain their first- mover advantages by retaining 70 to 90 percent of their market share years after FOB entry.

In addition, there is very little data to suggest that biologic drugs under development are likely to be unpatentable. Pioneer biologic drugs are covered by more and varied patents, including manufacturing and technology platform patents, than small-molecule branded products. Moreover, there is no evidence that patents claiming a biologic drug product have been designed around more frequently than those claiming small-molecule products.

Pioneer biologic manufacturers nevertheless have suggested that Congress institute a period of 12 to14 years of branded exclusivity that would begin once a pioneer biologic was approved by the FDA. During this period, the FDA would be prohibited from approving an FOB product that would compete with the pioneer biologic drug. This branded exclusivity would be in addition to, and would run concurrent with, a biologic drug’s existing patent protection. The economic model put forth by pioneer drug manufacturers to justify this period is based on the average time required to recoup the investment to develop and commercialize a typical biologic drug (referred to as the “Nature model”).

Central to each of these exclusivities is a public policy trade-off: a restriction on competition is provided in return for the development of a new drug product or new use of an existing product. A 12- to 14-year exclusivity period departs sharply from this basic trade-off, because it does not spur the creation of a new biologic drug or indication. The drug has already been incentivized through patent protection and market-based pricing.

The potential harm posed by such a period is that firms will direct scarce R&D dollars toward developing low-risk clinical and safety data for drug products with proven mechanisms of action rather than toward new inventions to address unmet medical needs. Thus, a new 12- to 14-year exclusivity period imperils the efficiency benefits of a FOB approval process in the first place, and it risks over-investment in well-tilled areas.

Moreover, to the extent that there are new biologic molecules that cannot obtain patent protection, an exclusivity period may be warranted. Because there is no evidence about the lack of patentability of new biologic products, nor that market forces have been insufficient to incentivize their development, the Commission has not recommended a specific length for an exclusivity period.

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Sens. Bill Nelson [D, FL] and Sen. Herbert Kohl [D, WI] have introduced a bill (s. 1315) to amend the Federal Food, Drug, and Cosmetic (Hatch-Waxman) Act to define the term “first applicant” for purposes of filing an abbreviated new drug application (ANDA) in order to give generic drug makers challenging brand-name patents an chance to get a 180-day market exclusivity.

Under the present law, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) § 505(j)(5)(B)(iv)(II)(bb) defines the term “first applicant” to mean:

As used in this subsection, the term ‘first applicant’ means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.

S. 1315 would amend the definition to:

As used in this subsection, the term ‘first applicant’ means

(AA) an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; or

(BB) an applicant for the drug not described in item (AA) that satisfies the requirements of subclause (III).’; and

(III) An applicant described in subclause (II)(bb)(BB) shall–

(aa) submit and lawfully maintain a certification described in paragraph (2)(A)(vii)(IV) or a statement described in paragraph (2)(A)(viii) for each unexpired patent for which a first applicant described in item (AA) had submitted a certification described in paragraph (2)(A)(vii)(IV) on the first day on which a substantially complete application containing such a certification was submitted;

(bb) with regard to each such unexpired patent for which the applicant submitted a certification described in paragraph (2)(A)(vii)(IV), no action for patent infringement was brought against the applicant within the 45-day period specified in paragraph (5)(B)(iii), or if an action was brought within such time period, the applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed); and

(cc) but for the effective date of approval provisions in subparagraphs (B) and (F) and sections 505A and 527, be eligible to receive immediately effective approval at a time before any other applicant has begun commercial marketing.’

In the end, this would mean that an applicant that that would have been considered a subsequent applicant subject to a first applicant’s 180-day exclusivity eligibility could now qualify as a first applicant gaining co-exclusivity of the 180-day exclusivity for all first applicants if there is no timely filed patent infringement lawsuit arising from its Paragraph IV certification, or if there is a court decision of patent invalidity or non-infringement or a substantive determination that there is no cause of action for patent infringement or invalidity.

In a related matter, the U.S. Supreme Court declined to hear the reverse payment case Arkansas Carpenters Health and Welfare Fund, Paper, A.F. of L., et al. v. Bayer AG and Bayer Corp., et al. where the Question Presented was:

Are pharmaceutical “reverse payment” agreements—whereby the manufacturer of a brand-name drug (and patent holder) pays a generic manufacturer (and alleged patent infringer) to not launch a generic version of the brand-name drug—per se lawful without regard to the amount of cash paid or the strength of the underlying patent challenge?

For now, the Supreme Court has left stand the earlier decision by the Federal Circuit upholding the district court decision granting Bayer’s motion for summary judgment, holding that any anti-competitive effects caused by the settlement agreements between Bayer and the generic defendants were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.

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A recent decision of an Australian appeal court concerning a patent for an enantiomer pharmaceutical dealt with matters of patent claim validity and patent term extension. The decision, H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, involves a decision of the Full Federal Court on rehearing an appeal by Alphapharm over an earlier decision regarding Lundbeck’s Australian Patent No. 623144 for the antidepressant drug escitalopram.

The Full Court upheld the earlier judge’s holding that the patent is valid and infringed but also upheld the finding that the term of Lundbeck’s patent was not properly extended.  As this decision may affect your Australian patents/patent applications we now summarise several key aspects of the decision.

Infringement

The initial judge had found non-literal infringement (effectively substitution of one halogen for another). This was overturned on appeal. This confirms that non-literal infringement is very rare in Australia, and therefore literal claim scope should be broader to achieve the same effective scope for infringement.

Novelty

The appeal court reviewed Australian authorities on anticipation. The issue was whether a racemate anticipated a claim that just named one enantiomer. By 2-1 majority, the court held the claim novel. There are two interesting aspects to this.

  1. There was much argument around the claim because the claim just stated the name of the enantiomer, just as some claims merely state the name of the virus or gene or protein. Where the invention is in isolation of a natural material, the judgement confirms that the claims should be drafted more specifically (e.g., “A composition comprising …”) or they risk anticipation by the substance in its native form. The dissenting judge may well have held that a composition of the substantially pure enantiomer was novel.
  2. Where a patentee argues that a prior disclosure is not enabling, the court must determine whether the prior disclosure is sufficient to enable the skilled addressee to perceive, understand and, where appropriate, apply the prior disclosure ‘necessarily’ to obtain the invention. This leaves little room for integers to be added to a prior publication for novelty purposes, even if relatively minor.

Utility

The appeal court concluded a claim to a dosage form where the compound was present in an amount from 0.1 to 100mg per unit dose lacked utility and was therefore invalid for including quantities outside of the range of 5mg–40mg shown by the evidence to be the minimum to maximum clinical dosage range. This aspect of the decision could be particularly problematic for patentees and suggests that every value in a claimed range must be useful. This ground was not however extensively discussed and may be confined to the facts of this particular case. If there is uncertainty that a range encompasses only useful values, then dependent claims with progressively narrow ranges should be included into the patent/patent application.

Patent term extension

The appeal court confirmed the original judge’s decision that an extension of the term is not available for a patent which relates to a ‘purified’ version (such as an isolated enantiomer) of an earlier ‘mixed’ or ‘impure’ pharmaceutical product (such as a racemate), where the original was also registered as a pharmaceutical.

The above is a very general summary of the most pertinent aspects of the decision. If you would like any further information relating the aspects of the decision outlined above please do not hesitate to contact us.  A more detailed analysis can be found here.

Note: The order removing the extension of term for escitalopram (Lexapro) has been delayed pending any appeal by Lundbeck to the High Court.

Today’s post is by Guest Barista James Cherry, a Partner with Freehills Patent & Trade Mark Attorneys in Australia.

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