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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ABAReviewToday’s book review is of the Annual Review of Intellectual Property Law Developments: 2006-2008 put out by the American Bar Association (ABA) Section of Intellectual Property Law. The debut volume covers over 300 recent legal developments including Supreme Court cases, e.g., eBay, MedImmune, KSR, Quanta, and Microsoft v. AT&T; Federal Circuit en banc decisions, e.g., In re Seagate and Egyptian Goddess; and Federal Circuit decisions on business method patents, e.g., In re Bilski and In re Comiskey.

This is the first in a series of annual reviews of significant IP developments, which the ABA Section of Intellectual Property Law plans to put out. The rebel in me enjoyed the fact that this annual review covers three years worth of decisions! Presumably that’s not part of a long-term plan.

This type of volume is meant to satisfy two purposes:  (1) to provide a good quick overview to the practitioner of important recent developments; and (2) to provide an easy-to-use way to incorporate the most recent decisions into legal research. This book succeeds on both counts. The book provides good, succinct summaries of recent decisions (and even some legislative and rule-making matters), providing enough information to allow the reader to place the decision in context without suffering information overload.

The result is that it is quite easy to go from entry to entry and absorb the key points; the reader can go to the case itself if more detail is needed. The book is also very nicely indexed by subject, in outline form, to allow the researcher an easy-to-use way to get to the relevant cases. This is not a source for deep case analysis – but that is not its purpose.

My only suggestion is that the editors could consider a rating system (one to four stars?) for each case, so that the reader could see at a glance what the potential impact of a given case might be on the body of IP law.

My bottom line is that this volume is a valuable addition to the IP library. I hope that the ABA will continue this effort in the coming years.

The Annual Review of Intellectual Property Law Developments: 2006-2008 is 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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In recent years, the USPTO has been very slow to process papers when moving from the international (PCT) stage to entry into the U.S. national-stage.   It’s common to have a year or more pass before the USPTO gets around to actually looking at the national-stage papers and mailing a Notice of Missing Requirements or an official Filing Receipt.

In a review of several dozen randomly selected US national-stage application, Carl Oppedahl has identified some factors within the applicant’s control can affect the number of months of USPTO delay.

In one example US application, the national-stage papers were missing the inventor’s Oath. The USPTO did not get around to looking at the national-stage papers until seven months later, at which time the USPTO mailed a Notice of Missing Requirements. The actual completion of the US national-stage requirements happened about two months after that when the missing Oath was filed. And then … the USPTO didn’t get around to looking at the Oath until ten months later, on January 9, 2009 when the official Filing Receipt got mailed.

If the applicant does not leave out any parts, the delays within the USPTO prior to mailing the official Filing Receipt are often in the range of four to eight months. If, on the other hand, the application is missing any items on filing the national–stage papers, then the delay within the USPTO can be substantial.

So, here is the practice tip from Carl:

When entering the US national stage, it is very much to the applicant’s advantage if every possible missing requirement is eliminated. Make very sure that the Oath was on file prior to the 30-month date. Make very sure that all the correct fees have been paid prior to the 30-month date. Try to give USPTO no possible excuse at all for withholding the official Filing Receipt. Stated differently, the applicant that leaves out something important from the national-stage papers is likely to see additional delays of a year or more (in addition to the already striking delays in USPTO ‘ s handling of national–stage papers even when nothing is missing) in progress or cue application toward the examining corps.

It might be argued that it doesn’t matter since the pendency for examination can be longer than a year or two anyway. Since the Examiners take up cases based upon when the national-stage requirements were met (and not based upon when the case was released to the Examining Corps) then the applicant is not prejudiced in when the Examiner takes up the case.

While there are plenty of art units with pendency that exceeds the delays in the USPTO’s handling of national-stage papers, some art units have shorter pendencies. In such an art unit, the USPTO delays in handling national-stage papers can cut into the substantive rights of the applicant, by delaying the eventual grant of the patent.

Thanks to Carl Oppedahl of the Oppedahl Patent Law Firm LLC for the practice tip.

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