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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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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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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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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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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