IP Law Alert : Intellectual Property Lawyers & Attorneys : Gibbons Law Firm : Copyrights, Patent Infringement, Unfair Competition

Recently certain members of the patent law bar have expressed surprise that the Federal Circuit has used the written description requirements of 35 U.S.C. §112, first paragraph to invalidate patents such as the University of California’s patent directed to insulin in Regents of the University of California v. Eli Lilly & Co., and Genentech’s patent directed to production of human growth hormone in Genentech, Inc. v. Novo Nordisk A/S. This issue has come to the forefront again in Ariad’s pending per curiam appeal from the Federal Circuit decision in Ariad Pharms., Inc. v. Eli Lilly & Co., vacated and rehearing en banc granted. Oral argument in the case was held on December 7, 2009. In the case under appeal, the Ariad patent was held not to meet the written description requirements of 35 U.S.C. §112, first paragraph.

The surprise of the patent bar to the Federal Circuit’s use of this written description requirement and the dual nature of this requirement to invalidate patents reminds me of the exclamation of the police chief in the movie Casablanca, upon being handed his winnings from roulette, “I’m shocked, shocked to find that gambling is going on here.” Written description and the dual requirements of 35 U.S.C. § 112 first paragraph for written description have been the bulwark of United States prosecution, especially interference practice for at least 35 years.

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Several bills are currently pending in Congress establishing expedited marketing approval pathways for biosimilar drugs. The proposed pathways are analogous to the pathway for small molecule chemical drugs established by the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act includes a data exclusivity provision whereby the FDA is prohibited from approving a competitor’s drug application relying on the innovator’s data for a statutory period of time. Recent debates concerning the biosimilar bills have focused on the data exclusivity period. These debates highlight the differences between biological drugs and small molecule chemical drugs and why a longer exclusivity period may be necessary to fill the “patent protection gap.”

Debate on Data Exclusivity Period

Under the Hatch-Waxman Act, a five-year exclusivity period is permitted for a new chemical entity. A three-year exclusivity period is permitted for new clinical investigations of small molecule drugs and other exclusivity periods are granted as incentives to develop drugs for children or small patient populations. With regard to biosimilars, proposals on data exclusivity terms have ranged from no exclusivity period to over 12 years. House bill H.R. 1427 sponsored by Representative Henry Waxman provides for five years of exclusivity while H.R. 1548 sponsored by Representative Anna Eshoo provides for an exclusivity period of up to 14.5 years. An FTC report questions whether any data exclusivity period is necessary, suggesting that existing patent protection and market-based pricing would offer sufficient incentive for biological drug development. The Biotechnology Industry Organization (BIO) counters that the FTC’s report failed to account for the advantage given to follow-on companies who rely on the innovator’s development and research work. In addition, BIO also notes that reliance on patent protection for biological drugs may be inadequate since the biosimilar regulatory approval pathway creates a “patent protection gap.”

Patent Protection Gap

According to BIO, a “patent protection gap” exists because a biosimilar drug is not required to be the “same” as the innovator drug. Representative Waxman’s bill requires only that the biologically similar drug have “no clinically meaningful differences between the biological product and the referenced product would be expected in terms of the safety, purity and potency if treatment were to be initiated with the biological product instead of the referenced product.” In other words, if the biosimilar drug is shown to have no “clinically meaningful difference” when compared to the innovator drug, it can theoretically gain approval even though the biosimilar drug may be different in structure, administration, or mechanism of action.

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The Federal Circuit’s recent decision in Therasense, Inc. v. Becton, Dickinson & Co., No. 2008-1511 (Fed. Cir. Jan. 25, 2010) held that applicant’s statements made in proceedings before foreign patent offices may be required disclosures in prosecution before the USPTO (“PTO”), particularly when those statements directly contradict other statements made during prosecution. From the court’s holding: “An applicant’s earlier statements about prior art, especially one’s own prior art, are material to the PTO when those statements directly contradict the applicant’s position regarding that prior art in the PTO.”

The Therasense case involved U.S. Pat. No. 5,820,551, for a strip electrode used to measure the level of glucose in blood. The ‘551 patent is related to an earlier U.S. patent and its European counterpart. The statement “Optionally, but preferably when being used on live blood, a protective membrane surrounds both the enzyme and the mediator layers, permeable to water and glucose molecules” appeared in the specifications of all three patents.

In 1993, the European patent was revoked in an opposition proceeding based on a German reference. In a successful appeal to withdraw the revocation, the patentee distinguished the patented invention’s “optionally, but preferably” membrane requirement from the German reference, which required a membrane.

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Last month, ICANN announced that its Board had approved changes to the Rules for the Uniform Domain Name Dispute Resolution Policy (“Rules”) providing for electronic filing of UDRP documents. Under the modified Rules, electronic filing will become mandatory effective March 1, 2010.

Both the World Intellectual Property Organization (“WIPO”) and the National Arbitration Forum (“NAF”) were quick to implement the paperless filings. WIPO began accepting paperless filings on December 14, 2009. The WIPO eUDRP procedures are explained in its new Supplemental Rules, Model Complaint and Filing Guidelines.

Similarly, the NAF began accepting paperless filings on December 29, 2009. The NAF has an opt-in form for parties to elect to participate in its paperless filing program prior to the mandatory eUDRP launch this coming March. NAF’s procedures are explained in its new Supplemental Rules, and it has prepared a new transmittal sheet for use in commencing a paperless proceeding.

Overall, the change to eUDRP is likely to be seen as a welcome improvement. In addition to being greener, eUDRP may further streamline resolution of UDRP proceedings. In fact, WIPO recently announced that its first eUDRP proceeding was resolved in just 37 days, and that user reactions to the new paperless procedures have been “highly positive.” We welcome comments on your experiences using the new eUDRP procedures.

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