This is the third installment on the Senate Committee for the Judiciary�s hearing on the new Patent Reform Act. This post will discuss the testimony of Ms. Kathryn L. Biberstein, Senior Vice President, General Counsel and Secretary, and Chief Compliance Officer of Alkermes, Inc. Readers can find the first four installments of this series here. Kathy Biberstein testified before the committee as a member of the Biotechnology Industry Organization (BIO), and spoke for that organization as well as Alkermes. She began by stating that many of the members of BIO are smaller companies that do cutting edge research requiring a tremendous amount of private funding. These companies rely on the patent system to ensure a return on the investment made by their benefactors. Post-Grant Review Biberstein came out against the proposed addition of the new re-examination procedure contained in the new Act. She stated that such a system

would create an essentially limitless opportunity to broadly challenge a patent administratively at any time during the life of the patent. This post-grant review provision would be a dramatic departure from domestic and international norms, casting a cloud of uncertainty over issued patents.

Biberstein voiced concern over there being no presumption of validity in the second-window, and wished for any post-grant review to include incentives to bring validity challenges closer to when the patent was granted. She also wants to repeal the inequitable conduct doctrine and ‘best mode’ requirement, in addition to having a first-to-file system and have the presumption of injunctive relief return. Apportionment of Damages Biberstein disagrees with the codification of a method to apportion damages, and wishes to retain use of the Georgia-Pacific factors. Her criticism of the “specific contribution [of a patent] over prior art” language was that it inaccurately limits the calculation of a patent’s value.

Such an approach ignores the fundamental facts that virtually all inventions are, to some degree, premised on prior art, and that many patented components are essential to the intended functionality of the overall infringing product ââ?¬â?? two facts that are particularly applicable to biotech patents.

PTO Rulemaking Authority Biberstein is not in favor of expanding the PTO’s authority to create substantive rules interpreting the patent laws. She believes that granting the PTO such power will upset the balance of the current system where Congress creates the law, the CAFC interprets it, and the PTO implements the laws. With the proposed changes, she stated that inconsistencies would abound and consequently stifle innovation. Interlocutory Appeals Biberstein finished her testimony by stating her and BIO’s concerns that the addition of an interlocutory appeal from a Markman ruling would overly burden the CAFC. She felt that adding such appeals to the CAFC’s docket could “bog down the appellate process, and hold up the underlying infringement suits for years.” She also mentioned that it would complicate litigation by littering the courts with “piecemeal appeals.” She then admitted that there was a problem with the high number of district court claims rulings being overturned, but that there must be further discussion to figure out a solution to the problem.

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