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Archive for September, 2007

Federal Circuit Imposes New Limits on Willful Infringement

Written by on Friday, September 14th, 2007

The recent opinion of the Federal Circuit in In re Seagate Technology (Fed. Cir. Docket No. 830; 8/20/07) imposed new limits on willful infringement by establishing a new standard: proof of willful infringement permitting enhanced damages now requires at least a showing of objective recklessness. 

This new standard overruled the prior standard set out in Underwater Devices Inc. v. Morrison-Knudsen, Co., 717 F.2d 1380 (Fed. Cir. 1983), which was that when a potential infringer has notice of another’s rights, he has an affirmative duty to exercise due care to determine whether or not he is infringing.

The Federal Circuit’s opinion addressed three key issues:

    1. Should a party’s assertion of the advice of counsel defense to willful infringement extend waiver of the attorney-client privilege to communications with that party’s trial counsel?  See In re EchoStar Commc’n Corp., 448 F.3d 1294 (Fed. Cir. 2006).
    2. What is the effect of any such waiver on work-product immunity?
    3. Given the impact of the statutory duty of care standard announced in Underwater Devices on the issue of waiver of attorney-client privilege, should this court reconsider the decision in Underwater Devices and the duty of care standard itself?

On the first issue, the Federal Circuit held that "as a general proposition, asserting the advice of counsel defense and disclosing opinions of opinion counsel do not constitute a waiver of the attorney-client privilege for communications with trial counsel."  However, the Federal Circuit declined to set out an absolute rule.

On the second issue, the Federal Circuit held that "an advice of counsel defense asserted to refute a charge of willful infringement" does not extend to trial counsel’s work product, absent exceptional circumstances.

On the third issue, the Federal Circuit overruled the standard announed in Underwater Devices, holding that "proof of willful infringement permitting enhanced damages requires at least a showing of objective recklessness."  The Court abandoned the affirmative duty of due care, and reemphasized that there is no affirmative duty to obtain an opinion of counsel.

 Peter Zura’s 271 Patent Blog provided a good summary of Federal Circuit opinion, as did the Patent Baristas, who also provided some additional background information on the issue, such as the Underwater Devices decision and the freedom-to-practice opinions.

So what is the significance of the opinion?

The Patent Baristas reported on the significance as follows:

The Federal Circuit has demonstrated once again that it is not afraid to effect a sea change in patent law jurisprudence in a big way. . . .

[I]t appears that Seagate signals a receding of the tide of willful infringement litigation. The decision appears to be intended by the court to make a willfulness case substantially more difficult to prove. In view of the complexity and high reversal rate on claim construction issues in patent infringement cases, how can it be argued in any but the simplest and clearest of cases (is there such a thing?) that an accused infringer knew or should have known of a strong case before litigation and adjudication? This would seem to require proof that the infringer was omniscient. Whether this logical conundrum was intended by the court or not, the effect will be to remove risk for accused infringers and shift some of the burden back to patent owners.

Clearly, the Federal Circuit used this case to impose new limits on the ability to obtain willful damages in patent infringement .  Is this a case of judicial legislating?  Or is it just  a case of the Federal Circuit correcting a prior misreading of the precedent?   

The fact that the Federal Circuit issued the opinion to coincide with the consideration of patent reform legislation in the House, which has also contemplated imposing limits on willful infringement damages, certainly is an indication that the Federal Circuit could have been influenced by the political debate going on in Congress. On the other hand, perhaps the Federal Circuit really did believe that the relevant precedent had been incorrectly decided, and that this alone prompted the Court to overturn the precedent. 

Somehow I am not quite convinced.  Are you? 

Biogenerics Legislation To Be Tabled in 2007

Written by on Thursday, September 13th, 2007

Biogenerics legislation will likely be tabled until 2008, reported the Kaiser Daily Health Policy Report.

According to the Kaiser Daily Health Policy Report:

Rep. Henry Waxman (D-Calif.) in a speech before the Generic Pharmaceutical Association on Thursday said legislation (HR 1038) that would allow FDA to approve generic versions of biotechnology drugs is unlikely to reach the House floor this year. . . .

Waxman said that although “enormous strides” have been made since he introduced the measure in February, scheduling issues would prevent the bill from being included in House legislation (HR 2900) that would overhaul FDA and reauthorize prescription drug user fees. Waxman tried to attach the generic biotech measure to the FDA overhaul bill in July but was unsuccessful.

The biotech industry can breathe a sigh of relief.  With the battle over patent reform legislation looming ahead this fall, biogenerics is one fight that the industry will not have to take on this year.

Patent Reform Bill Passed in House

Written by on Sunday, September 9th, 2007

The House passed its Patent Reform Bill on Friday with a 220-175 vote, reported the San Jose Mercury News.

According to the Mercury News, the passage of the Bill was in part due to a push by Democratic leaders, including Speaker Nancy Pelosi.  Sixty Republicans also supported the Bill, including Republicans in districts with large concentrations of high tech companies such as California, Virginia, and Texas.  The Senate plans to take up a similar bill this fall.

The passage of this Bill in the House is viewed as a victory for the high technology industry, but that victory comes at the expense of the biotech industry, which has not supported patent reform.

Ephraim Schwartz of InfoWorld reported on the differing views of the two industries last week:

One of the significant changes in the [Patent Reform] Act addresses the apportionment of damages clause. . . .

Because the high tech industry is built on thousands of small patents while the pharmaceutical industry typically would have one or two patents that covers years of research, pharmaceutical companies would like to see awards kept high to discourage patent infringement while high tech companies hope that by limiting damages it will also limit the huge number of so-called nuisance suits these large companies receive year in and year out.

Jim Greenwood, the President and CEO of the Biotechnology Industry Organzation (“BIO”), issued a press release on behalf of the organization expressing disappointment with the House vote.  The text of that press release stated as follows:

BIO appreciates the continued efforts by the House to improve the Patent Reform Act, but unfortunately cannot support the legislation passed today as it threatens continued biotechnological innovation.  We welcome improvements to the U.S. patent system, particularly those that increase patent quality, increase public participation, and provide additional resources to the Patent and Trademark Office (PTO).  However, the legislation that passed the House today and the legislation currently pending in the Senate do far more harm than good to our nation’s patent system.

While we are disappointed that the legislation passed the House, we were heartened that it did so narrowly and that there was strong bipartisan opposition to the bill.  This opposition demonstrates the serious concern of varied stakeholders — across many industries, research institutions and other interests — with the bill and the need for a more consensus-oriented approach to patent law reform.We look forward to working with the Senate to improve upon this legislation, particularly with respect to provisions relating to damages, inequitable conduct reform, post-grant review proceedings and PTO rulemaking authority.”

There is no word yet as to the official reactions to the House vote by our California biotech industry organizations, BIOCOM and Bay Bio, but their reactions are likely to be very similar to those of their national counterpart.

What will happen with patent reform when the Senate takes up its bill this fall?  We are likely heading for some heated debate.   The California Biotech Law Blog will keep you posted on the developments.

Category: Biotech Legislative Developments  |  Comments Off on Patent Reform Bill Passed in House

Kristie Prinz Interview with Dow Jones Marketwatch on Patent Holding Companies, Patent Reform

Written by on Thursday, September 6th, 2007

Dow Jones Marketwatch Reporter John Letzing recently interviewed me regarding patent holding companies and the subject of patent reform generally.  While the interviews focus more on the high tech industry than the biotech industry, I think that my blog readers will want to read the articles, as  John did an excellent job in addressing the issues.

Speculator of Mundane Patents Casts a Long Shadow

Lawmakers Take Aim at Patent Speculators

Category: Biotech Blog in the News  |  Comments Off on Kristie Prinz Interview with Dow Jones Marketwatch on Patent Holding Companies, Patent Reform

Congress To Consider SBIR Funding Increase

Written by on Wednesday, September 5th, 2007

Congress is set to consider an increase to SBIR funding, according to a recent report by Mass High Tech: The Journal of New England Technology.

Sen. Evan Bayh, D-Ind., introduced the legislation, which would increase from 2.5 to 5% by 2013 the amount that federal agencies with large research and development budgets would have to set aside for SBIR funding.

Mass High Tech: The Journal of New England Technology reported on the significance of the SBIR program as follows:

The SBIR program — which doled out $1.9 billion nationwide in 2005 — is a major source of federal funding for early-stage technology development in the United States. The grants are used to explore the feasibility of technologies sought by government agencies, including the U.S. Department of Energy and the U.S. Department of Defense.

Supporters of the SBIR budget increase include biotechnology executives who argue that the funding fills the gap left by declining venture capital investment in the early-stage firms.

Of course, the article points out that the debate on the legislation will likely focus on the role of venture capital firms, since companies majority-owned by large venture-capital backed firms do not qualify for SBIR awards.

The SBIR program is currently set to expire in 2008.

Read the rest of this entry »

Category: Biotech Legislative Developments  |  Comments Off on Congress To Consider SBIR Funding Increase

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