This website is an attempt to help reignite broader recognition of the full value of intellectual property. Much criticism has been levied against the usefulness of intellectual property and its place in our new economy, but there are those among us who continue to recognize the wisdom of maintaining strong intellectual property protection for worthwhile contributions that “promote the progress of science and useful arts.”

AwakenIP is also attempting to maintain the most comprehensive online resource of all information related to the Bilski case.

I wanted to give a shout out to AwakenIP since Jeff’s original website, KuesterLaw (launched in March of 1995), was the inspiration for my starting Patent Baristas.

Good luck, Jeff.

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Introduction of a new time limit for filing divisional applications

Up until now, a divisional application could be filed relating to any pending earlier European patent application at any stage of the grant procedure of this earlier application. Amended Rule 36(1) restricts this possibility by introducing a new time limit to file a divisional application.

From 1 April 2010, a divisional application can be filed within a time limit of 24 months starting from either the first official communication issued by the Examining Division in respect of the earliest application for which a communication has been issued (so-called “voluntary” division) or from any communication in which an objection of a lack of unity has been raised for the first time in respect to the earlier application. The former condition relying on the pendency of the earlier application shall still apply.

Regarding the European applications for which these time limits have already expired or will expire before 1 October 2010, a transitional period is provided until 1 October 2010 for filing divisional applications.

Multiple independent claims in the same category at the Search stage

The EPO usually raises an objection against applications comprising multiple independent claims in the same category (product, process, use, apparatus) during the Examination phase of these applications.

With the introduction of the new Rule 62bis, a similar objection is likely to be raised earlier in the procedure, before the issue of the European Search Report. The applicant will have two months to indicate the claims which should be the subject of the search or to file observations against this objection.

If the applicant fails to respond or to provide convincing arguments, the search will be carried out on the first independent claim in each category. The Examining Division will later invite the applicant to limit the claims to the searched claims, unless the Examining Division finds that the former objection was not justified.

Difficulties in performing a meaningful search

At present, when the Search Division considers that it is impossible to carry out a meaningful search into the state of the art on the basis of all or some of the subject-matter claimed, for instance in the case where claims lack of clarity, it shall either issue a reasoned declaration to that effect or draw up a partial search report. With the modified Rule 63, the Search Division will first invite the applicant to indicate the elements which should be searched within a period of two months. If the applicant fails to respond or to provide convincing arguments, the old procedure will be applied.

The applicant is therefore given a chance to indicate the object which should be searched in his view, before the EPO performs the search.

Compulsory response at an earlier stage of the procedure

It is currently advised, but not compulsory, to respond to the search report issued by the EPO with a written opinion. Without any response from the applicant, the Examining Division generally merely refers to the written opinion in its first official communication. In the case of EURO-PCT applications, the current rules do not require a response to the communication under Rule 161 issued shortly after the entry into European phase in order to allow the applicant to amend the claims to be examined by the EPO.

According to new Rule 70bis, it shall be compulsory to respond to the European Search Reports from 1 April 2010 if the written opinion contains objections. Such a response shall have to be made within either the time period for requesting the examination (6 months from the publication of the European Search Report) when examination has not yet been requested or within the period specified by the EPO for confirming the examination request when the examination has already been requested.

The modification of Rule 161 makes it also compulsory to respond to the objections raised during the international phase, when the EPO has acted as the administration in charge of the international search or the international preliminary examination, within a period of one month. This rule shall apply to applications for which a communication according to Rule 161 is issued after 1 April 2010.

These modifications will result in an acceleration of the grant procedure by, on the one hand, equating the EPO written opinion attached to the search report with a first official communication and, on the other hand, imposing a compulsory response to the first communications issued by the EPO, be it for direct EP applications or for EURO-PCT applications.

Restricted possibilities to amend the European application

In conjunction with the establishment of a compulsory response to the search report, Rule 137 (relating to the amendments of the European patent application) will undergo substantial changes from 1 April 2010 on.

A single opportunity will be left to amend the application in response to the Extended European Search Report according to amended Rule 137(2). Any other amendments will need the consent of the Examining division according to amended Rule 137(3). Opportunities to amend the application are therefore reduced when compared with the current practice.

Moreover, the applicant does not have until now any obligation to indicate the basis for amendments in the application as filed. With amended Rule 137(4), it will become compulsory to identify the introduced amendments (for instance by striking out the deleted parts and underlining the added parts) and to indicate the basis for these amendments in the application as filed. The Examining Division shall otherwise invite the applicant to provide these indications within a period of one month. The application shall be deemed to be withdrawn in the absence of any response to this invitation.

Amendments regarding the fees collected by the EPO

From 1 April 2010, the amount of most of the fees collected by the EPO shall be increased by 5 %. Moreover, with the amendment of Rule 64, a time limit of two months (and not any longer one month) will be granted to pay any additional search fee(s) in cases where the search division considers that the claims lack of unity and issues a partial search report.

New version of the EPO Guidelines for the Examination

The EPO has also published on its website a draft version (in English only) of the new Guidelines applicable as of 1 April 2010.

(via Cabinet Plasseraud)

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I’m not a district court decision junkie: since most patent cases revolve, at least in part, around claim construction, and since under Cybor the Federal Circuit reviews claim construction de novo, I tend to ignore many district court decisions – why bother getting into a claim construction-based case before the Federal Circuit has had its say on claim construction?  This case, however, Cancer Research Technology, et al. v Barr Laboraties et al. (really Schering v Barr) dealt with the question of prosecution history laches and inequitable conduct.  The i.c. part is primarily of interest to people practicing in the pharma and biotech fields, where patent applications are usually filed before extensive laboratory and clinical testing of compounds has been carried out.  The laches part is of greater general interest, although less so under the 20-years-from-filing regime.

At issue was US 5,260,291, directed to tetrazine derivatives and their use in treating various cancers.  The patent covers the compound temozolomide, which Schering markets under the name Temodar^® for the treatment of two types of brain cancers, glioblastoma multiforme and refractory anaplastic astrocytoma.  As explained in the ruling, the story started in the early 1980’s, when some researchers at Alston University in England developed some tetrazine derivatives and, in conjunction with UK pharmaceutical company May & Baker, began testing these for use against various cancers.  A priority application was filed in England in 1981; a US application, 06/410656, claiming priority to the UK application was filed in 1982.

A first OA was mailed November 18, 1983, in which the Examiner rejected the application for lack of utility, asserting (on the basis of an MPEP section that has long since been supplanted) that it was necessary for the application to include data showing efficacy of the compounds in humans, but that the application lacked such data.  Rather than file a substantive response, the applicants filed a continuation on March 6, 1984 and let the parent case go abandoned.  In October 1984 the same examiner made the same rejection against the continuation application, and again, the applicants didn’t respond, but instead filed another continuation and let the parent case go abandoned.

Although at various points in time the representatives before the USPTO changed, this pattern of rejection-for-lack-of-utility followed by non-response-file-a-continuation repeated itself.  Again.

And again.

And again.

And again.

All in all, over the course of ten years, the applicant filed ten continuations before it filed a substantive response to the lack-of-utility rejection, in February 1993.  And what was the substance of that substantive response?  That according to a 1986 BPAI decision, Ex Parte Krepelka, the applicants didn’t need to provide data showing efficacy in humans, and the animal test data already present in the application was sufficient.  In response, the examiner mailed a Notice of Allowability, and pointed to a 1987 journal article by one of the inventors that showed that some of the compounds were active against tumors in mice as further evidence of utility.

The ‘291 patent issued in November 1993, 11 years after the first application in the chain had originally been filed, entitled to 17 years of term from grant.  It then lay dormant until 2007, when Barr filed an ANDA and CRT/Schering sued.

At trial Barr stipulated to infringement of the asserted claims, but argued that the patent should be unenforceable due to prosecution history laches, i.e. unreasonable delay in prosecution by the applicants.  Judge Robinson accepted this argument, in the process rejecting CRT’s assertion that it hadn’t substantively responded because the examiners required human trial data, which was unavailable.  Judge Robinson ruled that not only was there no explanation given for the delay, but that the response actually filed in 1993 was based on a 1986 BPAI decision which itself invoked a 1969 CCPA decision.  Thus much earlier in prosecution, the applicants could have presented plausible arguments asserting that human test data was unnecessary, and at least made a reasonable attempt to advance prosecution of the case.  From the evidence adduced at trial, the only reason apparent to Judge Robinson for the prolonged delay was to enable CRT to find a strategic partner with which to commercialize the invention.  That was not a good enough reason.  Thus, said the Judge, the patent is unenforceable for prosecution laches.

The groundbreaking part of the decision dealt with the question of intervening rights.  In previous cases of prosecution laches, the defendants had relied on the long delay in prosecution – at a time when US patent applications were kept secret until they actually issued – to develop a business; in the words of the case law, the defendants had “intervening rights”.  CRT/Schering argued that Barr (nor anyone else) had developed such intervening rights here, and therefore Barr was not entitled to the relief sought.  Judge Robinson disagreed: the seminal CAFC cases dealing with prosecution laches, the 2002 and 2005 Symbol Technologies v Lemelson cases, did not impose a requirement for intervening rights to exist in order for a patentee to be guilty of prosecution laches.  Put differently, laches is wholly dependent on the applicant, and has nothing to do with whether or not third parties are in fact adversely affected by the applicant’s delaying tactics.

If upheld on appeal, this aspect of the decision could have adverse effects for parties with patents that issued on pre-June 1995 applications and that are thus still in force.  In principle it could also affect patents filed after June 1995, although presumably the fact that it was known to the applicants that those patents would be subject to a 20-years-from-earliest-filing term induced them to avoid delaying the grant of their patents.

With regard to inequitable conduct, the decision doesn’t break new ground, but it does serve as a reminder to practitioners in the life sciences to be in touch with the inventors through prosecution and continually remind them of their duty to disclose relevant information – and not necessarily just prior art.  The issue here was that the application specifically identified and claimed about a dozen compounds as being “particularly active” against lymphomas and leukemia, and described those compounds as being “important individual compounds” of the disclosed genus, and even describing three of them as being “of particular importance”.

The rub was that research by at least one of the inventors in the late 1980’s, while the application was still being kept alive at the USPTO, showed that, in fact, some of those compounds weren’t active.  Such inactivity per se wouldn’t have been fatal, had the applicants then scaled back the scope of the claims to cover only the active compounds.  But they didn’t: they pressed on with the broad claims and claims on the now-known-to-be-inactive compounds.  Which meant that the data showing inactivity was highly material to patentability: when an examiner says your claims lack utility, and you have data that shows he’s right, that data is going to be of interest to him.

Turning to the second prong of the inquiry, intent to deceive the USPTO, Judge Robinson inferred this on the part of the inventor on the basis of the fact that during prosecution of the patent he had published more than 40 papers on tetrazine derivatives, including papers showing the inactivity of some of the compounds, yet didn’t see fit to provide this information directly the USPTO.  She also noted that one of the attorneys involved in prosecuting the case testified that he would have explained to the inventors their duty to disclose, and that in any event the inventor had signed a declaration stating that he was aware of the disclosure requirement.

Having found both high materiality and intent, the finding of i.e. was inevitable.  Whether or not this part of the decision will hold up on appeal will hinge in no small part on the CAFC judges assigned to the case.  Reading the district court decision, it’s not clear that the inventor intended to deceive the USPTO.  There were several changes of attorneys during the long prosecution of the ‘291 patent, both in the U.S. and in England, and it seems likely that the inventor may not have know that patent prosecution was ongoing and even if he did, that he didn’t realize he had a duty to disclose the negative test results to the USPTO.

Irrespective of how the CAFC holds on the inequitable conduct question, it’s clear that practitioners need to stay in contact with the inventors during prosecution, advising them that if newly-gathered data impacts the patentability of the pending claims (e.g. shows that the claimed invention lacks utility, at least across its full breadth), that information may need to be reported to the USPTO.  Then again, more often than not, negative data developed along the way leads to an abandonment of the application or diminution of the scope of the claims, so not it’s not clear that facts analogous to those of the present case will repeat themselves anytime soon.

Today’s post is by Guest Barista Daniel J. Feigelson in Israel and was first published in his America-Israel Patent Blog.

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Taking the Federal Circuit at its literal word, some counsel have concluded that a client no longer needs to obtain a formal opinion of counsel upon learning of a patent that raises infringement concerns.  Recent cases show, however, that the failure to obtain an opinion of counsel, while no longer providing a de facto automatic ground for finding willful infringement, still weighs in the analysis of whether infringement was willful, and may heavily influence a trial court’s decision on whether to enhance damages should a jury find willful infringement.

(a) Impact of the Failure to Obtain an Opinion of Counsel on Determining if the Infringement was Willful

Enhancing damages for willful infringement involves a two-step process.  First, the fact finder, either the jury or the district court, must find that the infringing conduct rose to the level of being “willful infringement.”  Second, after considering the totality of the circumstances, the district court must determine whether, in its discretion, the damages should be enhanced, and if so to what degree.

In analyzing the first prong, i.e., was the infringement willful, the fact-finder applies the standard of willful infringement set forth in Seagate. Under this standard, the “patentee must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.”  Second, “the patentee must also demonstrate that this objectively-defined risk . . . was either known or so obvious that it should have been known to the accused infringer.”

Post-Seagate, some district courts have held that the presence or absence of an opinion of counsel has little relevance to whether there was an “objectively high likelihood” of infringement.  While the presence or absence of an opinion of counsel may not bear on whether there was or was not an objectively high risk of infringement, the reasoning contained in an opinion of counsel can be evidence to show there was no objectively high risk of infringement.  Seagate, 497 F.3d at 1374.  The absence of an opinion of counsel, however, has relevance to the second prong of Seagate’s standard, i.e., whether the accused infringer should have known of the high risk of infringement.  For example, denying an accused infringer’s motion in limine seeking to preclude the patentee from telling the jury that the accused infringer had not obtained an opinion of counsel, one court stated “that nothing in Seagate forbids a jury to consider whether a defendant obtained advice of counsel as part of the totality of the circumstances in determining willfulness[.]”

The Eastern District of Texas has denied an accused infringer’s JMOL motion seeking to overturn the jury’s finding of willful infringement, in part, “because it was undisputed at trial that Defendant chose not to obtain an opinion of counsel, aside from the informal investigation conducted by [its in-house counsel], [and] the jury could have taken this fact into account in determining that Defendant willfully infringed.”  The district court expressly stated that “the lack of opinion of counsel is one factor of many that the jury could have taken into account in determining whether Defendant willfully infringed.”

Even in Seagate, the Federal Circuit instructed that “[a]lthough an infringer’s reliance on favorable advice of counsel, or conversely his failure to proffer any favorable advice, is not dispositive of the willfulness inquiry, it is crucial to the analysis.”  Additionally, the Seagate court’s instruction that “standards of commerce” are factors that the district courts must consider in the willfulness analysis, allows for the possibility of finding willful infringement where an infringer fails to obtain an opinion of counsel under circumstances where a reasonable prudent business person would have sought an opinion of counsel.

The foregoing shows that failing to obtain an opinion of counsel creates evidence that a patentee can present to the jury to support a claim of willful infringement.  On the flip side, the Federal Circuit has instructed that “a competent opinion of counsel concluding either that [the accused infringer] did not infringe the [asserted] patent or that it was invalid would provide a sufficient basis for [the accused infringer] to proceed without engaging in objectively reckless behavior with respect to the [asserted]  patent.” Thus, where an accused infringer presents evidence that it obtained and relied in good faith on a competent opinion of counsel that evidence can defeat a patentee’s efforts to prove willful infringement.  Should an accused infringer obtain an opinion of counsel but choose not to waive privilege and produce the opinion, district courts have held that neither party may argue any aspects of opinions of counsel to the jury and the jury will not be instructed on any aspects of an opinion of counsel.  Spectralytics, Inc. v. Cordis Corp., 2009 WL 3851314, *4 (D. Minn. Jan. 13, 2009).

(b)     Impact of the Failure to Obtain an Opinion of Counsel on District Court’s Decision to Enhance the Damage Award

Post-Seagate opinions show that if a jury finds willful infringement, the failure of an accused infringer to have obtained an opinion of counsel can heavily influence the district court’s decision to enhance the damages.  Recently, the Federal Circuit instructed in i4i Ltd. Partnership v. Microsoft Corp., 589 F.3d 1246, 1273-75 (Fed. Cir. Dec. 22, 2009), that the factors a district court must consider in determining whether to enhance damages are “distinct and separate” from the factors the jury, or the district court if acting as the fact finder, considers in determining if the infringing conduct meets Seagate’s standard of willful infringement.  For enhancing damages, a district court considers the nine factors set forth in Read Corp. v. Portec, Inc., 970 F.2d 816 (Fed. Cir. 1992).  See i4i, 589 F.3d at 1274 (“the standard for deciding whether-and by how much-to enhance damages is set forth in Read, not Seagate”). The second Read factor addresses “whether the infringer, when he knew of the other’s patent protection, investigated the scope of the patent and formed a good-faith belief that it was invalid or that it was not infringed.”  An accused infringer’s failure to obtain an opinion of counsel may show that the accused infringer failed to adequately investigate the patent.  In i4i, for example, the Federal Circuit affirmed a 20% enhancement (amounting to $40 million) by the Eastern District of Texas court in the damage award where the district court found that the accused infringer, after learning of the patent, failed to obtain an opinion of counsel before continuing with its accused activity.  Id. at 1274-75.

More recently, the district court in I-Flow Corp. v. Apex Med. Tech., Inc., 2010 WL 114005, *2 (S.D. Cal. Jan. 6, 2010), enhanced a six million dollar damage award by one million dollars predominantly because the accused infringer failed to timely seek an opinion of counsel.  The district court found that when attempting to design around the asserted patent, the accused infringer did not obtain a formal opinion of counsel, but instead relied on conclusions from its technical employees that the redesigned version of the accused product would not infringe. While the attempt to design around the patentee’s product favored not enhancing damages, the district court found that the failure to obtain an opinion of counsel until after the patentee had filed its infringement suit supported enhancing the damages.  In considering the other Read factors, the district court found that only one other factor, the closeness of the case, favored enhancing damages.  Despite that only two of the nine factors favored enhancement, the district court opted to enhance the damage award, albeit only by about 16%.

Other cases show that post-Seagate district courts give weight to an accused infringer’s failure to have obtained an opinion of counsel when deciding whether to enhance damages.  For example in Finjan Software, Ltd. v. Secure Computing Corp., 2009 WL 2524495, *15 (D. Del. Aug. 18, 2009), the court enhanced the damage award by 50% based on the accused infringer copying the patented product and failing to obtain an opinion of counsel.  In Wordtech Systems, Inc. v. Integrated Network Solutions, Inc., 2009 WL 113771, *2-*3 (E.D. Cal. Jan. 15, 2009), the court trebled the damage award based on the accused infringer’s copying of the patentee’s product and its failure to seek an opinion of counsel after being notified by the patentee of the alleged infringement.  In Minks v. Polaris Indus., Inc., 2007 WL 788418, *1-*2 (M.D. Fla. March 14, 2007), aff’d, 546 F.3d 1364, 1380-81 (Fed. Cir. 2008), the court doubled the damage award because the accused infringer “waited until it had actually been accused of infringement before investigating the issue.”

(c)      Conclusion

Today’s poor economic climate, coupled with the Federal Circuit’s pronouncement that an accused infringer does not have an affirmative obligation to obtain an opinion of counsel, may entice some corporate counsel to forego obtaining opinions of counsel as a cost-savings measure.  But relying on the Federal Circuit’s pronouncement as justification for such action may give counsel a false sense of security.

The post-Seagate cases show that a patentee can strategically use an accused infringer’s failure to obtain an opinion of counsel as evidence presented to the jury to support the patentee’s claim for willful infringement.  Furthermore, the cases show that where a jury finds willful infringement, district courts give significant weight to the accused infringer’s failure to have timely obtained an opinion of counsel in deciding whether to enhance damages.  Conversely, if the accused infringer has obtained a competent opinion of counsel, and elects to waive privilege and rely on the opinion, the opinion provides evidence to refute the claim of willful infringement.  Relying on an opinion of counsel can also provide a defense to a charge of inducing infringement by negating the element of intent.  DSU Med. Corp. v. JMS Co., Ltd., 471 F.3d 1293, 1307 (Fed. Cir. 2006).

Further, even if the jury finds willful infringement, under the Read factors, the district court should be able to consider the opinion of counsel as a factor that supports refusing to enhance damages.  Where an accused infringer obtains an opinion of counsel, but opts not to waive privilege and refuses to disclose the opinion, that decision may effectively nullify the ability of both parties to use aspects of opinions of counsel in the willful infringement analysis.  (Should a patentee also assert claims of inducing infringement, however, other considerations should be assessed in view of Broadcom.)

Thus, in today’s patent litigation opinions of counsel still serve a valuable function in defending against claims of willful infringement.  Being penny-wise and pound-foolish, potential accused infringers act at their peril in opting not to seek an opinion of counsel upon learning of a patent that raises substantial infringement concerns for a significant accused product or process.

Today’s post is by Guest Barista Robert A. Matthews, Jr., Matthews Patent-Law Consulting.and was first published in his Patent Happenings® newsletter.

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Firstly, not all prior art references are citable. Rather, in order to be citable, a prior art reference must firstly be shown to be a piece of prior art information that the skilled person could have been reasonably expected to have “ascertained, understood, and regarded as relevant”.

Notably, prior art references have been excluded from consideration because (i) the prior art reference was published a short time before the priority date of claim under consideration and was not widely available (Wrigley), (ii) the prior art reference was not in the English language (Euroceltique), and (iii) the prior art reference was not directed to solving the same problem as the problem solved by the claimed invention (Lockwood).

Secondly, since the landmark High Court decision in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59, “obvious to try” does not make an invention obvious in Australia. In that High Court decision, the standard for determining inventive step/non-obviousness was stated as follows:

“Would the notional research group at the relevant date in all the circumstances…directly be led as a matter of course to try [the invention claimed] in the expectation that it might well produce [a useful desired result].”

This meant that, in circumstances where a range of alternatives was available (this often being the case in the chemical arts), there must be evidence that the person skilled in the art would go directly to the claimed alternative for inventiveness to be destroyed.

It is widely known that moves are afoot to better harmonise Australian law with international norms via the elimination of the “ascertained, understood and regarded as relevant” prerequisite for a prior art reference to be citable. What is perhaps less well known is that the APO is quietly moving to issue rejections based on the “obvious to try” standard. We will, of course, be on the lookout for any office actions which adopt this improper approach.

Today’s post is by Guest Barista Bill Bennett of Pizzeys.

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