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Patent Strategies in Light of the New Rules September 21, 2008

Posted by mais in claim analysis, India, IPM Strategies, patent intelligence, USA.
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Courtsy Russ Krajec’s Anything Under The Sun Made By Man

In Patent Drafting and Claim Writing, Patent Drafting Theory, Practical Tips for Patent Drafting, Patent Strategy, Patents in Business, Business Theory for Patents, The USPTO

The latest rules from the US Patent and Trademark Office are quite sweeping.  The new rules have several facets.  On one hand, the PTO is limiting the number of continuation and continuation in part applications, as well as requests for continued examination (RCE).  On the other hand, the PTO is limiting the number of claims you can have by forcing the applicant to file an Examination Support Document if you exceed the claims.

Another twist is that the Examination Support Document may be forced where two applications are filed nearly simultaneously.  The PTO may assume that they cover the same patentable material and force an Examination Support Document unless you can prove that the applications do not cover the same material.

(As a side note, I have spoken to several patent attorneys/agents about the new rules and I have not yet found one who would even agree to write an ESD, no matter what the cost.  The reasoning is similar to why I will not file accelerated examinations.)

Each of the various requirements put on the applicant presents several problems, including the specter of patent invalidity and possibly inequitable conduct if the various support documents and petitions are not properly done.

In some situations, I used to espouse a kitchen sink approach to patent prosecution, where you load up a patent application with as many ideas as possible, get an early filing date, and file many continuation applications as possible.  This strategy can blanket an area of technology very effectively and makes the best use of early disclosure.  The strategy also could be used to tailor claims to an infringer so that lengthy and costly court battles may be averted entirely.

In view of the new rules, I think another strategy may be better suited.

This strategy is very targeted and narrow, and looks to find specific areas that may be infringed in the future, but does not include any more than it needs.

The targeted strategy is driven from the need to avoid overlapping applications and avoid the potential that a continuation application may need to be filed.

The steps are as follows:

1.  Define a very specific strategy for patent coverage over the entire scope of the technology you wish to cover.  The strategy must be driven by the current and potential business needs of the client, as well as the possible turns a technology may take.

2.  Draft a complete set of claims for each targeted area.  Each element of the claims should be carefully and thoughtfully considered for the language, the scope of coverage, any way the claims may be construed or misconstrued, how an infringer may infringe, and for how it differentiates from the known prior art.

3.  Only after the claims are completed, analyze the claims with the inventor and the business manager, reviewing the areas described in step 2.

4.  Draft a specification that addresses each and every claim and every feature of every claim, and avoid any additional material if at all possible.  Each feature must be described completely, but avoid adding other ideas that may be patentably distinct and that you may wished were a stand-alone patent.

One interesting twist to the new rules is to attempt wherever possible to force a restriction by including patentably distinct sets of claims.  Each divisional application is a separate family of applications for the purposes of continuation applications and RCEs.

The new rules may tend to force less disclosure and much more tailored specifications that may stand or fall on the first couple Office actions, rather than specifications with all sorts of material that may keep an application alive through several continuations.  This may lead applicants to perform good searches based on the claim set of step 2 prior to drafting the specification of step 4.

The net result is a shift from large, comprehensive patents that may disclose a broad range of concepts to those which are very narrow and even skeletal.  Instead of ‘promoting the progress’ by encouraging as much disclosure as early as possible, I think the new rules encourage the exact opposite.

This discussion is by nature very broad and sweeping, but based on the strategies that the new rules seem to favor.  I am sure that many situations may cause other strategies to be used within the new rules, and I will discuss them as they come up.

Making biofules at your backyard @ $1 per gallon April 29, 2008

Posted by mais in Innovation, Patent, USA.
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E-fuel 100 Microfueler developed by Floyd Butterfield and Thomas Quinn, offers the flexibility to generate biofuel (Ethanol @ $1/gallon) at your backyard. This system is compact like a washing machine and operates on sugar content and yeast. Read more on NYT coverage

Perhaps, innovative part of the system is an advance membrane distiller, which separates water from ethanol at lower heat and fewer steps than other ethanol systems

Critics flaunted the claims and said that sugar costs 20-cents per pound, and system requires 10 to 14 pounds to make a gallon of ethanol, hence it is not viable to produce ethanol But Butterfield and his Silicon Valley finance whiz/business partner Thomas J. Quinn swears you can buy “inedible sugar” from South of the Border for 2 to 3 cents per pound.

Defending a patent infringement in court – take recourse of Reverse Doctrine of Equivalents July 11, 2007

Posted by mais in IPR Laws, Litigations, Patent, USA.
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Doctrine of Equivalents was set forth by US Supreme Court in 1950 to extent the protection of patent rights to a good patent holders beyond the literal meaning of the claims i.e. literal infringement. US Supreme Court also established Function-Way-Result test with the objective to ensure the fundamental fairness to it to all.

Reverse of the doctrine is also hold good, i.e. if the claim elements did not Function is the same Way to accomplish the same Result then there would not be actual infringement under the doctrine.

Till date, neither US Supreme Court nor Federal Circuit Courts of Appeal had reversed a finding of non-infringement based on reverse doctrine of equivalence.

read more from ipfrontlines authored by Jay Sandvos

US pushes bill to promote competitive presence of generic drug manft. March 7, 2007

Posted by mais in Drugs, USA.
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The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market.

The bill brought by Senator Patrick Leahy, (D-Vt.), and supported by Senators Herb Kohl (D-Wisc.), Chuck Grassley (R-Iowa), Russ Feingold (D-Wisc.), and Charles Schumer (D-NY).

The bill aims to end the trend of anti-competitive agreements between brand name pharmaceutical companies and generic companies to delay entry of affordable generics into the market.

Today, the law can’t stop the original patent holder from launching an “authorized generic” through a subsidiary or a third party. Sales of an authorized generic during the exclusivity period can cut the generic maker’s profits by 59 percent, according to research by Merrill Lynch analyst Greg Gilbert.

On the other hand Branded drug companies are lobbying with Bush administration to impose a new fees for the drug application filed by generic drug companies

Including Claims in Provisional Patent Applications? November 14, 2005

Posted by mais in USA.
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Curtsy-Patently-O: Patent Law Blog:  discusses “Including Claims in Provisional Patent Applications?”

An ongoing debate amongst some patent attorneys is whether to include claims in provisional applications. According to the rules of practice, claims are not required in the provisional application. (MPEP 601). However, there are a few good reasons for including claims in the application.

In the wake of Phillips v. AWH, it has become even more important to ensure that a patent?s specification accurately describes the meaning of the associated claim terms. This task is all but impossible in the absence of any claim terms to describe. Thus, it is important to draft at least a few model claims with the provisional application. Some practitioners, such as Russ Krajec, have advocated drafting the claims but then deleting them from the application before filing. Russ argues that claims in the provisional can only hurt the applicant.

I disagree. The claims can be helpful in ensuring adequate disclosure and enablement ? this is especially true in cases where the provisional is rushed through on a very short deadline and/or low budget. The claims, as part of the specification, can easily tie together loose ends that may have been created in the rush. As Todd Mayover aptly points-out, including claims in the provisional creates a clear record associating those claims with the earliest filing date or priority date. It is also unlikely that patent attorneys would seriously stick to the practice of initially drafting claims that will eventually be deleted ? this is especially true in the fast-paced area of provisional applications. One newfound fear is that including claims in the provisional leaves the patentee open to Festo-type prosecution history estoppel. However, we have no evidence that presenting new claims in a subsequent nonprovisional would create any such estoppel ? especially since the nonprovisional is newly-filed rather than simply an amended version.

An astute Patently-O reader provided the following comment:

I include at least one extremely broad, never likely obtainable claim in a provisional. First under US law, it is true that a provisional need not include one in order to be considered valid. But foreign courts can say otherwise and render the US provisional (if serving as a priority document) invalid in a foreign court. Not including a provisional claim is only useful if you are absolutely certain that you won’t go foreign.

I hear the arguments related to the effect of narrowing by amendment as creating PHE. In the post-Festo world, you can at least explain the amendment so as to overcome the presumption of PHE. Let’s face it, if you are relying on the DOE to win your case anyway and the case rests on whether you started broad and narrowed by amendment, you are fighting a likely unwinnable battle. In the last 10 years or so, how many DOE cases has the Fed. Circuit actually upheld? Not too many.

No U.S. practitioner has been able to cite a case, rule, regulation, expanded Board of Appeals decision, etc. from a foreign court that has categorically said, “A U.S. provisional application serving as a priority document [to this foreign application] that does not include at least one claim is nonetheless considered a permissible priority document.” Why take the chance of not including a claim in a provisional if there is a likelihood that the foreign counterpart could get knocked out.

Another reason to the include at least a broad claim is that most foreign laws have strict adherence to the rule that the broadest initially presented claim will set the claim scope for the application. So if you present a very broad claim initially, you can amend narrower. But if you present a narrower claim first then realize that you can go broader, you cannot amend to go broader. It is for this reason you can include a “claim” that says something like, “I claim, the product comprising any feature described, either individually or in combination with any feature, in any configuration.” or a “process to […] comprising any process described, in any order, using any modality, …”

US again threatns to suspend patent rights on health hazard grounds.. November 11, 2005

Posted by mais in Drugs, TRIPS, USA.
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Apprehension about offering the stringent Product Patent protection to Pharma inventions during the TRIPs negotiations are turning the to be true.

Even in developed world, companies holding the key patented medicine were reluctant to offer the medicines to the needy people at the time of community health crises and in order to avoid any catastrophy might govts like US has literally threat to them suspend/ revoke their patent rights over the life saving medicine.

Perhaps, most of developing countries are not strong enough to compel any such patent holder to make available the life saving drugs to the public on reasonable prices.

We have to ensure that natural human lives are always placed above the profit making motives of legal entities.

IPBiz: Washington Post on Tamiflu: U.S. bullies IP owners: “Monday, November 07, 2005
Washington Post on Tamiflu: U.S. bullies IP owners
But the U.S. isn’t a model of respect for intellectual property, either. Panicked by its own lateness, the Bush administration has bullied Roche into opening a new production operation in the United States; if Roche had refused, the administration was ready to break the patent. Sen. Chuck Schumer has gone further, denouncing Roche for elevating profits above health and demanding that the firm license its technology to other drugmakers or face legislation compelling it to do so. Coming on top of similar bullying four years ago of Bayer, the maker of an anti-anthrax drug, this browbeating sends a clear signal: If you make a drug that turns out to be really important, don’t expect patent laws to protect you.

Anchen files ANDA for Wellbutrin XL (buproprion) November 22, 2004

Posted by mais in Drugs, Patent, USA.
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Anchen files ANDA for Wellbutrin XL (buproprion)

Anchen files ANDA for Wellbutrin XL (buproprion)

By Lawrence B. Ebert

Taiwan-based generic company Anchen Pharmaceuticals has submitted an abbreviated new drug application (ANDA) to the FDA for Biovail’s Wellbutrin XL (once daily dose of bupropion for depression).

Litigation over bupropion has been extensive. Current issues are NOT about the drug itself (the composition of which is off patent) but about the formulations for controlled delivery of the drug. The Excel and Impax decisions of the Court of Appeals for the Federal Circuit have involved interpretation of the foreseeability prong of the US Supreme Court decision in Festo (535 US 722 (2002)).

Wellbutrin is a drug used to treat depression, but the underlying chemical is also used for smoking cessation (marketed as ZYBAN). Of depression, the chemical is different from Paxil, Prozac and Zoloft, and as a result, Wellbutrin can often successfully treat people with depression whose condition has not improved from taking these other drugs.

Although the chemical of Wellbutrin and Zyban has been off patent as a composition of matter for a long time, in 1995 Glaxo received a patent for the extended release formula of Wellbutrin SR. In 1999, generic drug manufacturer Andrx filed two ANDAs with the FDA seeking to sell generic versions of extended release Wellbutrin and Zyban. Andrx argued that because its generic used a different method of extended release, that it did not infringe on Glaxo’s patent. Four other generic manufacturers followed Andrx’s lead, and several have received tentative approval to manufacture and market their generic versions. In February of 2002, the US District Court for the Southern District of Florida ruled that Andrx did not violate Glaxo’s patent and therefore should be allowed to manufacture and market its generics. On appeal, however, the Federal Circuit Court of Appeals held that the district court in Florida erred in its construction of the patent infringement claims.

Glaxo owns U.S. Patent No. 5,427,798 (the ’798 patent) directed to controlled sustained release tablets containing bupropion hydrochloride. Pharmacologically, bupropion (m-chloro--t-butylaminopropiophenone) is a monocyclic aminoketone antidepressant. See U.S. Patent No. 4,393,078 (issued July 12, 1983) (the ’078 patent). These compounds treat depression and inebriation. In addition, they facilitate the cessation of smoking by producing neural stimulation in mammalian systems. See ’798 patent, col. 1, ll. 5-10; ’078 patent, col. 1, ll. 29-39; U.S. Patent No. 3,819,706 (issued June 23, 1974). To avoid the need for multiple dosages with the attendant fluctuations in plasma bupropion concentrations, Glaxo invented a sustained release formulation of the compound. While bupropion hydrochloride itself was separately patented, Glaxo obtained the ’798 patent to protect its sustained release formulation of the drug. Glaxo markets this patented sustained release formulation as Wellbutrin®SR for treatment of depression and as Zyban® for smoking cessation. The key ingredient for achieving sustained release in this invention is hydroxypropyl methylcellulose (HPMC), which is a partly O-methylated and O-(2-hydroxypropylated) cellulose. In oral preparations, HPMC extends drug release by transforming into a gel that swells upon ingestion. The hydrogel state of HPMC releases bupropion hydrochloride from an ingested tablet over a period of time.

The ’798 patent claims a sustained release tablet containing an admixture of bupropion hydrochloride and HPMC. However, many of the claims as originally filed did not recite HPMC as a limitation. During prosecution on the merits in the United States Patent and Trademark Office (Patent Office), the examiner rejected the claims that did not recite HPMC for lack of enablement under 35 U.S.C. § 112, 1. Glaxo amended those claims to overcome the rejection.

The first independent claim of the ’798 patent states:

1. A controlled release tablet comprising 25 to 500 mg of bupropion hydrochloride and hydroxypropyl methylcellulose, the amount of hydroxypropyl methylcellulose to one part bupropion hydrochloride being 0.19 to 1.1 and said tablet having a surface to volume ratio of 3:1 to 25:1 cm-1 and said tablet having a shelf life of at least one year at 59deg to 77deg F. and 35 to 60% relative humidity, said tablet releasing between about 20 and 60 percent of bupropion hydrochloride in water in 1 hour, between about 50 and 90 percent in 4 hours and not less than about 75 percent less in 8 hours.

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ANDA filing doesn’t constitute Willful patent infringement August 16, 2004

Posted by mais in Drugs, Litigation, Patent, USA.
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Glaxo Group Limited v. Apotex, Inc., 2004 U.S. App. LEXIS 15489 (Fed. Cir., July 27, 2004)
Apotex, Inc. (‘Apotex’) appeals the judgment of the United States District Court for the Northern District of Illinois, which found that Apotex’s filing of an Abbreviated New Drug Application (‘ANDA’) for a generic version of the antibiotic CEFTIN willfully infringed U.S. Patent No. 4,562,181 (the ”181 patent’) and U.S. Patent No. 4,820,833 (the ”833 patent’) owned by Glaxo Group Limited and SmithKline Beecham Corp. (collectively ‘Glaxo’). The Federal Circuit affirmed the district court’s determination that Apotex’s ANDA infringes both the ‘181 and ‘833 patents pursuant to 35 U.S.C. � 271(e)(2), and also affirmed that the patents at issue are not invalid. The Federal Circuit, however, reversed the district court’s finding that Apotex’s ANDA filing constituted willful infringement. The Federal Circuit held that the mere filing of an ANDA cannot constitute an act of willful infringement compensable by attorney’s fees under the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Federal Circuit explained that 35 U.S.C. � 271(e)(2) and 35 U.S.C. � 271(e)(4) create only an ‘artificial’ act of infringement for a ‘very limited and technical purpose that relates only to certain drug applications.’ This purpose is to permit patent holders to bring suit against generic companies despite the fact that the generic companies have not yet infringed the patents at issue. The Federal Circuit eloquently wrapped up its analysis by saying: ‘[t]he district court therefore erred in hanging a finding of willfulness on such a special-purpose peg.'”

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Who lost it…. plant breeder or farmer or we August 16, 2004

Posted by mais in Litigation, Patent, USA.
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Navigating the patent maze: Court Decisions: “Schmeiser v Monsanto
By this time, most of you have heard that ‘Monsanto won’ over Percy Schmeiser in the Canadian Supreme Court. Actually, Mr Schmeiser was found to have infringed Monsanto’s patent but no damages were assessed. It was a close decision and a momentous one for two main reasons. Several commentators have written about how genetically-engineered plants are essentially, if not expressly, protectable because of the gene introduced. In another blog entry, I will discuss that issue. For this entry, however, I raise the possibility that the Court has defined ‘use’ of a patented invention in such a way that that there may now be an exemption for basic science research in Canada.
Monsanto Canada Inc v Schmeiser 2004 SCC 34.

In particular, the court defined ‘use’ as utilization with a view to production or advantage. The use then that interferes with the rights granted to the patent owner is infinging. Amazingly, the Court characterized deprivation of their rights when ‘another person, without licence or permission, uses the invention to further a business interest.’
Does this imply that a use that is not commercial or furthering a business interest is non-infringing? Would a research use in the confines of a non-profit or educational institute be non-infringing?
There are several ways that the Canadian Courts can go. For example, the Canadians, like their southern neighbor counterpart court, may say that essentially all uses have a business purpose, even universities who may ‘use’ in furtherance of their business of education and money raising. Or, they may hold that that commercial use is not the only use that can be infringing. The Canadian Supreme Court hints that the latter route is appropriate when they write ‘Even in the absence of commercial exploitation, the patent holder is entitled to protection.”

In Schmeiser’s case, Mr Schmeiser contended that he didn’t use the patented gene, which conferred resistance to roundup, because he didn’t spray the canola crop with the herbicide. But, the court still found ‘use’ of the invention because Mr Schmeiser’s business was growing canola, and he grew canola containing the patented seeds. Furthermore, he had the advantage of the stand-by use, meaning that he could have sprayed Roundup ™ or could have sold the seed to other farmers who didn’t want to pay the fee to Monsanto.

Where does this leave those who may use a patented invention in the context of research? Without clarification of this issue by the Canadian courts, I wouldn’t assume that there is now a research exemption. That said, despite what is likely a huge amount of infringment of patents in university settings, very rarely are universities and scientists there ever stopped from using a patented invention. For more on this subject, I refer you to this article: “Accessing other people’s technology for non-profit researchAJARE.pdf Australian Journal of Agricultural and Resource Economics 46:3 389-416 (September 2002).

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Necessity’s Progeny — Nipper’s Patent Law Blog: Caselaw July 15, 2004

Posted by mais in Patent, USA.
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this link offers a good information on a latest case.. have a look over it,….

Necessity’s Progeny — Nipper’s Patent Law Blog: Caselaw06038004L.jpg is a good website for a comprehensive web search.

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