The USPTO has published in the Federal Register a notice of proposed rulemaking regarding appeals to the USPTOs Board of Patent Appeals and Interferences (BPAI). The proposed rules are in anticipation of the flood of appeals that will result if (read: when) the new USPTO rules limiting continuation practice go into effect. (see: USPTO Proposes Limiting Continuations)
The new rules, if enacted, will try to box in applicants and prevent attempts to use the appeals route in lieu of filing unlimited continuing applications. The final continuing applications rules that are expected as early as the week of August 13, 2007 (and which will have a 60 day period from the publication date until they become effective).
These are being offered to change procedures in such a way as to allow the Board to continue to resolve ex parte appeals in a timely manner, essentially by placing more of a burden on applicants to submit very concise appeals.
Among the fun new rules:
Proposed Bd.R. 41.37(o)(3) would require that, when responding to points made in the final rejection, the appeal brief shall specifically (1) identify each point made by the examiner and (2) indicate where appellant previously responded to each point that appellant has not previously responded to the point.
Proposed Bd.R. 41.37(o)(4) would require, for each rejection under 35 U.S.C. 112, first paragraph, that the argument shall also specify the errors in the rejection and how the rejected claims comply with the first paragraph of 35 U.S.C. 112, including, as appropriate, how the specification and drawings, if any, (1) describe the subject matter defined by the rejected claims, (2) enable any person skilled in the art to which the invention pertains to make and use the subject matter of the rejected claims, or (3) set forth the best mode contemplated by the inventor of carrying out the claimed invention.
Proposed Bd.R. 41.37(o)(5) would require, for each rejection under 35 U.S.C. 112, second paragraph, that the argument shall also specify how the rejected claims particularly point out and distinctly claim the subject matter which appellant regards as the invention.
Proposed Bd.R. 41.37(o)(6) would require, for each rejection under 35 U.S.C. 102 (anticipation), that the argument shall also identify any specific limitations in the rejected claims which are not described (explicitly or inherently) in the prior art relied upon in support of the rejection and, therefore, why the rejected claims are patentable under 35 U.S.C. 102.
Proposed Bd.R. 41.37(o)(7) would require, for each rejection under 35 U.S.C. 103, that the argument shall (1) specify the errors in the rejection, (2) if appropriate, specify the specific limitations in the rejected claims that are not described in the prior art relied upon in support of the rejection, and (3) explain how those limitations render the claimed subject matter unobvious over the prior art. A general argument that all limitations are not described in a single prior art reference would not satisfy the requirements of this paragraph.
If you wish to comment on the proposed rules, send them to mailto:BPAI.Rules@uspto.gov or facsimile to 571–273–0042, no later than September 28, 2007. The USPTO will make the comments available here.
See the Federal Register notice here.
Posted July 30th, 2007 by Stephen Albainy-Jenei in
Patent Reform,
Prosecution,
USPTO
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Patent Baristas has been featured in BlawgWorld 2007, an outstanding presentation of some of the top law blogs around the web in an eBlook format put together by Editor Sara Skiff, Publisher Neil Squillante and the eBook Team at TechnoLawyer.
BlawgWorld 2007 is a compilation of exemplary posts from authoritative law blogs of various specialties that presents them in an easy-to-navigate e-book pdf format you can download here for free. The format provides added access to these influential law sources for many lawyers who might not yet be reading or writing blogs regularly. The new eBook format makes it really easy to navigate this sampling to get a feel for law blogs.
Seventy-seven exceptional blogs are featured in this year’s BlawgWorld 2007, including Adam Smith, Esq., Blawg Review, May It Please The Court, Morepartnerincome, Patent Baristas, PHOSITA, Promote the Progress, SCOTUSblog and Wired GC.
The Barista article, “Are Conflicts of Interest on the Rise?,” provides a discussion of the global pharmaceutical market’s pressure on the marketplace—and the regulations that try to hold it back.
Congratulations to all whose blogs were selected for BlawgWorld 2007. This has been a enormous effort and we encourage you to check it out this great offering for yourself.
Download Your Free Copy of BlawgWorld 2007 with TechnoLawyer Problem/Solution Guide here now!
Posted July 30th, 2007 by Stephen Albainy-Jenei in
Blawg Reviews,
Current Affairs
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In a new paper “Confronting Myths and Myopia on the Road from Doha,” Daniel Cahoy, associate professor of business law at Penn State’s Smeal College of Business, looks at recent patent compulsory licenses issued by Thailand in terms of balancing access and innovation in essential medicines.
The WTO’s Doha round of trade negotiations expanded the rights governments to issue patent compulsory licenses, which allow countries to manufacture cheaper versions of patented pharmaceuticals for non-commercial use or in cases of health care emergencies.
For example, the government of Thailand announced in 2006 that it intended to issue several “compulsory licenses” for patents related to AIDS and heart medications. The move was directed specifically to reducing the price of branded drugs; the licenses set compensation to patent owners at a mere 0.5% royalty on generic sales.
Unfortunately, international laws supporting access to medicines appears to be ambiguous with few limitations on which countries can “break” patents simply to control costs, what circumstances create a necessary condition, or even what level of remuneration is required. Chief among his concerns is the level of compensation owed to a patent owner for the loss of exclusivity given the lack of standards in international law.
A lack of a clear floor or ceiling to compulsory license compensation can make patent property rights less predictable, encourage gamesmanship by developing or developed countries wishing to cut expenditures and even stifle access.
He suggests an innovative licensing framework that separates countries into three economic development tiers with different royalty mechanisms. Such a nuanced system, the article argues, will lead to more predictability and effective institutional mechanisms, ensuring continued innovation and greater access to essential medicines.
The recent fear of an explosion of avian influenza could impact both the developed and developing world equally harshly, and at the same time, making the need for effective medicines urgent. Therefore, should all nations — rich and poor — be able to benefit from lower costs as a result, perhaps to the detriment of innovation incentives?
Cahoy discusses multiple remuneration myths that have led many to overlook the potential of a remuneration-based approach to compulsory licenses.
Myth One: Equitable Compulsory Licenses Must Offer a Savings from the Market. Although compulsory licenses have been imposed to achieve many different ends over the years, recent attention has focused on licenses to “break” the patent owner’s power to impose monopoly pricing for a greater good.
The underlying belief is that fair remuneration or compensation is inevitably restricted to a small royalty figure. Cahoy argues that there is a very rational argument for requiring market compensation for compulsory licenses that does not completely undermine their use.
Myth Two: Pharmaceutical Companies should be Indifferent to Compulsory Licensing so Long as “Reasonable” Remuneration is Available. Regardless of whether there are justifications for the market compensation model of remuneration, many compulsory licensing advocates would argue that this high level of payment is simply not necessary. That is, so long as a pharmaceutical company can make back its costs, it will break even and not face a disincentive to future investment.
However, determining the adequacy or reasonableness of a license is a difficult analysis since the reasonableness of any payment depends on one’s perspective. Given the global nature of the market for a particular pharmaceutical, any attempt to value the impact of a single license on a drug’s investment return would be largely speculative and arbitrary.
Myth Three: Antitrust Compulsory Licenses Provide a Reliable Royalty Benchmark. Cahoy notes that essential in understanding remedial licensing is that the rates act as part of a corrective measure for bad behavior on the part of a patentee
Often as a consequence of monopolistic acquisition or licensing behavior, a patentee will be compelled to offer access to the patented invention to competitors on favorable licensing terms. Such terms could be based on a relatively small royalty, or even royalty free depending on the severity of the triggering offense. For proponents of greater use of low-cost licenses, remedial rates look attractively low. The nature of this remedial form of licensing casts doubt on whether such rates contribute much to the debate.
Using a remuneration-oriented approach, Cahoy’s proposes licensing schemes that keeps
innovation incentives intact, but also ensures that developing countries have access to pharmaceuticals. During public health crises, he argues for a three-tiered arrangement, in which remuneration is based on the economic status of the country issuing the compulsory license. Industrialized nations will be required to pay full market price, even during a pandemic.
To permit the most equitable accounting of the burden of public health expenses while ensuring relative ease of administration, the three-level system would provide: (1) a high compensation state for industrialized nations, (2) a development-factored royalty state for developing countries, and (3) a zero-royalty state for least developed countries. The strata might be initially defined by the WTO’s grouping of nations, which would be subject to change as a nation’s economic state either improves or declines.
Cahoy also identifies the adoption of a national exhaustion rule, which would limit importation into non-licensing countries, and manufacturing limits as important elements to any new compensation system. The likelihood that industrialized markets will yield reduced profits as a consequence of compulsory license negotiations is due to price-limiting strategies such as (1) parallel importation and (2) reference pricing.
Clearly, the issue of compulsory licensing requires further debate. Hopefully, we can all arrive at more equitable solutions.
See Cahoy’s entire article: “Confronting Myths and Myopia on the Road from Doha”
Posted July 27th, 2007 by Stephen Albainy-Jenei in
Current Affairs
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Several readers recently asked if there is a good (free) site that lists the expiration dates of pharmaceutical patents. The Generic Pharmaceutical Association (GPhA) has a chart listing Upcoming Patent Expirations for 2007-09. One fee-based service I know of is Drug Patent Watch.
One can also do the reviewing themselves, of course, but determining if a patent has truly expired can be a tricky business full of pitfalls. For those who want to get look into a patent’s status, there are a number of steps to perform.
First, if the patent application was filed after June 7, 1995, the expiration date is 20 years from the date it was filed. If the application was filed by June 7, 1995 and issued before June 8, 1978, the expiration date is 17 years from issuance. But, if the application was filed by June 7, 1995 and issued after June 7, 1978, the term is the later of 17 years from issuance or 20 years from filing.
However, keep in mind that a patent term may be extended for various reasons. Some patents have had their terms extended based on extreme delays in government approvals outside the Patent Office. This is very unusual, and applies almost always to pharmaceuticals (for example, Claritin® or Prozac®), food products (Aspartame) or medical devices or procedures, where FDA approval can sometimes eat up most of the patent term before the drug can be brought to market.
For a list of patents with term extensions, see the Patent and Trademark Office’s Extended Term List.
Some patents have less than the normal life span because their terms are limited to the terms of earlier-issued patents through the use of a terminal disclaimer, which is a result of filing two applications which claimed essentially the same invention. Terminal disclaimers will be marked on the later-issued patent. Sometimes these are flagged by an asterisk after the patent issue date, but sometimes they only appear in the text of the patent or with the related application data on the face of the patent.
Even after issuance, there are various ways a patent can expire early. For example, if the maintenance fees are not paid, the patent expires at the end of the surcharge period (4.5, 8.5 or 12.5 years after issue). However, the caveat to this is that expired patents may be revived up to 24 months after they expire, so long as the failure to pay the fee was unintentional. If the expiration date was more than two years in the past, the patent cannot be revived.
You can use the USPTO’s Patent Application Information Retrieval (PAIR) system to determine if maintenance fees have been paid.
In addition, you must determine if there has been any reexamination or voluntary disclaimer which resulted in a loss of some or all of the claim scope. This should be noted on a certificate attached to the patent image on the USPTO database, usually as the last page in the image file. It is possible that an issued patent can be withdrawn from issue on the order of the Commissioner of Patents.
Finally, you must also check to see if the patent been declared invalid by a court. Unfortunately, this can also be a tedious task to search through court records.
If you are genuinely concerned about a particular patent, it may be advisable to have a patent attorney (for example, one of the attorneys here at Frost Brown Todd) do a validity study and opinion on the patent. The attorney can perform a search to find prior art which might invalidate the patent, and will review the patent’s file at the USPTO to see if there is anything which might affect the validity or scope of the patent.
If you know of other sources for expired patent information, drop me a line and I will provide updated information here.
AstraZeneca’s patent on Toprol-XL® was found invalid after the CAFC affirmed a district court’s invalidity holding based on double patenting but vacated the district court’s inequitable conduct holding and remanded the case to see if the patent and another one should be held unenforceable. In re Metoprolol Succinate Patent Litigation, United States Court of Appeals for the Federal Circuit, No. 06-1254.
AstraZeneca sued after Andrx filed an Abbreviated New Drug Applications (ANDA) seeking FDA approval to market generic versions of Toprol-XL®, which Astra claimed infringed its patents pursuant to 35 U.S.C. § 271(e).
Astra sells metoprolol succinate in “extended release” forms under the brand name Toprol-XL®. Metoprolol is a therapeutically active compound, which can form salts by reaction with acids and is used in the treatment of angina, hypertension, and congestive heart failure. Metoprolol succinate is the salt of metoprolol with succinic acid.
In 1971, an Astra employee synthesized metoprolol succinate as well as the tartrate and sulfate salts of metoprolol and chose to commercialize the tartrate salt product. In 1982, another Astra employee synthesized a number of metoprolol salts, including metoprolol succinate.
In 1983, the employees left Astra to join another company, Lejus Medical AB and filed a patent application on delayed and extended release dosage forms of pharmaceutical compositions, including metoprolol succinate
As these things go, Astra of course noticed the publication of the application and commenced a transfer of ownership action with the Swedish Patent Office asserting that its employee invented metoprolol succinate. Astra and Lejus subsequently settled the ownership dispute when Lejus agreed to divide claims to “metoprolol succinate” and to a “pharmaceutical composition, characterized in that the active substance is metoprolol succinate” and to assign the divided claims to Astra.
Both before and after the US filing on two patent applications, Astra’s in-house counsel asserted to Lejus that Nitenberg, not Appelgren and Eskilsson, was the inventor of metoprolol succinate. But, Astra never revealed the inventorship issue to the USPTO during the prosecution of the two patents.
The CAFC reviewed the finding that the patent was invalid for double patenting noting that “[n]on-statutory, or ‘obviousness-type,’ double patenting is a judicially created doctrine adopted to prevent claims in separate applications or patents that do not recite the ’same’ invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.”
Astra tried arguing that the district court erred in concluding that Claim 8 of the ‘318 Patent and Claim 1 of the ‘154 Patent recited a species/genus relationship stating that the claims define an element/combination relationship. But, the CAFC said that such disputes “about the characterization of the relation between the two claims” in a double patenting context are irrelevant:
In Emert, this court held the claims of an application unpatentable for double patenting, finding that “the ‘887 application’s claimed invention, an oil soluble dispersant comprising B1, while not anticipated by the ‘624 patent due to the slight modification of three claim limitations, would have been prima facie obvious in light of the claim to the combination [A and B]” because the patentee “effectively conced[ed] that the differences between B and B1 are not material and would have been obvious to a person having ordinary skill in the art.” 124 F.3d at 1463. Similarly, in this case, Claim 1 of the ‘154 Patent claiming a compound (A1) is an obvious variation of Claim 8 of the ‘318 Patent claiming a composition comprised of one compound of an enumerated list (A1, A2, A3, etc.), an inner layer (B), and an outer layer (C). Specifically, it would have been an obvious variation of Claim 8 of the ‘318 Patent to omit the inner layer (B) and the outer layer (C). Astra offers no convincing reason why Emert does not apply.2 See also Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382-83 (Fed. Cir. 2003) (holding that later patent claiming pharmaceutical composition was obvious variant of earlier patent claiming pharmaceutical composition with “enhanced storage stability, the closed container, [and] the packaged unit-dosages”).
The court noted that In re Schneller, 397 F.2d 350 (C.C.P.A. 1968), is a later issued decision that refutes the suggestion that under the previous holdings of Walles, Allen, and Heinle, a patentee may claim an element after claiming the combination without fear of double patenting.
Judge Schall dissented noting that
I agree with the district court that, distilled to its essence, claim 8 of the ‘318 patent claims an oral pharmaceutical composition that has (i) a core that contains one of eleven possible active ingredients (metoprolol succinate being one of the eleven), (ii) an inner coating surrounding the core (that allows a controlled release of the active ingredient), and (iii) an outer coating (that resists dissolving in the stomach, with the goal of releasing the active ingredient close to or within the colon).
Claim 1 of the ‘154 patent, which is the sole claim of that patent, claims the compound metoprolol succinate. ‘154 patent, col.2. l.36. As just seen, metoprolol succinate is one of the possible active compounds of the composition of claim 8 of the ‘318 patent.
I believe that what is patented by claim 8 of the ‘318 patent is a three-element composition having (i) a core with any one of eleven possible compounds, one of them being metoprolol succinate; (ii) an inner coating; and (iii) an outer coating. Anything less than a compound with all three of these elements is not what is claimed. See General Foods, 972 F.2d at 1280 (”There is a claim 1 [of the ‘619 patent] and the first step of its 9 recited steps is designated ‘(a).’ . . . [S]tep (a) is not ‘claimed’ in the ‘619 patent, nor is it ‘patented’ or ‘covered’ . . . What is patented by claim 1 of ‘619 is a 9-step caffeine recovery process, nothing more and nothing less.” (emphases in original)). In contrast, what is claimed by claim 1 of the ‘154 patent is a single compound: metoprolol succinate.
Posted July 25th, 2007 by Stephen Albainy-Jenei in
Current Affairs
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Make no mistake about it. This is a story that has an abundance of human drama, which manifests itself in great suffering around the world. Roughly 40 million people worldwide are infected with HIV/AIDS, including more than 1.2 million Americans.
These numbers have meaning that numbers cannot convey. The meaning emerges in the stories of individuals, families and whole societies devastated by HIV/AIDS throughout the world. This is also a story that scares the bejeebers out of the patent community and all patent holders when filing provisional patent applications.
In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four key HIV/AIDS drug patents held by Gilead Sciences Inc. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor and WARF’s stem cells.
PUBPAT requested ex parte reexamination under 35 U.S.C. §§ 302-307 and 37 C.F.R. § 1.510 claiming they are all invalid under 35 U.S.C. §§102 and 103 and their existence is causing significant public harm and impeding scientific progress.
The patents challenged by PUBPAT, U.S. Patents Nos. 5,922,695, 5,935,946, 5,977,089 and 6,043,230, relate to the drug known generically as tenofovir disoproxil fumarate (TDF). Tenofovir disoproxil fumarate (also referred to as TDF or bis(POC)PMPA fumarate) is a nucleotide analog reverse transcriptase inhibitor (NtRTI) that is a significant treatment for HIV/AIDS patients. Gilead markets TDF in the United States under the brand name Viread and as a part of its Atripla combination product.
The Patent Office has now ordered reexamination of all four patents.
The ‘695 patent claims compounds comprising esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates, which are useful as intermediates for the preparation of PMPA. The ‘695 patent also claims methods of orally administering such phosphonomethoxy nucleotide analogs to patients infected with HIV.
The ‘089 patent claims (R)bis(POC)PMPA, compositions comprising (R)bis(POC)PMPA and a pharmaceutically acceptable carrier, and a method comprising orally administering to a patient infected with virus or at risk to viral infection a therapeutically effective amount of (R)bis(POC)PMPA.
The ‘230 patent claims a method of contacting a cell with an antiviral phosphonomethoxy nucleotide analog prodrug.
The ‘946 patent claims TDF, methods of making TDF and tablets containing TDF.
In order to have a reexamination declared, there must be a “substantial new question of patentability” present, which means that it is only necessary that:
(a) The prior art patents and/or printed publications raise a substantial question of patentability regarding at least one claim, i.e., the teaching of the (prior art) patents and printed publications is such that a reasonable examiner would consider the teaching to be important in deciding whether or not the claim is patentable; and
(b) The same question of patentability as to the claim has not been decided by the Office in a previous examination or pending reexamination of the patent or in a final holding of in validity by the Federal Courts in a decision on the merits involving the claim, see MPEP 2242, (I).
It is not necessary that a “prima facie” case of unpatentability exist as to the claim in order for “a substantial new question of patentability” to be present as to the claim.
Mainly, PUBPAT claims that these patents are anticipated or rendered obvious by Gilead’s own patent (U.S. Patent No. 5,922,695 issued to Arimilli et al. on July 13, 1999) and/or the prior art reference by Bischofberger et al., “Bis(POC)PMPA, an Orally Bioavailable Prodrug of the Antiretroviral Agent PMPA,” Conference on Retroviruses and Opportunistic Infections, 4th:104 (abstract no. 214) (January 2226, 1997), among others.
In addition, PUBPAT claims that these patents were also obvious in light of other prior art teachings that PMPA and bis(POC)PMPA were strong treatments for HIV and that bis(POC)PMPA fumerate would have been expected to have superior properties over free base bis(POC)PMPA. PMPA and bis(POC)PMPA were well known treatments for HIV
In a matter that really highlights the dangers of filing a provisional patent application without drafting a full application without all the details, PUBPAT points out that references can now be used against the patents where the documents published after the provisional — later than first thought.
The ‘230 and ‘695 patent claim priority to a provisional application, U.S. Appl. No. 60/022,708, filed July 26, 1996. However, PUBPAT argued, and the USPTO agreed, that the claims of these two patents are not entitled to claim priority to the ‘708 application’s July 26, 1996, filing date, because the ‘708 application’s specification was not sufficient to satisfy the written description requirement of 35 U.S.C. § 112. In the case of the ‘089 and ‘946 patents, the USPTO found that sufficient written description existed to support priority back to the ‘708 provisional.
A filing date will be accorded to a provisional application only when it contains:
a written description of the invention, complying with all requirements of 35 U.S.C. §112 1st paragraph
any drawings necessary to understand the invention, complying with 35 U.S.C. §113.
Therefore, it is essential that the disclosure of the invention in the provisional application be as complete as possible. In order to obtain the benefit of the filing date of a provisional application the claimed subject matter in the later filed non-provisional application must have support in the provisional application.
Related Documents
Patent Office Orders Granting Reexamination
(For Pwned, See Owned)
Posted July 25th, 2007 by Stephen Albainy-Jenei in
Prosecution,
USPTO,
Biotech News
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One of the less-noticed items during the Senate Judiciary Committee mark-up of the Patent Reform Bill (Senate Bill S. 1145) was the adoption of Senator Specter’s amendment on venue. Following is an analysis of that amendment:
S. 1145 (before today): Implements venue reform by limiting venue to where (1) either the patent holder or infringer resides (for a corporation, this means the principal place of business or state of incorporation), or (2) where infringer has committed acts of infringement and has a regular place of business.
There was discussion and concerns raised by Senator Cornyn about a change that would limit venue to 3 states (WI, CA, VA) which I believe referred to Leahy’s 2nd manager’s amendment. From an e-report:
*Cornyn: “The manager’s amendment already fixes the problem. I oppose abusive forum shopping. But I fear the Specter provision would effectively limit patent litigation to WI, CA, and VA. There would be an inadvertent backlog in patent litigation.”
The 2nd manager’s amendment was adopted (which included venue among them), then Senator Specter’s amendment on venue was adopted, superseding the manager’s amendment. The limitation to three states does not appear to be in the Specter Amendment. However, in my opinion, its effect is worse.
S. 1145 (after today):
(1) prohibits patent holders from “manufacturing venue” by assignment/incorporation to establish venue for a specific district (e.g., companies setting up shells in ED Texas to invoke that venue); [probably ok]
(2) expands venue restrictions to apply not just to claims for infringement as well as declaratory judgment actions [outrageous result when considered with changes below — DJ filers (infringers taking a preemptive strike) can file suit and take advantage of the subsequently described venue restrictions];
(3) Provides that venue for a US infringer will be (a) where infringer resides (the principal place of business or state of incorporation) or (b) where infringer has committed “substantial” acts of infringement and has a “regular and established physical facility”. [note the expansion of limitation from “regular place of business” to “physical facility of significance”];
(4) Provides that venue for a foreign infringer will be (a) the foreign corp’s residence, which is where its main U.S. subsidiary is located or (b) where the foreign corp. has committed “substantial” acts of infringement AND has a “regular and established physical facility” [this is an *outrageous* result — (a) provides LESS jurisdiction over a foreign corp than a U.S. corp. by limiting the jurisdiction only to where the U.S. subsidiary is located, and it gives incentive for a foreign corp with a U.S. subsidiary to “locate” in the most infringer friendly forum of their choosing; and (b) provides no jurisdiction over those foreign corporations without a U.S. subsidiary who do not meet the criteria of a “regular and established physical facility” in the U.S.]
(5) Provides a “safe harbor” for universities from venue reform restrictions by allowing venue for university plaintiffs to be where the university resides [nice nod to universities on its face, but universities (a) are, at best, reluctant plaintiffs, and (b) have no protection for their tech-transferees, which means that the incidences of universities having to be plaintiffs will rise, their tech-transferees will be further disadvantaged, and ridiculous accusations and controversy of further “commercial” activity and Bayh-Dole abuse by universities be further fed.];
(6) provides a safe harbor for individual inventor plaintiffs who qualify as a micro-entity by allowing venue where the individual resides [again, nice on its face, but any individual inventor who has $4.5 million necessary to litigate will be highly unlikely to qualify for micro-entity status].
Finally, the inclusion of the safe harbors for universities and individual inventors highlights the most outrageous component of this amendment: that which is missing and removed. The original language of S.1145 provided jurisdiction where either the infringer *or* patent holder resides (for a corp, this means the principal place of business or state of incorporation).
The amendment eliminates jurisdiction where the patent holder resides for all but universities and micro-inventors! This means 99% of aggrieved patent holders who need to turn to litigation to defend their patent rights will now be forced to seek recourse against U.S. based accused infringers only on the infringer’s “home turf” with friendly jury pools predisposed to the substantial local business operations of the accused infringer. Worse, an aggrieved patent holder who needs to enforce his rights against a foreign patent holder will have even more restrictive avenues, and in some cases, will have NO recourse where a “regular and established physical facility” of a foreign corp. cannot be established.
This means that the traditional rule that the plaintiff chooses the forum is eliminated for most all constitutionally protected patent holders. Worse, it also means that *neutral* sites are eliminated as forums which have jurisdiction over patent suits. The only jurisdiction where patent infringement remedies can be brought for most all patent infringement cases is based upon the forum which, if at all, is that which is most favorable to the accused infringer!
Today’s post comes from Guest Barista David P. Vandagriff, Vice President of Intellectual Property at Helius, Inc.
Posted July 23rd, 2007 by Stephen Albainy-Jenei in
Patent Reform,
Guest Post
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In a unanimous vote, the U.S. House Judiciary Committee gave the thumbs-up to new patent-reform legislation, the Patent Reform Act of 2007, H.R. 1908 (see also S. 1145, which the tech industry has been pushing.
The Patent Reform Act would:
Allow a second review of patents after they have been granted to challenge the validity of a newly issued patent.
Narrow the definition of willful infringement, which brings treble damages in infringement lawsuits.
Limit infringement damages to the economic value of the patent’s contribution to an overall product. Currently, damages are based on the entire market value of the product.
Implement a first-to-file standard.
Concerns by 3M Eli Lilly, General Electric, Johnson & Johnson and Proctor & Gamble were muted after amendments to the bill narrowed the “second window” of post-grant reviews.
One of the biggest changes limits post-grant review process by allowing challenges only in the first 12 months. The Senate Judiciary Committee approved much the same amendments.
According to Sen. Patrick Leahy, infringement damages would be limited, “unless the claimant shows that the patent’s specific contribution over the prior art is the predominant basis for market demand for an infringing product or process.”
Sen. Arlen Specter added an amendment to the Senate version that seeks to eliminate the popular practice of “forum shopping” by limiting venues for patent-infringement cases.
BIO expressed its concern with the bill stating that it threatens continued biotech innovation stating that:
We remain concerned, however, with provisions in the legislation that would change how damages against patent infringers are calculated, in a way that would often make infringement cheaper. We also believe changes are required to the provision that would require that courts peel away from the patented and infringed invention the value of all previously known elements and award damages based solely on the remaining elements. This provision severely devalues all underlying patent rights and could seriously undermine the incentive to develop novel new forms of medicines and other biotechnologies. Further, the bill continues to contain broad new rulemaking authority for the PTO, which is of great concern to BIO.
The Coalition for Patent Fairness sent out a press release giving a big group hug to the bill and stating that it supports patent reform legislation that will:
Balance the apportionment of damages. The standard for calculating damages should be based on the fair share of the patent’s contribution to the value of a product, and not on the value of a whole product that has many other components.
Establish fair standards for punitive damages. Awarding punitive, triple damages for “willful” patent infringement should be reserved for cases of the most egregious conduct, as required by the U.S. Supreme Court for virtually all other punitive damages.
Restrict forum shopping. Cases should be brought in courts with some reasonable connection to the case and not, by gaming the system, in courts solely because they historically favor patent claims.
Improve patent quality. The system should promote quality patents by providing a meaningful second chance for the experts at the PTO to review potentially problematic patents in a timely manner, and should promote sharing of information with the PTO to improve the process and increase innovation.
The bill now goes before the full U.S. House for a floor vote.
Earlier:
Posted July 19th, 2007 by Stephen Albainy-Jenei in
Patent Reform
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